Palvella Therapeutics

PVLA

時価総額 $17.3億

Phase 3 SELVA Pediatric Analyses Highlight Improvements in Overall Disease Severity and a Blinded Combined Score of Lesion Height, Vesicle Appearance, and Leaking/Bleeding

WAYNE, Pa., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular anomalies for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that members of its management team will participate in a fireside chat at the Chardan 10th Annual Healthcare Conference on Tuesday, October 20, 2026, at 1:45 p.m. ET. A live webcast of the fireside chat will be available on the Events and Presentations section of Palvella's website at www.palvellatx.com.

Palvella Therapeutics, Inc. advances QTORIN rapamycin for microcystic lymphatic malformations, completing NDA submission with strong Phase 3 data and FDA rolling review. Regulatory risk is now significantly reduced, with the FDA awarding a third year of OOPD funding post-positive Phase 3 results and no further efficacy studies required. PVLA's robust $250.6 million cash position supports manufacturing, regulatory, and launch efforts ahead of a targeted US commercial launch in H1 2027.

NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approved

Brings expertise in cutaneous vascular anomalies, including microcystic lymphatic malformations, venous malformations and angiokeratomas

WAYNE, Pa., Sept. 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 for serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will participate in two upcoming healthcare investor conferences.

QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic malformations in the U.S.

Palvella advances QTORIN rapamycin, targeting microcystic lymphatic malformations, with positive Phase 3 SELVA data and a rolling NDA submission underway. PVLA leverages a repeatable regulatory and commercial platform, aiming to expand QTORIN across multiple mTOR-driven dermatological indications, supporting a multi-indication commercial flywheel. Strong liquidity from a recent $230M equity raise enables PVLA to invest in commercialization and pipeline expansion, mitigating typical small biotech funding risks.

Palvella Therapeutics NASDAQ: PVLA is advancing topical therapies for serious rare skin diseases and vascular malformations that lack FDA-approved treatments, with its lead candidate, QTORIN rapamycin, moving toward a planned New Drug Application submission for microcystic lymphatic malformations.

WAYNE, Pa., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, announced today that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will participate in a fireside chat at the Canaccord Genuity 46th Annual Growth Conference on Wednesday, August 12, 2026, at 3:30 p.m. ET.