US, UK Finalize Pharma Pricing Deal to Boost Innovation

The United States and the United Kingdom reached an agreement in principle on pharmaceutical pricing. The update comes as part of the U.S.–U.K. Economic Prosperity Deal (EPD). The Trump administration says the agreement aims to correct what U.S. officials describe as long-standing imbalances in pharmaceutical trade. The EPD will raise U.K. payments for innovative medicines as well as secure continued pharmaceutical investment in the United States. Under the deal, the United Kingdom will reverse the decade-long trend of declining National Health Service (NHS) expenditures on innovative, life-saving medicines and boost the net price it pays for new medicines by 25%. “BioNJ is pleased to see an announced agreement between the United States and the United Kingdom, intended to ensure that innovation progresses across both ecosystems,” BioNJ said in a statement. “While we look forward to the details of this deal, an accurate accounting of the value that therapeutics bring to Patients is central to enabling a thriving life sciences innovation ecosystem and to ensuring that Patients will be able to access that innovation."

The 340B Rebate Pilot Model: Weighing 340B Program Integrity Against Financial Stability for the Safety Net

Since 1992, the 340B drug discount program has entitled certain federal grantee clinics and hospitals to purchase outpatient drugs at substantial discounts. The discounted drugs can be used for all of the entity’s patients, even those insured patients who pay amounts substantially above the discounted price. In this case, the revenue from patients and insurers can be retained as profits that are widely understood to be intended to improve access to care for patients who rely on the safety net. At the time of its passage, 340B was expected to be a small program. In addition to the federal grantee clinics, fewer than one percent of hospitals participated in the first decade of the program.

How Will a Rebate Model Impact Cash Flow in the 340B Drug Pricing Program?

Discover how the shift to a rebate model in the 340B Drug Pricing Program could impact cash flow for hospitals and clinics. This white paper from IQVIA’s Market Access Technology Solutions team presents data-driven models comparing eight drug inventory and rebate scenarios, including the new HRSA rebate pilot, to quantify financing (interest) costs for covered entities. The analysis finds that, even under conservative assumptions, interest costs associated with the rebate model are minimal, less than half a percent of drug list price, and unlikely to pose a financial barrier. With clear explanations of discount mechanisms, inventory models and sensitivity analyses, this white paper offers essential insights for policy makers, manufacturers and healthcare providers navigating the evolving 340B landscape.

Follow-On Cancer Drugs Target Earlier Stages Than Initial Drugs

The article, titled “Follow-On Cancer Drugs Target Earlier Stages Than Initial Drugs: Implications of the IRA”, provides new empirical evidence on how oncology drug development patterns are evolving under the Inflation Reduction Act (IRA). Using a novel FDA dataset covering 184 oncology drug approvals from 2000 to 2024, the study finds that 41.8 percent of cancer drugs received at least one follow-on approval, and 59.7 percent of these follow-on indications targeted earlier disease stages than the original approval. On average, follow-on approvals represented a 0.54 stage reduction, reflecting movement toward earlier, more treatable stages. The analysis suggests that the IRA’s shortened exclusivity period may be influencing development strategies, shifting efforts from deep, sequential development to broader, horizontal expansion across tumor types and populations, particularly affecting small-molecule drugs.

Patient Perspectives on Health Insurance Design: A Mixed-Methods Analysis

There remains a persistent lack of patient-centered evidence on insurance reform and real-world experiences of patients with chronic disease. This study gathered insights around insurance design from chronic disease beneficiaries. This mixed-methods analysis comprised an online survey and virtual focus group sessions (August to December 2023) involving US residents with chronic disease and health insurance. Patients’ perspectives on insurance design were explored. Survey data were analyzed descriptively. Key themes were identified from focus group transcripts and direct observations. In total, 146 patients across 15 chronic diseases completed the survey; 29 then participated in focus groups. Although most beneficiaries were satisfied with their health plan, concerns centered on prescription medication affordability due to high deductibles and cost exposure, the disproportionate effects of cost exposure based on income, and the unpredictability of out-of-pocket costs.

Otsuka Receives FDA Accelerated Approval for VOYXACT® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults With Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression

Princeton-based BioNJ Member Otsuka Pharmaceutical, Co. Ltd. announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. VOYXACT is a self-administered, subcutaneous injection dosed every four weeks. VOYXACT was granted accelerated approval based on the VISIONARY Phase 3 interim analysis, where it achieved a significant placebo-adjusted treatment effect of 51% (P<0.0001) reduction in proteinuria at nine months (n=320) of treatment (50% VOYXACT vs 2% placebo). VOYXACT is the first and only therapy to block A-PRoliferation-Inducing-Ligand (APRIL). Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as a surrogate endpoint in IgAN clinical trials to support accelerated regulatory approvals.

Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents and Adults

Princeton-based BioNJ Member Otsuka Pharmaceutical Development & Commercialization, Inc. announce the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for centanafadine, once daily extended release capsules, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. The NDA submission is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations. In Phase 3 clinical studies with children, adolescents, and adults, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale – 5 (ADHD-RS-5) in adolescents and children, and the ADHD Investigator Symptom Rating Scale (AISRS) in adults.

Novartis Receives FDA Approval for Itvisma®, the Only Gene Replacement Therapy for Children Two Years and Older, Teens and Adults With Spinal Muscular Atrophy (SMA)

East Hanover-based BioNJ Member Novartis announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve) for the treatment of children two years and older, teens, and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene, making it the first and only gene replacement therapy available for this broad population. Itvisma is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population.

