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, Palve ...

Core Insights - Palvella Therapeutics announced positive topline results from the Phase 3 SELVA study of QTORIN™ rapamycin for treating microcystic lymphatic malformations, meeting its primary endpoint with a statistically significant improvement [2][3] - The company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026, with potential approval in the first half of 2027 [3][10] Study Results - The primary endpoint, the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA), showed a mean improvement of +2.13 points (p<0.001) [5][6] - 95% of participants aged ≥ 6 who completed the efficacy evaluation improved on the mLM-IGA at Week 24, with 86% rated as "Much Improved" or "Very Much Improved" [6][9] - All four secondary efficacy endpoints also achieved statistical significance (all p<0.001) [2][5] Safety and Tolerability - QTORIN™ rapamycin was well-tolerated, with no drug-related serious adverse events reported and systemic rapamycin levels below 2 ng/mL at all timepoints [6][8] - Among the 50 participants, 70% experienced treatment-emergent adverse events, but all were rated mild or moderate [8][9] Future Plans - Palvella aims to present detailed results from the SELVA study at upcoming medical meetings and is advancing QTORIN™ rapamycin for other rare skin diseases [11] - The company has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA for QTORIN™ rapamycin [10]

Webcast conference call to take place tomorrow, Tuesday, February 24, 2026, at 8:00am ETWAYNE, 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 ...

Core Viewpoint - Palvella Therapeutics, Inc. is set to announce topline results from the Phase 3 SELVA clinical trial for QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations, highlighting the company's focus on rare skin diseases and vascular malformations with no FDA-approved therapies available [1]. Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for serious, rare skin diseases and vascular malformations [3]. - The company is led by veterans in rare disease drug development and is focused on a broad pipeline of product candidates based on its patented QTORIN™ platform [3]. - Palvella's lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel, is in development for microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas [3]. - The second product candidate, QTORIN™ pitavastatin, is being developed for the topical treatment of disseminated superficial actinic porokeratosis [3]. Upcoming Events - A conference call and webcast will be held on February 24, 2026, at 8:00 am ET to discuss the topline results from the SELVA clinical trial [1]. - A press release with the topline results will be issued at approximately 6:30 am ET on the same day [1]. - The live webcast can be accessed through the company's website, and a replay will be available for 90 days [2].

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 commerc ...

Core Insights - The Phase 3 SELVA study for QTORIN™ rapamycin is on track, with topline results expected in March 2026, and a New Drug Application (NDA) submission planned for the second half of 2026, pending positive results [1][4] - QTORIN™ rapamycin has the potential to be the first FDA-approved therapy for microcystic lymphatic malformations, a serious condition affecting over 30,000 patients in the U.S. [1][4] - The company is expanding its QTORIN pipeline, with plans to announce a new product candidate and a fourth clinical indication for QTORIN™ rapamycin in the second half of 2026 [2][13] QTORIN™ Rapamycin for Microcystic Lymphatic Malformations - Microcystic lymphatic malformations are a rare genetic disease with no FDA-approved therapies, characterized by malformed lymphatic vessels causing severe complications [4][5] - The SELVA study enrolled 51 subjects, exceeding the target of 40, and is designed to evaluate the efficacy of QTORIN™ rapamycin over a 24-week treatment period [4][5] - The FDA has granted multiple designations to QTORIN™ rapamycin, including Breakthrough Therapy and Orphan Designation [5] QTORIN™ Rapamycin for Cutaneous Venous Malformations - Positive Phase 2 results for QTORIN™ rapamycin in treating cutaneous venous malformations were announced in December 2025, with a significant improvement seen in 73% of trial participants [9] - The company plans to meet with the FDA for a Preliminary Breakthrough Therapy Designation Advice meeting in Q1 2026 and initiate a Phase 3 study in the second half of 2026 [9] QTORIN™ Rapamycin for Clinically Significant Angiokeratomas - The company has expanded the development of QTORIN™ rapamycin to include clinically significant angiokeratomas, with an estimated 50,000 diagnosed patients in the U.S. [9] - Fast Track Designation has been granted for this indication, and a Phase 2 study is expected to begin in the second half of 2026 [9] QTORIN™ Pitavastatin for Disseminated Superficial Actinic Porokeratosis - QTORIN™ pitavastatin is being developed for a premalignant skin disease with no FDA-approved therapies, targeting over 50,000 diagnosed patients in the U.S. [9][14] - The company plans to meet with the FDA in the first half of 2026 to discuss a Phase 2 clinical trial design, with initiation expected in the second half of 2026 [9] Corporate Update and Leadership - Palvella Therapeutics is focused on developing therapies for serious, rare skin diseases and vascular malformations, leveraging its QTORIN™ platform [12] - The leadership team has been strengthened with key hires in commercial, research and development, and regulatory affairs to support the anticipated U.S. launch of QTORIN™ rapamycin [13]

