FDA Fast Tracks Aclaris' Modzatinib for Lichen Planus, Phase 2b Trial Set for Q4
ACRS has more than doubled off its 52-week low of $1.52.
Summary
The FDA granted Fast Track designation to modzatinib (ATI-2138) for moderate to severe lichen planus, a disease with no approved therapies. This regulatory milestone enables more frequent FDA interactions, rolling NDA review, and potential Priority Review eligibility. Aclaris plans to start a phased Phase 2b trial in Q4 2026, moving the program toward registration. The company recently reported $170.6M in cash plus $40.2M raised post-quarter, providing runway to advance this and other pipeline assets. With the stock near its 52-week high, the designation validates the program's potential in an underserved market.
At the time of this announcement, ACRS was trading at $6.34 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $850.6M. The 52-week trading range was $1.52 to $6.52. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.