$PVLA News
Last published 6d ago
- 6d agoPVLAPALVELLA THERAPEUTICS, INC. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 7.01 Item 9.01
- 6d agoPVLAPalvella Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswireFDA Accepts NDA for QTORIN™ Rapamycin and Grants Priority Review for Microcystic Lymphatic Malformations; PDUFA Target Action Date Set for February 28, 2027 QTORIN™ Rapamycin Could Become the First FDA-Approved Therapy
- 1w agoPVLAPalvella Therapeutics to Participate in the Stifel 2026 Healthcare ConferenceGlobeNewswireWAYNE, Pa., Nov. 03, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel
- 1w agoPVLAPalvella Therapeutics to Host Third Quarter 2026 Financial Results and Corporate Update Conference Call on November 5, 2026GlobeNewswireWAYNE, Pa., Oct. 29, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel
- 2w agoPVLAPalvella Announces FDA Acceptance and Priority Review of QTORIN™ Rapamycin NDA; February 28, 2027 PDUFA Target Action Date SetGlobeNewswireQTORIN™ rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an estimated more than 30,000 diagnosed children and adults in the U.S.
- 3w agoPVLACHARDAN HEALTHCARE CONFERENCE – 10 YEARS OF DISRUPTIVE INNOVATION - PALVELLA THERAPEUTICS INCEarnings Call TranscriptsFor our next session here, we have Matt Kornberg from Palvella. Matt, thanks for joining us. Well, my name is Gautam. I'm a biotech analyst here at Chardon. Matt, we're at 15 minutes, so I'll jump right into it. So give
- 3w agoPVLACHARDAN HEALTHCARE CONFERENCE – 10 YEARS OF DISRUPTIVE INNOVATION - PALVELLA THERAPEUTICS INCEarnings Call TranscriptsFor our next session here, we have Matt Kornberg from Palvella. Matt, thanks for joining us. Well, my name is Gautam. I'm a biotech analyst here at Chardon. Matt, we're at 15 minutes, so I'll jump right into it. So give
- 3w agoPVLAPalvella Therapeutics to Present Phase 3 SELVA and Phase 2 TOIVA Results, Along With New Pediatric Analyses, at 2026 PeDRA Annual ConferenceGlobeNewswirePhase 3 SELVA Pediatric Analyses Highlight Improvements in Overall Disease Severity and a Blinded Combined Score of Lesion Height, Vesicle Appearance, and Leaking/Bleeding Phase 2 TOIVA Pediatric Analyses Highlight
- 4w agoPVLAPalvella Therapeutics to Participate in the Chardan 10th Annual Healthcare ConferenceGlobeNewswireWAYNE, Pa., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel
- 1mo agoPVLAPalvella Therapeutics Announces Three Poster Presentations Highlighting New Data in Microcystic Lymphatic Malformations and DSAP at Fall Clinical Dermatology 2026GlobeNewswirePhase 3 SELVA Patient, Caregiver, and Clinician Interviews Highlight Meaningful Clinical Improvements and High Treatment Satisfaction With QTORIN™ Rapamycin SELVA Maximal-Use Pharmacokinetic Substudy Demonstrates Low
- 2mo agoPVLAPalvella Therapeutics Appoints James R. Treat, M.D., Nationally Recognized Pediatric Dermatologist as Chief Medical OfficerGlobeNewswireBrings expertise in cutaneous vascular anomalies, including microcystic lymphatic malformations, venous malformations and angiokeratomas Leader in pediatric dermatology with nearly 20 years of distinguished clinical,
- 2mo agoPVLAPalvella Therapeutics to Participate in Upcoming Healthcare Investor ConferencesGlobeNewswireWAYNE, Pa., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel
- 2mo agoPVLAPalvella Therapeutics Completes Rolling Submission of New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic MalformationsGlobeNewswireQTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic
- 3mo agoPVLAPALVELLA THERAPEUTICS CG 46TH ANNUAL GROWTH CONFERENCE - PALVELLA THERAPEUTICS INCEarnings Call TranscriptsAll right. Good afternoon, everyone. Thank you so much for joining us. My name is Whitney Egyem. I'm one of the biotech analysts here at Canaccord. And it's my pleasure for the last slot of the day to be chatting with Pe
- 3mo agoPVLAPalvella Therapeutics to Participate in the Canaccord Genuity 46th Annual Growth ConferenceGlobeNewswireWAYNE, Pa., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel
- 3mo agoPVLAPalvella Therapeutics Second Quarter 2026 Financial Results Conference Call - PALVELLA THERAPEUTICS INCEarnings Call TranscriptsGood day, and thank you for standing by. Welcome to the Povella Therapeutics Second Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentati
