MEI Pharma Inc (NASDAQ: MEIP) shares are plunging in Thursday's after-hours session after the company provided an investor update following a recent meeting with the U.S. Food and Drug Administration.
During the meeting, the FDA informed MEI Pharma that a randomized trial would now be needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib.
MEI Pharma announced 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.'
Following FDA recommendations, MEI Pharma said it no longer plans to submit an FDA marketing application based on its single arm Phase 2 TIDAL study.
MEI Pharma is focused on the clinical development of novel therapies for cancer. Zandelisib is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.
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MEIP 52-Week Range: $1.68 - $3.91
The stock was down 48.1% in after hours, hovering around 94 cents at press time.
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