Palvella Therapeutics Awarded Up to $2.6 million Grant from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development to Support Phase 3 Single-Arm, Baseline-Controlled Trial in Microcystic Lymphatic Malformations
October 03, 2024 07:30 ET
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Palvella Therapeutics
FDA Orphan Products Grants are based on scientific and technical merit as determined by rare disease and regulatory experts Ongoing Phase 3 trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel...
Palvella Therapeutics and Ligand Pharmaceuticals Expand Strategic Partnership to Accelerate Phase 3 Development of QTORIN™ rapamycin for Microcystic Lymphatic Malformations and Additional High Unmet Need Clinical Indications
December 01, 2023 08:20 ET
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Palvella Therapeutics
Palvella Received $5 Million Upfront Payment QTORIN™ rapamycin has Potential to be First FDA Approved Therapy and Standard of Care in the U.S. for an Estimated more than 30,000 Diagnosed Patients...
Palvella Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations
November 16, 2023 07:45 ET
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Palvella Therapeutics
QTORIN™ rapamycin has potential to be first approved therapy and standard of care in the U.S. for Microcystic Lymphatic Malformations Microcystic Lymphatic Malformations is a chronically...
Palvella Therapeutics Announces Planned Pivotal Phase 3 Study Design of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations and Topline Results from Phase 2b CODY Study in Gorlin Syndrome
July 20, 2023 08:55 ET
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Palvella Therapeutics
QTORIN™ rapamycin has potential to become first approved therapy and standard of care for Microcystic Lymphatic Malformations in U.S.; significant commercial opportunity based on an estimated more...
Palvella Therapeutics Reports Topline Results from Pivotal Phase 3 VAPAUS Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Pachyonychia Congenita
July 20, 2023 08:45 ET
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Palvella Therapeutics
WAYNE, Pa., July 20, 2023 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company developing and commercializing novel therapies to treat patients suffering from...
Palvella Therapeutics Announces Positive Topline Results from Phase 2 Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations, a Serious, Rare Genetic Skin Disease with No FDA-approved Therapies
March 09, 2023 07:45 ET
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Palvella Therapeutics
QTORIN™ rapamycin generally well-tolerated; no drug related severe adverse events and no observed rapamycin in systemic circulation 100% of participants were either “Much Improved” or “Very Much...
Palvella Therapeutics Announces Pipeline Update on QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ Rapamycin) for Serious, Rare Genetic Skin Diseases with No FDA-approved Therapies
February 21, 2023 07:30 ET
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Palvella Therapeutics
- Pivotal Phase 3 data for the treatment of Pachyonychia Congenita anticipated mid-2023 - - Phase 2 data for the treatment of Microcystic Lymphatic Malformations anticipated March 2023 - - Phase 2b...
Palvella Therapeutics Announces Series D Financing of Up to $37.7 Million to Accelerate Late-Stage Development and Support Commercialization of Novel Therapies for Serious, Rare Genetic Skin Diseases
January 05, 2023 16:30 ET
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Palvella Therapeutics
Led by new investor Petrichor, with participation from new and existing investors Lead product candidate, QTORIN™ rapamycin, in late-stage clinical development for serious, rare genetic skin diseases...
Palvella Therapeutics Reports Top-Line Results from Pivotal Phase 2/3 VALO Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel in Patients with Pachyonychia Congenita
December 23, 2020 10:23 ET
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Palvella Therapeutics
~ VALO Study Misses Primary Endpoint in Phase 3 Randomized Withdrawal Portion ~ ~ VALO Study Achieves Primary Endpoint in Phase 2 Open-Label Portion ~ ~ Palvella Plans to Share Results with the U.S....
Palvella Therapeutics Completes $45 Million Series C Financing
May 28, 2020 16:08 ET
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Palvella Therapeutics
Investor Syndicate Comprised of Leading Biotech Investors Proceeds to Accelerate Pipeline of Rare Disease Therapies, Including Late-Stage Programs in Pachyonychia Congenita and Gorlin Syndrome ...