Press Releases
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Palvella Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations(Microcystic LMs). QTORIN rapamycin…
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Palvella Therapeutics Appoints Matthew E. Korenberg as Chief Financial Officer
Palvella Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations(Microcystic LMs). QTORIN rapamycin…
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Palvella Therapeutics Announces Presentations at the 12th Pediatric Dermatology Research Alliance (PeDRA) Annual Conference
Palvella Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations(Microcystic LMs). QTORIN rapamycin…
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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
Palvella Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations(Microcystic LMs). QTORIN rapamycin…
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Palvella Therapeutics and Pieris Pharmaceuticals Announce Definitive Merger Agreement
Palvella Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations(Microcystic LMs). QTORIN rapamycin…
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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
Palvella Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations(Microcystic LMs). QTORIN rapamycin…
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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
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 than 30,000 individuals…
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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
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 serious, rare genetic skin diseases…
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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
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 Improved” as rated…
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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
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 data for the…
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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
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 with no…
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