BioNTech And Duality Biologics Announced FDA Granted Fast Track Designation For BNT324/DB-1311 For Advanced/Unresectable, Or Metastatic Castration-resistant Prostate Cancer Patients Who Have Progressed On Or After Standard Systemic Regimens
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BioNTech and Duality Biologics announced that the FDA has granted Fast Track Designation for BNT324/DB-1311 for advanced or metastatic castration-resistant prostate cancer patients who have progressed on or after standard systemic regimens.
June 24, 2024 | 11:02 am
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BioNTech received FDA Fast Track Designation for BNT324/DB-1311, which is aimed at treating advanced prostate cancer. This designation could accelerate the development and review process, potentially leading to earlier market entry.
The FDA Fast Track Designation is a significant regulatory milestone that can expedite the development and review of BNT324/DB-1311. This increases the likelihood of the drug reaching the market sooner, which is positive for BioNTech's stock.
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