Why Is Pharma Giant Bristol-Myers Squibb Stock Trading Lower Today?
Portfolio Pulse from Vandana Singh
Bristol-Myers Squibb Company (BMY) and 2seventy Bio Inc (TSVT) stocks dropped due to a delay in expanded U.S. approval for their Abecma gene therapy. The FDA's ODAC will review the sBLA for Abecma based on the KarMMa-3 study, but the meeting date is unconfirmed, and the PDUFA target action date of December 16, 2023, will be missed. Abecma is approved for RRMM after four prior therapies and has generated significant revenue. The KarMMa-3 study showed a significant improvement in progression-free survival.
November 20, 2023 | 2:37 pm
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NEGATIVE IMPACT
Bristol-Myers Squibb's stock declined due to a delay in the FDA approval process for Abecma gene therapy, despite the therapy's strong revenue and positive study results.
The delay in FDA approval is a negative short-term catalyst for BMY's stock as it postpones potential revenue growth from the expanded use of Abecma. However, the strong revenue figures and positive study results may mitigate the impact.
CONFIDENCE 75
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
2seventy Bio Inc's stock experienced a significant drop following the FDA's delay in reviewing the sBLA for Abecma, which is critical for the company's product pipeline.
The FDA delay is particularly impactful for TSVT given the stock's sharp decline and the company's reliance on Abecma for future growth. The missed PDUFA date adds uncertainty to the approval timeline.
CONFIDENCE 80
IMPORTANCE 80
RELEVANCE 90