- Palvella said the study met its key secondary endpoint and all four additional secondary endpoints.
- In the Phase 3 SELVA study, QTORIN rapamycin was generally well tolerated.
- The company plans to submit an NDA to the U.S. FDA in the second half of 2026.
Shares of Palvella Therapeutics Inc (PVLA) jumped nearly 37% on Tuesday, after the company reported positive topline results from its Phase 3 SELVA study, potentially paving the way for a FDA submission.
The company said its lead candidate, QTORIN 3.9% rapamycin anhydrous gel, met its primary endpoint, showing a statistically significant improvement on the Microcystic Lymphatic Malformation Investigator Global Assessment scale.
The study also met its key secondary endpoint and all four additional secondary endpoints, each demonstrating statistical significance in patients with microcystic lymphatic malformations (MLM), a rare vascular condition. MLM is a benign, fluid-filled cyst that can form under the skin, often on the neck or the head.
QTORIN Rapamycin Was Well Tolerated
In the Phase 3 SELVA study, QTORIN rapamycin was generally well tolerated. Of the 50 patients who started treatment, 70% reported side effects, most of which were mild or moderate. Four serious adverse events were reported, but investigators said they were not related to the drug. The most common treatment-related issues were mild skin reactions at the application site.
88% of the patients completed the 24-week study. Nearly all eligible participants chose to continue treatment in the extension phase.
Based on these results, the company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026, with potential U.S. approval expected in the first half of 2027, the firm added.
How Did Stocktwits Users React?
Retail sentiment on Stocktwits flipped to ‘extremely bullish’ following the update, from ‘neutral’ a day earlier. Message volume on the platform was ‘extremely high’.
Year-to-date, the stock has gained around 16%
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