BioNJ’s Hart Talks Investment, Innovation in NJ

Debbie Hart has long been one of the most influential figures in New Jersey’s life sciences sector. As the founding President and CEO of BioNJ, Hart has spent more than three decades shaping the state’s innovation ecosystem as well as advocating for companies working at the forefront of biotechnology and medical research. Her leadership extends beyond the organization itself: Hart also chairs the New Jersey Commission on Science, Innovation and Technology. At CSIT, she plays a central role in advancing the State’s strategy around research, commercialization and high-growth technology development. With no shortage of things happening in a life sciences sector undergoing rapid change — and with a new administration preparing to take office here in Jersey, on the heels of a new federal administration — NJBIZ sat down with Hart to discuss the state of the industry, the challenges and opportunities ahead, and how BioNJ is positioning New Jersey to stay competitive.

BioNJ’s Hart on Policy, AI and What’s Next for NJ Life Sciences

This continues NJBIZ’s two-part conversation with Debbie Hart, President and CEO of BioNJ, as the discussion shifts from recent momentum in New Jersey’s life sciences sector to the forces shaping its next chapter. In part two, the conversation turns to collaboration and policy — from large-scale public-private partnerships such as HELIX in New Brunswick to the challenges of navigating federal tariffs and regulatory signals. Hart also weighs in on the growing role of artificial intelligence in health care and drug development, manufacturing and workforce trends, and BioNJ’s priorities as it works to support companies across the full life sciences continuum in the year ahead.

‘Totes of Hope’ Touch Young Hearts at BioNJ Gives Back Event

Some 200 employees from many of the State’s life sciences companies gathered last week at Insmed and Sanofi to fill “Totes of Hope: Hospital Care Kits.” The tote bags, each filled with a box of crayons, a coloring book, playing cards, a blanket, ginger candy and nonslip socks, to name a few items, will soon make their way to cancer patients at the Jack & Sheryl Morris Cancer Center in New Brunswick. These volunteers took part in the second annual “BioNJ Gives Back” event which, according to BioNJ President and CEO Debbie Hart, “Celebrates the power of community and compassion where employees give from the heart.” “I can tell you, when our patients receive these gifts, their faces light up. It means so much to them, especially when they’re in a hospital and going through cancer treatment,” said Kathleen Arcidiacono, Vice president of Nursing at the Jack & Sheryl Morris Cancer Center, which is affiliated with RWJBarnabas Health and the Rutgers Cancer Institute.

The Power of Community in Inflammatory Bowel Disease

For the millions of people in the United States living with inflammatory bowel disease (IBD), its impact goes well beyond physical symptoms. IBD is an immune-mediated disease where the immune system responds to perceived threats by primarily attacking the gastrointestinal (GI) tract. It is often described as an “invisible illness,” as symptoms are not always immediately apparent to others. While someone with IBD may look healthy from the outside, the reality is that they may be experiencing abdominal pain, diarrhea, fatigue, brain fog, mental health challenges, and more. Given the unpredictable and potentially embarrassing symptoms and physical signs of the disease, such as frequent or urgent bathroom use, perianal fistulae, an ostomy, and/or fatigue, people with IBD may feel the disease limits their ability to venture far from home or socialize comfortably and be fully present at work.

A University Patent Royalty Tax Would Sabotage America’s Innovation Engine

Commerce Secretary Howard Lutnick has proposed a 50% tax on the royalties that universities earn from licensing patented discoveries made with federal grants. This tax would undermine the Bayh-Dole Act and make it harder for universities to collaborate with private companies to turn federally funded research into groundbreaking new products that grow the economy, create jobs, and generate tax revenue. Most university tech transfer offices already operate at a loss. Taking up to half of their revenue on the most successful patented discoveries would inevitably force schools to cut resources for tech transfer efforts. In a recent poll, 94% of Bayh-Dole Coalition members warned universities would struggle to maintain current licensing levels if the tax is implemented. Congress foresaw this danger over 45 years ago.

House Passes BIO-backed Legislation to Increase Access to Capital

Legislation to free up capital for small innovative firms by removing regulatory barriers for both companies and investors passed the House―a move praised by the Biotechnology Innovation Organization (BIO). The Incentivizing New Ventures and Economic Strength Through Capital Formation (INVEST) Act was introduced by House Financial Services Committee Chair French Hill (R-AR) with Gregory Meeks (D-NY) and other co-sponsors from both parties. The bill expands access to capital and while increasing investment and ownership opportunities, “to ensure policy encourages responsible innovation and keeps the interests of startups and small businesses―the economic engine of this country―front and center,” according to the coalition letter.

