Dyne Therapeutics, Inc. (NASDAQ: DYN) is a clinical-stage biopharmaceutical company developing RNA-targeted therapies for muscle diseases. The company has no approved products and generates no product revenue as of the 10-K filed March 2, 2026. Its lead program, zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), targets Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping and is designed to enable production of near full-length dystrophin in muscle and the central nervous system. Z-rostudirsen is being evaluated in the DELIVER trial, a global Phase 1/2 clinical trial intended to be registrational, with a biologics license application (BLA) submission to the FDA for Accelerated Approval planned for the second quarter of 2026. The company is led by President and CEO John G. Cox and CFO Erick Lucera, as of March 2, 2026. Dyne carries accumulated net losses across fiscal years 2023, 2024, and 2025, consistent with a pre-revenue clinical-stage company funded through equity and capital markets.

Revenue model

Pre-revenue. No product sales or royalties are disclosed in the 10-K filed March 2, 2026. Operations are funded through capital raises; interest income on cash and marketable securities is the only disclosed income line.

Products and services

Lead asset: z-rostudirsen (DYNE-251), an RNA-targeted therapy for DMD amenable to exon 51 skipping, in global Phase 1/2 (DELIVER trial) with a BLA submission planned Q2 2026. Pipeline development candidates in IND-enabling studies: DYNE-253 (exon 53 skipping), DYNE-245 (exon 45 skipping), DYNE-244 (exon 44 skipping), and DYNE-255 (exon 55 skipping), all for DMD. Z-rostudirsen holds FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations, as well as Orphan Drug designation from the European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare.

Customers and end markets

Target patient population: individuals with Duchenne muscular dystrophy amenable to specific exon-skipping mutations. No commercial customers as of the filing date. End market is rare pediatric and adult neuromuscular disease.

Value-chain role

Clinical-stage drug developer. Conducts research, IND-enabling studies, and clinical trials internally. No manufacturing, commercialization, or distribution operations disclosed in the excerpts.

Geographic exposure

Clinical trials described as global (DELIVER trial). Regulatory filings reference the FDA (U.S.), European Medicines Agency, and Japanese Ministry of Health, Labour and Welfare. No commercial geographic revenue mix disclosed.

Source: SEC 10-K, filed 2026-03-02

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