Anixa's Stock Craters As FDA Slaps Clinical Hold On CAR-T Program
Anixa Biosciences Inc (NASDAQ: 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.
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