Palvella plans to release third-quarter results before markets open Nov. 5.

Palvella Therapeutics (PVLA) shares rose after the FDA granted priority review for its new drug application for Qtorin rapamycin, its lead product candidate. The company seeks U.S. approval for the topical mTOR.

Palvella Therapeutics (PVLA) received FDA Priority Review for QTORIN rapamycin gel to treat microcystic lymphatic malformations, with a decision expected by February 2027. The NDA is supported by positive Phase 3 trial results. PVLA stock rose 5.29% to $132.91 on Tuesday.

Palvella Therapeutics (NASDAQ:PVLA) announced FDA Priority Review for QTORIN 3.9% gel to treat microcystic lymphatic malformations, with a target action date of February 28, 2027. The application is based on positive Phase 3 SELVA study results, showing significant efficacy and a good safety profile. The therapy has received Breakthrough Therapy, Fast Track, and Orphan Drug designations. Palvella plans a potential U.S. launch in early 2027, pending approval.

Palvella Therapeutics (PVLA) received FDA acceptance and Priority Review for its QTORIN rapamycin NDA, targeting a February 28, 2027 decision. The NDA seeks approval to treat microcystic lymphatic malformations, a condition with no current FDA-approved therapies. Phase 3 SELVA results showed statistical significance across all efficacy endpoints. Palvella plans a potential U.S. launch in early 2027 if approved.

PALVELLA THERAPEUTICS, INC. (PVLA) filed an SEC Form 8-K — Other Events. Palvella Announces FDA Acceptance and Priority Review of QTORIN™ Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set QTORIN™ rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an esti

Palvella Therapeutics (PVLA) presented its rare-disease strategy at Chardan's conference, targeting a commercial launch in 2025. The company raised $230M in 2024, filed an NDA for QTORIN rapamycin, and expects an FDA decision by late October. Palvella is expanding its pipeline to six indications by year-end, with a focus on skin and vascular anomaly diseases. Management anticipates peak sales of $1B-$3B for its lead programs.