Palvella Therapeutics stock price rises due to positive Phase 3 clinical trial data

LootboxPhobia · 2026-02-24T16:47:44+00:00

Palvella Therapeutics announces that its QTORIN™ rapamycin treatment for microcystic lymphatic malformations has achieved positive results in Phase III studies, with the stock price rising 15%. The study met primary and key secondary endpoints, the therapy was well tolerated, and a FDA approval application is planned for 2026. If approved, it will become the first drug to treat this condition.

LootboxPhobia

2026-02-24 16:47:44

Abstract generation in progress

Investing.com – Palvella Therapeutics (NASDAQ:PVLA) stock rose 15% on Tuesday after the company announced positive topline results from the Phase 3 SELVA clinical trial of QTORIN™ 3.9% rapamycin topical gel for microcystic lymphatic malformations.

The Phase 3 trial met its primary endpoint, showing a statistically significant improvement in overall assessment of microcystic lymphatic malformations, with an average change of +2.13 points (p<0.0001). The study also achieved statistical significance on its pre-specified key secondary endpoint—the blinded mLM multi-component static scale—with an average improvement of 3.36 points (p<0.0001).

The trial enrolled 51 participants aged 3 and older at U.S. vascular anomaly centers, with 50 starting treatment. Among the 49 participants aged 6 and above who completed the 24-week efficacy assessment, 95% showed improvement on the mLM-IGA, and 86% were rated as “significantly improved” or “very significantly improved.”

QTORIN™ rapamycin was well tolerated, with no serious adverse events related to the drug reported. All participants maintained systemic rapamycin levels below 2 ng/mL at all time points. Of those who completed the efficacy assessment, 98% chose to continue treatment during the ongoing extension period.

Based on these results, Palvella plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026, with expected approval in the first half of 2027. If approved, QTORIN™ rapamycin will become the first FDA-approved therapy for microcystic lymphatic malformations, a condition affecting approximately 30,000 people in the U.S.

This therapy has received FDA breakthrough therapy, orphan drug, and fast track designations.

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