Avidity Biosciences' Del-Zota BLA Timeline Shift: Navigating Regulatory Feedback and Investment Narrative

Avidity Biosciences has announced a positive pre-BLA meeting with the FDA for its Duchenne muscular dystrophy therapy, del-zota, and updated its planned biologics license application submission to Q1 2026. The company is preparing multiple BLA filings in the coming year. The delayed timeline may de-risk the ultimate approval but could weigh on sentiment. Avidity Biosciences' share price has been on the slide, but might be up to 38% below fair value.

Avidity Biosciences (NASDAQ: RNA) has announced a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) regarding its Duchenne muscular dystrophy (DMD) therapy, delpacibart zotadirsen (del-zota). The company has updated its planned biologics license application (BLA) submission to the first quarter of 2026, following the meeting, a Seeking Alpha report.

Del-zota, which received Breakthrough Therapy designation, is an investigational drug being evaluated as a potential treatment for people living with DMD who have gene mutations amenable to exon 44 skipping (DMD44). The Breakthrough Therapy designation is meant to speed up the development and review of drugs to treat a serious condition or unmet medical need, as noted in a Reuters report.

The positive pre-BLA meeting with the FDA provided a clear path forward for Avidity's BLA submission. However, the delayed timeline may de-risk the ultimate approval but could weigh on investor sentiment. The Reuters piece also noted that Avidity Biosciences' share price has been on the slide and might be up to 38% below fair value.

Avidity Biosciences is preparing multiple BLA filings in the coming year, with the first submission planned for Q1 2026. The company remains highly confident in the potential of del-zota and is preparing a confirmatory study to support full global approval of the drug.