What IRA Drug Prices Will Mean for PBMs, Health Plans and Patients

As the first wave of negotiated Medicare Part D drug prices takes effect in January 2026, drug pricing experts say complicated subplots are brewing beneath the surface of the overall story of lower drug prices. Although the program is designed to reduce drug costs for the Medicare program, the reality is proving to be less straightforward, and there may be a spillover impact into the commercial market. Experts warn that the savings from Medicare price negotiation may not materialize as hoped, and that payers are expected to respond by applying increased utilization management for the negotiated drugs as a way to manage the costs of implementing this much-anticipated provision of the Inflation Reduction Act (IRA).

Acadia Pharmaceuticals Announces FDA Approval of DAYBUE® STIX (trofinetide) for Oral Solution, a New Powder Formulation of Trofinetide for the Treatment of Rett Syndrome

Bridgewater-based BioNJ Member Acadia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE® STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. The new formulation is expected to deliver the same efficacy and safety profile of DAYBUE oral solution, while offering children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their DAYBUE treatment. The efficacy and safety of DAYBUE STIX is based on the results of the LAVENDER™ study with DAYBUE oral solution in patients with Rett syndrome.

Genmab Announces Data From Multiple Clinical Trials Showing Treatment With Fixed-Duration Epcoritamab Led to Remissions in First-Line Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

Princeton-based BioNJ Member Genmab announced updated results from two ongoing clinical trials evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging antibody administered subcutaneously, as a monotherapy and in combination with other standard of care treatments in adult patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Results from two arms of the EPCORE® NHL-2 trial, evaluating first-line, fixed-treatment duration epcoritamab in combination with chemotherapies, demonstrated overall response rates (ORR) of 93% (Arm 8) and 98% (Arm 1) in patients with newly-diagnosed DLBCL, while a third arm (Arm 3) demonstrated a three-year overall survival (OS) rate of 96% in patients with FL following first-line combination treatment. In EPCORE DLBCL-3, the ORR was 73% in elderly patients with DLBCL treated with first-line, fixed-duration epcoritamab monotherapy who were unable to receive standard anthracycline-based chemotherapy.

Genmab Presents Pivotal Phase 3 Data from EPCORE® FL-1 Trial Demonstrating Clinical Benefit of EPKINLY® (epcoritamab-bysp) in Combination With Rituximab and Lenalidomide (R2) in Patients With Relapsed or Refractory Follicular Lymphoma

Princeton-based BioNJ Member Genmab announced primary data from the pivotal Phase 3 EPCORE® FL-1 study evaluating fixed duration EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study showed that treatment with EPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.14-0.31, p<0.0001) compared to standard of care R2. Additionally, the overall response rate (ORR) in patients treated with EPKINLY + R2 was 95% (95% CI: 91.5, 97.4) compared to 79% in patients treated with R2 (95% CI: 73.6, 84.1; P<.0001). The EPCORE FL-1 study included patients with R/R FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors.

Genmab Announces New Data from Phase 1b/2 EPCORE® CLL-1 Highlighting Potential of Epcoritamab as Monotherapy and in Combination for Patients With Richter Transformation (RT)

Princeton-based BioNJ Member Genmab announced new and updated data from three arms of the ongoing Phase 1b/2 EPCORE® CLL-1 trial (NCT04623541) evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination for the treatment of patients with Richter transformation (RT), a rare complication in which chronic lymphocytic leukemia (CLL) evolves into an aggressive lymphoma, most often diffuse large B-cell lymphoma (DLBCLEPCORE® CLL-1, Arm 2A (Epcoritamab Monotherapy). In Arm 2A of the trial, patients with RT (n=42) received epcoritamab monotherapy in the first-line setting or in second- or later-line settings, with a median follow-up of 22.9 months. In the first-line setting (n=21), patients achieved an overall response rate (ORR) of 57%, with 52% experiencing a complete response (CR). 

Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

Hampton-based BioNJ Member Celldex announced the initiation of its global Phase 3 trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment. ColdU and SD are characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. 

Positive Clinical Results from Phase 2 Trial of SGX945 for the Treatment of Behçet's Disease Published in Rheumatology (Oxford)

Princeton-based BioNJ Member Soligenix, Inc. announced that the results from its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease have been published in Rheumatology (Oxford), in an article entitled "Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome". The Phase 2a study, evaluating control of oral ulcers in Behçet's Disease, reported beneficial effects for 7 of 8 patients, over the 4 weeks of treatment as well as a potentially enduring effect through the 4 weeks of follow-up. Many Behçet's Disease treatments, including the most recently approved apremilast (Otezla®), do not have an enduring impact, necessitating frequent and continuous administration.

Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients With Mild-to-Moderate Psoriasis

Princeton-based BioNJ Member Soligenix, Inc. announced extended results of its ongoing Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. In this extension (Cohort 3) of the exploratory phase of the study, an additional four patients were enrolled and treated with an improved topical gel formulation of synthetic hypericin. The Cohort 3 patients were treated for the same 18-week period as Cohorts 1 and 2, but utilized an optimized gel formulation of synthetic hypericin. The gel formulation was specifically designed to improve ease of application to larger areas of the skin. SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. On average over the three evaluable patients (one patient discontinued for personal reasons), there were improvements in the Investigator Global Assessment (IGA), the Psoriasis Activity and Severity Index (PASI), the simplified psoriasis index, the dermatology life quality index and the Skindex-29 questionnaire. 

U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 8, 2026. The FDA filing acceptance is based on the Phase 3 SWOG S1826 (CA2098UT) study, evaluating Opdivo in combination with AVD for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV cHL. Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 SWOG S1826 (CA2098UT) study.

Bristol Myers Squibb and BioNTech Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer

Princeton-based BioNJ Member Bristol Myers Squibb and BioNTech SE announced the first interim data from a global randomized Phase 2 trial (NCT06449222) evaluating pumitamig (BNT327/BMS986545), an investigational bispecific antibody targeting PD-L1 and VEGF-A, plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer (“TNBC”) irrespective of PD-L1 expression levels. The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first-line and second-line treatment setting. The data will be presented at the 2025 San Antonio Breast Cancer Symposium (“SABCS”). The trial evaluated pumitamig in two dose levels and in combination with four different chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic TNBC.

Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults With Relapsed or Refractory Marginal Zone Lymphoma (MZL)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted approval of 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 (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion. This approval of Breyanzi is based on results from the MZL cohort in TRANSCEND FL, an open-label, multicenter, multi-cohort, single-arm study. Based on the U.S. Prescribing Information (USPI), in patients treated with Breyanzi in the third-line plus setting and included in the primary efficacy analysis set (n=66), the overall response rate (ORR) was 95.5% (95% CI: 87.3-99.1).

Sanofi’s Efdoralprin Alfa Earns Orphan Designation in the EU for Alpha-1 Antitrypsin Deficiency Related Emphysema

Morristown-based BioNJ Member Sanofi announce the European Medicines Agency (EMA) has granted orphan designation to efdoralprin alfa (SAR447537, formerly known as INBRX-101), an investigational recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, for the potential treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema, a rare respiratory condition with great unmet medical need. The EMA grants orphan designation to potential new medicines addressing rare, life-threatening or debilitating medical diseases or conditions that affect no more than 5 in 10,000 individuals in the EU. Efdoralprin alfa demonstrated superiority to a standard of care plasma-derived therapy in adults with AATD when dosed every three weeks (Q3W) or every four weeks (Q4W), meeting all primary and key secondary endpoints in the global phase 2 ElevAATe study (clinical study identifier: NCT05856331).

Sanofi’s Qfitlia and Cablivi Approved in China, Expanding Care for Rare Diseases

The National Medical Products Administration (NMPA) in China has approved two innovative Sanofi medicines for rare hematologic diseases: Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired thrombotic thrombocytopenic purpura. These approvals mark another step in Sanofi’s long-term commitment to China, reinforcing the company’s ambition to bring transformative medicines across diverse disease areas. With Qfitlia and Cablivi, Sanofi reaches its fourth and fifth approvals in China this year, following Tzield for stage 2 type 1 diabetes and Sarclisa for two indications in relapsed and newly diagnosed multiple myeloma. Qfitlia is the first antithrombin (AT)-lowering therapy for routine prophylaxis in people with hemophilia. Qfitlia is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in pediatric patients 12 years of age and older, and adults with severe hemophilia A (coagulation factor VIII deficiency, FVIII<1%) with or without factor VIII inhibitors, or severe hemophilia B (coagulation factor IX deficiency, FIX<1%) with or without factor IX inhibitors.

TUKYSA Added to First-Line Maintenance Therapy Extends Median Progression-Free Survival by Over 8 Months in Patients With HER2+ Metastatic Breast Cancer

BioNJ Member Pfizer Inc., with a site in Parsippany, announced detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA® (tucatinib) as part of an investigational first-line maintenance treatment combination, following chemotherapy-based induction, in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with TUKYSA, trastuzumab, and pertuzumab compared to those treated with placebo, trastuzumab, and pertuzumab, as assessed by the investigator (hazard ratio [HR] of 0.641, 95% confidence interval (CI): 0.514-0.799; 2-sided p<0.0001). In HER2CLIMB-05, the median progression-free survival (PFS) was 24.9 months (95% CI: 21.3-not reached) in the TUKYSA arm and 16.3 months (95% CI:12.6-18.7) in the placebo arm, representing an extension in median PFS of 8.6 months.

