Brings more than 25 years of experience advancing and commercializing high-impact therapies for serious diseases, including those with limited or no approved treatment options
FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules of the NDA before the full application is submitted
FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted
WAYNE, Pa., June 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 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 Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference 2026 on Tuesday, June 9, 2026 at 8:40 a.m. ET.
Yale-licensed U.S. patent provides broad protection for topical mevalonate pathway inhibition in porokeratosis, including disseminated superficial actinic porokeratosis (DSAP)
WAYNE, Pa., May 21, 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 it has been named the Healthcare & Life Sciences Company of the Year at the 2026 Philadelphia Alliance for Capital and Technologies (PACT) Ecosystem Awards.
In SELVA Phase 3 study, 100% of participants (13/13) aged 6–11 years were rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) scale at Week 24, with a mean improvement of +2.46 (p<0.001)
100% of patients with bleeding at baseline demonstrated a statistically significant improvement on the Cutaneous Venous Malformations Investigator Global Assessment Bleeding scale (cVM-IGA Bleeding) at Week 12 (+2.5 point improvement; p=0.003)
Palvella Therapeutics (NASDAQ:PVLA) said it remains on track to submit a New Drug Application in the second half of 2026 for QTORIN rapamycin in Microcystic Lymphatic Malformations, after reporting what executives described as positive Phase 3 results and outlining an expanded commercial plan suppor
FDA Pre-New Drug Application (NDA) meeting granted for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, with meeting expected in second quarter of 2026; NDA submission on track for second half of 2026
Clinically significant angiokeratomas represent a rare, chronic and debilitating lymphatic malformation with no FDA-approved therapies and an estimated more than 50,000 diagnosed patients in the U.S.
WAYNE, Pa., April 30, 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 it will report its first quarter 2026 financial results before market open on Thursday, May 7, 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.
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
Physician and seasoned life sciences investor with more than two decades of experience across clinical practice, biotechnology investing, and board leadership
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®
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
Review delineates differences in clinical strategies between microcystic and macrocystic lymphatic malformations to guide disease-specific clinical trial design and treatment approaches
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
Focused on therapies for rare skin diseases, this clinical-stage biotech saw a notable director purchase coincide with a decisive Phase 3 trial announcement and the closing of a $230 million equity offering.
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.
