The FDA crushed MEI Pharma Inc's (NASDAQ: MEIP) hopes of winning accelerated approval for its PI3K inhibitor, zandelisib, on the strength of phase 2 data.
In the meeting, the FDA informed that a randomized clinical trial is "needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib."
The FDA is set to hold an advisory committee meeting next month to discuss the need for randomized data on PI3K inhibitors.
The companies do not plan to submit an FDA marketing application based on the single-arm Phase 2 TIDAL study and will continue with the randomized Phase 3 COASTAL study as planned.
Working with its partner Kyowa Kirin, MEI linked zandelisib to a 70.3% response rate in follicular lymphoma patients in a Phase 2 trial.
Stifel downgraded MEI Pharma to Hold from Buy with a price target of $2, down from $6.
Jefferies downgraded the company to Hold from Buy with a price target of $1, down from $4.
H.C. Wainwright reduced the price target to $5 from $10.
Truist lowered the price target to $3 from $8, and BTIG cut the price target to $4 from $11 on MEIP stock.
Price Action: MEIP shares are down 63% at $0.67 during the market session on the last check Friday.
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