The FDA crushed MEI Pharma Inc’s (NASDAQ: MEIP) hopes of successful accelerated approval for its PI3K inhibitor, zandelisib, on the energy of part 2 information.
- Within the assembly, the FDA knowledgeable {that a} randomized medical trial is “wanted to adequately assess drug efficacy and security of PI3K inhibitor drug candidates, together with zandelisib.”
- The FDA is about to carry an advisory committee assembly subsequent month to debate the necessity for randomized information on PI3K inhibitors.
- The businesses don’t plan to submit an FDA advertising utility primarily based on the single-arm Section 2 TIDAL research and can proceed with the randomized Section 3 COASTAL research as deliberate.
- Working with its accomplice Kyowa Kirin, MEI linked zandelisib to a 70.3% response fee in follicular lymphoma sufferers in a Section 2 trial.
- Stifel downgraded MEI Pharma to Maintain from Purchase with a worth goal of $2, down from $6.
- Jefferies downgraded the corporate to Maintain from Purchase with a worth goal of $1, down from $4.
- H.C. Wainwright decreased the value goal to $5 from $10.
- Truist lowered the value goal to $3 from $8, and BTIG reduce the value goal to $4 from $11 on MEIP inventory.
- Worth Motion: MEIP shares are down 63% at $0.67 through the market session on the final verify Friday.
Newest Rankings for MEIP
Date | Agency | Motion | From | To |
---|---|---|---|---|
Feb 2022 | Jefferies | Initiates Protection On | Purchase | |
Might 2020 | SunTrust Robinson Humphrey | Initiates Protection On | Purchase | |
Feb 2019 | BTIG | Initiates Protection On | Purchase |
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