Crinetics
2 products tracked · names used in filings: Crinetics, Crinetics Pharmaceuticals, Inc., Crinetics Pharmaceuticals Europe GmbH
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Palsonify (paltusotine) approved in the EU
Marketing authorisation to Crinetics Pharmaceuticals Europe GmbH; Orphan, Additional monitoring · source
Palsonify (paltusotine): CHMP positive opinion
Crinetics Pharmaceuticals Europe GmbH; Orphan, Additional monitoring · source
PALSONIFY: PDUFA target action date (acromegaly)
Crinetics Pharmaceuticals, Inc. (CRNX); paltusotine; NDA; status: set; "Crinetics Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update Regulatory Interactions and Commercial, Medical and Corporate Preparations On-Track for PALSONIFY™ (paltusotine) New Drug Application with September 25, 2025 PDUFA Date Continued Progress on the Global Development…"; filed 2025-08-07 · source
paltusotine: PDUFA target action date (acromegaly (treatment and maintenance therapy))
Crinetics Pharmaceuticals, Inc. (CRNX); paltusotine; NDA; status: set; "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 CALM-CAH Phase 3 Study of Atumelnant for the Treatment of…"; filed 2025-05-08 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Palsonify paltusotine | Authorised | 2026-04-23 |
| 🇺🇸 | Palsonify paltusotine hydrochloride | Approved | 2025-09-25 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.