HYMPAVZI® (marstacimab) Reduced Bleeds by 93% Compared to On-Demand Treatment in Adults and Adolescents With Hemophilia A or B With Inhibitors

BioNJ Member Pfizer Inc., with a site in Parsippany, presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. The results demonstrated the superiority of HYMPAVZI in improving key bleeding outcomes compared to on-demand (OD) treatment with bypassing agents. HYMPAVZI was administered with a straightforward, once-weekly subcutaneous injection requiring minimal preparation and no treatment-related lab monitoring. The findings were published in Blood. Inhibitors, or antibodies, which neutralize factor replacement therapies and render them ineffective, may develop in people living with hemophilia. Inhibitors can be diagnosed with a blood test.

“LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Included in China’s Commercial Insurance Innovative Drug List

Nutley-based BioNJ Member Eisai and BioNJ Member Biogen announced that anti-Aβ protofibril* antibody “LEQEMBI®” (generic name: lecanemab), has been included in the “Commercial Insurance Innovative Drug List”, recently introduced by the National Healthcare Security Administration (NHSA) of China. The inclusion of LEQEMBI in this list marks a meaningful step toward expanding access to early Alzheimer’s Disease (AD) treatment in China. The Commercial Insurance Innovative Drug List is based on new policies of the Chinese government to support the development and access of innovative medicines. The list aims to help narrow the coverage gap between the basic reimbursement system under the National Reimbursement Drug List (NRDL) and innovative medicines that address areas of significant unmet need.

Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults

Parsippany-based BioNJ Member Teva Pharmaceuticals announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia. The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia. Olanzapine LAI is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. In the SOLARIS trial, it demonstrated an efficacy and safety profile consistent with currently available oral olanzapine formulations.

Lilly's Orforglipron Helped People Maintain Weight Loss After Switching from Injectable Incretins to Oral GLP-1 Therapy in First-of-its-Kind Phase 3 Trial

BioNJ Member Eli Lilly & Company, with a site in Branchburg, announced positive topline results from the ATTAIN-MAINTAIN trial. The Phase 3 study evaluated orforglipron, an investigational, once-daily oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist, for weight maintenance over 52 weeks after initial treatment for 72 weeks with the highest tolerated doses of Wegovy (semaglutide) or Zepbound (tirzepatide), in participants from SURMOUNT-5 who were offered the opportunity to be re-randomized to receive orforglipron or placebo. At one year, orforglipron met the primary and all key secondary endpoints compared to placebo, delivering superior weight maintenance as an adjunct to a healthy diet and physical activity, using the efficacy estimand and modified treatment-regimen estimand.

Updated Data for Lilly's Inluriyo™ (imlunestrant) Reinforce Efficacy Results as Monotherapy and in Combination With Verzenio® (abemaciclib) in ER+, HER2- Advanced Breast Cancer

BioNJ Member Eli Lilly & Company, with a site in Branchburg, announced updated results from the Phase 3 EMBER-3 study of Inluriyo (imlunestrant), an oral estrogen receptor antagonist, in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2–negative (HER2–) advanced or metastatic breast cancer (MBC), whose disease progressed on a prior aromatase inhibitor (AI), with or without a CDK4/6 inhibitor. As monotherapy, imlunestrant demonstrated a clinically meaningful 38% reduction in the risk of progression or death (median PFS 5.5 vs 3.8 months; HR=0.62 [95% CI 0.47–0.82]; nominal p=0.0007) and demonstrated an 11.4-month improvement in median OS (34.5 vs 23.1 months; HR=0.60 [95% CI 0.43–0.86]; p=0.0043; boundary for significance not met) versus endocrine therapy, in patients with ESR1-mutated disease.

Lilly's Jaypirca (Pirtobrutinib) Significantly Improved Progression-Free Survival, Reducing the Risk of Progression or Death By 80%, Versus Chemoimmunotherapy in Patients With Treatment-Naïve CLL/SLL

BioNJ Member Eli Lilly & Company, with a site in Branchburg, announced results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, versus bendamustine plus rituximab (BR), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions. Pirtobrutinib met its primary endpoint demonstrating a reduction in the risk of disease progression or death by 80% (HR=0.20 [95% CI, 0.11-0.37]; p<0.0001). These data will be published in the Journal of Clinical Oncology. PFS results favored pirtobrutinib across all pre‑specified subgroups, including those with high-risk molecular features such as TP53 mutations, complex karyotype, and unmutated IGHV, and was consistently observed among investigator assessments. 

