Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced the submission of a Marketing Authorization Application (MAA) to Brazil's National Health Surveillance Agency (ANVISA) for PALSONIFY™ (paltusotine), the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment of acromegaly in adults.

"The submission of our MAA for Palsonify in Brazil represents another important global milestone for this important therapy," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Once-daily, oral Palsonify is redefining the treatment paradigm as the next generation of acromegaly care in the US, following its approval by the FDA. We now look forward to working with ANVISA as they evaluate our MAA for Palsonify to treat acromegaly in adults in Brazil."

The MAA submission is supported by data from 18 clinical trials, including two Phase 3 trials that evaluated paltusotine for the treatment of acromegaly in medically untreated and treated patients. All primary and secondary endpoints were met in both Phase 3 studies. Treatment with paltusotine was well-tolerated and resulted in statistically significant biochemical control and patient reported symptom control compared to placebo.

PALSONIFY is approved in the US to treat adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. In Europe, Crinetics recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for granting the MAA for Palsonify for the proposed treatment of acromegaly in adults.