MEI Pharma, Inc. - MEIP STOCK NEWS

MEI Pharma and Kyowa Kirin have initiated the second arm of the global Phase 2 TIDAL study, dosing the first patient with relapsed or refractory marginal zone lymphoma. This arm evaluates zandelisib, a PI3K delta inhibitor, alongside a previous arm focusing on follicular lymphoma. Both arms aim for separate FDA accelerated approval applications. The study will assess objective response rates and tolerability of zandelisib. This collaboration between the companies highlights their commitment to advancing therapeutic options for patients with B-cell malignancies.

MEI Pharma, Inc. (NASDAQ: MEIP) will host a video webcast for investors and analysts on June 10, 2021, at 12:00 PM ET, following the 2021 ASCO Annual Meeting. The event will cover updates on the zandelisib program, including data presented at ASCO, with insights from Dr. Deepa Jagadeesh of the Cleveland Clinic. The webcast can be accessed on MEI's investor relations website, and a replay will be available for 30 days. MEI focuses on developing innovative cancer therapies and has four clinical-stage assets, including zandelisib, which is in a Phase 2 trial.

On May 19, 2021, MEI Pharma announced promising data for zandelisib, a PI3Kδ inhibitor, aimed at treating B-cell malignancies. Key findings include an 87% overall response rate in relapsed or refractory follicular lymphoma patients, with 93% in non-POD24 patients. The Phase 3 COASTAL study, comparing zandelisib plus rituximab to standard chemotherapy in indolent non-Hodgkin's lymphoma, is set to enroll 534 patients. Topline results from the ongoing Phase 2 TIDAL study are expected later this year, reinforcing the commitment to zandelisib's development as a potential best-in-class therapy.

MEI Pharma and Kyowa Kirin have announced updated clinical data from a Phase 1b study of zandelisib, a selective PI3Kδ inhibitor, in combination with zanubrutinib, for patients with relapsed or refractory B-cell malignancies. This data will be presented at the European Hematology Association (EHA) 2021 Virtual Congress from June 9-17, 2021. The study aims to assess the drug combination's tolerability and efficacy, potentially leading to improved therapeutic options for patients. The abstract is accessible on the EHA website.

MEI Pharma, Inc. (NASDAQ: MEIP) reported Q3 results for the period ended March 31, 2021, revealing a net loss of $31.3 million, or $0.28 per share, compared to a loss of $4.3 million, or $0.04 per share the previous year. Revenue increased to $2.4 million from $1.2 million, largely due to a license agreement with Kyowa Kirin. Key advancements include the completion of enrollment in the TIDAL study for zandelisib and promising preclinical data for voruciclib. The company has $164.6 million in cash with no debt and aims to submit data to the FDA for accelerated approval by year-end.

MEI Pharma, Inc. (NASDAQ: MEIP) announced the retirement of its chief medical officer, Robert Mass, effective May 3, 2021. Dr. Mass, who joined MEI in 2010, will serve as a strategic advisor post-retirement. Richard Ghalie, previously senior vice president of clinical development, has been promoted to chief medical officer. Under Ghalie's leadership, MEI's zandelisib program has progressed significantly, with plans for a new drug application to the FDA under the accelerated approval pathway.

MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. have completed enrollment in the follicular lymphoma primary efficacy population for the global Phase 2 TIDAL study. This study evaluates zandelisib, a potential cancer treatment. The primary efficacy population includes 91 patients with follicular lymphoma and 64 with marginal zone lymphoma. Topline data is expected in Q4 2021, with plans to submit for FDA accelerated approval. Zandelisib holds Fast Track designation for adult patients with relapsed follicular lymphoma who have undergone at least two prior systemic therapies.

MEI Pharma, Inc. (NASDAQ: MEIP) announced promising preclinical data for voruciclib, a CDK9 inhibitor, showing its effectiveness against KRAS mutant cancers. The findings, presented at the AACR Annual Meeting 2021, reveal voruciclib's ability to inhibit MYC and synergistically enhance the efficacy of KRAS inhibitors. Currently in a Phase 1b trial for B-cell malignancies and AML, the data supports the potential for voruciclib as a new treatment option. The company plans to further explore synergistic combinations and will host a webcast on April 13, 2021, to discuss the findings and company updates.

MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company, announced its participation in the 20th Annual Needham Virtual Healthcare Conference. The company will present a comprehensive overview and business update on April 12, 2021, at 12:45 p.m. Eastern Time. A live webcast can be accessed via MEI Pharma's website, with an archived replay available for 30 days post-event. MEI is focused on developing innovative cancer therapies, including zandelisib, currently in Phase 2 trials, aiming for FDA accelerated approval.