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Palvella Therapeutics, Inc.
PVLAHealthcareNASDAQUS
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Palvella Therapeutics is now a much more credible bet on QTORIN after their positive mLM data. They've also received some FDA feedback, which bodes well for their upcoming NDA submission. PVLA is now targeting a 2H2026 NDA submission for QTORIN rapamycin in mLM.
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 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 completion of its pre-New Drug Application (NDA) meeting with FDA for QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) in microcystic lymphatic malformations (microcystic LMs).
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. “We are incredibly honored to be recognized by PACT as Healthcare & Life Sciences Company of the Year,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella.
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 of2.
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
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 of care for the estimated more than 75,000 individuals with cutaneous venous malformations in the U.S. WAYNE, Pa., May 15, 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 new data from the Phase 2 TOIVA trial of QTORIN™ rapamycin in patients with cutaneous venous malformations (VMs) were presented at the 83rd Annual Meeting of the Society for Investigative Dermatology (SID) in Chicago, IL.
Uplisting reflects Palvella's continued progress advancing potential first-in-disease therapies for serious, rare skin diseases and vascular malformations
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 supported by a recent $230 million financing.
Palvella Therapeutics, Inc. (PVLA) Q1 2026 Earnings Call Transcript
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 porokeratosis planned for second half of 2026 Phase 2 LOTU trial of QTORIN™ rapamycin for clinically significant angiokeratomas initiated with topline results expected in second half of 2027 Completed upsized, oversubscribed equity financing of $230.0 million in February 2026; cash, cash equivalents and short-term investments of $261.9 million as of March 31, 2026 Company to host conference call at 8:30 a.m. ET today WAYNE, Pa.
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®
Shares of Palvella Therapeutics, Inc. (NASDAQ: PVLA - Get Free Report) have received an average rating of "Moderate Buy" from the fifteen analysts that are covering the stock, MarketBeat.com reports. One analyst has rated the stock with a sell rating, thirteen have assigned a buy rating and one has issued a strong buy rating on the
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 Manuscript emphasizes the importance of early therapeutic intervention in children to help reduce the risk of more serious complications over time Review supports the scientific rationale of QTORIN™ 3.9% rapamycin anhydrous gel as a potential targeted therapy for microcystic lymphatic malformations WAYNE, Pa., March 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 the publication of a comprehensive review article in the Journal of Vascular Anomalies (JoVA) titled “Microcystic and Macrocystic Lymphatic Malformations: Distinct Genetics and Clinical Strategies.
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
An executive at Palvella Therapeutics reported selling 4,302 common shares for approximately $508,000 on March 18, 2026. The disposal resulted from the immediate sale of shares acquired through option exercise.
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
Palvella Therapeutics (NASDAQ: PVLA - Get Free Report) will likely be issuing its Q4 2025 results before the market opens on Monday, March 30th. Analysts expect the company to announce earnings of ($0.95) per share for the quarter. Parties can check the company's upcoming Q4 2025 earning summary page for the latest details on the call
Palvella Therapeutics is positioned as a cautious Buy, driven by strong Phase 3 data for QTORIN rapamycin in microcystic lymphatic malformations (mLM). QTORIN's clinical profile demonstrates high efficacy and a benign safety profile, addressing a major unmet need in mLM and offering first-mover advantage in a niche orphan market. PVLA's mLM program alone could justify a multibillion-dollar valuation, with cVM label expansion potentially doubling revenue opportunity; current cash runway extends well beyond regulatory milestones.
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
Silo Pharma (NASDAQ: SILO - Get Free Report) and Palvella Therapeutics (NASDAQ: PVLA - Get Free Report) are both small-cap medical companies, but which is the better business? We will contrast the two companies based on the strength of their dividends, analyst recommendations, earnings, institutional ownership, profitability, valuation and risk. Risk and Volatility Silo Pharma has a
BEYONDmLM.com campaign designed to educate, engage, and empower patients, caregivers , and healthcare professionals
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