Palvella Therapeutics, Inc.

Palvella Therapeutics, Inc. ( PVLA ) Q3 2026 Earnings Call November 5, 2026 8:30 AM EST Company Participants Bohan Wei - Vice President of Corporate Development & New Product Planning Wesley Kaupinen - Founder, President, CEO & Director Ashley Kline Jeffrey Martini - Chief Scientific Officer Matthew Korenberg - CFO, Corporate Secretary & Treasurer Conference Call Participants Joshua Schimmer - Cantor Fitzgerald & Co., Research Division Ritu Baral - TD Cowen, Research Division Graig Suvannavejh -…

Palvella Therapeutics NASDAQ: PVLA is preparing for a potential U.S. launch of QTORIN rapamycin after the Food and Drug Administration accepted its application for the treatment of microcystic lymphatic malformations and granted it Priority Review.

FDA Accepts NDA for QTORIN™ Rapamycin and Grants Priority Review for Microcystic Lymphatic Malformations; PDUFA Target Action Date Set for February 28, 2027

WAYNE, Pa., Nov. 03, 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 present at the Stifel 2026 Healthcare Conference on Tuesday, November 10, 2026, at 9:2…

WAYNE, Pa., Oct. 29, 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 it will report its third quarter 2026 financial results before market open on Thursday, November 5, 2026.

QTORIN™ rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an estimated more than 30,000 diagnosed children and adults in the U.S.

Palvella Therapeutics NASDAQ: PVLA is preparing for a potential commercial launch of QTORIN rapamycin while advancing additional rare skin and vascular anomaly programs, Chief Financial Officer Matt Korenberg said during a Chardan investor session.

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 Tue…

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 c…

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.

Bank of America Corp DE grew its stake in shares of Palvella Therapeutics, Inc. (NASDAQ: PVLA) by 25.4% during the first quarter, according to the company in its most recent disclosure with the SEC. The fund owned 37,972 shares of the company's stock after buying an additional 7,700 shares during the quarter. Bank

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…

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.