Anixa's Stock Craters As FDA Slaps Clinical Hold On CAR-T Program

• Anixa Biosciences Inc ANIX shares drop after the FDA has requested additional information on its Chimeric Antigen Receptor-T cell therapy (CAR-T) being developed in partnership with Moffitt Cancer Center (MCC).


• The study under the Investigational New Drug (IND) application has been placed on clinical hold pending submission of additional information requested by the FDA.


• This technology is an autologous cell therapy that requires the manufacture of a unique drug product for each patient. The therapeutic product is comprised of engineered T-cells that target the follicle-stimulating hormone receptor (FSHR). FSHR is found at immunological levels exclusively on the granulosa cells of the ovaries.


• Within the next 30 days, FDA will provide a letter to MCC with detailed and specific information requested.


• Price Action: ANIX dropped 17% at $3.9 in the market trading hours on the last check Monday.

Related content: Benzinga's Full FDA Calendar