Palvella reports positive Phase 3 data for QTORIN rapamycin gel
Palvella Therapeutics presented Phase 3 SELVA findings for QTORIN rapamycin gel at the 26th Annual Fall Clinical Dermatology Conference. Among participants completing 24 weeks, 95% improved on the primary endpoint, 86% were rated Much Improved or Very Much Improved, and 98% chose to continue in an extension period. The company also reported at least 40-fold lower systemic rapamycin exposure than oral sirolimus and estimated 154,986 U.S. patients with diagnosed DSAP.
Why it matters
The reported Phase 3 results support Palvella's application for QTORIN rapamycin, while the pharmacokinetic findings indicate substantially lower systemic exposure than oral sirolimus. The company plans to begin a Phase 2 QTORIN pitavastatin trial in the fourth quarter of 2026.
Key facts
- 1The pharmacokinetic substudy included 24 participants. investing.com
- 2Palvella said the claims analysis covered patients diagnosed with DSAP during 2018-2025. investing.com
- 3Palvella completed its rolling FDA New Drug Application submission for QTORIN rapamycin in August 2026. investing.com
- 4The company plans to start a Phase 2 QTORIN pitavastatin trial in the fourth quarter of 2026. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.