Crinetics Pharmaceuticals (CRNX) said Thursday that the European Medicines Agency has validated its marketing authorization application for paltusotine, an oral treatment for endocrine disorder acromegaly.
The marketing authorization application will now undergo review by the Committee for Medicinal Products for Human Use. This submission is supported by 18 clinical trials, including two phase 3 studies that met all endpoints, showing paltusotine was well-tolerated and effective in acromegaly, the pharmaceutical company said.
The validation follows the US Food and Drug Administration's acceptance of paltusotine's new drug application for acromegaly treatment, with a Prescription Drug User Fee Act target action date of Sept. 25, Crinetics said.
The EMA also granted paltusotine an orphan drug designation for acromegaly treatment in late February, the company said.
Shares of the company rose 3.3% in recent after-hours activity.
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