On March 24, MEI Pharma Inc. (MEIP) along with Kyowa Kirin Co., Ltd. provided regulatory updates on zandelisib after meeting with the FDA. Consequently, the company’s stock collapsed in the after-hours and marked a new low.
During the regular session, MEIP barely remained in the green with a mild gain of 0.56%. After fluctuating between a high of $1.8350 and a low of $1.7950, the stock closed the session at $1.8100. Over 3.36 million shares were exchanged during the regular session, marking a volume above the average at 340%. Following the announcement, the stock took a harsh hit in the after-hours and plunged down to $0.9800. Thus, MEIP reported a new 52-week low in the after-hours against its previous $1.6800. The volume of shares exchanged in the after-hours was 2.92 million.
The pharmaceutical company, MEI Pharma Inc. develops therapies for cancer. Founded in 2000, the San Diego-based company has a market capitalization of $239.37 million. Currently, the company has 132.99 million shares outstanding in the market.
Zandelisib Regulatory Update
Recently, MEIP and Kyowa Kirin had a meeting with the FDA regarding the marketing authorization of zandelisib through the accelerated approval pathway. The pursuit was based on data from a single-arm Phase 2 TIDAL study of the P13K inhibitor drug candidate.
During the meeting, FDA conveyed the now added requirement of a randomized trial for assessing drug efficacy and safety of P13K inhibitor drug candidates. Thus, FDA informed that filing based only on Phase 2 TIDAL study data is not enough and the company should continue the ongoing randomized Phase COSTAL study as per the plans.
Therefore, the company announced not to submit an FDA marketing application based on the TIDAL study while focusing on the ongoing COASTAL study. Additionally, the company believes that it will be able to complete COASTAL study enrollment in 2024.
MEIP’s Upcoming Presentations
On March 8, the company announced its presentations in the upcoming American Association for Cancer Research Annual Meeting 2022. MEIP will be presenting two abstracts that highlight data from two oncology drug candidates in its pipeline during the conference. The conference will take place on April 8-13, 2022.
MEIP’s Q2 Fiscal 2022
For Q2 fiscal 2022 ended December 31, 2021, the company reported revenues of $18.2 million with a net loss of $5.8 million or $0.05 per share.
Moreover, MEIP ended the quarter with cash, cash equivalents, and short-term investments of $185.8 million.
