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.
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
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
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 aggregate gross proceeds to Palvella from this offering, before deducting underwriting discounts and commissions and offering expenses, were $230.0 million.
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 underwriting discounts and commissions. The aggregate gross proceeds to Palvella from this offering are expected to be $200 million, before deducting underwriting discounts and commissions and other offering expenses, assuming no exercise of the underwriters’ option to purchase additional shares. All shares of common stock are being offered by Palvella. The offering is expected to close on or about February 27, 2026, subject to the satisfaction of customary closing conditions.
WAYNE, Pa., Feb. 24, 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 has commenced an underwritten public offering of $150.0 million of shares of its common stock. In addition, Palvella expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock. All shares of common stock to be sold in the proposed offering are to be sold by Palvella. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the proposed offering.
