STAT+: The clock is ticking, and Cytokinetics is running out of December

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Hello, everyone. Damian here with the final edition of this newsletter for 2023. We’re taking a break for the holidays and will be back in your inbox bright and early on Jan. 3.

The need-to-know this morning

• Bristol Myers Squibb is purchasing Karuna Therapeutics, developer of a drug for schizophrenia, for $14 billion.
• The FDA approved a novel medicine for a rare and devastating nerve disease called ATTR-PN, clearing a treatment that promises to be more convenient than available therapies. The new drug, called Wainua, is made by AstraZeneca and Ionis Pharmaceuticals.
• Allovir is shutting down Phase 3 clinical trials of an off-the-shelf T-cell therapy for three types of infectious disease. The decision comes after independent study monitors concluded Allovir’s therapy was unlikely to achieve its efficacy goals.
• The FDA prescribing label for Carvykti, a CAR-T therapy for multiple myeloma made by Johnson & Johnson and Legend Biotech, has been updated to include the occurrence of secondary blood cancers in patients treated with the medication.
• Sarepta Therapeutics said an efficacy supplement was submitted to the FDA, seeking to expand the prescribing label of its gene therapy for Duchenne muscular dystrophy to all patients without restrictions on age or ambulatory status.

Biotech’s green 2023 is in doubt

After an extended bull run that had investors looking rosily forward to 2024, the closely watched XBI biotech index had its worst day since February on Wednesday, falling more than 4%. Then it recovered most of those losses yesterday in another dramatic move that didn’t appear tied to the actual fundamentals of developing new medicines, much less a single company’s misfortunes.

Continue to STAT+ to read the full story…