Why This FDA Update Is a Huge Step Forward for Precision BioSciences

A key update from the U.S. Food and Drug Administration (FDA) boosted Precision BioSciences Inc. (NASDAQ: DTIL) shares early on Wednesday. The agency has granted Fast Track Designation to PBCAR269A for the treatment of relapsed/refractory multiple myeloma.

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This is the firm’s second allogeneic chimeric antigen receptor (CAR T) cell therapy to receive Fast Track Designation for which the FDA previously granted Orphan Drug Designation. Precision BioSciences management noted that the designation will help it expedite the allogeneic CAR T cell therapy program aimed to address the unmet medical need among patients with relapsed/refractory multiple myeloma.

Chief Medical Officer Chris Heery has said that he is looking forward to working more closely with the FDA as the firm continues to investigate PBCAR269A as a potential new treatment option that can be more broadly available to patients who otherwise may be ineligible or unable to access existing autologous CAR T therapies. PBCAR269A is currently being evaluated in a Phase 1/2a multicenter study in the United States.

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Precision Bio stock traded up about 10% in Wednesday’s premarket and was last seen more than 5% higher, at $5.62 in a 52-week range of $4.45 to $23.67. The consensus price target is $17.57.

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