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Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.
FEATURED STORIES
Companies have claimed improvements to yield, batch consistency and output while acknowledging the risks and challenges created by the technology.
The mad rush for safe and effective obesity drugs has winners—including Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy—and losers. Here are five molecules that never made it to the market.
While it’s impossible to make apples-to-apples comparisons of the many obesity candidates with so many differences across clinical trials, we at BioSpace are giving it our best shot.
Job Trends
Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected Ebvallo, a T cell therapy approved in Europe for a transplant-related blood cancer, and placed a clinical hold on the company’s active drug applications.
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The group of like-named companies that include Novo Holdings and Novo Nordisk—the two tied to a multibillion-dollar buyout of Catalent currently under FTC review—ultimately send proceeds to the Novo Nordisk Foundation, one of the world’s largest charitable foundations.
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Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy.
The French giant is gaining access to darovasertib, a small molecule protein kinase C inhibitor already in Phase II/III trials, with rights for the whole world besides the U.S.
Novartis is licensing ARO-SNCA, a preclinical siRNA therapy for synucleinopathies, a group of neurodegenerative disorders including Parkinson’s disease.
The OMass partnership will boost Roche’s strategy in inflammatory bowel diseases, currently led by afimkibart, an anti-TL1A therapy the pharma obtained from its $7.1 billion acquisition of Telavant in 2023.
Novo Nordisk’s Wegovy has been on a winning streak as of late, with a metabolic dysfunction-associated steatohepatitis approval last month and prime position in the oral obesity race.
While the approval of Leqembi Iqlik bodes well for Biogen and Eisai’s planned application for a subcutaneous induction regimen next year, its financial impact remains “uncertain,” as potentially higher revenues from the injection could be offset by steeper costs of production, according to Jefferies.
While Eli Lilly’s orforglipron is full speed ahead for a regulatory filing this year, the pharma is also pushing forward with one more Phase II study of naperiglipron, which uses the same scaffold as Pfizer’s failed obesity drugs danuglipron and lotiglipron.
Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.
After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases.
With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very important for cancer.”