Shares of Palvella Therapeutics, Inc. (PVLA) gained nearly 40% on Tuesday morning after the company reported positive topline results from its Phase 3 SELVA study of QTORIN rapamycin for microcystic lymphatic malformations.
The stock is currently trading at $122.42, up $34.58 or 39.36%, on the Nasdaq. The stock opened at $112.00 after closing Monday at $87.84. The stock has traded between $18.23 and $127.69 in the past 52-week period. Trading volume was above average in the active session.
Palvella said the Phase 3 trial met its primary endpoint, showing statistically significant improvement in disease severity versus baseline. The therapy also achieved statistical significance across all key secondary endpoints and demonstrated a favorable safety profile with no drug-related serious adverse events.
The company plans to submit a New Drug Application to the FDA in the second half of 2026, with potential U.S. approval in the first half of 2027. If approved, QTORIN rapamycin would be the first approved therapy for patients with microcystic LMs.
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