On September 25, 2025, the U.S. Food and Drug Administration approved Crinetics Pharmaceuticals’ oral somatostatin receptor type 2 agonist, PALSONIFY (paltusotine), for the treatment of adults with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option. The approval marks the first once‑daily, oral therapy for acromegaly and represents a major regulatory milestone for the company. The decision was announced by Crinetics on September 26, 2025, following the FDA’s acceptance of the company’s New Drug Application in December 2024.
PALSONIFY selectively targets SST2 receptors, providing rapid and durable biochemical control of IGF‑1 levels while reducing the symptom burden associated with acromegaly. The drug’s oral formulation eliminates the need for monthly injections, addressing a key unmet need for patient convenience and adherence. Clinical data from the PATHFNDR‑1 and PATHFNDR‑2 Phase 3 trials demonstrated consistent efficacy and a favorable safety profile.
Crinetics expects PALSONIFY to reach U.S. market in early October 2025 and has launched the CrinetiCARE support program to facilitate patient access and adherence. The company is also pursuing a marketing authorization application in the European Union, with a first‑half 2026 decision anticipated, and has partnered with Sanwa Kagaku Kenkyuso to commercialize the drug in Japan. In addition, PALSONIFY is being evaluated in a Phase 3 trial for carcinoid syndrome, potentially expanding its indication portfolio.
An investor conference call was scheduled for 6:00 p.m. Eastern Time on September 26, 2025, to discuss the FDA approval and its implications for Crinetics’ commercial strategy. The approval is expected to open a new revenue stream for the company and position it as a leader in oral endocrine therapeutics. The announcement underscores Crinetics’ progress toward becoming a commercial enterprise.
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