FDA Lifts Clinical Hold on Immunome's COVID-19 Candidate IND

  • The FDA has lifted the clinical hold on Immunome Inc's IMNM Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) to treat COVID-19. 
  • Immunome previously announced that the FDA had placed its IND application on clinical hold due to a request for further information related to the preparation and administration of IMM-BCP-01 at clinical sites. 
  • In response, Immunome provided the FDA with a comprehensive report detailing the necessary information.
  • Related: Immunome Shares Seesaw After COVID-19 Antibody Cocktail Works Against Live Omicron Virus.
  • "We believe in the potential of IMM-BCP-01 and its ability to aid in the ongoing fight against SARS-CoV-2, especially as the new variants continue," said Purnanand Sarma, President & CEO of Immunome. "We are pleased to report that the clinical hold has now been lifted. We look forward to advancing the program into the clinic.
  • Price Action: IMNM shares are down 6.56% at $3.99 during the market session on the last check Friday.
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