BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer [Yahoo! Finance]
BioNTech SE - American Depositary Shares (BNTX)
Company Research
Source: Yahoo! Finance
safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration (“FDA”) to support development and expedite regulatory review Prostate cancer is the second leading cause of cancer-related deaths among men worldwide often diagnosed at advanced disease stages; patients with metastatic castration–resistant prostate cancer (“mCRPC”), an advanced form of prostate cancer, have a 5-year survival rate of around 36% All three clinical stage antibody-drug conjugate (“ADC”) candidates in BioNTech's and DualityBio's strategic collaboration have received FDA Fast Track designation supporting the potential of the companies' ADC technology MAINZ, Germany and SHANGHAI, China, June 24, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) t
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BNTX
Earnings
- 5/6/24 - Miss
BNTX
Sec Filings
- 6/28/24 - Form 6-K
- 6/24/24 - Form 6-K
- 6/17/24 - Form 6-K
- BNTX's page on the SEC website