Genmab Announces EPKINLY® (epcoritamab-bysp) in Combination With Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma

Princeton-based BioNJ Member Genmab announced that EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE® FL-1 study that evaluated fixed duration EPKINLY + R2 compared to standard of care R2. In the study, treatment with fixed duration EPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13-0.33, p<0.0001) compared to R2. Median progression-free survival (PFS) was not reached (NR) among patients treated with EPKINLY + R2 (95% CI: 21.9-NR) compared to 11.2 months for patients treated with R2 (95% CI: 10.5-NR).

European Commission Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment Approved for Non-Cystic Fibrosis Bronchiectasis in the European Union

Bridgewater-based BioNJ Member Insmed Incorporated announced that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. BRINSUPRI is a first-in-class therapy, offering the first and only approved treatment indicated for NCFB in the European Union (EU). BRINSUPRI was reviewed under accelerated assessment by the EMA as it is deemed to be of major interest for public health. NCFB is a chronic and progressive disease that can lead to permanent lung damage and lung function decline. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection.

Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

Iselin-based BioNJ Member Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 27, 2025 action letter, which results in a 60 day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet AMD. ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD.

Soligenix Achieves Enrollment Milestone for Planned Interim Analysis in Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma

Princeton-based BioNJ Member Soligenix, Inc. announced that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The confirmatory Phase 3 study (Fluorescent Light Activated Synthetic Hypericin 2, FLASH2), builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent successful comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study. FLASH2 is a randomized, double-blind, placebo-controlled, multicenter study that is enrolling approximately 80 subjects with early stage CTCL. The study Data Monitoring Committee (DMC) is empowered to conduct one formal Interim Analysis when approximately 60% (n = 48) of the total patients have completed the primary endpoint evaluation (i.e., Week 18 or before).

Positive Phase 3 Results Support ZIIHERA® as HER2-Targeted Therapy-of-Choice and Combination With TEVIMBRA® and Chemotherapy as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma

Hopewell-based BioNJ Member BeOne Medicines Ltd. announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with or without PD-1 inhibitor TEVIMBRA® (tislelizumab), as first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus. Both ZIIHERA plus TEVIMBRA and chemotherapy and ZIIHERA plus chemotherapy demonstrated clinically meaningful and highly statistically significant improvements in progression-free survival (PFS) compared to the control arm, trastuzumab plus chemotherapy.

U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Hopewell-based BioNJ Member BeOne Medicines Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by data from the global, multicenter, single-arm, open-label, Phase 1/2 study, BGB-11417-201 (NCT05471843), which enrolled 125 adult patients with R/R MCL who received prior treatment with a BTK inhibitor. Sonrotoclax achieved its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), demonstrating clinically meaningful responses in this heavily pretreated population.

Eisai Completes Rolling Submission to U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status

Nutley-based BioNJ Member Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector, LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). Upon acceptance of the sBLA, the FDA will set a Prescription Drug User Fee Act (PDUFA) action date. The sBLA is supported by data evaluating subcutaneous administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE) following the 18-month core study in individuals with early AD.

Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan

Nutley-based BioNJ Member Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that Eisai has filed a new drug application for “LEQEMBI®” (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Mild Cognitive Impairment (MCI) due to Alzheimer‘s disease (AD) or mild stage of AD dementia (collectively referred to as early AD). It was confirmed that the once-weekly administration of SC-AI 500mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits.

New Data Presented at CTAD 2025 Confirms Pharmacological Effect of LEQEMBI® (lecanemab-irmb) on Neurotoxic Aβ Protofibrils in CSF

Nutley-based BioNJ Member Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF).The findings represent the results from a large-scale clinical study demonstrating, for the first time, that binding of lecanemab to PF can be measured in CSF, enabling further understanding of how lecanemab slows Alzheimer’s disease (AD) progression. AD is a progressive, relentless disease with Aβ and tau as hallmarks. It is caused by a continuous underlying neurotoxic process driven by PF that begins before amyloid plaque accumulation and continues after plaque removal. Only LEQEMBI fights AD in two ways: targeting both protofibrils and amyloid plaque, which can impact tau downstream. In a CSF sub-cohort (n=410) of the Phase III Clarity AD study, total PF concentration in CSF was quantified using an ultrasensitive assay.

EmphyCorp is the First Ever Rx Nonsteroidal Bronchodilator Nasal Spray With No Adverse Effects that Reduces or Eliminates the Rate and Severity of Coughing in Patients With Chronic Coughing and Uncontrolled Coughing

Flemington-based EmphyCorp Inc., a private corporation, with several de-risked late-stage patented drugs for a Non-Steroidal Bronchodilator Nasal Spray Drugs that simultaneously treats several medical endpoints including Chronic Coughing, Uncontrolled Coughing, Low Oxygen, Shortness of Breath, Fatigue and by increasing the synthesis of Nitric Oxide, kills viruses, bacteri, and fungi in the nasal passages. To date, Emphycorp has successfully completed (24) human Clinical Studies which include Phase 2 and Phase 3 Clinical Trials for Interstitial Lung Disease (Pulmonary Fibrosis with COPD, Idiopathic Pulmonary Fibrosis-IPF Coughing and Improved Lung Function, CF), Core Respiratory Diseases (COPD, Asthma), Allergic Rhinitis, Sinusitis, Long COVID, Flu, and COVID-19 treatments. EmphyCorp has Orphan Drug Designation for all Interstitial Lung Diseases.

