Crinetics Pharma: FDA Approves PALSONIFY, First Daily Pill For Acromegaly

Crinetics Pharmaceuticals

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(RTTNews) - Crinetics Pharmaceuticals Inc. (CRNX) announced that the U.S. Food and Drug Administration has approved PALSONIFY (paltusotine) as a first-line treatment for adults with acromegaly who have not responded adequately to surgery or for whom surgery is not an option.

PALSONIFY is a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist and now stands as the first once-daily, oral therapy approved for this condition.

The approval is supported by data from two pivotal Phase 3 trials, which demonstrated that PALSONIFY was well tolerated and delivered rapid, durable, and consistent biochemical control along with reduced symptom burden.

PALSONIFY is expected to launch in the U.S. in early October.

A Marketing Authorization Application (MAA) for paltusotine is currently under review in the European Union, with a CHMP opinion anticipated in the first half of 2026. In Japan, Crinetics is collaborating with Sanwa Kagaku Kenkyuso (SKK) to develop and commercialize the drug.

Additionally, paltusotine is being evaluated for the treatment of carcinoid syndrome in the ongoing Phase 3 CAREFNDR trial, with global enrollment expected throughout 2025.

CRNX closed Thursday's regular trading at $35.89 up $0.71 or 2.02%. But in the after-hours trading, the stock dropped $0.03 or 0.08%.

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