FDA Grants Priority Review of ImmunoGen's Supplemental Biologics License Application for ELAHERE (Mirvetuximab Soravtansine-Gynx) in Platinum-Resistant Ovarian Cancer
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The FDA has accepted ImmunoGen, Inc.'s supplemental Biologics License Application (sBLA) for ELAHERE for platinum-resistant ovarian cancer and granted it Priority Review status. The PDUFA action date is set for April 5, 2024.
December 05, 2023 | 11:31 am
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ImmunoGen's ELAHERE sBLA for ovarian cancer treatment has been granted Priority Review by the FDA, indicating a significant regulatory milestone that could lead to full approval.
The FDA's Priority Review status for ImmunoGen's ELAHERE is a positive signal for the drug's potential full approval. This regulatory milestone is likely to be viewed favorably by investors, as it suggests a shorter review period and a higher level of FDA interest in the drug. Given that the PDUFA action date is set for April 5, 2024, the anticipation of this event could lead to increased investor optimism and potentially a rise in stock price in the short term.
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