What You Need to Know About Copay Accumulators and Maximizers

Well over 50 million people in the U.S. with commercial insurance have a health plan that uses copay accumulator or maximizer programs. Additional payers are considering adopting these programs in the future. A new primer examines the rise of these controversial cost-shifting programs that healthcare payers are implementing to reduce their prescription drug spending by shifting costs and increasing patient out-of-pocket burden. “Copay Accumulator and Maximizer Programs: Stakes Rise for Patients as Federal Rulemaking Lags” in Health Affairs Forefront examines how and why payers are implementing these cost-shifting programs, their impact on patients, and the state and federal policy landscape. Copay accumulators redirect manufacturer copay assistance funds from the patient to the insurance plan, leaving patients responsible for the entire deductible and cost-sharing maximum set by the plan once the copay assistance runs out.

Correcting the Inflation Reduction Act’s “Pill Penalty”

The Inflation Reduction Act (IRA) created an unintended disparity between small molecule treatments — which often come in pill form—and biologics. This so-called "pill penalty” threatens future research and development into essential cures. The IRA gives the Centers for Medicare & Medicaid Services (CMS) the authority “to negotiate” — although this effectively means “to set” — prices for a select number of prescription drugs covered by Medicare. Under the law, two categories of pharmaceuticals are recognized: small molecules and biologics. This disparity is both harmful and arbitrary. By favoring large-molecule development with a longer period, the policy unintentionally shifts research and development incentives away from small molecule drugs. Consequently, this has reduced funding opportunities for smaller biotech firms that are pioneering effective small-molecule treatments for serious health conditions.

Stop This Predatory Practice by Health Insurance Companies

For too many New Jerseyans, the cost of life-saving medications is more than just a burden, it’s an insurmountable barrier standing between them and their health. If you or a loved one has ever faced a sky-high copay or watched your savings disappear trying to afford essential medication, you know the devastating reality of our broken health care system. The New Jersey Legislature is considering a bill (S-3818/A-5217) that would put an end to a little-known exploitative insurance practice that is crushing patients. This legislation would require that patient assistance be applied to copayments, coinsurance, deductibles and other out-of-pocket costs. In plain terms, it would ensure that the financial assistance patients receive actually benefits them, rather than padding the profits of insurance companies.

Copay Accumulator and Maximizer Programs: Stakes Rise for Patients as Federal Rulemaking Lags

Health care costs in the United States continue to rise, placing greater financial pressure on health care purchasers and consumers. According to the KFF’s 2024 Employer Health Benefits Survey, average annual premiums for employer-sponsored health insurance increased in 2024 to $8,951 for individual coverage and $25,572 for family coverage, an annual increase of 6 percent and 7 percent respectively, outpacing both wage growth and inflation. To mitigate rising costs, employers and health plans are implementing various strategies to manage their spending, particularly on prescription drugs. For example, some US employers have adopted alternative funding programs, a strategy that was recently examined (and cautioned against) in Health Affairs Forefront. Similarly, payers are increasingly turning to controversial copayment accumulator and copayment maximizer programs, which help them reduce their prescription drug spending by shifting costs to patients and manufacturers. 

Bringing Systems Thinking to Drug Value Assessment

Drug value assessments generally fail to account for the complexities of health care systems and thus can misinform price negotiations and lead to overly restrictive access policies. Studies have found that conventional cost-effectiveness analyses tend to ignore broader real-world impacts and externalities that influence the use of drugs, a lesson learned during the COVID-19 pandemic. In addition, budget-impact analyses, which often accompany cost-effectiveness analyses, suffer from the same problem, sometimes wildly overestimating drug uptake because they underestimate how systems impede access. Value assessments can influence coverage policies for medications. However, the gap between projected and realized value can be profound. Cost-effectiveness analyses and budget-impact assessments that ignore real-world access barriers can themselves exacerbate barriers to access because they can distort coverage and pricing policies and diminish public trust.

Bayh-Dole Coalition Urges President Trump to Reverse Agency Violations of the Bayh-Dole Act

The Bayh-Dole Coalition sent a letter to President Trump calling attention to a series of actions by federal agencies that violate the Bayh-Dole Act and the recent Executive Order: Ensuring Lawful Governance and Implementing the President’s “Department Of Government Efficiency” Deregulatory Initiative. The Executive Order requires each agency head, in coordination with the Office of Management and Budget, to review any regulations that violate federal law and undermine technological innovation. “Under the previous administration, several federal agencies took actions that blatantly violate the Bayh-Dole Act and consequently undermine the development of critical technologies,” said Joseph P. Allen, executive director of the Bayh-Dole Coalition. “Unless reversed, these misguided decisions will squander billions in taxpayer-funded research, block new technologies from reaching the public and hand a competitive edge to countries like China.”

Building a Life Sciences Ecosystem: Insights from BioNJ With Debbie Hart

From Lab to Patient, Garage to Market with Philip Crowley

In this episode of From Lab to Patient, Garage to Market, Philip Crowley speaks with Debbie Hart, who worked alongside New Jersey’s biopharmaceutical industry leaders to establish BioNJ in 1994. Ms. Hart is recognized as a respected thought leader and influential advocate. Under Ms. Hart’s leadership, BioNJ has become the trusted voice of the life sciences industry in New Jersey – working directly with legislative leaders in both Trenton and Washington D.C. to advance the life sciences industry, foster medical innovation and patient access while ensuring health equity and healthcare affordability. Most recently, she was named by Governor Murphy as the Chair of the New Jersey Commission on Science, Innovation and Technology.

One Pandemic Benefit: Stronger Mental Health Support for Caregivers

As Featured in NJ Spotlight News 

In March 2020, as the pandemic spread across New Jersey, doctors, nurses and staff in hospitals and nursing homes scrambled to care for a growing number of patients infected with COVID-19, while also trying to address their own physical and mental health needs. Five years later, many hospitals have enhanced their mental health supports for caregivers as a result of the pandemic. But some experts say there is still a “tremendous amount” of stigma attached to mental health treatment for health care workers in the State. A 2021 report from the New Jersey Health Care Quality Institute and BioNJ detailed recommendations to create and support a resilient and diverse health care workforce as it emerged from the COVID-19 pandemic. These recommendations included developing and supporting behavioral health programs to target the “growing need” of providing mental health services to health care workers in the State.

Presenting the 2025 NJBIZ Health Care Power List

The NJBIZ Power List identifies individuals who, through their efforts, are helping to make New Jersey a better place to live, work and do business. Honorees are not necessarily better at their jobs than others in their profession, but they have contributed meaningfully to the advancement of the public interest through their work and/or community service. In addition to BioNJ President and CEO Debbie Hart and Vice President of Innovation and Entrepreneurship Pavita Howe, congratulations to these BioNJ Members for making the list: Kevin Ali, Organon; Diane Calello & Robert Johnson, Rutgers New Jersey Medical School; Thomas Cavalieri & Matthew Edson, Rowan University, Chris Cozic, Genmab; Robert Davis, Merck; Jennifer D’Angelo, New Jersey Innovation Institute; Joaquin Duato, Johnson & Johnson; Robert Garrett, Andre Goy & Gary Small, Hackensack Meridian Health; Fabian Gerlinghaus, Cellares; Perry Halkitis, Rutgers School of Public Health; Sho Islam, Middlesex County Office of Business Engagement; William Lewis, Insmed; Steven Libutti, Rutgers Cancer Institute; Amy Mansue, Inspira Health; David Moore, Novo Nordisk; Andrew Pecora, Outcome Matters Innovations; Ryan Saadi, Tevogen Bio; Brian Strom, Rutgers University; Debra Wentz, New Jersey Association of Mental Health and Addiction Agencies; and Tatsuyuki Yasuno, Eisai.