Novo Nordisk Files for FDA Approval of a Higher Dose of Wegovy® Injection 7.2 mg

Plainsboro-based BioNJ Member Novo Nordisk announced the submission of a sNDA to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg, to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity. Under the CNPV expedited program, review is expected within 1-2 months following the FDA’s acceptance of the filing. The sNDA includes results from STEP UP, a 72-week Phase 3, randomized, double-blind, placebo controlled and active-controlled superiority trial that evaluated the efficacy and safety of once-weekly semaglutide 7.2 mg compared to placebo and semaglutide 2.4 mg, as an adjunct to lifestyle intervention, in 1,407 adults with obesity (BMI ≥30 kg/m2).

Novo Nordisk Phase 2 Trial With Amycretin Reports Significant Weight Loss and HbA1c Reduction in Type 2 Diabetes

Plainsboro-based BioNJ Member Novo Nordisk announced positive headline results from a Phase 2 clinical trial with amycretin in people with type 2 diabetes. This marks the first evaluation of amycretin in people with type 2 diabetes, further demonstrating Novo Nordisk’s commitment to advancing innovation in the treatment of type 2 diabetes. Amycretin is a unimolecular agonist of the glucagon-like peptide 1 (GLP-1) and amylin receptors, intended for once-weekly subcutaneous administration and once-daily oral administration. The trial investigated the efficacy, safety and pharmacokinetics of once-weekly subcutaneous amycretin and once-daily oral amycretin compared to placebo in 448 people with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor as standard of care. Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial. 

Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Mantle Cell 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 mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. The decision is based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled adult patients with relapsed or refractory MCL who had received at least two prior lines of therapy including a BTK inhibitor. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 82.7% (95% CI: 72.7–90.2) and complete response (CR) rate of 71.6% (95% CI: 60.5–81.1), the study’s primary and key secondary endpoints, respectively.

AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination With Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma

BioNJ Member AbbVie, with a site in Madison, announced that EPKINLY® (epcoritamab-bysp), a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab and lenalidomide (EPKINLY + R2) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). This approval of EPKINLY is based on results from the pivotal Phase 3 EPCORE® FL-1 study that evaluated fixed duration EPKINLY + R2 compared to standard of care R2 and demonstrates the potential of this combination therapy to reshape FL treatment and to reach patients earlier in their treatment. FL is typically an indolent (slow-growing) form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes and impacts approximately 15,000 new patients per year in the U.S. The disease is considered incurable with current available therapies.

AbbVie to Present Phase 3 ECLIPSE Data Demonstrating Atogepant (AQUIPTA®) Superiority Over Placebo in Achieving Pain Freedom for the Acute Treatment of Migraine at the 19th European Headache Congress

BioNJ Member AbbVie, with a site in Madison, announced primary results from the pivotal Phase 3 ECLIPSE study, evaluating the safety, efficacy and tolerability of atogepant (60 mg) versus placebo for the acute treatment of migraine in adults (with or without aura). The study met its primary and key secondary endpoints, with atogepant demonstrating superiority in pain freedom and freedom from most bothersome migraine symptom (MBS) two hours after treatment of the first migraine attack. The Phase 3 ECLIPSE study demonstrated that atogepant was superior to placebo in achieving pain freedom at two hours after treatment of the first migraine attack in adults with a history of migraine (with or without aura) (24.3% for atogepant vs. 13.1% for placebo; odds ratio 2.36, 95% CI [1.76, 3.15]; p<0.0001).

U.S. FDA Approves PADCEV® Plus Keytruda® for Certain Patients With Bladder Cancer

BioNJ Member Pfizer Inc., with a site in Parsippany, and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), in combination with the PD-1 inhibitor Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), as neoadjuvant treatment and then continued after cystectomy (surgery) as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. The approval of this perioperative (before and after surgery) treatment was based on results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). In the EV-303 study, perioperative treatment with PADCEV plus pembrolizumab resulted in a 60% reduction in the risk of tumor recurrence, progression or death compared to surgery alone, meeting the primary endpoint of event-free survival (EFS) (Hazard Ratio [HR]=0.40; 95% confidence interval [CI]: 0.28-0.57; p<0.0001).

Sanofi’s Teizeild Recommended for EU Approval by the CHMP for Patients With Stage 2 Type 1 Diabetes

Morristown-based BioNJ Member Sanofi announced the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Teizeild (teplizumab) to delay the onset of stage 3 T1D in adult and pediatric patients eight years of age and older with stage 2 T1D. The positive opinion is supported by positive data from the TN-10 Phase 2 study (clinical study identifier: NCT01030861), which demonstrated that Teizeild significantly delayed the onset of stage 3 T1D by a median of approximately two years compared to placebo. At the end of the study, the proportion of patients who remained in stage 2 T1D was twice as high in the Teizeild group as in the placebo group (57% vs 28%). 

Sanofi and Regeneron’s Dupixent Approved as the First Targeted Medicine in the EU in Over a Decade for Chronic Spontaneous Urticaria

Morristown-based BioNJ Member Sanofi and BioNJ Member Regerneron, with a site in Basking Ridge, announce the European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti- immunoglobulin-E (IgE) therapy for CSU. Eligible patients can use Dupixent as a first-line targeted treatment option. The approval is based on data from two phase 3 clinical studies in the LIBERTY-CUPID program (NCT04180488). Study A and Study C included 284 patients aged 12 years and older who were symptomatic despite the use of antihistamines and who were naïve to anti-IgE therapy.

EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. The FDA also approved an every 4-week (monthly) dosing option for some patients who may benefit from resuming this dosing schedule across approved indications: wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and RVO. The FDA approval for the treatment of RVO is based on data from the Phase 3 QUASAR trial that evaluated the efficacy 

Libtayo® (cemiplimab) Approved in the European Union as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) With High Risk of Recurrence after Surgery and Radiation

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the European Commission (EC) has approved the PD-1 inhibitor Libtayo® (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. This expands the existing European Union (EU) indication for Libtayo in advanced CSCC to include patients at high risk of disease recurrence. Libtayo was also recently approved by the U.S. Food and Drug Administration (FDA) in October for the same indication. The approval is supported by data from the global Phase 3 C-POST trial, which evaluated adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation.

