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GSK completes acquisition of RAPT Therapeutics

On March 3, 2026 GSK plc (LSE/NYSE: GSK) reported the completion of its previously announced acquisition of RAPT Therapeutics, a California-based, clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients living with inflammatory and immunologic diseases.

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The acquisition includes ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody, currently in phase IIb clinical development for prophylactic protection against food allergens. IgE is a clinically validated target and is the only approved systemic therapy shown to protect patients from a harmful allergic and inflammatory immune response. Around 94% of severe food allergies are caused by IgE-mediated reactions.1

Current anti-IgE treatment for food allergy involves injections every 2 to 4 weeks, which can be a significant burden, particularly since most patients are children. Ozureprubart’s clinical profile offers the potential for less frequent dosing of every 12 weeks, supporting improved compliance and patient outcomes, as well as providing a new option to approximately 25% of patients currently ineligible for existing therapy. Ozureprubart complements GSK’s extensive commercial footprint and prescriber base in allergy.

Data from the phase IIb trial (prestIgE) assessing use of ozureprubart as monotherapy is expected in 2027, with phase III trials to be focused on both at-risk adult and paediatric populations.

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation, and Head of GSK Translational & Development Sciences, GSK said: "Ozureprubart is a promising asset that complements our expanding RI&I pipeline. Food allergies continue to place a heavy burden on patients and their families, and we are committed to progressing this potential best-in-class monoclonal antibody to deliver longer‑lasting protection."

Financial considerations
The total cash consideration for this acquisition amounts to an approximate aggregate equity value of $2.2 billion. Net of cash acquired, GSK’s upfront investment is approximately $1.9 billion.

The transaction gives GSK the global rights to the ozureprubart programme, excluding mainland China, Macau, Taiwan and Hong Kong. GSK will also be responsible for success-based milestone and royalty payments for ozureprubart owed to RAPT’s partner, Shanghai Jeyou Pharmaceutical Co., Ltd.

About food allergies
In the US, over 17 million people are diagnosed with food allergies, with more than 1.3 million people suffering severe reactions.2,3,4 Notably, 65% of severe food allergy patients are children and adolescents.1 This results in more than 3 million patient visits each year to hospital and emergency care.5 Disease burden is amplified by the frequency and complexity of allergic reactions, which can escalate to anaphylaxis, emergency care and impact a patient’s wellbeing and participation in social activities. Collectively, food allergies cost US families an estimated $33 billion in 2024, underscoring the need for more effective and durable therapies.

(Press release, GlaxoSmithKline, MAR 3, 2026, View Source [SID1234663224])

Fate Therapeutics to Participate in Leerink Partners 2026 Global Healthcare Conference

On March 3, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that management will participate in a fireside chat and host investor meetings at the Leerink Partners 2026 Global Healthcare Conference on Monday, March 9, 2026 in Miami, Florida.

Management will participate in a fireside chat at 9:20 AM ET on Monday, March 9. A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 90 days on the Company’s website following the event.

(Press release, Fate Therapeutics, MAR 3, 2026, View Source [SID1234663223])

Delcath Systems Announces Publication of CHOPIN Clinical Trial Results in The Lancet Oncology

On March 3, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology. The publication, titled "Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre, open-label, randomised, phase 2 trial" is published in The Lancet Oncology and presents detailed analyses from the trial, building on the positive topline results previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2025. The link to the article can be found at: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00720-X/abstract.

"The detailed analyses in this publication reinforce the synergistic potential of combining PHP with immunotherapy, showing not only superior PFS and OS but also enhanced hepatic control and deeper, more durable responses. This approach represents a significant advancement for patients with this challenging disease, where liver-dominant metastases drive poor outcomes," said Professor Ellen Kapiteijn, MD, Principal Investigator and Lead Author from Leiden University Medical Center’s Department of Medical Oncology.

"The full publication in The Lancet Oncology validates the impressive efficacy of combining our liver-directed PHP therapy with immune checkpoint inhibition," said Gerard Michel, Chief Executive Officer of Delcath Systems. "By more than tripling the 1-year progression-free survival rate and nearly doubling the 2-year overall survival, these results strongly underscore the clinical value of this combination and give us even greater confidence in adoption by treating physicians and patients. We are also encouraged by the potential to explore this paradigm in other liver-dominant cancers."

The CHOPIN trial randomized 76 patients with metastatic uveal melanoma (mUM; n=38 per arm) to percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s CHEMOSAT Hepatic Delivery System (HDS) alone or in combination with ipilimumab plus nivolumab. In both arms patients received two PHP treatments (weeks 1 and 7). In the combination arm patients also received ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) in weeks 0, 3, 6, and 9, with no maintenance therapy.

Key results (intention-to-treat population):

Primary endpoint – 1-year progression-free survival (PFS): 54.7% vs 15.8% (adjusted HR 0.34 [95% CI 0.19–0.60]; p=0.0002), Median PFS: 12.8 months vs 8.3 months
Overall Survival (OS): Median 23.1 months vs 19.6 months (HR 0.39 [95% CI 0.20–0.77]; p=0.0065) 2-year OS: 49.6% vs 22.1%
Objective Response Rate (ORR): 76.3% vs 39.5% Complete response (CR) rate: 13% vs 3%
Safety

Grade 3 or higher treatment-related adverse events occurred significantly more frequently in the combination arm (82%) than in the PHP-alone arm (41%); p=0.0006. The rate in the combination arm was similar to that reported in the FOCUS trial (81%). The most common grade 3/4 events were thrombocytopenia (34% vs 14%), leukopenia (26% vs 14%), γ-glutamyl transferase increase (18% vs 8%), and anemia (13% vs 3%). Most events were self-limiting or manageable with standard supportive care; no new safety signals were identified. One treatment-related death (immune-related triple M syndrome) occurred in the combination arm.

Overall, the authors conclude that the combination of PHP with ipilimumab and nivolumab offers a promising new approach for patients with metastatic uveal melanoma.

(Press release, Delcath Systems, MAR 3, 2026, View Source [SID1234663222])

Certara Simcyp® Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib

On March 3, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported its Simcyp Simulator enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix). PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in "Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib" (Loisios-Konstantinidis et al.), highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making.

Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate of CML was close to one case in 100,000 population in 2018,1 and it accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Given its potential for drug-drug interactions and the need to evaluate multiple dosing regimens, PBPK modeling with the Simcyp Simulator enabled a mechanistic assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens and clinical scenarios. These simulations provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA.

"As a member of the Simcyp Consortium, we have firsthand experience with Simcyp’s capabilities and value its leading scientific rigor essential for enabling regulatory acceptance of PBPK models," said Ioannis Loisios-Konstantinidis, Senior Principal Scientist, PK Sciences, Novartis Biomedical Research.

Key results from the PBPK modeling included:

Bridging between clinically tested and untested scenarios
Replacement of at least ten dedicated clinical pharmacology studies
Accurate characterization of asciminib pharmacokinetics across healthy volunteers and cancer patients
Predicting how medicines work in real-life patients taking other medications
"This collaboration exemplifies the scientific partnership that the Simcyp Simulator enables," said Rob Aspbury, President, Certara Predictive Technologies. "The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML."

(Press release, Certara, MAR 3, 2026, View Source [SID1234663220])

Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel

On March 3, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that its partner Pierre Fabre Pharmaceuticals (PFP) has submitted a request to the FDA for a Type A meeting.

Pierre Fabre Pharmaceuticals, in partnership with Atara, submitted a briefing book to the FDA addressing the points from the Complete Response Letter dated January 9, 2026, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tabelecleucel (tab-cel) Biologics License Application. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission.

"With our partners at Pierre Fabre Pharmaceuticals, we are eager to engage in a constructive discussion with the FDA to reach a path forward for tabelecleucel," said Cokey Nguyen, President and Chief Executive Officer of Atara. "The PTLD community, including physicians and patient advocacy groups have emphasized the urgent need for tabelecleucel and its ability to address a dire unmet medical need in this ultra-rare disease."

(Press release, Atara Biotherapeutics, MAR 3, 2026, View Source [SID1234663219])