The Food and Drug Administration announced Friday that the lengthy shortage of Novo Nordisk’s popular weight loss and diabetes
medications Ozempic and Wegovy has been resolved, marking the end of a two-and-a-half-year supply constraint. This follows the agency’s recent announcement regarding the end of shortages for Eli Lilly’s competing medications, Mounjaro and Zepbound. To ensure a smooth transition, the FDA will temporarily allow compounded versions of these drugs to remain available until April 22 for state-licensed pharmacies and May 22 for federal outsourcing facilities. The news triggered a significant decline in shares of Hims & Hers Health, which markets compounded versions of these medications, with the stock falling more than 20% during Friday morning trading.
In other industry developments, Concentra Biosciences, backed by Tang Capital Partners, has launched an unexpected takeover attempt of Acelyrin, which recently agreed to merge with Alumis. The proposal includes a cash offer of $3 per share plus rights to 80% of proceeds from potential future licensing or sales of company programs. This contrasts with the existing merger agreement, under which Acelyrin shareholders would receive approximately 45% of Alumis shares. Acelyrin’s board is reviewing the proposal while maintaining that the Alumis merger is still on track for completion in the second quarter.
Intra-Cellular Therapies reported strong performance for its mental health medication Caplyta, with net sales reaching nearly $681 million in the previous year, representing a 47% increase from 2023. The drug, currently approved for schizophrenia and bipolar depression treatment in the United States, has attracted significant interest from Johnson & Johnson, leading to a planned acquisition worth approximately $15 billion.
European regulators have granted conditional approval to Gilead Sciences’ seladelpar, marketed as Livdelzi in the United States, for treating primary biliary cholangitis. The authorization comes six months after FDA approval, with Gilead now conducting confirmatory trials to demonstrate the drug’s ability to reduce disease-related complications.
In pharmaceutical industry leadership news, Pfizer CEO Albert Bourla has been appointed as the new board chair of the Pharmaceutical Research and Manufacturers of America (PhRMA). Bourla, who has led Pfizer since 2019, succeeds Gilead Sciences CEO Daniel O’Day in this role. The leadership transition also includes Sanofi CEO Paul Hudson as chair-elect and Merck & Co.’s CEO Robert Davis as treasurer. Bourla emphasized his commitment to working with policymakers to enhance healthcare accessibility and affordability while advancing treatment options for chronic diseases.
Additionally, Incyte and Genesis Therapeutics have established a new artificial intelligence collaboration aimed at accelerating small molecule drug discovery. The partnership involves an initial payment of $30 million to Genesis, with potential additional payments of up to $295 million based on achievement of specific milestones. Under the agreement, Incyte will maintain development and commercialization rights for any successfully discovered drug candidates, though specific therapeutic areas have not been disclosed.