04:59 PM EDT, 09/26/2024 (MT Newswires) -- Crinetics Pharmaceuticals ( CRNX ) said Thursday it submitted a new drug application to the US Food and Drug Administration (FDA) for paltusotine, a drug in development to treat acromegaly.

The application is backed by 18 clinical studies results, featuring two Phase 3 trials that assessed paltusotine for treating acromegaly in both untreated and treated patients, the company said, adding that all primary and secondary endpoints were achieved in Phase 3 trials.

The company said it expects to get a notification from the FDA on the status of the submission in December.

Shares of Crinetics Pharmaceuticals ( CRNX ) were up 1.4% in after-hours trading.

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