Ipsen Confirms FDA Grants Priority Review For New Drug Application For Elafibranor For The Treatment Of Rare Cholestatic Liver Disease, PBC
Portfolio Pulse from Charles Gross
Ipsen and GENFIT announced the FDA has accepted the NDA for elafibranor, a potential treatment for PBC, a rare liver disease. The FDA granted priority review with a target PDUFA date of June 10, 2024.
December 07, 2023 | 10:17 am
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POSITIVE IMPACT
GENFIT's collaborative drug elafibranor received FDA priority review for its NDA, marking a significant advancement in its pipeline.
The FDA's acceptance of elafibranor's NDA for priority review is a strong positive development for GENFIT. It not only validates the drug's potential but also could accelerate its path to market, positively impacting GENFIT's stock in the short term.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80
POSITIVE IMPACT
Ipsen's NDA for elafibranor in treating PBC has been accepted by the FDA, with priority review indicating a significant regulatory milestone.
The acceptance of the NDA by the FDA and the priority review status are positive indicators for Ipsen. This suggests a higher likelihood of regulatory approval and a faster review process, which can be a catalyst for the stock price in the short term.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80