Concerns raised about safety and efficacy of Abecma
- Shares of 2seventy bio fell 16% on concerns about FDA panel meeting on Abecma gene therapy
- FDA raised concerns about higher rate of early deaths in patients receiving Abecma
- Abecma currently approved for adults with relapsed or refractory multiple myeloma
- FDA holding advisory committee meeting to assess benefits and risks of Abecma
- 2seventy focusing exclusively on commercialization and development of Abecma
Shares of 2seventy bio fell sharply on Wednesday as concerns grew over the upcoming FDA advisory committee meeting on Abecma, the gene therapy it sells in partnership with Bristol Myers Squibb. The FDA has expressed concerns about a higher rate of early deaths in patients receiving Abecma during a Phase 3 study. Currently approved for adults with relapsed or refractory multiple myeloma, Abecma has shown promising results in reducing the risk of disease progression or death. However, the FDA will seek advice from external experts to determine whether the benefits of Abecma outweigh its risks. In light of these developments, 2seventy has decided to focus exclusively on the commercialization and development of Abecma.
Factuality Level: 8
Factuality Justification: The article provides a factual account of the concerns raised by the FDA advisory committee meeting on Abecma, the gene therapy sold by 2seventy bio and Bristol Myers Squibb. It includes relevant information about the FDA’s concerns, the companies’ response, and the purpose of the advisory committee meeting. The article does not contain any obvious bias, misleading information, or sensationalism.
Noise Level: 3
Noise Justification: The article provides relevant information about the concerns surrounding the FDA advisory committee meeting on Abecma, a gene therapy sold by 2seventy bio and Bristol Myers Squibb. It includes details about the FDA’s raised concerns, the study results, and the upcoming advisory committee meeting. The article stays on topic and provides factual information supported by evidence. However, it lacks in-depth analysis, antifragility considerations, and accountability of powerful people.
Financial Relevance: Yes
Financial Markets Impacted: Shares of 2seventy bio and Bristol Myers Squibb
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The article pertains to financial topics as it discusses the impact of a Food and Drug Administration advisory committee meeting on the shares of 2seventy bio and Bristol Myers Squibb. However, there is no mention of an extreme event.
Public Companies: 2seventy Bio (Not available), Bristol Myers Squibb (Not available), Regeneron Pharmaceuticals (Not available)
Key People: Colin Kellaher (Not available)
Reported publicly:
www.marketwatch.com 
