Drug Development
The obesity market and Most Favored Nation drug pricing were among the topics de jour at the J.P. Morgan Healthcare Conference last week, while smaller biotechs sought to assure investors that their regulatory ducks are in a row; Novo Nordisk’s oral obesity pill got off to a hot start while the FDA delayed a decision on Eli Lilly’s investigational offering; and SpyGlass Pharma and AgomAb Therapeutics join the 2026 IPO club.
FEATURED STORIES
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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The FDA’s decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
Angion Biomedica Corp. discontinued a Phase II kidney disease trial while Novo Nordisk missed the mark in a NASH study.
BioNTech announced it is partnering with Pfizer to begin testing a next-generation universal vaccine against coronaviruses, including SARS-CoV-2, the coronavirus that causes COVID-19.
Italfarmaco is making headway against DMD as it announced positive results from a Phase III study, Clover’s homologous booster against Omicron increases antibodies, and much more.
89bio reported positive topline results from ENTRIGUE Phase II trial of pegozafermin in patients with severe hypertriglyceridemia.
Axsome hosted an investor day event to provide an update on plans for Sunosi and other developmental assets, including MDD treatment AXS-05.