WAYNE, Pa., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (“Palvella”) (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 malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it has commenced an underwritten public offering of $150.0 million of shares of its common stock. In addition, Palve ...

Webcast conference call to take place tomorrow, Tuesday, February 24, 2026, at 8:00am ETWAYNE, Pa., Feb. 23, 2026 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it will host ...

Publication includes a systematic review of 24 studies describing off-label cutaneous application of statins in porokeratosis Preliminary case reports suggesting clinical benefit underscore unmet need for development of a standardized, FDA-approved statin therapy evaluated in rigorous, well-designed clinical trials WAYNE, Pa., Feb. 02, 2026 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commerc ...

Core Insights - Recent advances in understanding the pathogenesis of venous malformations (VMs) highlight the PI3K/AKT/mTOR pathway as a key driver of disease proliferation, leading to increased off-label use of systemic rapamycin (sirolimus) for treatment [1][4] - A systematic review of 26 studies involving 98 patients treated with rapamycin for VMs supports the clinical potential of Palvella's QTORIN™ 3.9% rapamycin anhydrous gel, which is currently under evaluation in the Phase 2 TOIVA trial [2][3] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases without FDA-approved treatments [7] - The company is developing a pipeline based on its patented QTORIN™ platform, with QTORIN™ rapamycin being its lead product candidate [7] Industry Context - There is a significant unmet clinical need for effective treatments for cutaneous VMs, with no FDA-approved pharmacologic options currently available [2][6] - The estimated number of diagnosed patients with cutaneous VMs in the U.S. exceeds 75,000, highlighting the urgency for targeted therapies [5][6] Clinical Findings - The systematic review indicates that off-label use of rapamycin has shown efficacy in improving various clinical signs, including bleeding and quality of life, despite inadequate responses to standard treatments [4] - A targeted, topical formulation of rapamycin could provide clinical benefits by achieving therapeutic levels in the dermis while minimizing off-target effects associated with oral rapamycin [4] Regulatory Status - In April 2024, the FDA granted Fast Track Designation to QTORIN™ rapamycin for the treatment of VMs, indicating the potential for expedited development and review [5]

Core Insights - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases without FDA-approved treatments [1][3] - The company will present at two upcoming healthcare investor conferences, highlighting its commitment to engaging with investors [1][2] Company Overview - Founded by veterans in rare disease drug development, Palvella is dedicated to creating novel therapies for patients with serious, rare genetic skin diseases [3] - The company is developing a pipeline of product candidates using its patented QTORIN™ platform, with a focus on lifelong genetic skin diseases [3] - Palvella's lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel, is currently in Phase 3 and Phase 2 clinical trials for specific conditions [3] Upcoming Events - Wes Kaupinen, the CEO, will present at the Cantor Global Healthcare Conference on September 4, 2025, and at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 [2] - Live webcasts of the presentations will be available on Palvella's website, with archived replays accessible for approximately 90 days [2]

Core Insights - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases without FDA-approved treatments [1][3] - The company will have its CEO, Wes Kaupinen, participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025 [1] - Palvella's lead product candidate, QTORIN™ rapamycin, is currently in Phase 3 and Phase 2 clinical trials for specific conditions [3] Company Overview - Palvella Therapeutics is led by veterans in rare disease drug development and is focused on a broad pipeline of product candidates based on its patented QTORIN™ platform [3] - The company is specifically targeting serious, rare genetic skin diseases, many of which are lifelong [3] - QTORIN™ rapamycin is under investigation for microcystic lymphatic malformations and cutaneous venous malformations [3] Event Information - A live webcast of the fireside chat will be available on Palvella's website, with an archived replay accessible for approximately 90 days [2]