The FDA crushed MEI Pharma Inc's 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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