Lilly's Jaypirca (Pirtobrutinib) Meets its Primary Endpoint in First-of-its-Kind, Head-to-Head Phase 3 Study Versus Imbruvica (Ibrutinib)

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced results from the Phase 3 BRUIN CLL-314 clinical trial evaluating Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve. Pirtobrutinib met its primary endpoint of non-inferiority on overall response rate (ORR) compared to ibrutinib (87.0% [95% CI, 82.90-90.44] versus 78.5% [95% CI, 73.73-82.85]; p<0.0001) in the intent-to-treat (ITT) population.

Lilly's Triple Agonist, Retatrutide, Delivered Weight Loss of Up to an Average of 71.2 Lbs Along With Substantial Relief from Osteoarthritis Pain in First Successful Phase 3 Trial

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from the Phase 3 TRIUMPH-4 clinical trial evaluating the safety and efficacy of the two highest investigational doses of retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, in adults with obesity or overweight and knee osteoarthritis, and without diabetes, as an adjunct to healthy diet and physical activity. In this global registration trial, where 84.0% of participants had a baseline BMI of ≥35 kg/m², each dose of retatrutide (9 mg and 12 mg) met all primary and key secondary endpoints, delivering significant weight loss and improvements in pain and physical function at 68 weeks using both the efficacy and treatment-regimen estimands.

TECVAYLI® Plus DARZALEX FASPRO® Combination Selected for Commissioner’s National Priority Voucher Pilot program

New Brunswick-based BioNJ Member Johnson & Johnson is pleased the U.S. Food and Drug Administration (FDA) has selected the teclistamab MajesTEC-3 supplemental Biologics License Application (sBLA) to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program as it aligns with the program’s priority to deliver more innovative therapies for American people. We look forward to working with the U.S. FDA to bring this transformational regimen to patients with multiple myeloma as soon as possible. The sBLA is based on the Phase 3 MajesTEC-3 results, which showed TECVAYLI^® (teclistamab-cqyv) plus DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj) demonstrated a statistically significant progression-free survival (PFS) and overall survival advantage compared to standard treatment after three years in patients with relapsed/refractory multiple myeloma.

U.S. FDA Approves AKEEGA® as the First Precision Therapy for BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer With 54% Reduction in Disease Progression vs Standard of Care

New Brunswick-based BioNJ Member Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). Patients with BRCA mutations often have more aggressive forms of prostate cancer leading to poor prognosis, representing a significant unmet need not addressed by previously available therapies. The approval is based on positive results from AMPLITUDE (NCT04497844), a randomized, double-blind, placebo-controlled, international Phase 3 clinical study.

Johnson & Johnson’s INLEXZO™ (Gemcitabine Intravesical System) Delivers 74 Percent Disease-Free Survival at One Year in BCG-Unresponsive, High-Risk, Papillary-Only NMIBC

Raritan-based BioNJ Member Johnson & Johnson announced that new data from the investigational Cohort 4 of the Phase 2b SunRISe-1 study show treatment with gemcitabine intravesical system resulted in high one-year disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, papillary-only non-muscle invasive bladder cancer (NMIBC). Cohort 4 of the Phase 2b SunRISe-1 study focused on 52 patients with papillary-only, high-risk NMIBC whose disease did not respond or stopped responding to BCG therapy and who were ineligible for or declined radical cystectomy. The therapy was administered every three weeks for six months, followed by every 12 weeks for up to an additional 18 months, to evaluate its potential to prevent the recurrence or progression of high-grade papillary tumors.

Earlier Use of CARVYKTI® Demonstrated Lasting Treatment-Free Remissions at 2.5 Years in Patients With Relapsed or Refractory Multiple Myeloma

New Brunswick-based BioNJ Member Johnson & Johnson announced updated results from the Phase 3 CARTITUDE-4 study supporting durable treatment-free remissions as early as second line treatment with CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). In 80 percent of as-treated patients with relapsed or refractory multiple myeloma (RRMM) and standard-risk cytogenetics who were treated with CARVYKTI® as early as first relapse, the disease did not progress and no further treatment was required at 2.5 years (30 months). These results add to the body of clinical and real-world experience established across more than 9,000 patients treated with CARVYKTI® globally. Additional translational analyses demonstrated that patients receiving CARVYKTI® in earlier lines had improved immune fitness, which suggests a correlation with longer progression-free survival (PFS).

KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free Survival, Overall Survival and Pathologic Complete Response Rates for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery

Rahway-based BioNJ Member Merck & Co. announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial showed KEYTRUDA® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv), given as neoadjuvant and adjuvant treatment (before and after surgery), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus neoadjuvant chemotherapy and surgery. The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer (la/mUC) and cisplatin-ineligible MIBC.

Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults With Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)

Rahway-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV based on the Phase 3 ZENITH study. The currently approved indication in the European Union (EU) is for adults with PAH with WHO FC II to III, to improve exercise capacity. The CHMP recommendation will now be reviewed by the European Commission (EC) for amending the marketing authorization in the EU, Iceland, Liechtenstein and Norway, and a final decision is expected in the first quarter of 2026.

FDA Conditionally Approves Merck Animal Health's EXZOLT™ CATTLE-CA1 for the Prevention and Treatment of New World Screwworm (Cochliomyia hominivorax) Larvae (myiasis)

Merck Animal Health, a division of Rahway-based BioNJ Member Merck & Co., announced the U.S. Food and Drug Administration (FDA) has granted a conditional approval for EXZOLT™ CATTLE-CA1 (fluralaner topical solution). This innovative product is in the newest class of parasiticides known as isoxazolines. The pour-on solution is effective for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis). It is also conditionally approved for the treatment and control of cattle fever tick (Rhipicephalus microplus). EXZOLT CATTLE-CA1 was granted conditional approval based on demonstration of safety and a reasonable expectation of effectiveness when administered according to label directions based on global studies conducted by Merck Animal Health in recent years.

Blujepa (gepotidacin) Approved by U.S. FDA as Oral Option for Treatment of Uncomplicated Urogenital Gonorrhoea (uGC)

Warren-based BioNJ Member GSK plc announced that the U..S Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and paediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). This milestone follows the US FDA approval of gepotidacin earlier this year as an oral treatment for female adult and paediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI).

GSK’s RSV Vaccine, Arexvy, Receives Positive CHMP Opinion for All Adults 18 Years and Older

Warren-based BioNJ Member GSK plc announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to all adults aged 18 years and older. The European Commission’s final decision is expected in February 2026. If approved, the expanded indication would make the vaccine available for all adults aged 18 years and older. Arexvy was the first RSV vaccine approved in Europe for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and in those aged 50-59 years who are at increased risk for RSV disease. 

Exdensur (depemokimab) Approved by U.S. FDA for the Treatment of Severe Asthma

Warren-based BioNJ Member GSK plc announced that the U.S. Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older. The FDA approval of Exdensur is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care. Treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively [rate ratio (95% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per year).

Exdensur (depemokimab) Approved in the UK for Treatment of Asthma With Type 2 Inflammation and Chronic Rhinosinusitis With Nasal Polyps

Warren-based BioNJ Member GSK plc announced the marketing authorization of Exdensur (depemokimab) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Exdensur is now approved in two indications: as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype who are inadequately controlled on maximum moderate-dose or high-dose inhaled corticosteroids (ICS) plus another asthma controller; and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.

Depemokimab Receives Positive CHMP Opinion for Severe Asthma With Type 2 Inflammation and Chronic Rhinosinusitis With Nasal Polyps

Warren-based BioNJ Member GSK plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of depemokimab in two indications: as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller; and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. The European Commission decision on approval is expected in Q1 2026.

Nucala (mepolizumab) Receives Positive CHMP Opinion for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Warren-based BioNJ Member GSK plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). The European Commission decision on approval is expected in Q1 2026. COPD affects more than 40 million people in Europe and more than 390 million people globally. It is estimated that over 35% of COPD patients who are inadequately controlled on inhaled triple therapy have a raised blood eosinophil count (BEC) of at least 300 cells/μL.

Novo Nordisk A/S: More Efficacious Dose of Wegovy® Recommended by the European Medicines Agency Can Help People With Obesity Achieve an Average of 20.7% Weight Loss

Plainsboro-based BioNJ Member Novo Nordisk announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a higher dose of Wegovy® (semaglutide 7.2 mg), bringing it a step closer to offering individuals with obesity in the EU a new Wegovy® option for even greater weight loss. The new dose of Wegovy® has demonstrated an average weight loss of 20.7% at 72 weeks, in people with obesity who do not have diabetes. These substantial weight loss results complement the already established health benefits of Wegovy® in obesity-related complications, including significant reduction in the risk of cardiovascular events such as heart attack and stroke, and reduction in pain from knee osteoarthritis. The positive opinion is based on the results from the STEP UP and STEP UP T2D clinical trial program in people with obesity with and without type 2 diabetes.

