Vertex Pharmaceuticals Inc. is buying Crinetics Pharmaceuticals Inc. for $85 per share in cash, which translates to about $10 billion in equity value. Both boards approved the transaction, expected to close in the third quarter of 2026.
Crinetics Pharmaceuticals Inc.’s green light under priority review from the U.S. FDA for Palsonify (paltusotine) in first-line acromegaly sets up a not-uncommon David vs. Goliath-type scenario in the indication caused by excessive growth hormone made by the pituitary gland.
Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
Clearing the way for a U.S. regulatory bid in the second half of this year are positive top-line results from Pathfindr-2, the second of two successful phase III studies testing the efficacy and safety of Crinetics Pharmaceuticals Inc.’s oral, once-daily paltusotine for acromegaly.
The majority of patients with acromegaly who switched from therapy with injected somatostatin receptor ligands to Crinetics Pharmaceuticals Inc.’s once-daily, oral drug paltusotine maintained stable levels of insulin-like growth factor 1 in a phase III trial, moving the company’s first-in-class lead closer to becoming the potential new standard of care for the rare hormonal disorder.
