Palvella gets FDA priority review for lead asset (PVLA:NASDAQ)

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.

H.C. Wainwright reiterated a Buy rating and $246 price target for Palvella Therapeutics (PVLA) after positive pediatric data from dermatology conferences. The stock trades at $122.96, with a Strong Buy consensus and targets ranging from $205 to $267. Palvella presented data from Phase 3 SELVA and Phase 2 TOIVA trials, showing strong responses in young patients. The company reported a Q2 loss of $1.52 per share, wider than expected, but has $251 million in cash.