The biotech company reported statistically significant Phase 3 data for QTORIN gel.
Shares of Palvella Therapeutics Inc (PVLA) jumped nearly 45% in pre-market trading 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.
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.
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