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

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8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

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

Stephens initiated coverage of Palvella Therapeutics with a rating of Overweight and set a new price target of $220.00

Mizuho initiated coverage of Palvella Therapeutics with a rating of Outperform and set a new price target of $205.00

BTIG Research initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $167.00

Craig Hallum initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $175.00

Raymond James upgraded Palvella Therapeutics from Outperform to Strong Buy and set a new price target of $143.00

Oppenheimer initiated coverage of Palvella Therapeutics with a rating of Outperform and set a new price target of $85.00

Raymond James initiated coverage of Palvella Therapeutics with a rating of Outperform and set a new price target of $54.00

Truist initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $56.00

Chardan Capital Markets initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $50.00

Stifel initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $45.00

Palvella remains on track to submit an NDA in the second half of 2026 Microcystic lymphatic malformations are serious, chronic, lifelong vascular malformations that can cause persistent leaking, bleeding, infection, functional impairment, and significant daily burden for patients and families QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S. WAYNE, Pa., June 03, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing n

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. A live webcast of the fireside chat will be available on the Events and Present

Yale-licensed U.S. patent provides broad protection for topical mevalonate pathway inhibition in porokeratosis, including disseminated superficial actinic porokeratosis (DSAP) DSAP is a serious, rare, premalignant genetic skin disease affecting an estimated more than 50,000 diagnosed patients in the U.S., with no FDA-approved therapies Palvella plans to initiate a Phase 2 clinical trial of QTORIN™ pitavastatin in DSAP in the second half of 2026 WAYNE, Pa., May 27, 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 f

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) 87% of participants (20/23) in SELVA with moderate or worse leaking/bleeding at baseline were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the mLM-IGA Leaking/Bleeding at Week 24, with a mean improvement of +2.48 (p<0.001) 100% of SELVA participants who completed the efficacy evaluation period (43/43) were at least somewhat satisfied with QTORIN™ rapamycin on the TSQM-9 overall satisfaction item at We

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) 100% of patients with bleeding at baseline reported being "satisfied" or "very satisfied" with QTORIN™ rapamycin on the overall satisfaction item of the Treatment Satisfaction Questionnaire for Medication at Week 12 Baseline qualitative patient interviews underscore the substantial physical, functional, and psychosocial burden of cutaneous venous malformations QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard

Uplisting reflects Palvella's continued progress advancing potential first-in-disease therapies for serious, rare skin diseases and vascular malformations WAYNE, Pa., May 13, 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 has received approval from Nasdaq to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global

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 Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic lymphatic malformations; BEYONDmLM.com disease awareness campaign launched to educate, engage, and empower patients, caregivers, and healthcare professionals Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for second half of 2026 Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic

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. Phase 2 single-arm, baseline-controlled trial expected to enroll up to 15 subjects at leading vascular anomaly centers and high-volume dermatology centers in the U.S. Topline results from the Phase 2 trial are expected in the second half of 2027 WAYNE, Pa., May 04, 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

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. To access the live webcast, includi

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 WAYNE, Pa., April 20, 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 two late-breaking abstracts highlighting results from the Phase 3 SELVA and Phase 2 TOIVA studies of QTO

Physician and seasoned life sciences investor with more than two decades of experience across clinical practice, biotechnology investing, and board leadership Author of a visionary 2015 Journal of Investigative Dermatology editorial highlighting the need for greater innovation and investment in rare skin diseases Deep medical and patient care experience will help guide the continued expansion of Palvella's pipeline and QTORIN™ platform WAYNE, Pa., April 13, 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 ser

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® Mr. Taylor to lead Palvella's U.S. sales organization in preparation for the potential U.S. launch of QTORIN™ rapamycin for microcystic lymphatic malformations, a serious, rare, lifelong genetic disease affecting an estimated more than 30,000 diagnosed patients in the U.S. WAYNE, Pa., April 07, 2026 (GLOBE NEWSWIRE) -- Palvella Ther

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 Ms. McDonough to lead Palvella's Market Access and Patient Services organizations, advancing payer engagement, patient support, specialty distribution, and access strategy for the Company's QTORIN™ programs targeting serious, rare skin diseases and vascular malformations WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (Nasdaq: PVLA), a clinical-stage biopharmaceut

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

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. To access the live webcast, includi

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. To access the live webcast

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