Keros Therapeutics Eyes 2027 DMD Data as Rinvatercept Takes Center Stage

Key Points

• Rinvatercept is becoming Keros Therapeutics’ central growth program. The muscle-regeneration candidate is being tested in Duchenne muscular dystrophy, with initial safety and tissue-composition data expected in the first half of 2027.
• Keros plans to evaluate rinvatercept’s effects on lean muscle, bone density and fat using quarterly DEXA scans, while functional benefits may require longer follow-up and a future placebo-controlled trial. The company also expects to begin an ALS Phase II study in 2027.
• Partnered eleriscept is in three Phase III trials under Takeda, but investors may await pivotal data before assigning significant value; Takeda has indicated a potential BLA filing in 2028–2029. Keros says milestone proceeds extend its cash runway into the second half of 2028.

Keros Therapeutics NASDAQ: KROS is repositioning its pipeline around rinvatercept, a skeletal-muscle regeneration candidate being developed for neuromuscular diseases, while its partnered program eleriscept advances through late-stage development under Takeda, Chief Executive Officer Jasbir Seehra said during a fireside chat hosted by Chardan.

Seehra said Keros focuses on the TGF-β signaling pathway. The company partnered eleriscept with Takeda in 2024, and the program is now in three Phase III trials. Keros previously deprioritized and stopped pursuing tenetacept after the asset showed a safety signal in a Phase II study.

“We have a third asset that is now increasing skeletal muscle by increasing muscle regeneration that is going into neuromuscular indications,” Seehra said of rinvatercept.

Takeda partnership and financial runway

Seehra said Keros’ shares declined following the safety signals in its discontinued program, shortly after the Takeda transaction was completed. The company also returned $375 million of capital during 2025 amid activist investor involvement, which he characterized as part of a reset for the company.

While eleriscept remains in Takeda’s hands, Seehra said investors may not assign significant value to the program until there is greater visibility into Phase III data. Takeda has indicated that it expects to file a biologics license application, or BLA, in the 2028 to 2029 timeframe, he said, suggesting that pivotal data could emerge around that period.

Keros received a milestone payment from Takeda during the prior quarter, Seehra said. Including that payment, the company is guiding for cash runway into the second half of 2028.

Rinvatercept study in Duchenne muscular dystrophy

Keros has initiated a Phase II open-label study of rinvatercept in Duchenne muscular dystrophy, or DMD, and expects to begin sharing data in the first half of 2027. The company expects multiple readouts as patients remain on treatment.

Unlike therapies designed to replace dystrophin, the protein lacking in DMD, rinvatercept is intended to increase muscle regeneration, according to Seehra. He said the treatment inhibits two ligands that act as negative regulators of skeletal muscle, including activin A, which he described as an inflammatory cytokine in the TGF-β pathway.

Seehra said DMD muscle can initially function despite deficient dystrophin, but progressive breakdown, inflammation and impaired regeneration contribute to deterioration over time. He contrasted rinvatercept’s approach with glucocorticoids, which can reduce inflammation but are also catabolic to muscle.

He said rinvatercept is intended to address muscle wasting, inflammation, fibrosis, bone loss and fat accumulation associated with the disease and existing standard of care. The treatment could potentially be used alongside glucocorticoids, exon-skipping therapies and gene therapies rather than as an alternative to them, he said.

• Early 2027 data are expected to focus on safety and signals of tissue-level changes.
• Keros plans to use DEXA scans conducted every three months to evaluate lean mass, bone density and fat.
• Functional assessments may take longer to interpret because they can be more variable and require additional patients and treatment duration, Seehra said.

The company expects a future placebo-controlled study would need to demonstrate functional benefit. Measures discussed by Seehra included the North Star Ambulatory Assessment, timed functional tests such as the 10-meter walk/run, rising from a seated position and four-stair climbing, as well as upper-body function measures for non-ambulatory patients.

ALS planning

Keros also plans to engage regulators in the second half of 2026 regarding the design of a Phase II trial of rinvatercept in amyotrophic lateral sclerosis, or ALS. Seehra said the company expects that study to begin in 2027.

In ALS, Keros’ approach is aimed at strengthening muscle fibers that remain innervated as neuromuscular junctions deteriorate. Seehra said the strategy is not expected to alter the eventual outcome of the disease by itself, but could potentially delay symptoms such as loss of ambulation or respiratory function by preserving skeletal muscle.

He said treatments targeting factors involved in neuromuscular-junction breakdown would still be needed to change the disease’s ultimate course. Keros believes rinvatercept’s inhibition of both myostatin and activin A could provide greater potency than approaches targeting myostatin alone, he added.

Seehra described 2027 as a key year for Keros, with anticipated DMD data updates and additional clinical trial initiations.

About Keros Therapeutics (NASDAQ:KROS)

Keros Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing therapies that regulate signaling within the transforming growth factor beta (TGF-β) superfamily. These biological pathways influence blood-cell production, bone health, muscle growth and cardiovascular function, and may play a role in several serious diseases.

The company's investigational portfolio has included elritercept (KER-050), an engineered ligand trap designed to enhance red blood cell production and address anemia associated with conditions such as myelodysplastic syndromes and myelofibrosis.

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