Shots:
- The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA’s review, with CHMP opinion expected in H1’26
- Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO in treatment-naïve & experienced pts, respectively, showing rapid, sustained biochemical control with symptom reduction per ASD; OLE data at ENDO’25 showed durable IGF-1 control & symptom relief
- Palsonify (PO, QD), a SST2 nonpeptide agonist, is advancing into P-III (CAREFNDR) trial for carcinoid syndrome, with global enrolment expected throughout 2025
Ref: Crinetics Pharmaceuticals | Image: Crinetics Pharmaceuticals | Press Release
Related News:- Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly
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