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 with the data from the single-arm Phase 2 TIDAL study that involved follicular lymphoma (FL) patients.
Following the latest regulatory guidance, the duo does not plan to submit a marketing application based on TIDAL data.
However, the companies will continue to focus on the Phase 3 COASTAL study, an ongoing randomized trial for the candidate. MEI Pharma (MEIP) expects there will be sufficient cash for operations to complete its enrollment in 2024.
“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 companies said about the meeting.
In November, MEI Pharma (MEIP) gained after announcing data from the TIDAL study.