FDA's Oncologic Drugs Advisory Committee Will Meet To Review Data For Supplemental Marketing Application For Bristol Myers Squibb And 2Seventy Bio's Abecma (Idecabtagene Vicleucel) For Earlier Lines Of Triple-class Exposed Relapsed Or Refractory Multiple
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The FDA's Oncologic Drugs Advisory Committee (ODAC) is set to review a supplemental marketing application for Abecma, a therapy developed by Bristol Myers Squibb and 2Seventy Bio, for use in earlier lines of treatment for triple-class exposed relapsed or refractory multiple myeloma. The exact date for the ODAC meeting is not confirmed, and the FDA has indicated that a decision on the application will not be reached by the original PDUFA target date of December 16, 2023.
November 20, 2023 | 12:06 pm
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NEUTRAL IMPACT
Bristol Myers Squibb, co-developer of Abecma, may experience stock volatility due to the pending FDA review and delayed decision past the PDUFA target date.
The delay in FDA decision may cause uncertainty among investors, potentially leading to short-term stock volatility for Bristol Myers Squibb. However, the eventual approval could be a positive catalyst.
CONFIDENCE 75
IMPORTANCE 70
RELEVANCE 80
NEUTRAL IMPACT
2Seventy Bio, involved in the development of Abecma, may face stock fluctuations due to the FDA's delayed decision on the supplemental marketing application.
As a smaller biotech company, 2Seventy Bio may be more sensitive to regulatory news. The delay in the FDA's decision could lead to investor uncertainty and affect the stock in the short term.
CONFIDENCE 75
IMPORTANCE 70
RELEVANCE 80