BioNTech and DualityBio Bag FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer
Portfolio Pulse from Benzinga Newsdesk
BioNTech SE and Duality Biologics announced that their antibody-drug conjugate candidate BNT323/DB-1303 received FDA Breakthrough Therapy designation for advanced endometrial cancer treatment. This designation follows promising data from a Phase 1/2 study in patients with HER2-expressing advanced endometrial cancer who had previously progressed on immune checkpoint inhibitors.
December 21, 2023 | 1:01 pm
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BioNTech's BNT323/DB-1303 received FDA Breakthrough Therapy designation, which may accelerate its development and review process for advanced endometrial cancer treatment.
The FDA's Breakthrough Therapy designation is a significant positive development for BioNTech, as it indicates the potential of BNT323/DB-1303 to offer substantial improvement over existing therapies. This could lead to increased investor confidence and a positive short-term impact on BioNTech's stock price.
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