Novartis Facility Expansion Bolsters Global $23B U.S. Investment

The Switzerland-based innovative medicines company, which maintains its U.S. subsidiary headquarters in East Hanover, is strategically building out its “coast-to-coast” manufacturing network. This plan ensures that all key medicines for U.S. patients are produced end-to-end domestically. As part of this expansion, Novartis is investing in its existing New Jersey sites—including a radioligand therapy (RLT) manufacturing facility in Millburn and its Morris Plains cell therapy production site. New Jersey remains central to Novartis’ production of highly complex, advanced therapies: The commitment to expand New Jersey’s manufacturing footprint ensures the state remains a critical component of the company’s ambitious goal to localize its entire supply chain.

NJ Companies Make Top 10 on Newsweek Most Responsible List

Newsweek released its America’s Most Responsible Companies for 2026 list ― naming two New Jersey firms among the top 10. The annual ranking recognizes 600 organizations across the country for leadership in corporate responsibility and for their strong performance across environmental, social and governance criteria. In 2025, 20 New Jersey businesses made the list. Merck ― which had held the top spot for three years in a row ― fell to No. 7, but remained the highest-ranking company in the State. Congratulations to these BioNJ Members for being named to the list: Amgen, CBRE, IBM, J.P. Morgan, Korn Ferry, Marsh McLennan, Merck & Co., Pfizer, Regeneron, Thermo Fisher Scientific and Vertex Pharmaceuticals.

DESTINY-Ovarian01 Phase 3 Trial of ENHERTU® Initiated as First-Line Maintenance Therapy in Patients With HER2 Expressing Advanced Ovarian Cancer

Basking Ridge-based Daiichi Sankyo announced that the first patient has been dosed in the randomization phase of the DESTINY-Ovarian01 Phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab. DESTINY-Ovarian01 is being conducted in collaboration with the European Network of Gynecological Oncological Trial Groups (ENGOT), with the Spanish cooperative group (GEICO) as the lead ENGOT group, The GOG Foundation, Inc. (GOG-F) and Asia-Pacific Gynecologic Oncology Trials Group (APGOT). ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

New Hypertension Publication Underscores Aprocitentan’s Potential in Managing Hypertension Patients With CKD

Idorsia Ltd, with a facility in Cherry Hill, announced the publication of a new analysis from the landmark Phase 3 PRECISION study in Hypertension titled “Aprocitentan in Patients with Chronic Kidney Disease and Resistant Hypertension”. The analysis examined the efficacy and safety of aprocitentan (TRYVIO™/JERAYGO™) in patients with chronic kidney disease (CKD) and confirmed resistant hypertension ― a population with very limited treatment options and high cardiovascular and renal risk. Aprocitentan, the first approved antihypertensive targeting the endothelin pathway, was well tolerated. It significantly reduced both office and nighttime ambulatory blood pressure (BP), as well as markedly lowered albuminuria – a key marker of kidney damage – without increasing the risk of hyperkalemia. There are 1.4 billion people worldwide living with hypertension.

LEO Pharma Submits Adolescent Label Expansion Application for Anzupgo® to EMA

LEO Pharma, with a site in Madison, announced submission of a label expansion application to the European Medicines Agency (EMA) to expand the use of Anzupgo® (delgocitinib) cream to adolescents aged 12 to 17 years, living with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate in the European Union. The label expansion application has been accepted for review by EMA. Research on adolescents with CHE shows that the disease can impact far beyond the skin. CHE can have considerable negative impact on quality of life, affecting psychosocial well-being, school performance and participation in leisure activities. The label expansion application is supported by results from DELTA Teen, a Phase 3 trial with Anzupgo^® (delgocitinib) 20mg/g cream, that investigated  the efficacy and safety of twice-daily applications of Anzupgo® compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate .

NJEDA and CoreWeave Announce Creation of $20M AI Hub Fund to Support Innovative Startups

The New Jersey Economic Development Authority (NJEDA) and BioNJ Member CoreWeave, along with other accredited investors, announced a $20 million investment to support a fund for startups that are associated with the NJ AI Hub Strategic Innovation Center (SIC). The investment fund will help startups access capital, overcome challenges, and accelerate growth, strengthening New Jersey’s standing as a national leader in AI innovation. The NJEDA Board approved the $10 million investment into the fund, which will be matched by an equal investment from CoreWeave and affiliated investors. “With this new Hub Fund, along with our ongoing efforts to shape AI’s future, we are reviving the Garden State’s legendary legacy of innovation and, in the process, making our State more competitive in the global economy for decades to come,” said Governor Phil Murphy.

