Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced that the European Commission (EC) has approved PALSONIFY® (paltusotine), the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the treatment of adult patients with acromegaly.

"The European Commission's decision to approve Palsonify reflects the strength of the clinical data and marks a pivotal step toward bringing this important therapy to even more people living with acromegaly," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "This approval represents another exciting milestone for Palsonify as it accelerates to become the new standard in acromegaly care in the U.S., and soon abroad. This is also a notable achievement for Crinetics in pursuit of our vision to become the global leader in endocrinology."

The EC approval is supported by positive results from the pivotal data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 trials, which evaluated PALSONIFY's safety and efficacy in previously treated and medically untreated adults with acromegaly. Across both trials, PALSONIFY consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy. PALSONIFY also has Orphan Drug Designation in the EU.

Participants also reported significant reductions in signs and symptoms associated with acromegaly – including headaches, joint pain, sweating, fatigue, weakness, swelling, and/or numbness/tingling – as measured by the Acromegaly Symptom Diary (ASD), a validated patient-reported outcome tool developed to capture the symptoms that matter to people living with acromegaly.

Treatment with PALSONIFY was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trial. The most frequently reported adverse reactions with paltusotine were diarrhea, abdominal pain, nausea, and abdominal discomfort.

The approval by the EC is valid in all 27 member states of the EU and three European Economic Area (EEA) countries. Crinetics is currently planning initial commercialization efforts in Germany and Austria.

PALSONIFY is approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Crinetics is also in partnership with Sanwa Kagaku Kenkyusho Co., Ltd (SKK) to develop and commercialize PALSONIFY for acromegaly in Japan, where the Ministry of Health, Labour and Welfare recently granted an orphan drug designation. SKK recently submitted a new drug application (NDA) in Japan for paltusotine for the treatment of acromegaly. In Brazil, Crinetics recently submitted a Marketing Authorization Application (MAA) to Brazil's National Health Surveillance Agency (ANVISA) for PALSONIFY for the proposed treatment of acromegaly in adults.