Palvella Therapeutics Shares Jump as Phase 3 SELVA Trial Hits Primary Endpoint for QTORIN Rapamycin

Positive top-line results show significant improvement in microcystic lymphatic malformations, a rare genetic disease with no FDA-approved treatments.

Published on Feb. 25, 2026

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Palvella Therapeutics reported positive top-line results from its phase III SELVA study evaluating QTORIN 3.9% rapamycin in hydrogel as a once-daily topical treatment for microcystic lymphatic malformations (mLM), a rare, serious, and chronically debilitating genetic disease with no FDA-approved therapies. The study met the primary endpoint and key secondary endpoint, with the majority of participants showing significant improvement in clinical assessments.

Why it matters

The positive results from the SELVA trial represent a major milestone for Palvella Therapeutics and patients suffering from mLM, a disease with no approved treatments. The high rate of participant rollover into the open-label extension suggests strong treatment acceptability and perceived benefit, which could support the drug's regulatory approval and commercial potential.

The details

According to Palvella, SELVA produced a 'highly statistically significant' improvement on the primary endpoint, the microcystic lymphatic malformation Investigator Global Assessment Scale (mLM-IGA), with a mean improvement of +2.13 at week 24 and a p-value of less than 0.001. 95% of participants completing the 24-week efficacy evaluation period improved on the primary endpoint, and 86% were rated as 'much improved' (+2) or 'very much improved' (+3). The key secondary endpoint, the blinded mLM-MCSS, also showed highly statistically significant improvement, as did all four additional secondary endpoints.

  • SELVA was a single-arm, baseline-controlled phase III study in patients three years and older, with efficacy evaluated over 24 weeks followed by an extension period.
  • Palvella plans to submit an NDA for QTORIN rapamycin in the second half of 2026.

The players

Palvella Therapeutics

A clinical-stage biopharmaceutical company developing innovative therapies for immunological and inflammatory diseases, including QTORIN rapamycin for the treatment of microcystic lymphatic malformations.

Dr. Michael Kelly

An investigator in the SELVA trial and a physician at the Cleveland Clinic, who discussed the clinical context and patient examples from the study.

Wes Kaupinen

The Chief Executive Officer of Palvella Therapeutics, who discussed the company's regulatory timeline, intellectual property strategy, and commercialization plans for QTORIN rapamycin.

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