TIVDAK® (tisotumab vedotin) Approved by European Commission for Previously Treated Recurrent or Metastatic Cervical Cancer

Princeton-based BioNJ Member Genmab A/S announced that the European Commission (EC) has granted marketing authorization for TIVDAK® (tisotumab vedotin), an antibody-drug conjugate (ADC), as monotherapy treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is the first and only ADC to be granted European Union (EU) marketing authorization for people living with recurrent or metastatic cervical cancer. Despite progress in cervical cancer prevention and early detection, there remains a high need for new treatment options, particularly in advanced forms of the disease. In fact, cervical cancer is the fourth most common cause of cancer death among women globally. In the European Union, cervical cancer is the 11th most frequently occurring cancer among women. Up to 15% of adults with cervical cancer present with metastatic disease at diagnosis and, for those diagnosed at earlier stages who receive treatment, up to 61%v will experience disease recurrence.

TIVDAK® (tisotumab vedotin) Approved by Japan Ministry of Health, Labour and Welfare for the Treatment of Advanced or Recurrent Cervical Cancer that has Progressed on or after Chemotherapy

Princeton-based BioNJ Member Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare has approved TIVDAK® (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. TIVDAK is the first and only ADC to be approved for people living with cervical cancer in Japan. The approval is based on data from the randomized, open-label, global Phase 3 innovaTV 301 clinical trial that evaluated the efficacy and safety of TIVDAK compared to chemotherapy in patients with advanced or recurrent cervical cancer who were previously treated with chemotherapy. The trial included 502 patients, 101 of which were Japanese. The trial met its primary endpoint of overall survival (OS), demonstrating a 30% reduction in risk of death (HR: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038) compared to chemotherapy. 

Investigational Rinatabart Sesutecan (Rina-S®) Continues to Show Encouraging Antitumor Activity in Patients With Advanced Ovarian Cancer

Princeton-based BioNJ Member Genmab A/S announced updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels. With a median on-study follow-up of 48 weeks, 1 out of 10 patients experienced disease progression and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). The data are from the dose expansion cohort of the multi-part study evaluating the safety and efficacy of Rina-S as a single agent in solid tumors that are known to express FRα.

PD-L1 Measured by Blood Test Reveals Important Clinical Information

Monmouth Junction-based BioNJ Member researchers from Creatv Bio, Division of Creatv MicroTech, Inc. and The Mayo Clinic, in collaboration with BriaCell Therapeutics Corporation, have shown in a study of Metastatic Breast Cancer (mBC) patients treated with SV-BR-1-GM vaccine in combination with an immunotherapy drug, that the vaccine can change the PD-L1 expression of the tumor. The PD-L1 expression is determined by the LifeTracDx® blood test, which captures Circulating Tumor Cells (CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) by staining the cells for PD-L1 marker. The data of 36 patients showed that a decrease in CTCs/CAMLs numbers significantly correlated with better Progression Free Survival and trended for better Overall Survival. In addition, SV-BR-1_GM therapy appeared to upregulate PD-L1 expression in 15 patients which correlated with better responses to combination treatment with the anti-PD-L1 check point inhibitor.

Palatin Announces Positive Topline Results from Phase 2 Ulcerative Colitis (UC) Study of Oral Melanocortin-1 Receptor Agonist PL8177

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced positive topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor (MC1R) agonist, in patients with active ulcerative colitis (UC). This study was designed to assess the safety, tolerability, and effectiveness of PL8177 when taken orally by adults with active UC. The Phase 2 randomized, placebo-controlled study evaluated twelve patients (nine in the PL8177 arm and three in the placebo arm) with active ulcerative colitis, (defined as having a Mayo Endoscopic Total Score of at least two), for eight weeks of treatment. Treatment with oral PL8177 was well tolerated and no treatment-related side effects were reported.

Palatin Announces MC4R Agonist Bremelanotide Co-Administered With GLP-1/GIP Tirzepatide Meets Primary Endpoint in Phase 2 Obesity Study

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced that its BMT-801 Phase 2 obesity co-administration study met its primary endpoint and was highly statistically significant. The Company reported positive topline data with co-administered melanocortin-4 receptor (MC4R) agonist bremelanotide plus glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) tirzepatide and highlighted next steps in its obesity program for its novel next-generation MC4R long-acting peptides and oral small molecules. Topline data results from the study were highly statistically significant for the study’s primary endpoint, which was percent weight loss in patients for the co-administration of MC4R agonist bremelanotide plus GLP-1/GLP tirzepatide compared to placebo, over the 8-week treatment period.

Palatin’s Oral MC4R Agonist PL7737 Receives FDA Orphan Drug Designation for Obesity Due to Leptin Receptor Deficiency

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced the U.S. Food & Drug Administration (FDA) has granted “orphan drug” designation to PL7737, an oral treatment that activates the melanocortin-4 receptor, for leptin receptor (LEPR) deficiency, including obesity caused by this condition. “This FDA orphan designation is a key step in developing Palatin’s MC4R receptor agonists for rare obesity conditions,” said Carl Spana, Ph.D., President and CEO of Palatin. “Currently, the only FDA-approved treatment for obesity due to leptin receptor deficiency is a daily injection. PL7737’s oral form could provide a more convenient and effective option for these patients and others with rare genetic obesity disorders. We are also exploring PL7737 for hypothalamic obesity and plan to begin a Phase 1 SAD/MAD study in late 2025.”

PTC Therapeutics Presents New Sepiapterin Data from Ongoing Studies

Warren-based BioNJ Member PTC Therapeutics, Inc. shared new data from the Phase 3 APHENITY trial and subsequent open-label extension study. These data provide further evidence of the potential meaningful benefits of sepiapterin treatment for the full spectrum of phenylketonuria (PKU) patients, including significant diet liberalization. Over 97% of subjects participating in the Phe tolerance protocol of the APHENITY open-label extension study demonstrate the ability to liberalize their diet while on sepiapterin treatment, with a mean increase in protein intake of 126%. Sixty-six percent of subjects participating in the Phe tolerance sub study reached or exceeded the age-adjusted recommended daily allowance of protein intake for an individual without PKU, while maintaining control of blood Phe levels. Genetic variant analysis of subjects participating in the APHENITY study demonstrates that over 70% had a Genotype-Phenotype Value (GPV) consistent with classical PKU.

Soligenix Announces Publication Demonstrating CiVax™ Booster Induces Rapid Broad Protection Against COVID-19 Variants

Princeton-based BioNJ Member Soligenix, Inc. announced a publication describing the preclinical efficacy of CiVax™, a thermostabilized subunit vaccine against SARS-CoV-2. Using custom-developed immunoassays, the combination of a primary adenovirus vaccine (COVID-19 Vaccine AstraZeneca) coupled with a CiVax™ booster was shown to induce broader protection against COVID-19 variants in non-human primates than a 2-shot mRNA series (such as the Moderna vaccine Spikefax® or the Pfizer vaccine Cominarty®) in humans. "The CiVax™ vaccine has demonstrated broad and robust immune responses in mice, which has been recapitulated in NHPs and further shown to yield protection against infection with COVID-19 variants of concern," stated Axel Lehrer, PhD, Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaiʻi at Mānoa.

Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The decision is based on results from the global, Phase 2 TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 97.1% (95% CI: 91.7–99.4) and complete response (CR) rate of 94.2% (95% CI: 87.8–97.8), the study’s primary and key secondary endpoints, respectively. 

Taiho Pharmaceutical to Acquire Next-Generation ADC Drug Discovery Company Araris Biotech

Princeton-based BioNJ Member Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG, a Swiss biotechnology company developing next-generation antibody drug conjugates (ADCs), announced that they have entered into a definitive agreement pursuant to which Taiho Pharmaceutical will fully acquire Araris. Following necessary procedures, the Acquisition is expected to be completed in first half of 2025. The acquisition follows a research collaboration between Taiho Pharmaceutical and Araris signed in November 2023. Araris is a spin-off company of the Paul-Scherrer-Institute in Switzerland and pioneering the development of best-in-class ADCs with superior design, high linker solubility and simple manufacturing that address the shortcomings of current generation ADCs. ADCs are designed to selectively deliver cytotoxic drugs (payloads) to cancer cells by attaching them to antibodies that bind specifically to cancer cells through linkers. 

Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Princeton-based BioNJ Member Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce the filing of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home. IgAN is a progressive, autoimmune, chronic kidney disease that is associated with a high risk for progression to end-stage kidney disease (ESKD) over the lifetime of many patients.

Joint Research Results on Regulatory T cells between Osaka University Immunology Frontier Research Center and Chugai Published in Nature

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that research results conducted under a comprehensive collaboration agreement with Osaka University Immunology Frontier Research Center (IFReC) have been published in the online edition of the science journal Nature. This study is the first to elucidate the regulatory network of FoxP3, a master transcription factor essential for maintaining Treg function, in human induced regulatory T cells (iTreg), and proposes the possibility of new autoimmune disease treatment through Treg regulation. By combining genome-wide CRISPR screening and a novel single-cell resolution, signaling pathways and related factor groups involved in FoxP3 regulation were identified. Furthermore, by knocking out important factors identified from the related factor groups, more functional and stable Treg induction was made possible. This research is expected to promote scientific understanding of Treg biology and apply to new autoimmune disease treatments through Treg regulation.

Chugai Launches “LUNSUMIO for Intravenous Infusion,” a Bispecific Antibody for Relapsed or Refractory Follicular Lymphoma in Japan

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that it launched “LUNSUMIO® for intravenous infusion 1 mg” and “LUNSUMIO® for intravenous infusion 30 mg” (generic name: mosunetuzumab (genetical recombination)) (hereafter, LUNSUMIO), antineoplastic agent / anti-CD20/CD3 humanized bispecific antibody for the treatment of patients with relapsed or refractory follicular lymphoma who have received two or more prior standard therapies. This approval is based on the results of a Japanese Phase I study with an expansion cohort (FLMOON-1 study) conducted in patients with relapsed or refractory follicular lymphoma who had received two or more prior standard therapies, as well as an overseas Phase I/II clinical trial conducted by Roche in the same patient population.

New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction With TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable

Parsippany-based BioNJ Member Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced the presentation of a patient and healthcare professional (HCP) attitudes and experiences survey study, complementing the successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) evaluating TEV-'749. More than 92% of patients, 87% of nurses and 72% of physicians were either satisfied or very satisfied when asked about TEV-'749, overall, including initiation regimen, monthly dosing schedule and dosing options. With nearly 30 years of clinical and real-world use, olanzapine is one of the most commonly prescribed second-generation oral antipsychotics for the treatment of schizophrenia globally, with a well-established efficacy and safety profile.

FDA Approves Novartis Radioligand Therapy Pluvicto® for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

East Hanover-based BioNJ Member Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. The expanded indication, which approximately triples the number of patients eligible to receive Pluvicto, is based on results of the Phase III PSMAfore trial. In the study, Pluvicto reduced the risk of radiographic progression or death by 59% (HR=0.41; 95% CI: 0.29, 0.56; p<0.0001) compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy. At an updated exploratory analysis, Pluvicto more than doubled median radiographic progression-free survival (11.6 months vs. 5.6 months).

Novartis Receives Third FDA Approval for Oral Fabhalta® (iptacopan) – the First and Only Treatment Approved in C3 Glomerulopathy (C3G)

East Hanover-based BioNJ Member Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition. Fabhalta is the only oral inhibitor of the alternative complement pathway to selectively target what is thought to be the underlying cause of the disease. Before the approval of Fabhalta, patients had to rely on supportive care, broad immunosuppression, and symptom management. C3G is a progressive and ultra-rare kidney disease that, until now, has had no approved treatments. The average age of diagnosis is around 23 years old. Prognosis is poor, with approximately half of people living with C3G progressing to kidney failure within 10 years of diagnosis, requiring lifelong dialysis and/or kidney transplantation.

New Novartis Phase III Data Demonstrate Meaningful Efficacy and Safety Results of Intrathecal Onasemnogene Abeparvovec in Broad Patient Population With SMA

East Hanover-based BioNJ Member Novartis announced positive safety and efficacy results from the Phase III program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to <18 years with spinal muscular atrophy (SMA). In the Phase III STEER study, treatment with OAV101 IT led to a statistically significant 2.39-point improvement on the Hammersmith Functional Motor Scale Expanded (HFMSE), a gold standard for SMA-specific assessment of motor ability and disease progression, vs. 0.51 points in the sham control arm (P=0.0074).1-5 In the Phase IIIb STRENGTH study, treatment with OAV101 IT in patients who have discontinued treatment with nusinersen or risdiplam demonstrated stabilization of motor function over 52 weeks of follow-up.

Rilzabrutinib Granted Orphan Drug Designation in the U.S. for Two Rare Diseases With No Approved Medicines

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD). There is still a significant unmet medical need for these two rare diseases, and neither have any currently approved medicine. FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. Rilzabrutinib is currently under regulatory review in the US, the EU, and China for its potential use in immune thrombocytopenia (ITP). The target action date for the FDA regulatory decision for ITP, which was granted fast track designation, is August 29, 2025. Rilzabrutinib also received orphan drug designation for ITP in the US, EU and Japan.

Qfitlia Approved as the First Therapy in the U.S. to Treat Hemophilia A or B With or Without Inhibitors

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS Phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates (ABR) across hemophilia patients with or without inhibitors. By lowering AT, a protein that inhibits blood clotting, Qfitlia helps increase thrombin generation to restore hemostasis in people with hemophilia. Qfitlia uses small-interfering RNA technology, which enables low treatment frequency, subcutaneous dosing, and low volume injections.

Dupixent Approved as the First-ever Biologic Medicine in Japan for Patients With COPD

Bridgewater-based BioNJ Member Sanofi announced the Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. The approval in Japan was based on data from the landmark BOREAS Phase 3 study. The study evaluated Dupixent added to background maximal standard-of-care inhaled therapy (with nearly all patients on triple therapy or double therapy if inhaled corticosteroids were contraindicated) in adults with uncontrolled COPD and elevated blood eosinophils. In the study, Dupixent significantly reduced exacerbations and improved lung function compared to placebo. Safety results in the study were generally consistent with the known safety profile of Dupixent in its approved indications.

