FDA Issues Clinical Hold On Immunome's COVID-19 Antibody Program

Immunome Inc IMNM has received an FDA clinical hold letter in response to its recently submitted IND requesting further information related to the preparation and administration of IMM-BCP-01 at clinical sites.

• The Company has already initiated the requisite work and expects to provide the requested information quickly.
• Related: Why Are Immunome Shares Trading Higher Today?
• Unrelated, the FDA also guided on the clinical protocol for IMM-BCP-01, including patient selection criteria.
• The U.S. Department of Defense funded the investigational work.
• In December, Immunome said that it expects its antibody cocktail, IMM-BCP-01, to neutralize the omicron variant. 
• The Company is working to confirm this activity in laboratory testing and expects initial results to be available in January 2022.
• Price Action: IMNM shares are down 9.40% at $10.50 premarket on the last check Tuesday.