Core Insights - The Phase 3 SELVA study for QTORIN™ rapamycin is on track, with topline results expected in March 2026, and a potential NDA submission planned for the second half of 2026 if results are positive [1][4] - QTORIN™ rapamycin aims to be the first FDA-approved therapy for microcystic lymphatic malformations, a serious condition affecting over 30,000 patients in the U.S. [1][4] - The company is expanding its QTORIN pipeline, with plans to announce a new product candidate and a fourth clinical indication for QTORIN™ rapamycin in the second half of 2026 [2][9] Clinical Development - The SELVA study has enrolled 51 subjects, exceeding the target of 40, and includes an 8-week observational period followed by 24 weeks of active treatment [4] - Positive Phase 2 results for QTORIN™ rapamycin in cutaneous venous malformations were announced in December 2025, leading to a request for a Preliminary Breakthrough Therapy Designation meeting with the FDA [2][5] - A Phase 2 study for QTORIN™ pitavastatin in disseminated superficial actinic porokeratosis and QTORIN™ rapamycin in clinically significant angiokeratomas is expected to start in the second half of 2026 [2][5] Market Potential - Microcystic lymphatic malformations are characterized by malformed lymphatic vessels causing significant morbidity, with no FDA-approved therapies currently available [4][5] - Cutaneous venous malformations affect over 130,000 diagnosed patients in the U.S., with no existing FDA-approved treatments [5] - Clinically significant angiokeratomas are estimated to affect more than 50,000 patients in the U.S., also lacking FDA-approved therapies [5] Intellectual Property and Leadership - The company has strengthened its intellectual property portfolio with new patents for QTORIN™ rapamycin and QTORIN™ pitavastatin, extending protection through 2038 and 2046 respectively [9] - Key leadership hires have been made to enhance commercial, R&D, and medical affairs capabilities, supporting the anticipated U.S. launch of QTORIN™ rapamycin [9]

Core Insights - Palvella Therapeutics has appointed Dr. Vimal Patel as Senior Vice President of Medical Affairs, bringing over 25 years of experience in dermatology and immunology to the role [1][2][3] - Dr. Patel will lead the Medical Affairs organization to enhance scientific engagement, KOL collaboration, and disease state awareness for the QTORIN™ programs targeting serious, rare skin diseases [1][2] Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies for serious, rare skin diseases without FDA-approved treatments [5][6] - The company is developing a pipeline based on its patented QTORIN™ platform, with lead candidates including QTORIN™ 3.9% rapamycin anhydrous gel and QTORIN™ pitavastatin [6][7] Leadership Experience - Dr. Patel previously served at Incyte as Dermatology Therapeutic Area Head, where he led medical strategy for various dermatological conditions and contributed to the launch of therapies like OPZELURA and povorcitinib [2][3] - His prior experience includes senior roles at Sun Pharma and Johnson & Johnson, where he contributed to the success of multiple high-impact therapies in dermatology and immunology [3] Strategic Vision - Dr. Patel emphasizes the importance of rigorous science and strong clinical evidence in advancing therapies for rare skin diseases, aligning with Palvella's mission-driven approach [4] - The QTORIN™ platform is seen as a pioneering solution with the potential to transform treatment paradigms for rare skin diseases by addressing their underlying pathobiology [4]

Core Insights - The FDA has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, highlighting its potential to address a significant unmet medical need [1][2][3] - Palvella Therapeutics plans to initiate a Phase 2 trial for QTORIN™ rapamycin in the second half of 2026, following discussions with the FDA [1][4] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is developing a pipeline of product candidates based on its QTORIN™ platform, with QTORIN™ rapamycin as the lead candidate targeting microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas [5] Industry Context - Angiokeratomas are chronic skin lesions with no FDA-approved therapies, affecting an estimated 50,000 diagnosed patients in the U.S. [1][2] - The FDA's Fast Track program aims to expedite the development and review of drugs for serious conditions, facilitating earlier access for patients [3]

Core Insights - The FDA has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, highlighting its potential to address a significant unmet medical need [1][2][3] - Palvella Therapeutics plans to initiate a Phase 2 trial for QTORIN™ rapamycin in the second half of 2026, following discussions with the FDA [1][4] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is developing a pipeline of product candidates based on its QTORIN™ platform, with QTORIN™ rapamycin as the lead candidate targeting microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas [5][6] Industry Context - Angiokeratomas are chronic skin lesions with no FDA-approved therapies, affecting an estimated 50,000 diagnosed patients in the U.S. [1][2] - The FDA's Fast Track program aims to expedite the development and review of drugs for serious conditions, facilitating earlier access for patients [3]