Crinetics gets FDA approval for PALSONIFY (paltusotine) as first oral acromegaly treatment

Crinetics Pharmaceuticals, Inc.

FDA approved PALSONIFY (paltusotine) for adults with acromegaly with inadequate response to surgery or not surgical candidates.
First once-daily oral SST2 agonist; approval based on Phase 3 PATHFNDR-1/2 trials showing rapid, durable biochemical control and reduced symptom burden.
Product expected available in U.S. early October; CrinetiCARE support program launched for patients.
MAA under review in EU (CHMP opinion H1 2026); also evaluating paltusotine in Phase 3 CAREFNDR trial for carcinoid syndrome.
Investor conference call on Sept 25, 2025 at 6:00 pm ET to discuss FDA approval.

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