The crushed FDA MEI Pharma Inc. (NASDAQ: MEIP) hopes to gain accelerated approval for its PI3K inhibitor, zandelisib, based on Phase 2 data.
- At the meeting, the FDA advised that a randomized clinical trial is “necessary to adequately evaluate the 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 a marketing application to the FDA based on the single-arm Phase 2 TIDAL study and will continue with the randomized Phase 3 COASTAL study as planned.
- Together with partner Kyowa Kirin, MEI has linked zandelisib to a 70.3% response rate in patients with follicular lymphoma in a phase 2 trial.
- Stifel downgraded MEI Pharma to Hold from Buy with a price target of $2, down from $6 previously.
- Jefferies downgraded the company to Hold from Buy with a price target of $1, down from $4 previously.
- HC Wainwright reduced the price target to $5 from $10.
- Truist lowered the price target to $3 from $8, and BTIG reduce price target to $4 from $11 on MEIP stock.
- Price action: MEIP shares were down 63% at $0.67 during Friday’s last check trading session.
Latest reviews for MEIP
|February 2022||Jefferies||Initiates coverage on||To buy|
|May 2020||Sun Trust Robinson Humphrey||Initiates coverage on||To buy|
|February 2019||BTIG||Initiates coverage on||To buy|
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