Palvella Therapeutics (PVLA) said Monday that the US Food and Drug Administration has granted rolling review for its New Drug Application for Qtorin rapamycin to treat microcystic lymphatic malformations.

Microcystic lymphatic malformations are a rare, chronically debilitating genetic disease caused by dysregulation of the PI3K/mTOR pathway. The malformed lymphatic vessels can protrude through the skin, persistently leak and bleed, and cause recurrent infections, cellulitis, and hospitalization.

"We remain on track to complete submission of the Qtorin rapamycin NDA in the second half of 2026 and intend to utilize the benefits of rolling review, Breakthrough Therapy and Fast Track designations to support an efficient path toward potential approval," Chief Executive Wes Kaupinen said in a statement.

Shares of the biopharmaceutical company were up 5% pre-bell.