Palvella Therapeutics (NASDAQ:PVLA) said it remains on track to complete its new drug application submission for QTORIN rapamycin in microcystic lymphatic malformations, or mLM, during the second half of 2026, with potential FDA approval targeted for the first half of 2027.
The company has submitte
Palvella Therapeutics (NASDAQ:PVLA) held its second-quarter earnings conference call on Tuesday. Below is the complete transcript from the call. This transcript is brought to you by Benzinga APIs. For real-time access
First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of 2026
Hybrid public meeting on August 5th will explore approaches to selecting and prioritizing promising FDA-approved drugs for repurposing, with the potential to accelerate patient access to effective therapies for significant unmet medical needs
WAYNE, Pa., July 28, 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 it will report its second quarter 2026 financial results before market open on Tuesday, August 4, 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.
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
