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Zeleciment rostudirsen (z-rostudirsen)

Duchenne muscular dystrophy

Also known as DYNE-251
Manufacturer
Dyne Therapeutics
Regulatory submission
BLA submitted May 2026
Last updated
78 sources

Product information and disease descriptionProduct description

Phase of product development

7 evidence topics · 7 sources

Fast Track designation

“the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DYNE-251” (opens the source at this quote in a new tab)

Orphan drug and rare pediatric disease designations

“was granted U.S. Food and Drug Administration (FDA) orphan drug and rare pediatric disease designations.” (opens the source at this quote in a new tab)

Breakthrough Therapy designation

“has granted Breakthrough Therapy Designation to DYNE-251” (opens the source at this quote in a new tab)

Regulatory status statement

“has not received approval from the US FDA, EMA, or any other regulatory authorities.” (opens the source at this quote in a new tab)

Regulatory submission: BLA submitted May 2026

“WALTHAM, Mass., May 26, 2026 (GLOBE NEWSWIRE)” (opens the source at this quote in a new tab)

“announced the submission of a Biologics License Application (BLA)” (opens the source at this quote in a new tab)

Priority Review and FDA action date

“Priority Review granted; PDUFA target action date set for January 21, 2027” (opens the source at this quote in a new tab)

Launch: Anticipated in the first quarter of 2027

“Dyne continues to expect a potential U.S. launch of z-rostudirsen in Q1 2027, assuming approval is received on the anticipated timeline.” (opens the source at this quote in a new tab)

FDA Advisory Committee meeting date

No evidence found.