Clene shares are trading lower after the FDA determined that the initial findings on biomarker NfL reduction from the Phase 2 programs were insufficient to support accelerated approval.
Portfolio Pulse from Benzinga Newsdesk
Clene Inc.'s stock price has dropped following the FDA's decision that the Phase 2 biomarker NfL reduction findings do not support accelerated approval.
December 21, 2023 | 8:12 pm
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NEGATIVE IMPACT
Clene Inc.'s shares are trading lower due to the FDA's negative view on the Phase 2 biomarker NfL reduction data, impacting the potential for accelerated approval.
The FDA's decision directly impacts Clene Inc.'s regulatory progress, which is a critical factor for biotech companies. The negative outcome is likely to diminish investor confidence and could lead to a short-term decline in stock price.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100