Chlamydia Vaccine Candidate Granted Fast Track Designation by the U.S. FDA

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration has granted fast track designation to its mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the potential of the vaccine candidate to address a serious condition and address an unmet public health need. The chlamydia vaccine candidate has been designed to protect against primary genital tract infection and reinfection by the bacterium Chlamydia trachomatis. Following a promising pre-clinical program, Sanofi is planning a Phase 1/2 randomized, clinical study designed to evaluate the immunogenicity and safety of the chlamydia vaccine candidate in adults aged 18 to 29 years. The study is due to start in coming days.

Tolebrutinib Regulatory Submission Accepted for Priority Review in the U.S. for Patients With Multiple Sclerosis

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA decision is September 28, 2025. A regulatory submission is also under review in the EU. The regulatory submissions in the US and the EU are supported by the results from the Phase 3 studies HERCULES in nrSPMS and GEMINI 1 and 2 in relapsing MS (RMS). The findings support the differentiated mechanism of tolebrutinib to target disability progression independent of relapse activity, and the scientific hypothesis that smoldering neuroinflammation represents a key inflammatory process in MS and is a critical driver of disability accumulation.

Sanofi to Acquire Dren Bio’s Bispecific Myeloid Cell Engager for Deep B-cell Depletion, Broadening Immunology Pipeline

Bridgewater-based BioNJ Member Sanofi and Dren Bio, Inc. have entered into a definitive agreement under which Sanofi has agreed to acquire DR-0201, a targeted bispecific myeloid cell engager (MCE) that has shown robust B-cell depletion in pre-clinical and early clinical studies. DR-0201 is a potential first-in-class CD20-directed bispecific antibody that targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis. Recent early clinical study data in autoimmune diseases suggest that deep B-cell depletion might have the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.

Bristol Myers Squibb Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo® (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo for Resectable Non-Small Cell Lung Cancer in Patients With Tumor Cell PD-L1

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab), in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The CHMP adopted a positive opinion based on results from the CheckMate -77T trial, in which the perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint. 

Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a new Opdivo® (nivolumab) formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in the European Union (EU).

Hepion Pharmaceuticals Announces 1-for-50 Reverse Stock Split

BioNJ Member Hepion Pharmaceuticals Inc. implemented a 1-for-50 reverse stock split. The Morristown company’s common stock began trading on a split-adjusted basis on March 18 under the same ticker symbol, with a new CUSIP number (426897 401). The move aims to regain compliance with Nasdaq’s $1 minimum bid price requirement. Approved by stockholders on March 10, the split will reduce outstanding shares from approximately 54.25 million to 1.08 million while maintaining shareholder ownership proportions. No fractional shares will be issued-holdings will be rounded up to the nearest whole share.

World’s First Early Alzheimer’s Disease Treatment Developed in Japan LEQEMBI® Receives Prime Minister’s Award at the 12th Technology Management and Innovation Awards

Nutley-based BioNJ Member Eisai Co., Ltd. announced that humanized antisoluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (lecanemab) for the treatment of early Alzheimer’s disease (early AD) has received the Prime Minister’s Award at the 12th Technology Management and Innovation Awards hosted by the Japan Techno-Economics Society (JATES). This award recognized LEQEMBI as “a world-first treatment for early AD developed in Japan which selectively binds to and clears neurotoxic substances (abnormal proteins), thereby reducing the rate of disease progression. While companies and researchers around the world gave up on development, LEQEMBI is the result of Eisai’s long-term research on dementia. The increase in dementia patients in an aging society is serious, with enormous medical and nursing care costs, and considerable burden on caregivers. The contribution to addressing these challenges is of immense social significance.”

Proton Pump Inhibitor “Pariet® S” Approved in Japan as RX-to-OTC Switch

Nutley-based BioNJ Member Eisai Co., Ltd. announced that it has obtained manufacturing and marketing authorization approval for the proton pump inhibitor "Pariet® S" (RX-to-OTC switch, pharmaceutical requiring guidance) in Japan for the indications of stomach pain, heartburn and bloating. Rabeprazole sodium, the active ingredient in “Pariet S”, is a PPI developed at Eisai’s Tsukuba Research Laboratories. The medicine was first launched in Japan in 1997 as a prescription pharmaceutical under the brand name “Pariet” and has since been approved in more than 100 countries worldwide. It is widely prescribed to people struggling with acid-related disorders. In recent years, there is a tendency for increased stomach acid secretion due to disrupted eating habits, stress, and a decline in the infection rate of Helicobacter pylori.

Lexicon Pharmaceuticals Announces Exclusive License Agreement With Novo Nordisk for LX9851

BioNJ Member Lexicon Pharmaceuticals, with a site in Bridgewater, announced that it has entered into an exclusive license agreement with BioNJ Member Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders. Under the terms of the agreement, Novo Nordisk obtains an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications. Lexicon will be responsible for completing agreed upon Investigational New Drug (IND) application-enabling activities for LX9851. Novo Nordisk will be responsible for filing the IND, all further development, manufacturing and commercialization of LX9851. LX9851, discovered and developed by Lexicon, is a potent and selective oral small molecule inhibitor of Acyl-CoA Synthetase 5 (ACSL5)​. ACSL5 plays a key role in the metabolic pathway which regulates fat accumulation and energy balance.

Novo Nordisk A/S: Rybelsus® (oral semaglutide 14 mg) Demonstrates Superior Reduction in Cardiovascular Events in the SOUL Trial at ACC 2025

Plainsboro-based BioNJ Member Novo Nordisk A/S presented the full results from the SOUL cardiovascular outcomes trial, demonstrating that Rybelsus® (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD). The SOUL trial achieved its primary endpoint, demonstrating a 14% reduction in risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and CVD and/or CKD when treated with Rybelsus® compared to placebo. Each component of MACE, being CV death, nonfatal myocardial infarction and nonfatal stroke, contributed to the risk reduction. Cardiometabolic diseases span a wide range of conditions, including cardiovascular and peripheral artery disease, type 2 diabetes and chronic kidney disease. When combined, these conditions represent the leading cause of death globally. 

Ozempic® (once-weekly semaglutide 1.0 mg) Shown to Improve Walking Distance and Quality of Life in Adults With Type 2 Diabetes and Peripheral Artery Disease (PAD) at ACC 2025

Plainsboro-based BioNJ Member Novo Nordisk A/S presented the full results from STRIDE, a Phase 3b peripheral artery disease (PAD) outcomes trial investigating the effects of once-weekly injectable Ozempic® (semaglutide 1.0 mg) in adults with type 2 diabetes and PAD. The double-blind, randomised, placebo-controlled STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep incline, compared to placebo at week 52. The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance at week 52, health-related quality of life (Vascular Quality of Life Questionnaire-6) at week 52, and maximum walking distance at week 57.

Novo Nordisk and The United Laboratories Announce Exclusive License Agreement for UBT251, a GLP-1/GIP/Glucagon Triple Receptor Agonist

Plainsboro-based BioNJ Member Novo Nordisk A/S and The United Laboratories International Holdings Limited announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology), have entered into an exclusive license agreement for UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon in early stage clinical development for the treatment of obesity, type 2 diabetes, and other diseases. Under the license agreement, Novo Nordisk will obtain exclusive worldwide rights (excluding Chinese mainland, Hong Kong, Macau and Taiwan) to develop, manufacture and commercialize UBT251. United Biotechnology recently completed a randomized, double-blind, placebo-controlled Phase 1b trial in China designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple subcutaneous injections of UBT251 in people with overweight or obesity.

Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadership

New Brunswick-based BioNJ Member Johnson & Johnson announced it has completed its acquisition of Intra-Cellular Therapies, Inc. Intra-Cellular Therapies is now part of Johnson & Johnson and will operate as a business unit within Johnson & Johnson Innovative Medicine. With this acquisition, Johnson & Johnson adds CAPLYTA^® (lumateperone) to its robust portfolio of differentiated medicines. CAPLYTA^® is a once-daily oral therapy approved to treat adults with schizophrenia, as well as the first and only US FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate. In February 2025, Intra-Cellular Therapies announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental new drug application for CAPLYTA^® as an adjunctive treatment for adults with major depressive disorder (MDD). 

RYBREVANT® (amivantamab-vmjw) Plus LAZCLUZE™ (lazertinib) Outperforms Osimertinib With a Significant and Unprecedented Overall Survival Benefit in Patients With EGFR-mutated Non-small Cell Lung Cancer

Raritan-based BioNJ Member Johnson & Johnson announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. Median OS is projected to exceed one year beyond the median of three years observed with osimertinib and has not yet been reached. This is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib. 

Nipocalimab, the First and Only Investigational Treatment to be Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Adults With Moderate-to-Severe Sjögren’s Disease, has Now Received Fast Track Designation

New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjögren’s disease (SjD), having previously been granted Breakthrough Therapy designation (BTD) for the investigational therapy late last year. Currently, no advanced therapies are approved to treat this disease. Building upon the BTD, which nipocalimab is the first and only therapeutic to receive for SjD, the U.S. FDA’s FTD is also designed to accelerate the delivery of new therapeutics to patients by facilitating the development and expediting the review of drugs that demonstrate the potential to treat serious conditions and help address unmet needs for serious or life-threatening conditions.

European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease

BioNJ Member Pfizer Inc., with a site in Peapack, announced that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older. The amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. 

WINREVAIR™ (sotatercept-csrk) Reduced the Risk of a Composite of All-Cause Death, Lung Transplantation and Hospitalization for Pulmonary Arterial Hypertension (PAH) by 76% Compared to Placebo in the Phase 3 ZENITH Trial

Rahway-based BioNJ Member Merck & Co. announced the first presentation of results from the Phase 3 ZENITH trial evaluating WINREVAIR™ (sotatercept-csrk) compared to placebo in adults with pulmonary arterial hypertension (PAH, Group 1 PH) WHO* functional class (FC) III or IV at high risk of mortality who were on maximum tolerated background PAH therapy. At a median follow-up of 10.6 months (range, 0.3-26.1), WINREVAIR reduced the relative risk of major morbidity and mortality events (the composite of all-cause death, lung transplantation and PAH worsening-related hospitalization of ≥24 hours) by 76% (HR=0.24 [95% CI, 0.13-0.43]; p<0.0001 [1-sided]) compared to placebo. For patients treated with WINREVAIR, 17.4% (n=15/86) experienced one or more major morbidity and mortality events, compared with 54.7% (n=47/86) of patients in the placebo arm.

Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial

Rahway-based BioNJ Member Merck & Co. announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous administration of pembrolizumab, together with berahyaluronidase alfa (MK-3475A; from now on referred to as “subcutaneous pembrolizumab”). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. The study met its primary endpoints, demonstrating noninferior pharmacokinetics (PK) for subcutaneous pembrolizumab administered with chemotherapy with a median injection time of two minutes, versus intravenous (IV) KEYTRUDA® (pembrolizumab) administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The secondary endpoints of objective response rate (ORR), progression-free survival (PFS) and duration of response (DOR) and safety were consistent for subcutaneous pembrolizumab with chemotherapy compared to IV KEYTRUDA with chemotherapy. 

European Commission (EC) Approves Merck’s CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE is a pneumococcal vaccine specifically designed to help protect adults from the serotypes responsible for the majority of invasive pneumococcal disease (IPD) cases. The EC approval of CAPVAXIVE is based on safety and immunogenicity data from the Phase 3 STRIDE clinical program. This decision authorizes the marketing of CAPVAXIVE in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. 

Merck Enters Exclusive License Agreement for HRS-5346, an Investigational Oral Lipoprotein(a) Inhibitor, for Cardiovascular Disease from Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Rahway-based BioNJ Member Merck & Co. and Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Phase 2 clinical trial in China. Under the agreement, Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region. Hengrui Pharma will receive an upfront payment of $200 million and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $1.77 billion, as well as royalties on net sales of HRS-5346, if approved.

Blujepa (gepotidacin) Approved by U.S. FDA for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) in Female Adults and Paediatric Patients 12 Years of Age and Older

Warren-based BioNJ Member GSK plc announced that the U.S. Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. The approval is based on positive results from the pivotal Phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. 

GSK’s Application to Expand Use of Nucala (mepolizumab) for the Treatment of COPD Accepted for Review by the European Medicines Agency

Warren-based BioNJ Member GSK plc announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The application is supported by results from the positive Phase III MATINEE trial, which showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations with mepolizumab compared to placebo. The trial recruited patients across a wide spectrum of COPD phenotypes and clinical presentations. These data indicate that mepolizumab, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations. 

GSK, UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to Collaborate on First-of-its-Kind Dementia Research Initiative

Warren-based BioNJ Member GSK plc announced a major new research collaboration with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to advance understanding of neurodegeneration with a first-of-its-kind dementia study. The innovative project aims to use the UK’s health data ecosystem to explore a potential association between GSK’s shingles vaccine, Recombinant Zoster Vaccine (RZV), and a reduced risk of dementia. If successful, this could serve as a blueprint for population level health data research models, reinforcing the UK’s position as a leading destination for scientific research. More than 55 million people worldwide have dementia, with cases increasing as the global population ages. Research to identify potential opportunities to reduce the risk of dementia is much needed but challenging given the multiple, complex factors which may contribute to the development of the disease.

ELAHERE® (mirvetuximab soravtansine-gynx) Shows Consistent Survival Benefit in Long-Term Analysis for Certain Ovarian Cancer Patients

BioNJ Member AbbVie, with a site in Madison, announced the final analysis of the confirmatory Phase 3 MIRASOL trial evaluating the efficacy and safety of ELAHERE® (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy. Ovarian cancer patients often present with late-stage disease and are historically first treated with platinum-based chemotherapy, which they may become resistant to and require another therapy, such as ELAHERE. In the United States, ovarian cancer is the leading cause of death from gynecological cancers. Each year, approximately 20,000 women are diagnosed. Unfortunately, most patients develop platinum-resistant disease, which is difficult to treat.

Lilly's Lepodisiran Reduced Levels of Genetically Inherited Heart Disease Risk Factor, Lipoprotein(a), by Nearly 94% from Baseline at the Highest Tested Dose in Adults With Elevated Levels

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive Phase 2 results for lepodisiran, an investigational small interfering RNA (siRNA) therapy designed to lower the production of lipoprotein(a) [Lp(a)], a genetically inherited risk factor for heart disease. In the Phase 2 ALPACA study, lepodisiran significantly reduced Lp(a) levels by an average of 93.9% over the 60 to 180-day period after treatment with the highest tested dose (400 mg), meeting the primary endpoint.i Participants who received the 16 mg and 96 mg lepodisiran doses experienced a 40.8% reduction and a 75.2% reduction in Lp(a) levels over the same time period, respectively. Lepodisiran also met additional secondary endpoints, showing reductions in Lp(a) levels following one or two administrations of each of the three tested doses across all timepoints assessed throughout the nearly 18-month-long study. 