NJ AI Hub Chooses Plug and Play to Launch AI Accelerator

The New Jersey Artificial Intelligence Hub, founded by partners Princeton University, the State of New Jersey, Microsoft and CoreWeave, said it will launch an AI Accelerator, powered by the global innovation platform Plug and Play, early next year. The AI Accelerator will link New Jersey’s AI startups and higher-ed-affiliated entrepreneurs with mentors, investors and industry partners, and attract other startups to the state. Located at the Hub’s facility in West Windsor, the accelerator will take advantage of New Jersey’s strengths in health care, pharmaceuticals, smart infrastructure, advanced manufacturing, financial services, energy, materials, telecommunications and logistics. Plug and Play will run selected cohorts each year that support and help startups at various stages. “The AI Accelerator is a major step toward cementing New Jersey as a global center for innovation,” said Liat Krawczyk, Executive Director of the NJ AI Hub.

Bristol Myers Squibb Donates $32K to Fund Lab Equipment for Charter School

Princeton-based BioNJ Member Bristol Myers Squibb and the charter school Foundation Academies (FA) said that the pharmaceutical giant donated $32,500 to help create a state-of-the art chemistry lab at a new FA Collegiate campus opening in August 2026 and expanding STEM opportunities for students in Trenton.This project marks a transformative step for FA scholars by introducing Advanced Placement (AP) Chemistry for the first time at Foundation Academies. With BMS’s investment, students gain access to college-level science education, empowering them to earn college credit, pursue STEM degrees and build pathways to high-impact careers. The grant reflects BMS’s commitment to advancing educational opportunities for all and cultivating the next generation of innovators. 

NJ Innovation Evergreen Fund Invests $6.2M in Three Startups

The New Jersey Innovation Evergreen Fund continues its rapid growth and evolution in the State―serving as an important tool toward expanding the Garden State’s innovation ecosystem. The initiative increases access to strategic resources and venture capital. It creates partnerships between the State and private sector to corporations and Qualified Venture Funds to support entrepreneurs, with the State auctioning discounted tax credits to large corporations. The NJEDA announced it closed on investments totaling $6.2 million for three cutting-edge businesses through the NJIEF. Under the program, the state acts as an equity investor in emerging companies deploying up to $600 million into companies alongside the QVFs. Meanwhile, the tax credit purchasers make commitments to provide strategic support of the innovation ecosystem, including networking, mentoring and educational opportunities.

Carolyn Bertozzi Returns to Lilly Board of Directors

The board of directors of BioNJ Member Eli Lilly and Company, with a site in Branchburg, elected Carolyn R. Bertozzi, Ph.D., as a returning member. She will serve on the Board's Science and Technology and Ethics and Compliance Committees. Currently serving as the Baker Family Director of Sarafan ChEM-H, Anne T. and Robert M. Bass professor in the School of Humanities and Sciences and professor, by courtesy, of Chemical and Systems Biology and of Radiology at Stanford University, Dr. Bertozzi is also an Investigator of the Howard Hughes Medical Institute. She has been recognized with many honors and awards for her research accomplishments and is an elected member of the National Academy of Medicine, National Academy of Sciences and American Academy of Arts and Sciences.

NPC Announces Board Leadership, Gilead’s Rekha Ramesh as 2026 Board Chair

The National Pharmaceutical Council (NPC), a 70+-year-old health policy research organization, announced Rekha Ramesh, MPP, Vice President, U.S. Policy, Government Affairs, Gilead Sciences, Inc., as Chair of NPC’s Board of Directors for 2026. Ms. Ramesh has previously served in several leadership roles on NPC’s Board of Directors, including serving as Vice Chair in 2025. NPC serves patients and society with policy-relevant research on the value of patient access to innovative medicines and the importance of scientific advancement. Ms. Ramesh has extensive experience in policy and government affairs. She has been a policy and government affairs leader at BioNJ Member Gilead for over two decades. Prior to Gilead, she worked as a Consultant at Health Management Associates and an Associate Analyst at the Congressional Budget Office.

LEO Pharma Appoints Marika Murto to Lead Global Product Strategy

LEO Pharma, with a site in Madison, announced the appointment of Marika Murto, Ph.D., as Senior Vice President of Global Product Strategy and member of the Global Leadership Team. Marika joins LEO Pharma from Amgen, where she most recently served as Associate Vice President and U.S. Commercial Lead for Bone Health, driving strategic brand positioning and cross‑functional collaboration. Her career at Amgen included senior global and affiliate leadership roles, including General Manager for the Netherlands, Global Product Team Lead for Bone Health, and Country Director for Finland. She has also held senior commercial positions at Pfizer and Roche, gaining expertise across oncology, vaccines, specialty medicines and portfolio strategy.

Doing Business in Eurasia

Throughout Spring 2026 - 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 2026 - 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.

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.