Crinetics announces FDA acceptance of NDA for paltusotine

Crinetics (CRNX) Pharmaceuticals announced the U.S. Food and Drug Administration, FDA, accepted its New Drug Application, NDA, for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. If approved, paltusotine will be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for adults living with acromegaly. “With our patient-centered clinical development of paltusotine, we were guided by an unwavering ambition to deliver a new generation of treatment that provides a once-daily, oral alternative to the currently marketed peptide analog drugs,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “We look forward to working with the FDA throughout the review of our new drug application, as we also prepare for a potential commercial launch by building out our infrastructure and engaging with payers and the endocrinology community.”