Early approval not on the cards for MEI's novel cancer candidate

25 March 2022

A regulatory setback for San Diego-based oncology specialist MEI Pharma (Nasdaq: MEIP) has sent the company’s shares into freefall ahead of the opening bell in New York on Friday.

MEI Pharma has been working with Japan’s Kyowa Kirin (TYO: 4151) on zandelisib, an investigational therapy which uses PI3K inhibition to target cancer.

MEI has been talking with the US Food and Drug Administration about the potential for a nod under the Accelerated Approval pathway, based on data from the single arm Phase II TIDAL study.

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