Business
Crinetics Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update
Regulatory Interactions and Commercial, Medical, and Corporate Preparations On-Track for Paltusotine New Drug Application with September 25, 2025 PDUFA Date
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"Regulatory Interactions and Commercial, Medical, and Corporate Preparations On-Track for Paltusotine New Drug Application with September 25, 2025 PDUFA Date CALM-CAH Phase 3 Study of Atumelnant for the Treatment of Adults with Congenital Adrenal Hyperplasia to Initiate with Uncompromising Primary Endpoint to Normalize Androstenedione Levels with Physiologic Glucocorticoid Replacement R&D Day Scheduled for June 26 to Share Early-Stage Pipeline Strategy and Data $1.3B in Cash, Cash Equivalents, and Investment Securities as of March 31, 2025 Anticipated to Provide Runway into 2029 Management Hosting Conference Call at 4:30 p.m. ET Today SAN DIEGO, May 08, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today reported financial results for the first quarter ended March 31, 2025. “Crinetics is stronger than we have ever been,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “We are approaching a pivotal moment in our company’s history. We are on-track with the FDA review and preparations for the anticipated launch of paltusotine for acromegaly, while also moving forward with multiple late-stage studies. We are excited to unveil our Phase 3 study for adult CAH patients aimed at demonstrating normalization of androstenedione levels with physiological glucocorticoid replacement to define an uncompromising standard of care in CAH. We’re also excited to start the clinical development program for CRN09682, the first candidate from our nonpeptide drug conjugate platform. We look forward to sharing more about this and our other early programs at our upcoming R&D Day. With a robust financial foundation and strong momentum across clinical, regulatory, and commercial fronts, we are poised to deliver on our mission of advancing innovative therapeutics to improve the lives of patients with endocrine diseases around the world.” First Quarter 2025 and Recent Highlights: The review process for paltusotine’s New Drug Application (NDA) for acromegaly appears to be on track with productive and consistent engagement with the Food & Drug Administration (FDA). Launch of CrinetiCARE™ patient support services platform and a patien...