Announcement • Jun 30
Palvella Therapeutics, Inc. Announces Appointment of Matt Pauls to Board of Directors Palvella Therapeutics, Inc. announced the appointment of Matt Pauls, J.D., M.B.A., to its Board of Directors. Mr. Pauls brought more than 25 years of experience advancing and commercializing high-impact therapies for serious diseases, including those with limited or no approved treatment options. He has extensive public company and rare disease experience, including executive and Board roles at Savara Inc, Soleno Therapeutics, Strongbridge Biopharma, and Insmed Incorporated. Since 2020, he has served as Chair of the Board of Directors and Chief Executive Officer of Savara Inc., a clinical-stage biopharmaceutical company focused on rare respiratory diseases. From 2014 to 2019, he served as President and Chief Executive Officer and a member of the Board of Directors of Strongbridge Biopharma plc, which was subsequently acquired by Xeris Pharmaceuticals. At Strongbridge, he led the company through its Nasdaq initial public offering, oversaw the successful commercialization of KEVEYIS and Macrilen, and advanced RECORLEV® through pivotal Phase 3 development for Cushing’s syndrome. Earlier in his career, he served as Chief Commercial Officer of Insmed Incorporated, where he led global commercial and technical operations, and held senior commercial leadership roles at Shire Pharmaceuticals, Bristol Myers Squibb, and Johnson & Johnson. From 2023 to 2026, he served on the Board of Soleno Therapeutics, including as Lead Independent Director from 2024 through its $2.9 billion acquisition by Neurocrine Biosciences in 2026. During his tenure, Soleno secured FDA approval and successfully launched VYKAT XR, the first and only FDA-approved treatment for hyperphagia in patients with Prader-Willi syndrome, a serious, rare genetic disease. He currently serves on the Boards of Pelthos Therapeutics, a commercial-stage biopharmaceutical company focused on building and advancing a portfolio of differentiated cutaneous infectious disease products that address unmet patient needs, and Atsena Therapeutics, a clinical-stage gene therapy company focused on inherited retinal diseases that cause blindness. He also previously served on the Boards of Amplo Biotechnology and Zyla Life Sciences and as Chair of the Board of Directors of Mast Therapeutics. Mr. Pauls holds a B.S. and M.B.A. from Central Michigan University and a J.D. from Michigan State University College of Law. PVLA
Live News • Jun 30
FDA Begins Rolling Review of Palvella Therapeutics QTORIN NDA for Rare Disease Palvella Therapeutics received FDA rolling review status for its New Drug Application for QTORIN rapamycin, a topical treatment for microcystic lymphatic malformations, and has already submitted the first module. The company plans to complete the filing by the second half of 2026 and is targeting a potential standalone U.S. launch in the first half of 2027.
The QTORIN program already holds Breakthrough Therapy and Fast Track designations. If approved, it would be the first FDA-authorized therapy for microcystic lymphatic malformations, a rare disease affecting more than 30,000 people in the U.S., which could create a new revenue stream that uses Palvella’s existing operating base.
Palvella’s stock trades at $154.84, with a return of 54.4% year to date, reflecting strong market focus on QTORIN as the company’s lead value driver.
The key tension for Palvella is clear: the stock is already pricing in meaningful expectations for QTORIN, while regulatory, launch timing and uptake remain uncertain. Announcement • Jun 29
Palvella Therapeutics, Inc.(NasdaqGM:PVLA) dropped from Russell 2500 Value Benchmark Palvella Therapeutics, Inc.(NasdaqGM:PVLA) dropped from Russell 2500 Value Benchmark