Regeneron and Tessera Therapeutics to Jointly Develop TSRA-196, an Investigational Gene Editing Therapy for Alpha-1 Antitrypsin Deficiency (AATD)

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, and Tessera Therapeutics, Inc. announced a global collaboration to develop and commercialize TSRA-196, Tessera’s lead investigational in vivo Gene Writing program for the treatment of alpha-1 antitrypsin deficiency (AATD), an inherited monogenic disease that can affect the lungs, liver, or both organs, and currently impacts approximately 200,000 people in the U.S. and Europe. TSRA-196 is designed to precisely correct the genetic mutation underlying AATD, with the goal of restoring production of functional alpha-1 antitrypsin (AAT) protein through a one-time, durable treatment option for patients. Tessera expects to file an Investigational New Drug and multiple Clinical Trial Applications for TSRA-196 with the U.S. Food and Drug Administration (FDA) by the end of the year.

Made Scientific and Cellergy Therapeutics Partner to Accelerate Pioneering Mitochondrial Therapy CLG-001 into Clinical Trials

Princeton-based BioNJ Member Made Scientific and Cellergy Therapeutics Ltd., a biotechnology company focused on mitochondrial transplantation therapies, announced a strategic manufacturing partnership. The collaboration is designed to advance Cellergy’s innovative mitochondrial therapy, CLG-001, toward its first-in-human clinical studies in both the U.S. and Israel. CLG-001 represents a novel therapeutic strategy, utilizing mitochondria purified from healthy donors to restore cellular energy production in patients. This approach targets conditions driven by mitochondrial dysfunction, including metabolic disorders, neurodegenerative diseases and age-related conditions. Under the agreement, Cellergy will leverage Made Scientific’s Good Manufacturing Practice (GMP) capabilities to scale and implement its proprietary mitochondrial isolation and purification process.

Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Princeton-based BioNJ Member Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd. and Cullinan Therapeutics, Inc. announced the companies have initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations who have previously received platinum-based systemic chemotherapy. Zipalertinib previously received Breakthrough Therapy Designation in 2021, which with FDA agreement, allows submission of portions of the application as they are completed. The companies anticipate completion of the NDA submission in the first quarter of 2026 with an associated request for priority review.

SCYNEXIS Lands Key Role in $35M Federal Grant to Combat Drug-Resistant Fungi

Jersey City-based BioNJ Member SCYNEXIS, Inc. said it was selected to participate in a major federal research effort aimed at combating the global health threat posed by drug-resistant fungal infections. The company’s novel antifungal compounds, known as fungerps, are among the projects funded by a new, five-year grant expected to provide $7 million annually to an academic consortium. The federal funding, contingent upon the availability of funds from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), will establish a Center of Excellence in Translational Research (CETR). This CETR is jointly led by researchers from the Hackensack Meridian Center for Discovery and Innovation (CDI) in New Jersey and the Johns Hopkins Bloomberg School of Public Health, alongside other academic and commercial partners.

SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced that it has completed the transfer of the BREXAFEMME (ibrexafungerp) New Drug Application (NDA) to BioNJ Member GSK. “We are pleased to announce this important milestone for SCYNEXIS. With the transfer of the BREXAFEMME NDA now complete, GSK will be able to initiate regulatory interactions with the U.S. Food and Drug Administration (FDA) to discuss the relaunch of BREXAFEMME for vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) in the U.S. market,” said David Angulo, M.D., President and Chief Executive Officer. “Furthermore, SCYNEXIS stands to receive net sales milestones and royalties following the relaunch providing a significant future source of non-dilutive capital.”

GSK and LTZ Announce Strategic Collaboration to Advance Novel Myeloid Cell Engagers in Oncology

Warren-based BioNJ Member GSK and LTZ Therapeutics announced a strategic research collaboration to advance the development of novel myeloid cell engagers (MCEs) to address significant unmet need in oncology. The research collaboration aims to develop up to four potential first-in-class MCE therapies targeting hematologic cancers and solid tumors. The agreement grants GSK an exclusive option to license worldwide development and commercial rights for these pre-clinical therapies. MCEs are an emerging class of immuno-oncology treatments designed to use the body’s own immune system to recognize and kill tumor cells, providing a novel approach to target cancers with a favorable safety profile. Myeloid cells make up a significant majority of tissue resident immune cells in the body, providing potential for a broad and sustained infiltration of tumors when they are used to target and kill cancerous cells. 

FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Perioperative Treatment for Adults With Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population. These approvals are based on data from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas.

European Commission Approves Subcutaneous Administration of KEYTRUDA® (pembrolizumab) for All Adult Indications Approved in the European Union

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection) of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. KEYTRUDA SC™, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], is a subcutaneous injection containing pembrolizumab and berahyaluronidase alfa and has been approved for use across all 33 KEYTRUDA indications for adult patients in Europe. Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc.

Merck’s WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint in Phase 2 CADENCE Study in Adults With Combined Post- and Precapillary Pulmonary Hypertension (CpcPH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Rahway-based BioNJ Member Merck & Co. announced positive topline results from the Phase 2 CADENCE study evaluating WINREVAIR™ (sotatercept-csrk) in adults for the treatment of combined post- and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction. CADENCE met its primary endpoint, showing a statistically significant and clinically meaningful reduction in pulmonary vascular resistance from baseline at 24 weeks compared to placebo. Based on a preliminary assessment, the safety profile observed in the CADENCE study was generally consistent with the known safety profile for WINREVAIR. WINREVAIR is U.S. Food and Drug Administration (FDA) approved as an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO* Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events.

