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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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.