MEIP - MEI Pharma falls on setback to U.S. marketing application for lymphoma therapy

The late-stage biotech MEI Pharma (NASDAQ:MEIP) has lost ~44% in the pre-market Friday after disclosing that the current data will not be adequate to support a marketing application in the U.S. for zandelisib, a phosphatidylinositol-3-kinase (“PI3K”) inhibitor drug candidate. Updating the outcome of a meeting with the U.S. Food Drug Administration (FDA), the company and its Japanese partner Kyowa Kirin (OTCPK:KYKOF) said that the regulator informed a randomized trial would be required to evaluate PI3K inhibitors, including zandelisib. MEI Pharma (MEIP) and Kyowa Kirin (OTCPK:KYKOF) had expected to seek the marketing authorization for zandelisib under the accelerated approval pathway based on the data from the single-arm Phase 2 TIDAL study that involved follicular lymphoma (FL) patients . “Based on this view, the agency discouraged a filing based on the Phase 2 TIDAL study data and emphasized that the companies continue efforts with the ongoing, randomized Phase 3 COASTAL study as planned,” the

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MEI Pharma falls on setback to U.S. marketing application for lymphoma therapy