Merck Announces Positive Topline Results from the Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) in Treatment-Naïve Adults With HIV-1 Infection

Rahway-based BioNJ Member Merck & Co. announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve) (MK-8591A-053). The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels <50 copies/mL at Week 48, was met, with DOR/ISL demonstrating non-inferiority to once-daily oral bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50 mg/200 mg/25 mg)]. The primary safety objective of the trial was also met, with the safety profile of DOR/ISL being comparable to BIC/FTC/TAF.

Johnson & Johnson Receives European Commission Approval of IMAAVY®▼ (nipocalimab), a New FcRn Blocker Offering Sustained Disease Control in a Broad Population of People Living With Generalized Myasthenia Gravis (gMG)

New Brunswick-based BioNJ Member Johnson & Johnson announced announced that the European Commission has approved a Marketing Authorisation for IMAAVY^®▼(nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). gMG is a chronic, incurable autoantibody disease that causes debilitating symptoms such as muscle weakness, difficulty chewing, swallowing and speaking. This approval is for the treatment of a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody-positive.

Johnson & Johnson Set to Revolutionize the Treatment of Cancer With the Acquisition of Halda Therapeutics

New Brunswick-based BioNJ Member Johnson & Johnson announced that it has entered into a definitive agreement to acquire Halda Therapeutics OpCo, Inc., a clinical-stage biotechnology company with a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTACTM) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer, for $3.05 billion in cash. The transaction is expected to close within the next few months, subject to antitrust clearance and other customary closing conditions. The lead candidate, HLD-0915, is a clinical-stage therapy for prostate cancer, of which new diagnoses are projected to reach 1.7 million globally by 2030. Given the existing unmet need, this once-daily therapy has the potential to transform patient outcomes with its novel precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment. 

New Long-Term Data Reinforces TREMFYA® (Guselkumab) as the Only IL-23 Inhibitor Proven to Substantially Inhibit Structural Joint Damage in Active Psoriatic Arthritis

New Brunswick-based BioNJ Member Johnson & Johnson announced new data from the Phase 3b APEX study showing that TREMFYA® continued to reduce both signs and symptoms of active psoriatic arthritis (PsA) and inhibit progression of structural damage at 48 weeks. These data were presented at the Inflammatory Skin Disease Summit (ISDS) 2025. At Week 24, TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo with results consistent for patients with active PsA receiving TREMFYA® every four weeks (Q4W) or every eight weeks (Q8W), as assessed by the PsA-modified van der Heijde-Sharp (vdH-S) score. The inhibition of structural joint damage was sustained through Week 48.

Kyowa Kirin Announces Initiation of Phase 3 AOBA Study of KK8398 (Infigratinib) in Patients With Achondroplasia in Japan

BioNJ Member Kyowa Kirin Co., Ltd., with a site in Princeton, and Kura Oncology announced that the first patient has been dosed on November 20 in the AOBA study (jRCT2031240562), initiating the Phase 3 clinical study in Japan of KK8398 (infigratinib), an investigational FGFR1–3 oral inhibitor, for patients with achondroplasia. The AOBA study is a multicenter, open-label, single-arm Phase 3 study being conducted domestically. This Phase 3 study in Japan will evaluate the efficacy and safety of KK8398 in approximately six patients aged 3 to under 18 years, with a 52-week treatment and observation period. The primary endpoint is annualized height growth velocity; secondary endpoints include growth and body proportion parameters, quality of life (QOL), and safety measures. The study seeks to provide a new treatment option in Japan while aligning with data from global studies.

KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)

BioNJ Member Kyowa Kirin Co., Inc., with a site in Princeton, announced KOMZIFTI™ (ziftomenib), the first and only once-daily oral menin inhibitor to be approved for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, has been included in the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a Category 2A recommended treatment option for adults with relapsed/refractory AML with NPM1 mutation. KOMZIFTI received full approval by the U.S. Food and Drug Administration on November 13, 2025, for the treatment of adults with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The approval was supported by data from the KOMET-001 clinical trial, including a 21.4% CR/CRh rate and median duration of CR/CRh response of 5 months.

U.S. FDA Approves Expanded Indication for Lilly's Jaypirca (pirtobrutinib), the First and Only Non-Covalent (reversible) BTK Inhibitor, for Adults With Relapsed or Refractory CLL/SLL Previously Treated With a Covalent BTK Inhibitor

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) has granted approval to Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor. This FDA action expands the Jaypirca label to include patients earlier in their treatment course and also converts the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval. Jaypirca, the first and only FDA-approved non-covalent (reversible) BTK inhibitor, is a highly selective kinase inhibitor that utilizes a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in patients with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).

LEO Pharma Announces Positive Topline 32-Week Key Results in ADHAND Trial

LEO Pharma, with a site in Madison, announced positive topline key results from the 32-week analysis of the Phase 3b ADHAND trial evaluating tralokinumab for the treatment of adult patients with atopic dermatitis with moderate-to-severe hand involvement, who are candidates for systemic therapy. ADHAND is a Phase 3b, interventional, adaptive, placebo-controlled clinical trial evaluating the efficacy and safety of tralokinumab 300 mg administered every two weeks as a monotherapy compared with placebo in patients living with moderate-to-severe atopic dermatitis on the hands who are candidates for systemic therapy. After the first 16 weeks double-blinded treatment period, all patients received open-label, 300 mg tralokinumab every 2 weeks for 16 weeks.

