Brings more than 25 years of experience advancing and commercializing high-impact therapies for serious diseases, including those with limited or no approved treatment options Extensive public company and rare disease experience, including executive and Board roles at Savara Inc.
FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules of the NDA before the full application is submitted FDA previously granted Breakthrough Therapy and Fast Track designations for QTORIN™ rapamycin, providing an expedited
FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted Palvella remains on track to complete the NDA submission in the second half of 2026 QTORIN™ rapamycin has the potential to
Palvella remains on track to submit an NDA in the second half of 2026 Microcystic lymphatic malformations are serious, chronic, lifelong vascular malformations that can cause persistent leaking, bleeding, infection, functional impairment, and significant daily burden for patients and families
WAYNE, Pa., June 02, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular
Yale-licensed U.S. patent provides broad protection for topical mevalonate pathway inhibition in porokeratosis, including disseminated superficial actinic porokeratosis (DSAP) DSAP is a serious, rare, premalignant genetic skin disease affecting an estimated more than 50,000 diagnosed patients in
WAYNE, Pa., May 21, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular
In SELVA Phase 3 study, 100% of participants (13/13) aged 6–11 years were rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) scale at Week 24, with a mean improvement of +2.46 (p
100% of patients with bleeding at baseline demonstrated a statistically significant improvement on the Cutaneous Venous Malformations Investigator Global Assessment Bleeding scale (cVM-IGA Bleeding) at Week 12 (+2.5 point improvement; p=0.003) 100% of patients with bleeding at baseline reported
Uplisting reflects Palvella’s continued progress advancing potential first-in-disease therapies for serious, rare skin diseases and vascular malformations WAYNE, Pa., May 13, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage
FDA Pre-New Drug Application (NDA) meeting granted for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, with meeting expected in second quarter of 2026; NDA submission on track for second half of 2026 Accelerating U.S. launch readiness for QTORIN™ rapamycin for
Clinically significant angiokeratomas represent a rare, chronic and debilitating lymphatic malformation with no FDA-approved therapies and an estimated more than 50,000 diagnosed patients in the U.S. Phase 2 single-arm, baseline-controlled trial expected to enroll up to 15 subjects at leading
WAYNE, Pa., April 30, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular
James Treat, MD, Professor of Clinical Pediatrics and Dermatology at the Children’s Hospital of Philadelphia to present clinical results on Wednesday, May 20, 2026, at 4:30 p.m. ET WAYNE, Pa., April 20, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc.