RegulatoryApr 27, 2026, 05:14 PM
CRNX PALSONIFY Approved by European Commission for Acromegaly
AI Summary
Crinetics Pharmaceuticals, Inc. announced that the European Commission (EC) has approved PALSONIFY (paltusotine) for the treatment of adult patients with acromegaly. This marks the first once-daily, oral therapy approved for acromegaly in the European Union and Crinetics' first regulatory approval outside of the U.S. The approval is based on strong clinical data from the pivotal PATHFNDR-1 and PATHFNDR-2 Phase 3 trials, which demonstrated rapid onset, reliable biochemical control, and sustained efficacy. Crinetics plans initial commercialization efforts in Germany and Austria, with further regulatory submissions underway in Japan and Brazil.
Key Highlights
- European Commission approved PALSONIFY (paltusotine) for adult acromegaly.
- PALSONIFY is the first once-daily, oral therapy approved for acromegaly in the EU.
- Approval supported by positive results from pivotal PATHFNDR-1 and PATHFNDR-2 Phase 3 trials.
- PALSONIFY demonstrated rapid onset, reliable biochemical control, and sustained efficacy.
- This marks Crinetics' first regulatory approval outside of the U.S.
- Initial commercialization efforts are planned for Germany and Austria.
- PALSONIFY also has Orphan Drug Designation in the EU.
- NDA submitted in Japan and MAA submitted in Brazil for PALSONIFY.