Q32 Bio announced that it has received a Fast Track designation for bempikibart, its investigational treatment for alopecia areata (AA), currently under investigation in a Phase 2B clinical trial program. According to the U.S. Food and Drug Administration (FDA), Fast Track helps speed up the development and review process for new drugs for conditions for which there is unmet medical need. In their press release, Q32 Bio quoted Jodie Morrison, the company’s Chief Executive Officer: “The Fast Track designation granted by the FDA recognizes the seriousness of AA and the significant current unmet medical need while underscoring bempikibart’s potential as a novel, differentiated therapy for patients needing new options.” Bempikibart (ADX-914) is monoclonal antibody that blocks IL-7 and TSLP signaling in the immune system. In March 2025, NAAF Board Member Dr. Brett King presented early results from the SIGNAL-AA Phase 2A clinical trial of bempikibart at the American Academy of Dermatology meeting in Orlando, Florida. As NAAF previously shared, the findings were promising, showing significant hair regrowth in patients with severe and very severe alopecia areata after 24 weeks of treatment. Notably, when treatment was discontinued, individuals who had experienced regrowth continued to see further improvement during the 12- to 24-week follow-up period, suggesting the potential for a long-lasting response even after stopping treatment. The study of bempikibart as a potential treatment for alopecia areata is continuing with the Phase 2B extension of the SIGNAL-AA clinical trial, which is now recruiting patients. For more information on the trial, visit this page on the NAAF website or complete the study screener here. Read the Q32 Bio press release: Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata Read more on the bempikibart study results: Late-Breaking Data on Bempikibart for Severe Alopecia Areata, with Brett King, MD, PhD Read more about the SIGNAL-AA Part B clinical trial for bempikibart.
