Palvella Therapeutics, Inc. ((PVLA)) announced an update on their ongoing clinical study.
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Palvella Therapeutics, Inc. is conducting a Phase 3 clinical study titled ‘SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations.’ The study aims to assess the change in microcystic lymphatic malformations IGA after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel in approximately 40 participants, with the option for extended treatment.
The intervention being tested is QTORIN 3.9% Rapamycin Anhydrous Gel, a drug designed to treat microcystic lymphatic malformations by evaluating its safety and efficacy over a 24-week period.
The study follows an interventional design with a single-group model and no masking, focusing primarily on treatment. This straightforward design aims to provide clear insights into the drug’s effectiveness.
The study began on January 16, 2024, with its primary completion anticipated in 2025. The most recent update was submitted on July 22, 2025, indicating ongoing recruitment and progress.
This study could significantly impact Palvella Therapeutics’ stock performance and investor sentiment, particularly if the results are positive, given the involvement of the FDA Office of Orphan Products Development. Competitors in the rare disease treatment space will be closely monitoring these developments.
The study is currently ongoing, with further details available on the ClinicalTrials portal.