Dermata Therapeutics Inc. has announced the initiation of the manufacturing process for the drug product intended for the Phase 3 STAR-2 trial of XYNGARI™. The company expects the STAR-2 trial to begin in the fourth quarter of 2025. Following this timeline, Dermata anticipates publishing topline results from the trial in the first half of 2027. Additionally, patients participating in the STAR-2 trial will have the opportunity to enter a 9-month extension study to collect further safety and efficacy data. This data will support a potential new drug application (NDA) for XYNGARI™ with the U.S. Food and Drug Administration. The company projects the completion of the extension study by the end of the fourth quarter of 2027, with a possible NDA filing in the first half of 2028.
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