Palvella Therapeutics Announces New QTORIN™ Product Candidate, QTORIN™ Pitavastatin, for the Treatment of Disseminated Superficial Actinic Porokeratosis (DSAP), a Rare, Chronic, and Pre-Cancerous Genetic Skin Disease with No FDA-Approved Therapies

Core Insights - Palvella Therapeutics has announced QTORIN™ pitavastatin as a new product candidate for the treatment of disseminated superficial actinic porokeratosis (DSAP), a serious skin disease with no FDA-approved therapies available [1][3] - The company plans to initiate a Phase 2 clinical trial for QTORIN™ pitavastatin in the second half of 2026, following discussions with the FDA [1][3] Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases without FDA-approved treatments [5][6] - The company utilizes its patented QTORIN™ platform to develop novel topical product candidates, with QTORIN™ pitavastatin being the second product candidate in its pipeline [5][6] Disease Context - DSAP is characterized by persistent lesions that can lead to chronic skin integrity loss and has the potential to transform into squamous cell carcinoma [2] - There are over 50,000 diagnosed patients in the U.S. suffering from DSAP, highlighting a significant unmet medical need [2]