Lupin Launches Risperidone Long-Acting Injectable With 180-day CGT Exclusivity in the U.S., the First Product from its Proprietary Long-Acting Injectable Platform PrecisionSphere™

Lupin Limited, with a site in Bridgewater, announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials, with 180-day CGT exclusivity in the U.S. This follows the recent approval received from the United States Food and Drug Administration (U.S. FDA). This is Lupin’s first product using proprietary technology from PrecisionSphereTM, the long-acting injectable (LAI) platform developed by Lupin’s subsidiary Nanomi B.V.’s (Nanomi). Nanomi’s LAI platform has demonstrated efficacy and safety in drug delivery. Its proprietary PrecisionSphereTM technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. Lupin is expanding the reach of its PrecisionSphere™ technology by fostering collaborations with companies looking to extend their product lifecycles.

The Palisades Difference: Entrepreneurial Science Meets Mechanism-Driven Development

Cliffside Park-based Pop Test Oncology dba Palisades Therapeutics operates differently. As an entrepreneurial biotech operating at the intersection of precision oncology and regenerative medicine, Palisades has cultivated a culture that defies conventional pharmaceutical thinking. Their leadership doesn't assign scientists to narrow jobs — they empower them to think like entrepreneurs. To ask questions. To follow mechanisms where they lead, not where org charts dictate. This philosophy has yielded remarkable insights into PT150 and PT157, their lead glucocorticoid receptor (GR) antagonists. PT150 is advancing for advanced prostate cancer, where it demonstrates superior anti-metastatic efficacy compared to standard-of-care enzalutamide. PT157, its dimer analog, extends this mechanism with enhanced bioavailability and patent exclusivity potential. The compelling oncology data — validated through both in vivo zebrafish tumor xenograft models and transcriptomic pathway analysis—positions these compounds as next-generation anti-metastatic agents.

TPR1: Universal Precision Medicine for Drug-Resistant TB & Hard-to-Treat Respiratory Infections – A New Platform from Palisades Therapeutics

Cliffside Park-based Pop Test Oncology LLC operating as Palisades Therapeutics has developed TPR1, a universal anti-mycobacterial platform showing nanogram potency against resistant TB and the hard-to-treat NTM infections—M. avium, M. abscessus—that disproportionately devastate cystic fibrosis patients and immunocompromised populations. And unlike existing TB drugs, TPR1 achieves this with an exceptional 1,000-fold safety margin and zero of the dose-limiting toxicities that plague current regimens. The Platform Advantage: Our theranostic approach combines TPR1 (and related compounds PT159/PT160) with IHoP, the first diagnostic that detects TB-driven organ damage—specifically pancreatic disruption—before it becomes irreversible. This isn't just companion diagnostics; it's real-time patient protection integrated into treatment optimization.

The 'Undruggable' Myth Ends Here: Introducing PT162—A New Architecture for p53 Reactivation

In an industry where "undruggable" targets like p53 often lead to billions in failed research, the conventional playbook—chasing single "magic bullet" molecules—has hit a wall. Yet, while Big Pharma retreats to safer bets, Pop Test Oncology operating as Palisades Therapeutics has advanced a breakthrough that defies standard classification. Introducing PT162: The First Tri-Embodiment Architecture Engineered to Restore the "Guardian of the Genome." The Challenge: Mutant p53 drives ~50% of metastatic cancers, yet effective reactivators have remained elusive due to toxicity and poor bioavailability. The industry standard has been "one drug, one target," a strategy that fails to address the complexity of mutation-driven resistance. The Solution: PT162’s Tri-Embodiment Architecture Leveraging our "brain trust" model of entrepreneurial science, we have engineered a proprietary platform featuring three distinct, progressively active molecular embodiments designed for true precision medicine:

Citius Oncology Announces U.S. Commercial Launch of LYMPHIR™, a Novel Cancer Immunotherapy for Cutaneous T-Cell Lymphoma (CTCL)

Cranford-based Citius Oncology, Inc. announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (r/r) Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA approval of LYMPHIR was based on data from Pivotal Study 302 (NCT01871727), which evaluated the efficacy and safety of LYMPHIR in patients with Stage I–III CTCL who had received at least one prior systemic treatment. The study demonstrated an Objective Response Rate (ORR) of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. Moreover, LYMPHIR demonstrated meaningful activity on severe pruritus (itchiness), a significant quality of life issue for CTCL patients.

Sandoz Launches Afqlir® (aflibercept) in Europe, Providing Affordable Treatment Option for Patients With Retinal Diseases

Princeton-based Sandoz announced the European launch of Afqlir® (aflibercept). Afqlir®, a 2 mg vial kit and pre-filled syringe for intravitreal injection, was approved by the European Commission in November 2024 for the same indications in adult patients as the reference medicine, Eylea®, namely the treatment of various retinal diseases to prevent disease-related blindness. Studies confirm that Afqlir® matches the reference medicine in efficacy, safety and pharmacokinetics. Aflibercept is considered a gold standard for treating various neovascular retinal diseases. Conditions like age-related macular degeneration (AMD), retinal vein occlusion (RVO) and diabetic macular edema (DME) are leading causes of vision loss and their global prevalence is increasing.