- 3mo agoPVLAPalvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswireFirst module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of 2026 Preparing for a planned
- 3mo agoPVLAPalvella Therapeutics Chief Scientific Officer Jeff Martini, Ph.D. Selected to Present at Upcoming FDA Public Workshop on Drug RepurposingGlobeNewswireHybrid public meeting on August 5th will explore approaches to selecting and prioritizing promising FDA-approved drugs for repurposing, with the potential to accelerate patient access to effective therapies for
- 3mo agoPVLAPalvella Therapeutics to Host Second Quarter 2026 Financial Results and Corporate Update Conference Call on August 4, 2026GlobeNewswireWAYNE, Pa., July 28, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel
- 4mo agoPVLASVRASLNOSBBP+2Palvella Therapeutics Appoints Accomplished Rare Disease Biotech Executive and Commercial Leader Matt Pauls, J.D., M.B.A., to Board of DirectorsGlobeNewswireBrings more than 25 years of experience advancing and commercializing high-impact therapies for serious diseases, including those with limited or no approved treatment options Extensive public company and rare disease
- 4mo agoPVLAPalvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic MalformationsGlobeNewswireFDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules of the NDA before the full application is submitted FDA previously granted Breakthrough
- 4mo agoPVLAFDA Grants Rolling Review of Palvella’s QTORIN™ Rapamycin NDA for Microcystic Lymphatic MalformationsGlobeNewswireFDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted Palvella remains on track to complete the
- 5mo agoPVLAResVita Bio Appoints John D. Doux, M.D., M.B.A., to Board of DirectorsPR NewswireResVita Bio, a biotechnology company pioneering a topical cell therapy modality where living, genetically engineered bacteria continuously produce...
- 5mo agoPVLAPalvella Therapeutics Announces Completion of FDA Pre-NDA Meeting for QTORIN™ Rapamycin in Microcystic Lymphatic MalformationsGlobeNewswirePalvella 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,
- 5mo agoPVLAPalvella Therapeutics to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference 2026GlobeNewswireWAYNE, 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
- 5mo agoPVLAPalvella Therapeutics Strengthens QTORIN™ Pitavastatin Intellectual Property with Yale-Licensed U.S. Patent Providing Protection into 2043GlobeNewswireYale-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
- 5mo agoPVLAPalvella Therapeutics Named Healthcare & Life Sciences Company of the Year at the Philadelphia Alliance for Capital and Technologies (PACT) Ecosystem AwardsGlobeNewswireWAYNE, 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
- 5mo agoPVLAPalvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Supporting QTORIN™ Rapamycin as a Potential First-in-Disease Therapy for Multiple Serious, Rare Vascular MalformationsGlobeNewswireIn 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)
- 6mo agoPVLAPalvella Therapeutics Announces New Data from the Phase 2 TOIVA Trial of QTORIN™ Rapamycin in Cutaneous Venous Malformations Presented at the 83rd Annual Meeting of the Society for Investigative DermatologyGlobeNewswire100% 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
- 6mo agoPVLAPalvella Therapeutics Announces Uplisting to the Nasdaq Global MarketGlobeNewswireUplisting 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
- 6mo agoPVLAPalvella Therapeutics First Quarter 2026 Financial Results Conference Call - PALVELLA THERAPEUTICS INCEarnings Call TranscriptsThank you for standing by. My name is Rochelle, and I will be your operator today. At this time, I would like to welcome everyone to the Pallaviglia Therapeutics First Quarter 2026 Financial Results Conference Call. All
- 6mo agoPVLAPalvella Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswireFDA 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
- 6mo agoPVLAPalvella Therapeutics Announces First Patients Dosed in Phase 2 LOTU Trial of Fast Track-Designated QTORIN™ Rapamycin for Clinically Significant AngiokeratomasGlobeNewswireClinically 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,
