Core Insights - Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) experienced a significant stock increase of 35.39% week-on-week following FDA approval of its drug treatment for acromegaly [1][2]. Company Developments - The FDA officially approved Crinetics' drug, Palsonify, which targets adults with acromegaly who have had inadequate responses to surgery or for whom surgery is not an option [3]. - The approval was based on data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials, which demonstrated rapid onset, reliable biochemical control, and sustained efficacy [3]. - Crinetics is also pursuing a marketing authorization application with the European Union for Palsonify, expected to be approved by next year [4]. - The company has partnered with Japanese firm Sanwa Kagaku Kenkyusho (SKK) to develop and commercialize paltusotine for acromegaly in Japan [4].
Crinetics Pharma (CRNX) Flies 35% Higher on FDA Approval of Acromegaly Drug