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Benzinga
Benzinga
Technology
Vandana Singh

Why Are TC Biopharm Shares Trading Higher Today

United States United Kingdom FDA
  • The FDA has granted Orphan Drug designation to TC Biopharm Ltd's (NASDAQ:TCBP) lead product OmnImmune for use in Acute Myeloid Leukemia. 
  • After reviewing the Phase 1b/2a trial results in relapsed/refractory AML patients, the FDA approved the Company's application for Orphan Drug Status.
  • "We look forward to the advancement of OmnImmune® in the Phase 2b/3 trial and to helping patients with AML in the near future," stated CEO Bryan Kobel.
  • Also Read: Newly-Listed TC Biopharm Highlights Early Data From Acute Myeloid Leukemia Trial.
  • The status allows for a seven-year exclusive marketing window post-approval of the drug, certain lowered application fees, and tax incentives.
  • OmnImmune is an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells. 
  • Phase 2/3 trials will begin enrollment in Q1 of 2022 in the UK, expanding into the US in 2022.
  • Price Action: TCBP shares are up 32% at $1.32 during the market session on the last check Thursday.
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