FDA Accepts Priority Review For Genmab/Pfizer's Supplemental Biologics License Application To Convert The Accelerated Approval Of Tivdak To Full Approval For Recurrent Or Metastatic Cervical Cancer, With Priority Review With PDUFA Action Date Of May 9
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The FDA has accepted a priority review for Genmab and Pfizer's supplemental Biologics License Application to convert the accelerated approval of Tivdak to full approval for recurrent or metastatic cervical cancer. The PDUFA action date is set for May 9.
January 09, 2024 | 11:49 am
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POSITIVE IMPACT
Genmab's supplemental Biologics License Application for Tivdak has been accepted for priority review by the FDA, which could lead to full approval for cervical cancer treatment.
The acceptance of the priority review by the FDA is a positive development for Genmab, as it brings Tivdak closer to full approval. Full approval can lead to increased market confidence and potential sales growth, positively impacting GMAB's stock in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Pfizer, in collaboration with Genmab, has received FDA priority review for the supplemental Biologics License Application of Tivdak, which may lead to full approval for the treatment of recurrent or metastatic cervical cancer.
Pfizer's collaboration with Genmab on Tivdak and the FDA's acceptance for priority review is likely to have a positive impact on Pfizer's stock. Full approval would strengthen Pfizer's oncology portfolio, potentially leading to increased revenue from the drug.
CONFIDENCE 80
IMPORTANCE 70
RELEVANCE 70