Articles from Palvella Therapeutics

Phase 3 single-arm, baseline-controlled trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) currently enrolling participants at leading vascular anomaly centers across the U.S.

Mr. Korenberg is a seasoned executive with significant operational and financial leadership experience, including senior roles at Ligand Pharmaceuticals (NASDAQLGND) and in healthcare investment banking at Goldman Sachs

Poster presentations include data supporting QTORIN™ rapamycin 3.9% anhydrous gel as a potential targeted therapy for the treatment of microcystic lymphatic malformations and a review of the Phase 3 SELVA study

FDA Orphan Products Grants are based on scientific and technical merit as determined by rare disease and regulatory experts

Palvella Received $5 Million Upfront Payment

QTORIN™ rapamycin has potential to be first approved therapy and standard of care in the U.S. for Microcystic Lymphatic Malformations

QTORIN™ rapamycin has potential to become first approved therapy and standard of care for Microcystic Lymphatic Malformations in U.S.; significant commercial opportunity based on an estimated more than 30,000 individuals in the U.S. with Microcystic Lymphatic Malformations

WAYNE, Pa., July 20, 2023 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, today announced topline results from VAPAUS, a 24-week, randomized, double-blind, placebo-controlled pivotal Phase 3 study of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of Pachyonychia Congenita (PC).

QTORIN™ rapamycin generally well-tolerated; no drug related severe adverse events and no observed rapamycin in systemic circulation

- Pivotal Phase 3 data for the treatment of Pachyonychia Congenita anticipated mid-2023 -

Led by new investor Petrichor, with participation from new and existing investors