The J.P. Morgan Healthcare Conference (JPM25) featured pipeline updates from major biopharmaceutical companies, highlighting strategic shifts and upcoming clinical milestones. Pfizer is making a significant push into obesity treatment, Regeneron is preparing for crucial Phase III data readouts, and BioNTech is expanding its cancer immunotherapy programs.
Pfizer's Obesity Strategy
Pfizer CEO Albert Bourla announced the company's intensified focus on its experimental obesity drug, danuglipron, referred to as "danu." Late-stage studies are expected to commence in the latter half of 2025. Danuglipron is a once-daily oral medication, designed to offer an alternative to injectable drugs like Novo Nordisk's Wegovy and Eli Lilly's Zepbound. Pfizer aims to differentiate itself by pursuing oral formulations or injectables with mechanisms of action distinct from semaglutide-based treatments.
Regeneron's Pipeline Advancements
Regeneron CEO Leonard Schleifer provided updates on several key pipeline assets. Itepekimab, an investigational treatment for chronic obstructive pulmonary disease (COPD), is slated to deliver Phase III data this year. This could add another significant product to Regeneron's respiratory portfolio, complementing Dupixent. The company also anticipates Phase III results for two cancer drugs: fianlimab, a checkpoint inhibitor targeting melanoma, and linvoseltamab, a bispecific antibody for multiple myeloma. Ordspono, an antibody for lymphoma already approved in the EU, is undergoing resubmission for FDA approval after an earlier rejection related to patient enrollment issues.
Sarepta's Muscular Dystrophy Programs
Sarepta Therapeutics reported substantial market uptake for its Duchenne muscular dystrophy gene therapy, Elevidys, with sales nearing $400 million. The company is reinvesting in Elevidys, initiating a Phase III trial for limb-girdle muscular dystrophy. Sarepta also highlighted its $10 billion deal with Arrowhead Pharmaceuticals to develop seven RNA interference products targeting facioscapulohumeral muscular dystrophy, myotonic dystrophy type 1, idiopathic pulmonary fibrosis, and spinocerebellar ataxia 2.
BioNTech's Cancer Immunotherapy Expansion
Building on its mRNA vaccine success, BioNTech is advancing its mRNA-based cancer immunotherapies and anti-PD-1 antibodies. BNT327/PM8002, developed in collaboration with Biotheus, is currently in Phase I, II, and III trials for small cell lung cancer, triple-negative breast cancer, and other solid tumors. Autogene cevumeran, an mRNA cancer immunotherapy developed with Genentech/Roche, has entered a Phase II trial for urothelial carcinoma, with another Phase II trial underway for colorectal cancer. BNT323/DB-1303, an antibody-drug conjugate (ADC) targeting endometrial cancer, is completing a Phase I trial, with data expected in 2025. BioNTech did not provide updates on its COVID-19 vaccines, noting stable market shares and existing purchase agreements with the EU.