Actor and Comedian Kenan Thompson Teams Up With Phathom Pharmaceuticals to Raise Awareness About GERD and VOQUEZNA® (vonoprazan)

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced a partnership with actor, comedian, and author Kenan Thompson, best known as the longest-running cast member on Saturday Night Live. For the first time ever, Thompson is publicly speaking out about his experience with GERD as part of the GERD IS NO JOKE campaign to raise awareness about the condition and encourage others to talk with their doctor about treatment options.

Thompson, who has been diagnosed with the most common form of GERD, called Non-Erosive GERD, found heartburn relief with VOQUEZNA® (vonoprazan) after struggling with other treatments. VOQUEZNA is the first and only treatment of its kind approved by the U.S. Food and Drug Administration (FDA) to help manage his condition. VOQUEZNA is approved for use in adults for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn.

Palisades Therapeutics Granted Breakthrough Patent for Novel Addiction Treatment

Cliffside Park-based Pop Test Oncology LLC dba Palisades Therapeutics proudly announces that the United States Patent and Trademark Office (USPTO) has granted a groundbreaking patent for an innovative pharmaceutical composition and treatment method aimed at combating addiction and related disorders. This new approach offers hope for millions struggling with nicotine, opioid, methamphetamine, and alcohol addictions, as well as associated anxiety and withdrawal symptoms. Next-Generation Compounds Show Promise... At the heart of this innovation are newly developed compounds known as PT155, PT156, PT157, and PT158. These are advanced analogs of PT150, a Phase 2 clinical-stage therapeutic that has already demonstrated safety and efficacy in preclinical and clinical studies.

Kenvue Ribbon-Cutting Marks Official Opening of New Global Headquarters in Summit

Kenvue Inc. held a ribbon-cutting ceremony for its new 290,000 sq. ft. global headquarters in Summit. The company – which marked the start of construction of its 100,000 sq. ft. state-of-the-art Science and Innovation Lab at a ceremony last year – has officially moved its headquarters from Skillman to Summit. “I am thrilled to welcome Kenvue as they establish their home in Summit, cementing the company’s commitment to building the future of consumer health right here in the Garden State,” said Governor Phil Murphy. The company said locating its LEED Gold certified global headquarters in Summit offers Kenvue the opportunity to foster a collaborative environment, where teams previously spread across seven geographic locations across the U.S. can come together and take advantage of the new spaces designed to accelerate innovation, and enhance consumer experiences.

DATROWAY® Launched in Japan as the First TROP2 Directed Therapy for Patients With Previously Treated Unresectable or Recurrent HR Positive, HER2 Negative Breast Cancer

Basking Ridge-based Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan) has been launched in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. DATROWAY is the first ever TROP2 directed medicine to be launched in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) available based on Daiichi Sankyo’s DXd ADC Technology. Marketing approval of DATROWAY was granted by the Japan Ministry of Health, Labour and Welfare (MHLW) in December 2024 based on the results from the TROPION-Breast01 Phase 3 trial where DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR).

Late-Breaking at CROI 2025: SCORPIO-PEP Phase 3 Trial – Ensitrelvir is the First and Only COVID-19 Oral Antiviral to Demonstrate Prevention of COVID-19 as Post Exposure Prophylaxis

Florham Park-based Shionogi & Co. presented new data from its global, double-blind, randomized, placebo-controlled Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post-Exposure Prophylaxis (SCORPIO-PEP) assessing ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) as oral post-exposure prophylaxis. SCORPIO-PEP is the first and only Phase 3 study of a COVID-19 oral antiviral as a post-exposure prophylaxis to meet the primary endpoint of preventing COVID-19. The study met both the primary endpoint and the key secondary endpoint. The primary analysis population included 2,041 household contact participants with a negative screening SARS-CoV-2 test and excluded those found to already be positive by PCR at the central laboratory. 

DESTINY-Gastric05 Phase 3 Trial of ENHERTU® Initiated in Patients With Previously Untreated HER2 Positive Advanced Gastric Cancer  

Basking Ridge-based Daiichi Sankyo’s announced the first patient has been dosed in the DESTINYGastric05 Phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (5-FU or capecitabine) and BioNJ Member Merck & Co.'s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) versus trastuzumab in combination with platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) and pembrolizumab in previously untreated patients with unresectable, locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) cancer with PD-L1 CPS ≥1. An exploratory cohort of patients with PD-L1 CPS <1 will be randomized to either ENHERTU plus fluoropyrimidine or trastuzumab plus platinum-based chemotherapy. 

DATROWAY® Launched in Japan as the First TROP2 Directed Therapy for Patients With Previously Treated Unresectable or Recurrent HR Positive, HER2 Negative Breast Cancer

Basking Ridge-based Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan) has been launched in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. DATROWAY is the first ever TROP2 directed medicine to be launched in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) available based on Daiichi Sankyo’s DXd ADC Technology. Marketing approval of DATROWAY was granted by the Japan Ministry of Health, Labour and Welfare (MHLW) in December 2024 based on the results from the TROPION-Breast01 Phase 3 trial where DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR).

Mitsubishi Tanabe Pharma America Announces Publication of Preclinical Research on the Role of Edaravone in Mitigating TDP-43 Mislocalization in ALS

Jersey City-based Mitsubishi Tanabe Pharma America, Inc. announced the publication of new preclinical research in Free Radical Biology and Medicine, highlighting the role of edaravone in mitigating TDP-43 mislocalization, a hallmark feature observed in more than 97% of sporadic amyotrophic lateral sclerosis (ALS) cases. The study, conducted using induced pluripotent stem cell (iPSC)-derived motor neurons from a single patient with ALS, demonstrated that edaravone significantly reduced the abnormal cytoplasmic accumulation of TDP-43, restoring its nuclear localization. This mislocalization is a key driver of neuronal dysfunction and degeneration in ALS, and suggests that edaravone may offer a varied therapeutic approach for ALS by targeting oxidative stress and TDP-43 mislocalization through distinct molecular pathways.

Idorsia Announces the Publication of Positive Data With Daridorexant in Patients With Chronic Insomnia and Nocturia

Idorsia Ltd, with a site in Cherry Hill, announced the publication of “A randomized cross-over trial of daridorexant for the treatment of chronic insomnia and nocturia” in the Journal of Sleep Research. The new data provides evidence of the benefit of Idorsia’s dual orexin receptor antagonist, daridorexant (QUVIVIQ™), at a daily dose of 50 mg, in patients aged >=55 years with chronic insomnia and comorbid nocturia, with efficacy data on symptoms of both conditions, improvement in daytime functioning, and a good safety and tolerability profile. Chronic insomnia is defined as difficulty initiating and/or maintaining sleep at least three times a week for a minimum of three months and a significant negative impact on daytime functioning. 

