Bristol-Myers Squibb (BMY) recently found itself in a challenging position, receiving a double blow of adverse news. First, the FDA’s Oncologic Drugs Advisory Committee announced a delay in its approval decision for Abecma, a potential treatment for earlier lines of relapsed refractory multiple myeloma (RRMM). Concurrently, Bayer (BAYRY) decided to halt its Phase 3 trial of the cardiovascular drug asundexian due to lack of efficacy. While these developments may initially seem unrelated, they hold implications for Bristol-Myers’ milvexian, raising questions about the future of both drugs.
Connecting the Dots: Asundexian and Milvexian
Asundexian and milvexian are both blood-thinning drugs currently undergoing Phase 3 studies, with the aim of preventing stroke and systemic embolism in patients with atrial fibrillation. Both fall under the category of “FXI(a) inhibitors,” designed to reduce the risk of strokes without a corresponding increase in bleeding risk, a concern associated with some existing standards of care.
The Significance of Bayer’s Decision: Asundexian
Bayer’s decision to discontinue its Phase 3 trial of asundexian holds broader implications. Market participants have inferred that this move could be a negative data point for milvexian, which Bristol-Myers is co-producing with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ).
The critical aspect is that asundexian failed to demonstrate better efficacy than Eliquis, a blood-thinner manufactured by Pfizer (PFE) and Bristol-Myers. Consequently, the Phase 3 analysis did not support the continuation of asundexian’s development. For context, Bayer had anticipated asundexian could generate sales as high as $5.5 billion, making its discontinuation a significant development in the pharmaceutical landscape.
FDA’s Delay on Abecma
On the other hand, the FDA’s decision to delay its approval decision on Abecma for RRMM is impacting shares of 2seventy bio (TSVT) more significantly. TSVT is jointly developing Abecma with Bristol-Myers and is expected to feel the financial repercussions of a potential FDA rejection more acutely than Bristol-Myers itself.
In fiscal year 2022, TSVT reported revenue of $91.5 million while posting a net loss of ($254.2) million. The delay in the FDA decision has added uncertainty to their financial outlook.
Abecma’s Positive Phase 3 Results
However, it’s important to note that despite the delay, Abecma has shown promising results in its Phase 3 study. Already approved for adult RRMM patients after four or more prior lines of therapy, Abecma demonstrated a statistically significant improvement in progression-free survival (PFS) when compared to standard treatment regimens.
By reducing the risk of disease progression or death in comparison to the standard regimen, Abecma successfully met its primary endpoint in the Phase 3 trial. These positive outcomes have the potential to make Abecma a valuable addition to the treatment landscape for multiple myeloma.
Challenging the Status Quo: Darzalex
Currently, Darzalex, a drug produced by JNJ, is one of the most commonly used treatments in multiple myeloma and is expected to generate sales of nearly $10.0 billion this year. Abecma’s success could challenge Darzalex’s dominance in the field, offering patients and physicians a compelling alternative.
Bottom-line: Despite the negative headlines and setbacks, Bristol-Myers Squibb is demonstrating resilience in its stock performance, with losses remaining manageable. While the FDA will not meet its initial deadline for the Abecma decision, there is still potential for approval following the delay. The drug’s positive Phase 3 results suggest that Abecma could bring a new ray of hope to patients battling multiple myeloma, reshaping the treatment landscape in the coming years.
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