Sandoz Launches TYRUKO® (natalizumab-sztn) in U.S., as First and Only Multiple Sclerosis Biosimilar

Princeton-based Sandoz announced that TYRUKO® (natalizumab-sztn) is available to patients in the US. Developed by Polpharma Biologics, TYRUKO® is the first and only US Food and Drug Administration (FDA) approved natalizumab biosimilar for the treatment of relapsing forms of multiple sclerosis (MS). TYRUKO® is approved by the FDA as monotherapy to treat all indications covered by reference medicine Tysabri®(natalizumab), including relapsing forms of MS and Crohn’s disease in adults. TYRUKO® is available through a Risk Evaluation and Mitigation Strategy (REMS) program designed to inform prescribers, infusion site healthcare providers and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with natalizumab, including increased risk of PML with the presence of anti-JCV antibodies, longer treatment duration and prior immunosuppressant use. 

Evotec-Partner Bayer Starts Phase 2 Study for Treatment of Patients With Alport Syndrome

Princeton-based Evotec SE announced that its partner Bayer AG has initiated a Phase 2 clinical study of a kidney disease program originating from the multi-target research collaboration between Evotec and Bayer in kidney diseases. Under the terms of the collaboration agreement, Evotec is eligible to receive a milestone payment upon first patient dosing, which is expected in early 2026. The study drug, BAY 3401016, a monoclonal antibody (“mAb”) targeting the protein Semaphorin-3A (“Sema3A”) is being developed as a potential treatment for Alport syndrome, a rare genetic kidney disease. Bayer’s ASSESS study is a randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome. The program originates from a strategic collaboration, which Evotec and Bayer entered in August 2016.

Teva Launches Rise: A Global Open Innovation Platform to Accelerate AI, Industry 4.0, Smart Manufacturing, Digital Health and Biotech Breakthroughs for Pharma’s Biggest Challenges

Parsippany-based BioNJ Member Teva Pharmaceutical Industries Ltd. unveiled Teva Rise, a global open innovation platform designed to harness the power of a variety of disruptive technologies including AI, industry 4.0 smart manufacturing, digital health and biotech, by connecting startups and technology companies with Teva’s business units. The initiative aims to co-create solutions for the challenges faced by the pharmaceutical industry, and to drive patient impact and business transformation in line with Teva’s Pivot to Growth strategy. The launch of Teva Rise comes at a pivotal moment for the pharmaceutical industry, as AI and digital transformation reshape and accelerate drug development, manufacturing and patient care. By opening its doors to global innovators, Teva is accelerating the adoption of next-generation technologies and strengthening its transformation into a leading biopharmaceutical company. 

GSK and Fleming Initiative Scientists Unite to Target AMR With Advanced AI

Warren-based BioNJ Member GSK and the Fleming Initiative announced six major new research programs, called ‘Grand Challenges’ which harness some of the best scientific expertise and the latest technologies, including advanced AI, to find new ways to slow the progress of antimicrobial resistance (AMR). According to the recent (October 2025) WHO GLASS Report highlighting a worsening global AMR situation, around one in six laboratory confirmed bacterial infections were caused by bacteria resistant to antibiotics. Annual deaths associated with AMR are predicted to rise by 74.5% from 4.71m in 2021 to 8.22 million in 2050. The Fleming Initiative – a groundbreaking collaboration established by Imperial College London and Imperial College Healthcare NHS Trust – brings together research scientists, policymakers, clinicians, behavioral experts, public and commercial partners to provide the networks, expertise and skills to provide equitable solutions to AMR at a global scale.

Apimeds and MindWave Announce Merger, Integrating Biotech Growth With AI-driven Digital Treasury

Apimeds Pharmaceuticals, a Matawan company, recently announced a merger with MindWave Innovations, aimed at improving biopharmaceutical innovation and digital-asset financial technology. The merger will be supported by a simultaneous PIPE of up to $100 million to advance Apimeds’ clinical programs and expand MindWave’s digital asset infrastructure. MindWave is a global leader in AI-driven Bitcoin and yield-generation technologies, with its platform is designed to help institutions securely hold, manage, and generate yield from Bitcoin reserves. Apimeds focuses on developing non-opioid, biologic-based therapies for pain management. Its lead product candidate, Apitox, is in late-stage clinical development for the treatment of knee osteoarthritis.

Governor’s STEM Scholars Selects 101 Future Innovators for 2025-2026 Class

The Governor’s STEM Scholars has selected 101 outstanding New Jersey high school and college students to join its 2025-2026 class, representing the next generation of scientists, engineers, and innovators advancing the State’s research and development economy. A public-private partnership between the Research & Development Council of New Jersey, the Office of the Governor, the New Jersey Department of Education, the Office of the Secretary of Higher Education and the State’s leading research institutions, the Governor’s STEM Scholars works to strengthen New Jersey’s STEM talent pipeline by connecting students directly with the people and places powering innovation across the Garden State. Throughout the year, scholars will immerse themselves in the world of STEM (Science, Technology, Engineering and Math) through hands-on learning and professional engagement.

NEST Center Launches Multi-Million Dollar Amenity Overhaul to Boost Innovation Ecosystem

The Northeast Science and Technology (NEST) Center, a prominent life sciences and technology campus in Kenilworth, is set to undergo a major transformation with the kickoff of a multi-million-dollar renovation focused on enhancing its communal and amenity spaces. The joint venture partnership that owns the campus announced the start of a project that will renovate and create over 75,000 square feet of central amenity and common space. The upgrades will primarily focus on the 1.2 million-square-foot 15 NEST building, aiming to establish a collaborative, cutting-edge campus ecosystem for both current and future tenants, which already include the New Jersey Institute of Technology, Revlon and CoreWeave.

