The Food and Drug Administration announced Friday that the prolonged shortage of Novo Nordisk’s popular metabolic medications Ozempic and Wegovy has been resolved, marking the end of a two-and-a-half-year supply constraint. This development follows the FDA’s earlier declaration that shortages of Eli Lilly’s competing treatments, Mounjaro and Zepbound, had also concluded. Both pharmaceutical companies have faced significant manufacturing challenges amid soaring demand, particularly for obesity treatments.
To ensure a smooth transition, the FDA has established a grace period for compounded alternatives. Pharmacies operating under state licenses have until April 22 to continue manufacturing these alternatives, while federally authorized outsourcing facilities have until May 22. This news notably impacted Hims & Hers Health, a provider of compounded versions, whose shares dropped more than 20% during Friday morning trading.
In other industry developments, Concentra Biosciences, backed by Tang Capital Partners, has launched an unexpected takeover bid for Acelyrin, which recently agreed to merge with Alumis. The proposal offers Acelyrin shareholders $3 per share in cash plus 80% of potential future licensing or sale proceeds. This contrasts with the current merger plan, which would give Acelyrin stockholders
approximately 45% of Alumis shares, currently valued around $5 each. Acelyrin’s board is reviewing the proposal, with their planned Alumis merger scheduled for second quarter completion.
Intra-Cellular Therapies reported impressive growth for their mental health drug Caplyta, with net sales reaching nearly $681 million in the previous year, representing a 47% increase from 2023. The medication, approved for schizophrenia and bipolar depression treatment in the United States, caught Johnson & Johnson’s attention, leading to their recent $15 billion acquisition agreement expected to finalize this year.
European regulators have granted conditional approval to Gilead Sciences’ seladelpar, marketed as Livdelzi in the U.S., for treating primary biliary cholangitis. The authorization comes six months after FDA approval, with ongoing confirmatory trials to demonstrate the drug’s ability to reduce PBC-related complications in patients with compensated cirrhosis. Gilead acquired the treatment through its $4.3 billion purchase of CymaBay Therapeutics.
In leadership news, Pfizer CEO Albert Bourla has been appointed as chair of the Pharmaceutical Research and Manufacturers of America’s board, succeeding Gilead Sciences CEO Daniel O’Day. Bourla expressed commitment to collaborating with policymakers to enhance healthcare accessibility and affordability. The leadership transition includes Sanofi CEO Paul Hudson as chair-elect and Merck & Co.’s CEO Robert Davis as treasurer.
Additionally, Incyte and Genesis Therapeutics have established an artificial intelligence partnership aimed at accelerating small molecule drug discovery. The collaboration involves an initial $30 million payment to Genesis, with potential additional payments of up to $295 million based on achievement of specific milestones. Under the agreement, Incyte maintains development and commercialization rights for any resulting drug candidates, though specific disease targets remain undisclosed.
These developments reflect significant progress in addressing pharmaceutical supply challenges, advancing treatment options, and fostering technological innovation within the industry. The resolution of the Ozempic and Wegovy shortages particularly marks a crucial milestone in meeting the growing demand for metabolic disorder treatments, while new partnerships and leadership changes indicate continued evolution in pharmaceutical research and development approaches.