- 6mo agoPVLAPalvella Therapeutics to Host First Quarter 2026 Financial Results and Corporate Update Conference Call on May 7, 2026GlobeNewswireWAYNE, 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
- 6mo agoPVLAPalvella Therapeutics to Present QTORIN™ Rapamycin Results from Phase 3 SELVA and Phase 2 TOIVA Studies at the International Society for the Study of Vascular Anomalies World Congress 2026GlobeNewswireJames 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
- 7mo agoPVLAPalvella Therapeutics Appoints John D. Doux, M.D., M.B.A., Dermatologist and Recognized Leader in Rare Skin Diseases, to Board of DirectorsGlobeNewswirePhysician 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
- 7mo agoARQTINCYPVLAPalvella Therapeutics Appoints Accomplished Commercial Leader Kent Taylor as Senior Vice President of SalesGlobeNewswireMr. 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
- 7mo agoPVLAPalvella Therapeutics Full Year 2025 Financial Results Conference Call - PALVELLA THERAPEUTICS INCEarnings Call TranscriptsGood day, and thank you for standing by. Welcome to the Povella Therapeutics Full Year 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, t
- 7mo agoPVLAPalvella Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate UpdateGlobeNewswireNew 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 Accelerating U.S. launch
- 7mo agoPVLAPalvella Therapeutics Announces Scientific Publication in Journal of Vascular Anomalies Highlighting the Infiltrative Growth and Therapeutic Challenges of Microcystic Lymphatic MalformationsGlobeNewswireReview delineates differences in clinical strategies between microcystic and macrocystic lymphatic malformations to guide disease-specific clinical trial design and treatment approaches Manuscript emphasizes the
- 7mo agoPVLAPalvella Therapeutics Highlights Continued Progress Across Rare Skin Disease Pipeline with Two Poster Presentations at the 2026 American Academy of Dermatology Annual MeetingGlobeNewswirePoster #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,
- 7mo agoPVLAPalvella Therapeutics to Host Full Year 2025 Financial Results Conference Call and Provide a Corporate Update on March 31, 2026GlobeNewswireWAYNE, 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
- 7mo agoKRYSPVLAPalvella Therapeutics Strengthens Leadership Team with Appointment of Rare Disease Commercial Leader Jennifer J. McDonough as Senior Vice President of Market Access and Patient ServicesGlobeNewswireMs. 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
- 8mo agoPVLAPalvella Therapeutics Announces Issuance of European Patent Covering Anhydrous Compositions of RapamycinGlobeNewswirePatent 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
- 8mo agoPVLAPalvella Therapeutics Launches "BEYOND mLM" Disease Awareness Campaign for Microcystic Lymphatic Malformations in Collaboration with Leading Lymphatic, Vascular, and Dermatology Nonprofit OrganizationsGlobeNewswireBEYONDmLM.com campaign designed to educate, engage, and empower patients, caregivers, and healthcare professionals Campaign developed and launched in close collaboration with leading nonprofit organizations, including
- 8mo agoPVLAPalvella Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Exercise in Full of the Underwriters' Option to Purchase Additional SharesGlobeNewswireWAYNE, 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
- 8mo agoPVLAPalvella Therapeutics Announces Pricing of Upsized Public OfferingGlobeNewswireWAYNE, 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
- 8mo agoPVLAPalvella Therapeutics Announces Proposed Public OfferingGlobeNewswireWAYNE, 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
- 8mo agoPVLAPalvella Therapeutics Conference Call to Discuss Topline Results from the Phase 3 SELVA Study - PALVELLA THERAPEUTICS INCEarnings Call TranscriptsGood day, and thank you for standing by. Welcome to the Pavela Therapeutics Conference Calls to discuss top-line results from the Phase 3 Selva Study. At this time, all participants are in listen-only mode. After this sp
- 8mo agoPVLAPalvella Therapeutics Announces Positive Topline Results from Phase 3 SELVA Clinical Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic MalformationsGlobeNewswirePrimary 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