Genmab Receives FDA Breakthrough Therapy Designation For Epcoritamab For Relapsed Or Refractory Follicular Lymphoma After Two Or More Lines Of Systemic Therapy, European Medicines Agency Validates Application For Epcoritamab For The Same Indication
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Genmab has been granted FDA Breakthrough Therapy Designation for Epcoritamab, aimed at treating relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Additionally, the European Medicines Agency has validated an application for Epcoritamab for the same indication.
November 27, 2023 | 12:03 pm
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Genmab's Epcoritamab has received FDA Breakthrough Therapy Designation and EMA validation for treating follicular lymphoma, which could accelerate its development and review process.
The FDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. This designation, along with the EMA's validation of the application, is a strong positive signal for Genmab's Epcoritamab, suggesting a higher likelihood of regulatory approval and potential market exclusivity. This news is likely to be viewed positively by investors and could lead to a short-term increase in Genmab's stock price.
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