RWJUH Named National Rare Disease Center of Excellence

The National Organization for Rare Disorders has designated Robert Wood Johnson University Hospital, in partnership with Rutgers Robert Wood Johnson Medical School, a National Rare Disease Center of Excellence, the RWJBarnabas Health facility.  RWJUH is the first hospital in the state to receive the designation. Across the nation, there are fewer than 50 such Centers of Excellence. “This prestigious designation highlights our academic medical center’s deep commitment to delivering world-class, multidisciplinary care and advancing research that holds the promise of breakthroughs for patients with rare and complex conditions,” said Bill Arnold, CEO of RWJUH, president of the RWJBarnabas Health Southern Region and executive vice president of RWJBarnabas Health. 

Robert Wood Johnson Medical School Student Wins N.J. Entrepreneur Award

Medical school student and entrepreneur Joy Xie won the top prize in the Global Student Entrepreneur Awards event held by the Entrepreneurs’ Organization New Jersey Chapter. Xie, a second-year medical student at Rutgers Robert Wood Johnson Medical School and co-founder of Clinisynq, a digital platform designed to support clinical trials, was one of seven student entrepreneurs competing to win $5,000. Xie will represent the Garden State in the GSEA U.S. Nationals on Jan. 26, 2026. Xie, who holds a bachelor’s degree in molecular biology from Princeton University with minors in finance and global health, co-founded Clinisynq with three other medical students. This platform aims to improve clinical trial efficiency by supporting medication adherence, enabling real-time adverse event reporting and improving communication between patients and research teams.

NJEDA Aspire Tax Credits Awarded to Support Phase 3 of HELIX in New Brunswick

The New Jersey Economic Development Authority (NJEDA) Board recently approved a tax credit award under the Aspire Program for Phase 3 of the New Jersey Health + Life Science Exchange (HELIX) building in New Brunswick. Known as H-3, the proposed development consists of a 42-story, nearly 560,000-square-foot mixed-use tower that will include affordable residential units, commercial office space, specialized laboratories, and housing for Rutgers School of Medicine students. The HELIX will bring together New Jersey’s public, private, and academic sectors to create a world-class hub of innovation and a strong base of support and talent pipeline for innovative companies. “The HELIX exemplifies Governor Murphy’s vision to drive inclusive economic growth and strengthen New Jersey’s position as a national leader in discovery and innovation,” said NJEDA Chief Executive Officer Tim Sullivan. 

Whitehawk Therapeutics Appoints Dr. Margaret Dugan as Chief Medical Officer

Morristown-based Whitehawk Therapeutics announced the appointment of Dr. Margaret Dugan, as its Chief Medical Officer. Dr. Dugan brings more than 30 years of global oncology drug development experience, with deep expertise in early-stage clinical development and regulatory strategy, positioning Whitehawk to advance its ADC programs toward clinical trials. Dr. Dugan’s career includes more than 15 years at Novartis, where she built and led the early development organization, advancing multiple programs from proof-of-concept to full clinical development and supporting global regulatory approvals. She has overseen more than 12 Phase 1 programs and was responsible for numerous regulatory approvals, including capmatinib, ceritinib and temozolomide.

BD Appoints Technology and Finance Veterans to Board, Bolstering Expertise in AI and Digital Strategy

Franklin Lakes-based BD (Becton, Dickinson and Company) announced the appointment of Robert “Robbie” Huffines and Jacqueline “Jacky” Wright to its board of directors. The appointments are aimed at strengthening the board’s expertise in key strategic areas —particularly digital transformation, Artificial Intelligence (AI), finance and health care. The addition of Mr. Huffines and Ms. Wright marks the appointment of three new independent directors in 2025, demonstrating BD’s ongoing commitment to strong corporate governance and regular board refreshment. Mr. Huffines is a Former Global Chairman of Investment Banking at J.P. Morgan Chase & Co. Meanwhile, Ms. Wright most recently served as the first Chief Technology and Platform Officer at McKinsey & Company.

The 3 Rivers Venture Fair

February 4 & 5, 2026 | Organized by Pittsburgh Venture Capital Association (PVCA)

The 3 Rivers Venture Fair (3RVF), the premier venture conference in the Ohio Valley region, returns on February 4 & 5 at the Rivers Casino Events Center! Every eighteen months, hundreds of investors, entrepreneurs, and top-tier service providers from around the world gather in Pittsburgh for this two-day meeting of ideas and investments. Don't miss out on this chance to propel your startup forward! Visit 3rvf.com/apply to get started.

Doing Business in Eurasia

Throughout Spring 2025 - Fall 2026 | Hosted by Mid-Atlantic - Eurasia Business Council

Mid-Atlantic - Eurasia Business Council is pleased to invite you to its Doing Business in Eurasia seminar series that will be taking place throughout Spring 2025 - Fall 2026. The upcoming seminars organized by the Mid-Atlantic - Eurasia Business Council will be held in Philadelphia, PA; Harrisburg, PA; Wilmington, DE; Pittsburgh, PA; New York, NY; Allentown, PA; Baltimore, MD; and Princeton, NJ. The Doing Business in Eurasia seminar series addresses emerging business opportunities for foreign companies and discusses the legal and regulatory environment in Eurasian countries, including Central Asia, Eastern Europe and European Union.

Community Colleges, NJBIA to Report Out on Career Pathways Projects

The State’s community colleges and NJBIA have scheduled a series of online presentations that will update the public on the progress of various Pathways to Career Opportunities initiatives related to rapidly growing industries where highly skilled workers are in-demand. Leaders in business, industry, labor unions, workforce development boards, county vocational-technical schools, colleges and universities and community-based organizations are urged to participate in these collaborative meetings to gain insights into work that’s shaping the future of the workforce in these five sectors: Manufacturing & Supply Chain Management; Technology & Innovation; Health Services; Infrastructure & Energy; and Emerging Industries.  

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.