Hemogenyx' clinical hold lift plan is accepted by FDA

Shares of London-listed blood disease specialist Hemogenyx Pharmaceuticals (LSE: HEMO) were up more than 9% at 1.80 pence, after it revealed in a stock exchange filing a positive development for its investigational product.

Hemogenyx said that the US Food and Drug Administration (FDA) has accepted its plan to address the FDA's concerns that resulted in a clinical hold (CH) of the HEMO-CAR-T Investigational New Drug (IND) application.

Further to the announcement on July 10, 2023, Hemogenyx says that it carefully considered the comments provided by the FDA in connection with the CH and responded in August 2023 with a detailed plan, supported by laboratory tests, to address those comments.  The Company has now received confirmation from the FDA that the Company's plan satisfactorily addresses the agency's comments.