Zeleciment rostudirsen (z-rostudirsen, DYNE-251)

Note: 8-K filed 2026-07-20 (accession 0001193125-26-308343, Item 8.01): 'The FDA has granted the BLA Priority Review and assigned a Prescription Drug User Fee Act target action date of January 21, 2027.' Submission is for Accelerated Approval based on dystrophin expression as a surrogate endpoint, supported by the registrational expansion cohort of the Phase 1/2 DELIVER trial; confirmatory Phase 3 FORZETTO trial initiated May 2026. Designations per the company press release of the same date (Breakthrough Therapy, Fast Track and Rare Pediatric Disease from FDA; Orphan Drug from FDA, EMA and Japan MHLW): https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-announces-us-fda-acceptance-biologics-license . Reaffirmed in the Q2 2026 earnings 8-K EX-99.1 filed 2026-07-29 (accession 0001193125-26-323940). This row is already present in data/pdufa-calendar.json as an unnamed scraper candidate ('Dyne Therapeutics, Inc.' / drugName null / 2027-01-21) — this entry resolves it.