Palvella Therapeutics

We’re thrilled to announce the first patient has been dosed in SELVA, a multicenter, Phase 3 clinical trial evaluating the safety and efficacy of QTORIN? 3.9% Rapamycin Anhydrous Gel (QTORIN? rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs). Read more about SELVA here: https://bit.ly/40CUYPZ #firstpatientdosed? #lymphaticmalformations #raredisease

Palvella’s recently awarded FDA Orphan Drug Grant to support the Phase 3 SELVA study evaluating QTORIN? rapamycin for the treatment of microcystic lymphatic malformations was featured in today’s FDA Law blog?by James Valentine and Sarah Wicks from Hyman Phelps & McNamara. Palvella was awarded up to $2.6 million from the FDA’s Office of Orphan Products Development to support the SELVA study. www.fdalawblog.net #raredisease? #lymphaticmalformations

We’re thrilled to announce the first patient has been dosed in SELVA, a multicenter, Phase 3 clinical trial evaluating the safety and efficacy of QTORIN? 3.9% Rapamycin Anhydrous Gel (QTORIN? rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs). Read more about SELVA here: https://bit.ly/40CUYPZ #firstpatientdosed? #lymphaticmalformations #raredisease

Be sure to catch our presentations today at #PeDRA2024! Joyce Teng, M.D., Ph.D., Professor of Dermatology and Pediatrics, Stanford University and Palvella’s Jeffrey Martini, PhD, Chief Scientific Officer will be sharing data on QTORIN? rapamycin 3.9% anhydrous gel as a potential targeted therapy for microcystic lymphatic malformations as well as insights about the Phase 3 SELVA study, a 24-week, single-arm, baseline-controlled clinical trial of QTORIN? rapamycin for the treatment of microcystic LMs. View the presentations: https://lnkd.in/eQDJzTQZ #lymphaticmalformations #raredisease

Today, we are excited to welcome Matthew Korenberg as our new Chief Financial Officer! Matt is a seasoned #biotech executive with significant operational and financial leadership experience. His contributions will be instrumental as we work to become the leading rare disease company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases. Learn more: https://bit.ly/3YdjUe7

Attending #PeDRA2024? Don’t miss Palvella’s presentations highlighting QTORIN? rapamycin 3.9% anhydrous gel as a potential targeted therapy for microcystic lymphatic malformations and a review of the Phase 3 SELVA study, a 24-week, single-arm, baseline-controlled clinical trial of QTORIN? rapamycin for the treatment of microcystic LMs. Presentations by: Joyce Teng, M.D., Ph.D., Professor of Dermatology and Pediatrics, Stanford University and Palvella’s Jeffrey Martini, PhD, Chief Scientific Officer. https://bit.ly/3YmHEh7 #lymphaticmalformations #raredisease

Today, we announced Palvella is the recipient of an FDA Orphan Product Grant up to $2.6 million which will support the advancement of our ongoing Phase 3 single-arm baseline-controlled trial in microcystic lymphatic malformations. This underscores our belief in the potential of QTORIN? rapamycin which has also received FDA Breakthrough Therapy, Fast Track, and Orphan Designations for this serious, rare and chronically debilitating genetic disease. Learn more: https://bit.ly/3BrEnnz #lymphaticmalformations #raredisease?

Palvella Therapeutics and Pieris Pharmaceuticals announced a proposed merger to create a Nasdaq-listed, clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for serious, rare genetic skin diseases for which there are no FDA-approved therapies. The combined company is expected to have approximately $80.5 million of cash and cash equivalents at closing, sufficient to fund the combined company through multiple clinical trial milestones including pivotal Phase 3 clinical trial results for QTORIN? rapamycin for the treatment of microcystic lymphatic malformations. See press release linked below. https://lnkd.in/eZnW3r2Z

Palvella announces expansion of strategic partnership with Ligand Pharmaceuticals (NASDAQ: LGND) to Accelerate Phase 3 Development of QTORIN rapamycin for Microcystic Lymphatic Malformations! https://lnkd.in/gZwpFQvk