PVLA

James Treat, MD, Professor of Clinical Pediatrics and Dermatology at the Children's Hospital of Philadelphia to present clinical results on Wednesday, May 20, 2026, at 4:30 p.m. ET WAYNE, Pa., April 20, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (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 two late-breaking abstracts highlighting results from the Phase 3 SELVA and Phase 2 TOIVA studies of QTO

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8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

Physician and seasoned life sciences investor with more than two decades of experience across clinical practice, biotechnology investing, and board leadership Author of a visionary 2015 Journal of Investigative Dermatology editorial highlighting the need for greater innovation and investment in rare skin diseases Deep medical and patient care experience will help guide the continued expansion of Palvella's pipeline and QTORIN™ platform WAYNE, Pa., April 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 to treat patients suffering from ser

8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

Mr. Taylor brings a strong track record launching multiple high-profile therapies, most recently serving as Senior Vice President, Sales at Arcutis Biotherapeutics (NASDAQ:ARQT), where he led U.S. sales efforts for ZORYVE®, a next-generation topical PDE4 inhibitor; previously, he held leadership roles at Incyte (NASDAQ:INCY) supporting the launch of OPZELURA® Mr. Taylor to lead Palvella's U.S. sales organization in preparation for the potential U.S. launch of QTORIN™ rapamycin for microcystic lymphatic malformations, a serious, rare, lifelong genetic disease affecting an estimated more than 30,000 diagnosed patients in the U.S. WAYNE, Pa., April 07, 2026 (GLOBE NEWSWIRE) -- Palvella Ther

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10-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs) on track for planned submission in second half of 2026 Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic LMs; potential to become the first FDA-approved therapy and first-line, standard-of-care treatment for serious, lifelong disease affecting an estimated more than 30,000 diagnosed patients in the U.S. Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for second half of 2026 Initiation of Phase 2 trial of QTORIN™ rapamycin for the treatment of clinically significant angiokeratomas plan

Review delineates differences in clinical strategies between microcystic and macrocystic lymphatic malformations to guide disease-specific clinical trial design and treatment approaches Manuscript emphasizes the importance of early therapeutic intervention in children to help reduce the risk of more serious complications over time Review supports the scientific rationale of QTORIN™ 3.9% rapamycin anhydrous gel as a potential targeted therapy for microcystic lymphatic malformations WAYNE, Pa., March 30, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel

Poster #76954 highlights QTORIN™ rapamycin's single phase anhydrous gel formulation designed to optimize dermal bioavailability of rapamycin for mTOR-driven skin diseases while overcoming the crystallization, stability, and dermal penetration challenges posed by rapamycin Poster #76929 highlights a qualitative patient and caregiver interview study evaluating the burden of living with porokeratosis, a serious, rare genetic skin disease characterized by numerous pre-cancerous, pruritic lesions and substantial functional and psychosocial burden WAYNE, Pa., March 27, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc., ("Palvella" or "the Company") (NASDAQ:PVLA), a clinical-stage biopharmac

WAYNE, Pa., March 24, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. ("Palvella" or "the Company") (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 the Company will report its full year 2025 financial results before market open on Tuesday, March 31, 2026. Palvella management will host a conference call for investors at 8:30 a.m. ET on that same day to discuss the results and provide a corporate update. To access the live webcast

Ms. McDonough previously served as Senior Vice President of Patient Access, Analytics, and Operations at Krystal Biotech (NASDAQ:KRYS), where she helped lead the U.S. launch of VYJUVEK®, supporting its growth from FDA approval in 2023 to $389 million in annual sales in 2025 Ms. McDonough to lead Palvella's Market Access and Patient Services organizations, advancing payer engagement, patient support, specialty distribution, and access strategy for the Company's QTORIN™ programs targeting serious, rare skin diseases and vascular malformations WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (Nasdaq: PVLA), a clinical-stage biopharmaceut

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Patent strengthens global intellectual property protection for QTORIN™ rapamycin, Palvella's lead product candidate from the QTORIN™ platform, in development for serious, rare skin diseases and vascular malformations with no FDA-approved therapies Patent protection extends into 2038 QTORIN™ rapamycin has previously been granted European Orphan Drug Designation for the treatment of microcystic lymphatic malformations, potentially providing 10 years of market exclusivity in the European Union upon approval There are currently no approved therapies in the European Union for microcystic lymphatic malformations  WAYNE, Pa., March 16, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. ("P

BEYONDmLM.com campaign designed to educate, engage, and empower patients, caregivers, and healthcare professionals Campaign developed and launched in close collaboration with leading nonprofit organizations, including the Consortium of iNvestigators of Vascular AnomalieS (CaNVAS), Lymphangiomatosis & Gorham's Disease Alliance (LGDA), the Lymphatic Education & Research Network (LE&RN), Pediatric Dermatology Research Alliance (PeDRA), and VAccess.org Microcystic lymphatic malformations (microcystic LMs) are a rare, chronically debilitating and lifelong disease affecting an estimated more than 30,000 diagnosed patients in the United States, with no FDA-approved therapies available WAYNE, Pa.

4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)

4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)

WAYNE, Pa., March 02, 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 closed its previously announced upsized public offering on February 27, 2026. The offering consisted of 1,840,000 shares of its common stock, which included the exercise in full of the underwriters' option to purchase 240,000 additional shares, at a price to the public of $125.00 per share. The agg

8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

424B5 - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

WAYNE, Pa., Feb. 25, 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 the pricing of its upsized public offering of 1,600,000 shares of its common stock at a price to the public of $125.00 per share. In addition, Palvella has granted the underwriters a 30-day option to purchase up to an additional 240,000 shares of its common stock at the public offering price, less underwrit