NJ’s Life Science Commercial Real Estate Set to Expand

The New Jersey life sciences market is poised to add a total of 565,000-square feet of space, a 6 percent expansion of its life sciences stock, making it the 8th-largest active pipeline among U.S. markets in the study. New Jersey’s life sciences sector’s total is 9.88-million-square feet, which is the 4th-largest, behind only Boston, San Francisco and San Diego. Life sciences real estate had a remarkable run during the pandemic as biotech hubs like Boston and San Francisco saw lab space demand climb as traditional office markets struggled with remote work shifts. But now, rising interest rates, a wave of new supply, and the newly announced government funding cuts are reshaping the landscape. As such, the sector isn’t slowing so much as recalibrating. Still, with venture capital funding showing signs of a rebound, there’s cause for conservative optimism in 2025.

Ribbon Cut on Major Artificial Intelligence Hub

Gov. Phil Murphy, along with representatives from the New Jersey Economic Development Authority (NJEDA), Princeton University, Microsoft and CoreWeave, officially opened the NJ AI Hub, a state-of-the-art, collaborative ecosystem that will integrate world-class research, innovation, education, and workforce development. The NJ AI Hub will provide a physical location where AI start-ups can collaborate, helping to support new, diverse innovators and drive long-term economic growth. The involved partners will focus on three main pillars of programming at the NJ AI Hub, including 1) research and development; 2) commercialization and accelerating innovation; and 3) strengthening AI education and workforce development. Together, the founding partners will invest over $72 million to support the long-term success of the NJ AI Hub.

FDA Awards Cellares First-of-its-Kind Designation

The U.S. Food and Drug Administration’s Center for Biologics and Evaluation and Research awarded the Cellares' Cell Shuttle the first-ever Advanced Manufacturing Technology designation. BioNJ Member Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater. The Cell Shuttle performs automated, end-to-end, cell therapy manufacturing. Cellares officials say that the “unprecedented designation” acknowledges the Cell Shuttle’s ability to automate and reliably manufacture cell therapies – while representing a significant step forward in the advanced manufacturing of cell therapies. “The AMT designation for our Cell Shuttle is a testament to its potential to transform patient outcomes by delivering scalable and cost-effective cell therapy manufacturing to small, early stage biotechs and large pharma companies with commercialized cell therapies,” said Fabian Gerlinghaus, CEO and co-founder of Cellares.

Cellares Marks Latest Milestone, Potential of Manufacturing Platform

Bridgewater-based BioNJ Member Cellares and Cabaletta Bio announced the successful completion of the manufacturing Technology Adoption Program (TAP) using the Cell Shuttle platform. Cellares, operates its first commercial-scale Integrated Development and Manufacturing Organization (IDMO) Smart Factory in Bridgewater. The program examined the ability of Cellares’ IDMO Smart Factory to automate, lower costs and scale out manufacturing for Cabaletta Bio’s clinical-stage drug, rese-cel, a CD-19-targeting CAR T cell therapy designed to treat patients with a broad range of autoimmune diseases. On a single Cell Shuttle, the TAP successfully produced automated, concurrent manufacture of multiple rese-cel batches. The companies say this successful collaboration facilitates the opportunity to engage in a clinical and commercial manufacturing relationship.

LillyDirect Platform Expands to Facilitate Access to Alzheimer's Disease Care

BioNJ Member Eli Lilly and Company, with a site in Branchburg, has expanded its LillyDirect digital healthcare platform to offer connections to independent in-person and telehealth options for people in the U.S. living with Alzheimer's disease, the majority of whom have not been formally diagnosed. Both clinicians and people living with Alzheimer's disease have expressed the need to increase the capacity of our health care systems to diagnose and manage more of the nearly 7 million Americans living with the disease. Many patients face prolonged wait times to see a dementia specialist. These wait times are predicted to rise to more than 1 year in 2025 and can be even longer for people who live in rural and medically underserved areas. Nearly 1 in 5 Medicare beneficiaries drive more than 50 miles each way to see a neurologist. 

CoreWeave Goes Public, Debuts on Nasdaq

BioNJ Member CoreWeave announced its initial public offering at $40 per share. The company is a leader in the artificial intelligence space, delivering a cloud platform to power AI scaling. CoreWeave has been rapidly moving toward its IPO – and recently launched its roadshow to gauge the public interest. Some broader headwinds led the company to scale down its IPO from 49 million shares of Class A common stock to 37.5 million shares at $40 per share. CoreWeave is expected to raise around $1.5 billion. “As a company proudly headquartered in New Jersey, CoreWeave is deeply invested in the future of this state — and in the people who call it home,” said Brian Venturo, Co-Founder and Chief Strategy Officer at CoreWeave. “This is more than just a space for innovation; we believe it’s a launchpad for aspiring technologists, engineers and creators across N.J. who no longer need to leave home to build world-class careers in AI. New Jersey is not just participating in the AI revolution — we’re driving it."

Jersey City Ophthalmology Start-Up Raises $93M Series B

Character Biosciences announced it completed a $93 million Series B financing round. The Jersey City-based company develops targeted therapies for progressive polygenic diseases. The funding will accelerate the advancement of its pipeline precision therapies to treat degenerative eye diseases. Character Biosciences has partnered with over 150 ophthalmology treatment centers nationwide to conduct an age-related macular degeneration (AMD)-focused observational trial. The efforts and approach have led to the discovery and advancement of Character Biosciences lead candidates. The therapies target key drivers of retinal cell death and vision loss, including CTX203 – A first-in-class lipid regulator that aims to prevent progression of advanced AMD and CTX114 – A best-in-class complement inhibitor designed to slow the progression of geographic atrophy in advanced dry AMD. Meanwhile, Character Biosciences will also leverage its AI-driven, genomics-based platform to expand its pipeline into more ophthalmic diseases.

NJII and Cognome Partner to Advance AI-Powered Healthcare Solutions

The New Jersey Innovation Institute (NJII) and Cognome have announced a strategic partnership to transform patient care with artificial intelligence (AI) and machine learning (ML) solutions. This partnership leverages Cognome’s ethical AI tools, developed at two leading academic healthcare systems, with NJII’s professional services to deliver next-generation clinical intelligence, operational efficiencies and outcomes improvement. Healthcare Innovation Solutions (HCIS), the quality and performance improvement subsidiary of NJII, will play a key role in bringing these innovative and cutting-edge AI solutions to the marketplace. NJII, an NJIT corporation, is dedicated to accelerating healthcare technology and fostering innovation throughout New Jersey and beyond. Cognome offers advanced AI and ML models, as well as the first-of-its-kind AI Governance platform, ExplainerAITM, purpose-built for healthcare. NJII aims to drive AI adoption starting with proper governance, model implementation and co-development with our healthcare partners.

NJBIZ In the Lead 2025: Start-Ups

New Jersey’s boosters – yes, they exist – cite a number of characteristics that make the State attractive to businesses, particularly new businesses that trade heavily on intellectual capital. Foremost among those characteristics is a highly educated workforce capable of doing the metaphorical heavy lifting of innovation and disruption. These start-ups are making a mark on the State in a good way. They are pursuing new and better ways of doing things we all do every day. Or they are discovering things to do that most of us never thought of. Or they are perfecting methods that work better for the environment, make people healthier, or improve efficiency and productivity for businesses. In short, the companies profiled on NJBIZ’s list represent the future of the State’s economy. 

Princeton-Based BioCentriq Rebrands

Princeton-based BioCentriq is rebranding and relaunching as Made Scientific, the cell therapy contract development and manufacturing organization. The former BioCentriq was founded in 2019 as a New Jersey Innovation Institute subsidiary. GC Group of South Korea purchased the company for $73 million in May 2022. The CDMO said the new name – in full, Made Scientific (Manufacturing and Development Excellence) – “signifies an emboldened mission to accelerate life-saving cell therapies from development to commercialization.” The rebrand follows the company’s move to a new, 60,000-square-foot, state-of-the-art cell therapy manufacturing facility and company headquarters in Princeton. Made Scientific said the site is now operational for development programs. GMP services will also come online in the second quarter of 2025, according to the company.

Hackensack Meridian Neuroscience Institute First in NJ to Implant Deep Brain Stimulation Device to Improve Outcomes for Patients With Complex Symptoms

Hackensack Meridian Neuroscience Institute says it is the first in the State to implant a new type of deep brain stimulation (DBS) device that offers more personalized treatment for patients with Parkinson’s disease and essential tremor. Hackensack Meridian Neuroscience Institute at JFK University Medical Center implanted the state’s first Vercise™ Cartesia™ X Directional Leads this month. The device with 16 contact directional leads allows for precise care for patients diagnosed with complex essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. Hackensack Meridian Neuroscience Institute at Jersey Shore University Medical Center also implanted its first Vercise Cartesia X Directional leads this month.

NJEDA Approves Programs to Advance NJ’s Leadership in AI

The New Jersey Economic Development Authority (NJEDA) Board has approved the creation of the Next New Jersey Program – AI and the AI Innovation Challenge Administration Grant Program, which build on Gov. Phil Murphy’s goal of establishing the State as a leader in AI by encouraging private investment into New Jersey’s growing AI sector and promoting collaboration between citizens and government in AI innovation. The Next New Jersey Program – AI will provide tax credits to eligible businesses investing in large-scale AI data centers and companies engaging in AI-related activities. The $500 million program leverages AI to stimulate innovation, boost productivity, and attract high-tech investments, positioning New Jersey as a key player in the rapidly evolving AI economy. For more information, including additional eligibility requirements, click here. 

CoreWeave Appoints New Chief Marketing Officer to Drive AI Cloud Growth

BioNJ Member CoreWeave, the AI hyperscaler, has named Jean English as Chief Marketing Officer (CMO) to strengthen its market presence and brand leadership in the AI cloud sector. With more than 20 years of marketing experience — including a decade as CMO at top cloud, AI and cybersecurity firms — Ms. English will lead CoreWeave’s global marketing strategy. Ms. English previously served as CMO at Juniper Networks, Palo Alto Networks, NetApp and IBM Cloud, where she helped scale enterprise growth and AI-driven cloud solutions. Her appointment is part of CoreWeave’s expanding leadership team, which recently added CISO Jim Higgins (formerly at Snap Inc. and Block, Inc.) and CIO Sandy Venugopal (previously at SentinelOne and Uber).

Tevogen Bio Bolsters Commercialization With Key Leadership Hire

In a move aimed at accelerating its path to commercialization, BioNJ Member Tevogen Bio has appointed health care industry veteran David E. Banko as Global Head of Government Affairs and Patient Access. The biotech firm, which specializes in AI-driven immunotherapy drug discovery, is positioning itself for growth in key therapeutic areas, including oncology, virology, neurology and rheumatology. Mr. Banko’s expertise in market access strategy, health policy and payer engagement will be critical as Tevogen advances its pipeline toward regulatory approval and market entry. Tevogen Bio, headquartered in Iselin, has been gaining attention for its innovative approach to immunotherapy, aiming to deliver accessible and cost-effective treatment options. The company’s latest leadership hire reflects a broader industry trend — biotech firms are increasingly prioritizing market access strategies earlier in the drug development process to ensure commercial viability.

Phathom Pharmaceuticals Announces Leadership Succession

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced that Steven Basta has been appointed President and Chief Executive Officer and a member of the Board of Directors, effective immediately. Mr. Basta succeeds Terrie Curran, who is stepping down as President and CEO and as a member of the Board of Directors for personal reasons. “We are excited to welcome Steve to Phathom during this important growth period for our company,” said Michael Cola, Chairman of Phathom. “Steve is an accomplished biopharmaceutical leader with a strong track record of developing and commercializing novel treatments and building growth-oriented organizations. To expand upon Phathom’s strong foundation, the Board seeks to further accelerate our commercial growth and believes Steve’s breadth of experience, extensive commercial expertise and passion for bringing novel therapies to patients will be extremely valuable as we continue getting VOQUEZNA® in the hands of patients in need.”

GSK Responsible Business Report 2024

Our purpose is to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of 2030, as a successful, growing company with strong momentum, where outstanding people can thrive.

We are committed to getting ahead of issues that matter for society and for the long-term performance of our company. Building trust by operating responsibly is integral to our strategy and our culture. This approach helps us deliver long-term growth, build trust with our stakeholders and reduce risk to our operations, supports our people to thrive and delivers health impact at scale.  

Annual Healthcare Symposium

April 16, 2025 | Hosted by Rutgers Business School

The biopharma industry’s primary focus is to develop and deliver innovative drugs that improve patient health by treating diseases, relieving suffering and extending life expectancy of the population. Through its research and development, the industry strives for delivering new treatments for unmet medical needs. The industry faces challenges in providing those treatment therapies and options to the society in an affordable way. It faces barriers and constraints in the delivery of the fruits of the innovations. It navigates complex regulatory landscape and reimbursement policies in providing access of the innovative therapies to the patients. The speakers at the symposium will share their thoughts and ideas on those issues and challenges in the development and the delivery of the innovative therapies.This is a free event.

C-SOPS Grand Opening

April 24, 2025 | Hosted by Rutgers University

Join us for the Grand Opening of our new labs in Cranbury. This state-of-the-art facility comprises 20,000 sq.ft. of prime pharmaceutical development space embedded within a 230,000 sq.ft. GMP building for commercial manufacturing, allowing us to greatly expand our experimental capabilities for solid dose, injectable, and inhalable products. The agenda includes a formal ceremony, a tour, several technical presentations, and seven stations to highlight some of the cutting-edge research being developed at our center. Dr. Muzzio will also share a perspective on future directions on advanced manufacturing technology and its potential role in reshoring drug manufacturing.

The Jersey City Summit

May 15, 2025 | Hosted by Roundtable & Advisory

Jersey City continues to evolve as one of the most dynamic urban centers in the region, and this transformation is once again set to take center stage at The Jersey City Summit for Real Estate Investment, Placemaking & Innovation 2025. Celebrating a special 10th anniversary, this event will take place on Thursday, May 15, 2025, with owners and venue partner, The 601W Companies. The Summit will be at Harborside – taking over the entire 4th Floor overlooking the Manhattan skyline. Harborside is well into a generational transformation with plans well underway to make it the epicenter of the Hudson waterfront and one of the region’s leading live-learn-work-play neighborhoods.

Students 2 Science STEM Volunteer Opportunities

Inspire the next generation of STEM leaders – Volunteer at Students 2 Science (S2S), a recognized leader in providing rigorous, hands-on STEM experiences for students in 5th-12th grades. S2S is currently recruiting volunteers for its in-lab ISAAC program, which offers rigorous, hands-on STEM experiences for middle and high school students in state-of-the-art laboratories in East Hanover and Newark, NJ. For more information, click here. To register to volunteer with S2S or if you have any questions, please email info@students2science.org or call (973) 947-4880 ext. 545.