Dyne and Keros: Competing DMD Approaches in Clinical-Stage Biotech

Two clinical-stage biopharmaceutical companies are making significant strides in the treatment of Duchenne muscular dystrophy (DMD), a severe neuromuscular disorder. Dyne Therapeutics and Keros Therapeutics each bring distinct therapeutic strategies and pipeline strengths to one of biotech’s most competitive therapeutic areas. With both advancing promising candidates and demonstrating impressive clinical progress, investors face the challenging task of evaluating which company offers more compelling upside potential.

Keros’ Strategic Focus: The KER-065 Path Forward

Keros Therapeutics has sharpened its strategic direction significantly in recent months. The company is concentrating its efforts on KER-065, its lead product candidate designed to target dysfunctional signaling of the transforming growth factor-beta (TGF-β) protein family. By binding to and inhibiting TGF-β ligands—including myostatin and activin A, which suppress muscle and bone mass—KER-065 aims to address the underlying biology of neuromuscular disease.

Clinical progress has been noteworthy. In March 2025, Keros reported initial Phase I results from a healthy volunteer study. Subsequently, in August 2025, the FDA granted orphan drug designation for KER-065 in DMD, a significant regulatory milestone. The company plans to initiate a Phase II trial in DMD patients during the first quarter of 2026.

Beyond its lead candidate, Keros secured a meaningful partnership in December 2024 with Takeda Pharmaceuticals to develop and commercialize elritercept globally (outside Greater China). The arrangement became effective January 16, 2025, and provides milestone payments as the program advances. In July 2025, the first patient was dosed in the Phase III RENEW study evaluating elritercept for myelodysplastic syndrome-related conditions, triggering a $10 million milestone payment.

The company has also made deliberate operational adjustments. In August 2025, Keros discontinued its pulmonary arterial hypertension program and implemented a 45% workforce reduction, streamlining to approximately 85 full-time employees. These moves are expected to generate roughly $17 million in annual cost savings, reflecting a laser-focused approach to capital efficiency. As of September 30, 2025, Keros maintained $693.5 million in cash and equivalents, with management expecting remaining capital to support operations into the first half of 2028 after accounting for committed shareholder returns.

Dyne’s Diverse Portfolio: The Multi-Indication Approach

Dyne Therapeutics pursues a broader therapeutic strategy, leveraging its proprietary FORCE platform to develop candidates for multiple genetically driven neuromuscular diseases. The company’s portfolio encompasses programs in DMD, myotonic dystrophy type 1 (DM1), facioscapulohumeral dystrophy (FSHD), and Pompe disease.

In the DMD space, Dyne is evaluating zeleciment rostudirsen (z-rostudirsen or DYNE-251) through the DELIVER study. This investigational therapy targets individuals with DMD who carry mutations amenable to exon 51 skipping. In a recent update, the Registrational Expansion Cohort met its primary endpoint, demonstrating statistically significant dystrophin expression increase to 5.46% of normal at six months. Notably, the candidate showed encouraging functional benefits across all six prespecified endpoints, with meaningful preservation of lung function—a critical factor in DMD morbidity.

Dyne plans to submit a biologics license application for accelerated approval of z-rostudirsen in the second quarter of 2026. The candidate has received Breakthrough Therapy Designation from the FDA and Orphan Drug Designation in Japan.

The company’s DM1 program is equally compelling. Zeleciment basivarsen (z-basivarsen or DYNE-101), under investigation in the ACHIEVE study, earned Breakthrough Therapy Designation in June 2025 following a Type C meeting with the FDA in May 2025. Dyne submitted a revised protocol in June 2025 for the Registrational Expansion Cohort of this study.

Additionally, Dyne is progressing DYNE-302 for FSHD and DYNE-401 for Pompe disease through preclinical and IND-enabling stages. As of September 30, 2025, Dyne held $791.9 million in cash, cash equivalents, and marketable securities, with expected funding sufficiency into the third quarter of 2027.

Financial Outlook and Market Positioning

From an earnings perspective, consensus estimates suggest divergent trajectories. The Zacks Consensus Estimate for Keros projects a 145% improvement in 2025 EPS, with recent upward estimate revisions. Dyne’s consensus estimate projects a 2.67% EPS decline for 2025, though both 2025 and 2026 estimates have moved favorably over the past two months.

Stock performance over the past year reflects market confidence in both companies, though with different magnitudes. Keros shares have surged 63.9% compared to a 31.7% gain for Dyne, outpacing the broader biotech industry’s 15.8% gain over the same period.

From a valuation standpoint, Keros trades at a significant discount. The company’s shares currently trade at 0.81X trailing 12-month book value, substantially lower than Dyne’s 3.72X, suggesting investors have priced in either greater near-term execution risk or different expectations for future capital needs.

Strategic Considerations and Investment Thesis

Both companies occupy important positions in the competitive DMD therapeutic landscape. Dyne brings a deeper and more diversified pipeline with multiple Breakthrough Therapy Designations and a clear regulatory pathway for near-term approvals. The company’s strategy of pursuing multiple indications provides portfolio diversification and reduces single-program risk.

Keros, conversely, has adopted a highly focused approach, betting heavily on KER-065 and capitalizing on its TGF-β mechanism. The company’s operational restructuring, while reducing scope, has enhanced capital efficiency and sharpened strategic execution. Any positive clinical update on KER-065 could serve as a meaningful catalyst.

The investment decision ultimately hinges on preferred risk profiles. Dyne Therapeutics offers broader diversification with multiple near-term readouts, while Keros presents a concentrated bet on a differentiated mechanism with cheaper valuation multiples. Keros currently carries a Zacks Rank #1 (Strong Buy), reflecting analyst conviction in its near-term potential, whereas Dyne holds a Zacks Rank #3 (Hold). For investors seeking concentrated exposure with aggressive upside, Keros presents the more compelling case, though Dyne’s pipeline breadth appeals to those preferring diversified neuromuscular disease exposure.