PRECISION BIOSCIENCES INC 8-K

What Happened
Precision BioSciences, Inc. (filed on Feb 11, 2026) announced that the U.S. Food and Drug Administration issued a "Study May Proceed" notification for its investigational new drug (IND) application for PBGENE‑DMD, a program for treating Duchenne muscular dystrophy (DMD). The clearance enables initiation of clinical trial site activities for the FUNCTION‑DMD Phase 1/2 study. The company stated a goal of activating the first clinical site in the U.S. in the first half of 2026.

Key Details

• Filing: Current Report on Form 8‑K filed Feb 11, 2026 announcing the IND clearance.
• Program & trial: PBGENE‑DMD for DMD; enables start of the FUNCTION‑DMD Phase 1/2 clinical trial.
• Regulatory milestone: FDA issued a "Study May Proceed" notification for the IND.
• Timeline goal: Precision BioSciences aims to activate the first U.S. clinical site in H1 2026.
• Disclosure note: The 8‑K includes standard forward‑looking statement language and points investors to the company’s prior SEC filings (10‑K/10‑Q) for risk factors.

Why It Matters
This IND clearance is a key regulatory milestone that allows Precision BioSciences to begin on‑the‑ground clinical activity for PBGENE‑DMD. For investors, it marks progress from preclinical/regulatory work toward human testing—an important step in the development timeline that can drive near‑term operational activity and future value inflection points. However, it is not an approval of safety or efficacy; timelines (including the H1 2026 site activation goal) are forward‑looking and subject to the risks and uncertainties described in the company’s SEC filings.