Company projects over $1B peak U.S. sales for treatment targeting microcystic lymphatic malformations after positive Phase III data.
Palvella Therapeutics plans to submit a New Drug Application (NDA) for QTORIN rapamycin in the second half of 2026, targeting microcystic lymphatic malformations. The decision follows decisively positive Phase III trial results, according to management during the Q1 2026 earnings call.
The company forecasts peak U.S. sales exceeding $1B for the treatment. Palvella also highlighted a strengthened balance sheet, positioning it for a potential FDA approval and commercial launch. No prior sales or revenue figures were disclosed for comparison.
Shares of Palvella (PVLA) showed no immediate market reaction in after-hours trading following the announcement.