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Executive Summary

Crinetics presented two-year open-label extension data at ENDO 2026 showing that once-daily oral PALSONIFY (paltusotine) maintains IGF-1 control, stable symptom scores, and stable or reduced pituitary tumor volumes in acromegaly patients. The data reinforce the drug's safety and durability profile, supporting its commercial differentiation as the only oral therapy in a market dominated by injectables.

Key Facts

• Two-year pooled OLE data from PATHFNDR-1 and PATHFNDR-2 show stable IGF-1 levels at 0.81-0.82x ULN (switched patients) and sustained reduction to 0.96x ULN (previously untreated patients).
• No new safety signals; discontinuation rate due to AEs was only 2.4% (4 of 167 patients).
• Pituitary tumor volume was stable in all PATHFNDR-1 patients and reduced >20% in 7 of 83 PATHFNDR-2 patients at OLE Week 24; remaining patients had stable volumes.
• Cabergoline combination data from ACROBAT Advance showed further IGF-1 improvement in patients not normalized on paltusotine monotherapy.
• PALSONIFY is already launched in the U.S., also approved in the EU, and is in Phase 3 for carcinoid syndrome (CAREFNDR).
• Pipeline includes late-stage atumelnant (congenital adrenal hyperplasia, Cushing's) and early-stage discovery programs.

Financial Impact

Positive differentiation supports revenue growth trajectory for PALSONIFY as first oral acromegaly therapy; no hard financial figures provided in this release.

Risk Factors

• Small patient numbers in OLE (n=167) limit statistical power; adverse event rates (diarrhea 15.6%, arthralgia 11.4%) remain relevant for tolerability discussions.
• Competition from injectable SRLs and emerging oral alternatives could pressure adoption.
• Carcinoid syndrome Phase 3 data (CAREFNDR) is binary risk; a miss would remove a significant pipeline value driver.

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Documents Analyzed

This report is based on 1 press release from GlobeNewswire.

US Market Status