Biontech SE

NASDAQ:BNTXUnited States

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• BioNTech, Duality Biologics Receive FDA Fast-Track Designation for Prostate Cancer Drug, from 40 minutes ago by MT Newswires

  40 minutes ago by MT Newswires
  Companies Mentioned: BNTX
  08:05 AM EDT, 06/24/2024 (MT Newswires) -- BioNTech (BNTX) and Duality Biologics said Monday that the US Food and Drug Administration has granted fast-track designation for their experimental drug, BNT324/DB-1311, to treat metastatic castration-resi...

• DJ BioNTech Cancer Treatment Gets US FDA Fast Track Designation, from 1 hour ago by Dow Jones

  1 hour ago by Dow Jones
  Companies Mentioned: BNTX
  
  By Chris Wack
  
  BioNTech and Duality Biologics (Suzhou) said that the U.S. Food and Drug Administration granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer.
  

• BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer, from 2 hours ago by GlobeNewswire

  2 hours ago by GlobeNewswire
  Companies Mentioned: BNTX

• BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer, from 2 hours ago by Dow Jones

  2 hours ago by Dow Jones
  Companies Mentioned: BNTX
  
  The forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech's control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech's ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; BioNTech's and its counterparties' ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators' ability to commercialize and market, if approved, its product candidates; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.