AZITRA

Regulatory snapshots: global drug submissions, approvals, clinical trial approvals, and other decisions involving Accord, Applied, Astrazeneca, Azitra, Briacell, Glycomine, Imcheck, Merck, Moderna, Nicox, Novartis, Valneva.

Azitra Inc. received FDA Fast Track Designation for ATR-04, a topical treatment for EGFRi-induced skin toxicity, potentially expediting its market entry. ATR-04, a live biotherapeutic product, aims to address skin rashes caused by EGFR inhibitors, affecting 150,000 U.S. patients annually. Azitra plans a Phase 1/2 clinical trial by 2024 to evaluate ATR-04's efficacy and safety. Despite recent advancements, the company warns of uncertainties in clinical trial outcomes and potential benefits from the FDA designation.