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

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

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

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

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

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

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

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

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

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

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

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 of

Primary endpoint met with statistically significant improvement (mean change of +2.13; p<0.001) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) Achieved statistical significance on pre-specified key secondary endpoint (p<0.001) and all four secondary efficacy endpoints (all p<0.001) 95% of trial participants aged ≥ 6 who completed the efficacy evaluation period improved on the mLM-IGA at Week 24 86% of trial participants aged ≥ 6 who completed the efficacy evaluation period were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the mLM-IGA at Week 24 QTORIN™ rapamycin was well-tolerated, with no drug-related serious adverse events reported a

WAYNE, Pa., Feb. 23, 2026 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), 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 host a conference call and webcast tomorrow, Tuesday, February 24, 2026, at 8:00am ET to discuss topline results from the Phase 3 SELVA clinical trial assessing the efficacy and safety of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic ly

Publication includes a systematic review of 24 studies describing off-label cutaneous application of statins in porokeratosis Preliminary case reports suggesting clinical benefit underscore unmet need for development of a standardized, FDA-approved statin therapy evaluated in rigorous, well-designed clinical trials  WAYNE, Pa., Feb. 02, 2026 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), 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 th

Phase 3 SELVA study evaluating QTORIN™ rapamycin 3.9% anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations (microcystic LMs) remains on track, with topline results anticipated in March 2026; pending positive results, an NDA submission is planned for the second half of 2026 Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic LMs which has the potential to become the first FDA-approved therapy and a first-line, standard-of-care treatment for this serious, lifelong disease affecting an estimated more than 30,000 diagnosed patients in the U.S. Following positive Phase 2 results for QTORIN™ rapamycin for the treatment of cutaneous venous malformations a

Seasoned dermatology and immunology executive brings more than 25 years of experience advancing and launching innovative therapies, including OPZELURA®, povorcitinib, ILUMYA®, ODOMZO®, REMICADE®, and STELARA® Dr. Patel to lead Palvella's Medical Affairs organization, advancing scientific engagement, KOL collaboration, disease state awareness, and medical education for the Company's QTORIN™ programs targeting serious, rare skin diseases, including microcystic lymphatic malformations and cutaneous venous malformations WAYNE, Pa., Jan. 07, 2026 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on dev

Fast Track designation designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet need With Fast Track designation, QTORIN™ rapamycin for angiokeratomas may be eligible for Accelerated Approval and Priority Review in the future, if applicable criteria are met Palvella plans to initiate a Phase 2 trial evaluating QTORIN™ rapamycin for clinically significant angiokeratomas in the second half of 2026 Angiokeratomas are characterized by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients WAYNE,

73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the Overall cVM-IGA at Week 12 Achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints, including dynamic change endpoints and static severity endpoints QTORIN™ rapamycin was generally well-tolerated, with no drug-related serious adverse events reported Based on Phase 2 results, Palvella to pursue near-term discussions with FDA regarding the potential fo

Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025 Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026 Expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FD

Primary endpoint met with statistically significant improvement (mean change of +2.13; p<0.001) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) Achieved statistical significance on pre-specified key secondary endpoint (p<0.001) and all four secondary efficacy endpoints (all p<0.001) 95% of trial participants aged ≥ 6 who completed the efficacy evaluation period improved on the mLM-IGA at Week 24 86% of trial participants aged ≥ 6 who completed the efficacy evaluation period were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the mLM-IGA at Week 24 QTORIN™ rapamycin was well-tolerated, with no drug-related serious adverse events reported a

WAYNE, Pa., Feb. 23, 2026 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), 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 host a conference call and webcast tomorrow, Tuesday, February 24, 2026, at 8:00am ET to discuss topline results from the Phase 3 SELVA clinical trial assessing the efficacy and safety of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic ly

73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the Overall cVM-IGA at Week 12 Achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints, including dynamic change endpoints and static severity endpoints QTORIN™ rapamycin was generally well-tolerated, with no drug-related serious adverse events reported Based on Phase 2 results, Palvella to pursue near-term discussions with FDA regarding the potential fo

Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025 Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026 Expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FD

DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients QTORIN™ pitavastatin has the potential to be the first pathogenesis-directed therapy designed to directly inhibit the mevalonate pathway, the causal driver of DSAP, in the pathogenic skin tissue Company plans to initiate a Phase 2 trial evaluating QTORIN™ pitavastatin for DSAP in the second half of 2026 Company to host webcast conference call today, November 5, 2025 at 8:30am ET WAYNE, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (

WAYNE, Pa., Nov. 04, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no FDA-approved therapies, today announced that it will report its third quarter 2025 financial results before market open on Tuesday, November 11, 2025. 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 of the call with slides, please click here or visit the "Events & Presentations" sec

Clinically significant angiokeratomas are characterized by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients Company plans to initiate a Phase 2 trial evaluating QTORIN™ rapamycin for clinically significant angiokeratomas in the second half of 2026 Company to host webcast conference call today, September 24, 2025 at 8:30am ET WAYNE, Pa., Sept. 24, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suff

Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations completed enrollment, exceeding enrollment target by over 25%; top-line results on track for the first quarter of 2026 Top-line results for Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for cutaneous venous malformations remain on track for the fourth quarter of 2025 QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic lymphatic malformations and cutaneous venous malformations Company plans to announce both a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ p

WAYNE, Pa., Aug. 07, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, today announced that it will report its second quarter 2025 financial results on Thursday, August 14, 2025. Palvella management will host a conference call for investors at 8:30 a.m. ET on Thursday, August 14, 2025, to discuss financial results and provide a corporate update. To access the live webcast of the call with slides, please click here or visit the "Events

Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) has exceeded enrollment target of 40 patients; enrollment expected to close in June 2025 Phase 3 SELVA trial top-line results anticipated in the first quarter of 2026 Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for the treatment of cutaneous venous malformations top-line results on track for the fourth quarter of 2025 QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs and cutaneous venous malformations Cash and cash equivalents of $75.6 million as of Ma

Seasoned dermatology and immunology executive brings more than 25 years of experience advancing and launching innovative therapies, including OPZELURA®, povorcitinib, ILUMYA®, ODOMZO®, REMICADE®, and STELARA® Dr. Patel to lead Palvella's Medical Affairs organization, advancing scientific engagement, KOL collaboration, disease state awareness, and medical education for the Company's QTORIN™ programs targeting serious, rare skin diseases, including microcystic lymphatic malformations and cutaneous venous malformations WAYNE, Pa., Jan. 07, 2026 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on dev

Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration

Ms. Kline to lead Palvella's commercial buildout for planned standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,0000 patients in the U.S., if approved Under Kline's leadership at Dompé, Oxervate®, a first-in-disease topical therapy for rare disease neurotrophic keratitis, scaled to over $500 million in annual U.S. sales while achieving early profitability WAYNE, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing an