Crinetics Pharmaceuticals, Inc. announced on September 26, 2024, the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine. This investigational, once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist is being developed for the proposed treatment and long-term maintenance therapy of acromegaly.
The NDA submission is supported by data from 18 clinical trials, including two Phase 3 trials, PATHFNDR-1 and PATHFNDR-2. Both Phase 3 studies met all primary and secondary endpoints, demonstrating that treatment with paltusotine was well-tolerated and resulted in biochemical control and patient-reported symptom control compared to placebo.
This submission represents a significant step towards potentially offering a new generation of therapy for people living with acromegaly. Crinetics anticipates receiving notification from the FDA on the status of the NDA submission in December 2024, marking a key regulatory timeline for the company.
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