Bristol‑Myers Squibb reported that its Phase 2 registrational study of Reblozyl (luspatercept‑aamt) in adults with alpha‑thalassemia met all primary and secondary endpoints in both non‑transfusion‑dependent and transfusion‑dependent cohorts. The study, identified as NCT05664737, showed a statistically significant increase in hemoglobin levels for non‑transfusion‑dependent patients and a significant reduction in red‑blood‑cell transfusion burden for transfusion‑dependent patients, with all key secondary endpoints also achieved and safety consistent with the known profile of Reblozyl in thalassemia.
The positive results expand Reblozyl’s potential patient population beyond its current indications for beta‑thalassemia and myelodysplastic syndromes. By demonstrating efficacy in alpha‑thalassemia, the drug could open a new revenue stream in a disease with limited treatment options, potentially increasing the company’s growth portfolio and overall market share in the hemoglobinopathy space.
Bristol‑Myers Squibb’s Q4 2025 financials provide context for the clinical milestone. Total revenue rose to $12.5 billion, a 1% year‑over‑year increase, driven by a 16% rise in the Growth Portfolio to $7.39 billion, largely from immuno‑oncology, Reblozyl, Camzyos, and Breyanzi. Adjusted EPS reached $1.26, beating consensus, while non‑GAAP gross margin contracted 2.1 percentage points to 71.9% due to a shift toward lower‑margin growth products. Reblozyl sales grew 22% year‑over‑year to $666 million in Q4 2025, up 76% from 2024, underscoring the drug’s commercial momentum.
CEO Christopher Boerner said in February 2026 that "2026 is data‑rich, and we are advancing a truly differentiated pipeline with multiple pivotal readouts expected in the back half of the year." The statement reflects the company’s confidence in its pipeline and its strategy to capitalize on the momentum generated by the Q4 2025 results and the new alpha‑thalassemia data.
The company will present the data at an upcoming medical congress and discuss it with the Center for Drug Evaluation in China, indicating a potential regulatory pathway in that market. Combined with the 2026 guidance of $46.0 billion to $47.5 billion in revenue and $6.05 to $6.35 in adjusted EPS—both above consensus—Bristol‑Myers Squibb signals strong growth prospects and a broadened commercial reach for Reblozyl.
The announcement underscores Bristol‑Myers Squibb’s strategy to strengthen its Growth Portfolio and mitigate headwinds from patent cliffs in legacy products. By adding a new indication for Reblozyl, the company positions itself to capture unmet medical needs in alpha‑thalassemia while reinforcing its pipeline strength and market leadership in hemoglobinopathies.
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