Regeneron Says FDA Issued Complete Response Letters For Biologics License Application For Odronextamab In Relapsed/Refractory (R/R) Follicular Lymphoma And R/R Diffuse Large B-cell Lymphoma
Portfolio Pulse from Benzinga Newsdesk
Regeneron announced that the FDA issued Complete Response Letters for the Biologics License Application for Odronextamab in treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, indicating a setback in its approval process.
March 25, 2024 | 11:02 am
News sentiment analysis
Sort by:
Descending
NEGATIVE IMPACT
Regeneron faces a regulatory hurdle as the FDA issues Complete Response Letters for Odronextamab, affecting its potential market entry for treating certain lymphomas.
The issuance of Complete Response Letters by the FDA is a significant regulatory obstacle for Regeneron, directly impacting the approval timeline and market entry for Odronextamab. This news is likely to be viewed negatively by investors, potentially leading to a short-term decrease in Regeneron's stock price due to the delayed potential revenue and increased uncertainty.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100