Positive Data from Phase 2 CADENCE Trial Proves Sotatercept-csrk Effective

Biotech firm announces promising results for new treatment targeting adults with pulmonary arterial hypertension.

Mar. 29, 2026 at 5:52pm

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Pharmaceutical company Acceleron Pharma has announced positive results from its Phase 2 CADENCE clinical trial, providing definitive proof-of-concept for its investigational drug WINREVAIR (sotatercept-csrk) in treating adults with pulmonary arterial hypertension. The trial demonstrated significant improvements in key measures of cardiovascular function and exercise capacity.

Why it matters

Pulmonary arterial hypertension is a rare and life-threatening condition that affects the arteries in the lungs, making it difficult for the heart to pump blood effectively. Current treatments have limited efficacy, so new therapeutic options are desperately needed to improve outcomes for patients.

The details

The Phase 2 CADENCE trial enrolled 147 adults with pulmonary arterial hypertension who were randomized to receive either WINREVAIR or a placebo over a 24-week treatment period. The trial met its primary endpoint, showing a statistically significant improvement in pulmonary vascular resistance compared to placebo. Patients also experienced meaningful gains in exercise capacity and other hemodynamic measures.

  • The Phase 2 CADENCE trial was conducted from January 2025 to March 2026.
  • Acceleron Pharma announced the positive trial results on March 29, 2026.

The players

Acceleron Pharma

A biopharmaceutical company focused on developing novel therapies for serious and rare diseases.

WINREVAIR (sotatercept-csrk)

Acceleron's investigational drug candidate for the treatment of pulmonary arterial hypertension.

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What they’re saying

“These positive results from the CADENCE trial provide definitive proof-of-concept for WINREVAIR and its potential to transform the treatment of pulmonary arterial hypertension.”

— Habib Dable, President and Chief Executive Officer of Acceleron Pharma

What’s next

Acceleron Pharma plans to meet with regulatory authorities to discuss the next steps for WINREVAIR, including the potential initiation of a Phase 3 pivotal trial.

The takeaway

The promising data from the CADENCE trial represents a major milestone in the development of new treatments for pulmonary arterial hypertension, a debilitating condition with limited therapeutic options. If approved, WINREVAIR could offer a much-needed new approach to managing this rare and life-threatening disease.