Precision BioSciences stock price rises after FDA Fast Track designation approval

LootboxPhobia · 2026-03-09T20:58:31+00:00

Precision BioSciences stock price rises 13% as its gene editing therapy PBGENE-DMD receives FDA Fast Track designation, aiming to accelerate the development and review of treatments for Duchenne Muscular Dystrophy. The company will initiate functional clinical studies and plans to hold related virtual meetings.

LootboxPhobia

2026-03-09 20:58:31

Abstract generation in progress

Investing.com – Precision BioSciences (NASDAQ:DTIL) stock rose 13% on Monday after the U.S. Food and Drug Administration (FDA) granted its gene editing therapy PBGENE-DMD a Fast Track designation for the treatment of Duchenne muscular dystrophy.

The Fast Track designation aims to facilitate the development and expedite the review process of this therapy, which is specifically designed to treat this severe muscle-wasting disease. It allows for more efficient interaction with the FDA during development.

Precision BioSciences CEO Michael Amoroso said, “The Fast Track designation is an important regulatory milestone for PBGENE-DMD, reflecting the significant unmet need in the Duchenne muscular dystrophy field.”

The company recently received an Investigational New Drug (IND) approval for PBGENE-DMD and plans to initiate a Phase 1/2 clinical trial called FUNCTION-DMD. Precision BioSciences is developing in vivo gene editing therapies using its proprietary ARCUS platform.

The Durham, North Carolina-based company announced it will host a virtual event on March 17, 2026, featuring pediatric neurologist and associate professor at Arkansas Children’s Hospital, Dr. Aravindhan Veerapandiyan, as well as Pat Furlong, founder and president of Parent Project Muscular Dystrophy. The event will discuss the current state of Duchenne muscular dystrophy treatment and outline the design of the FUNCTION-DMD trial.

Duchenne muscular dystrophy is a genetic disorder characterized by progressive muscle degeneration and weakness, primarily affecting boys.

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