FDA Clears Precision BioSciences to Begin Clinical Trial for Duchenne Muscular Dystrophy Therapy

Reuters

Feb 11

FDA Clears Precision BioSciences to Begin Clinical Trial for Duchenne Muscular Dystrophy Therapy

Precision BioSciences Inc. announced that it has received a Study May Proceed notification from the U.S. Food and Drug Administration (FDA) for its investigational gene editing therapy, PBGENE-DMD, intended for the treatment of ambulatory Duchenne muscular dystrophy (DMD) patients. This regulatory clearance enables the company to begin activating clinical trial sites and initiating Institutional Review Board (IRB) activities for the planned Phase 1/2 FUNCTION-DMD clinical study. The study aims to evaluate the safety, tolerability, and efficacy of PBGENE-DMD, including dystrophin protein expression and functional outcomes. Precision BioSciences plans to further discuss the program and study at a virtual investor event following the Muscular Dystrophy Association conference in March.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Precision BioSciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260211634383) on February 11, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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