Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.
In addition to a suite of big deals announced Monday, the 2025 J.P. Morgan Healthcare Conference kicked off with some of the biggest players in biopharma promising pushes into new cancer treatments, impending data readouts and alternative routes into obesity treatment. Here’s what you need to know heading into Day Two.
Pfizer “All In” On Obesity
Pfizer announced plans to go “all in” on its experimental obesity drug danuglipron. Calling it “danu” for short, CEO Albert Bourla said late-stage studies are likely for the second half of 2025. With danuglipron, a once-daily pill, Pfizer aims to avoid directly competing with the current injectable drugs dominating the market, Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. “Probably it’s a little bit too late,” for that, Bourla said). Instead, according to Bourla, Pfizer aims to get into the obesity market through either orals or injectables with a different mechanism of action from semaglutide-based treatments like Wegovy and Zepbound.
Regeneron Gears Up for Phase III Readouts
Regeneron CEO Leonard Schleifer gave updates on the biotech’s seemingly full pipeline. Itepekimab, an investigational treatment for chronic obstructive pulmonary disease (COPD) will deliver Phase III data this year, potentially adding another drug to stand alongside Dupixent, its COPD drug already on the market in the US. Phase III results for two cancer drugs, fianlimab, a checkpoint inhibitor for melanoma and linvoseltamab, a bispecific antibody for multiple myeloma, are also expected this year. Ordspono, an antibody used for treating lymphoma, is already approved in the EU and Regeneron is preparing resubmission for FDA approval after an early 2024 rejection due to issues with patient enrollment status in confirmatory trials.
Sarepta Touts Strong Launch for Elevidys
Sarepta Therapeutics announced a large market take for its Duchenne muscular dystrophy gene therapy Elevidys, just shy of $400 million. Sarepta is turning Elevidys right around and putting it back in the pipeline, expecting a Phase III readout for in a related condition, limb-girdle muscle dystrophy. Market analysis Monday from BMO Capital Markets has Sarepta pushing its sales north of $2 billion globally if a potential EU approval comes through. Also touted at JPM25 was a previously announced $10 billion deal with Arrowhead Pharmaceuticals to produce seven RNA interference products aimed at facioscapulohumeral muscular dystrophy, myotonic dystrophy type 1, idiopathic pulmonary fibrosis and spinocerebellar ataxia 2.
BioNTech Pushes Further into Cancer
BioNTech, springboarding off its global COVID-19 mRNA vaccine successes, touted pushes into mRNA-based cancer immunotherapies and anti-PD-1 antibodies. BNT327/ PM8002, in development with Biotheus, is in multiple Phase I, II, and III trials for small cell lung cancer, triple-negative breast cancer and other solid tumors. That’s on top of autogene cevumeran, an mRNA cancer immunotherapy developed with Genentech/Roche, for which the first patient has been treated in a Phase II trial for urothelial carcinoma; a Phase II trial in colorectal cancer is also underway. BNT323/DB-1303, an antibody-drug conjugate (ADC) for endometrial cancer, is wrapping up a Phase I trial with data expected in 2025. BioNTech noted no news regarding its COVID-19 vaccines, besides reporting stable market shares and purchase agreements in place with the EU.
Moderna Bearish on Vaccines Despite Analyst Takes
Rival vaccine manufacturer Moderna, for its part, felt bearish on vaccination rates at JPM. But Truist analysts Asthika Goonewardene and Karina Rabayeva said that they believe the declining outlook on COVID-19 vaccination rates in 2025 may be restricted to just Moderna’s vaccine, perhaps reflecting a consumer survey produced by Truist showing that consumers preferred the Pfizer/BioNTech COVID-19 vaccine 48% of the time versus 29% for Moderna. Nevertheless, Moderna is pushing forward on a pipeline of an RSV vaccine for patients 60 years and older which just showed positive Phase III data, as well as a seasonal flu vaccine, a combo flu/COVID vaccine, a cytomegalovirus vaccine, and most timely of all, a norovirus vaccine, all of which are currently in Phase III trials.