Crinetics’ Palsonify approved by European Commission for acromegaly

Crinetics (CRNX) announced that the European Commission 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 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 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. Treatment with Palsonify was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trial. The approval by the EC is valid in all 27 member states of the EU and three European Economic Area countries. Crinetics is currently planning initial commercialization efforts in Germany and Austria. Palsonify is approved by the 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 a partnership to develop and commercialize Palsonify for acromegaly in Japan.