Welcome to our dedicated page for MEI Pharma news (Ticker: MEIP), a resource for investors and traders seeking the latest updates and insights on MEI Pharma stock.
MEI Pharma, Inc. (NASDAQ: MEIP), based in San Diego, is an oncology-focused biotechnology company dedicated to the clinical development of innovative cancer therapies. The company's mission is to improve the quality of life and outcomes for cancer patients through the development of novel treatments.
Core Business and Drug Candidates:
- Pracinostat: MEI Pharma's lead drug candidate, Pracinostat, is an oral histone deacetylase (HDAC) inhibitor. It has received breakthrough therapy designation from the FDA when used in combination with azacitidine for treating patients with newly diagnosed acute myeloid leukemia (AML) who are aged 75 or above, or those unfit for intensive chemotherapy.
- ME-401 (formerly PWT143): A next-generation oral phosphatidylinositide 3-kinase delta (PI3K delta) inhibitor being developed for patients with recurrent chronic lymphocytic leukemia (CLL) or follicular non-Hodgkin's lymphoma (NHL).
- ME-344: This isoflavone-based mitochondrial inhibitor is being explored for the treatment of HER2-negative breast cancer, demonstrating MEI Pharma's commitment to addressing unmet needs in oncology.
Recent Achievements and Partnerships: MEI Pharma has made significant strides in its clinical programs. The breakthrough therapy designation for Pracinostat underscores its potential impact in the treatment landscape of AML. In addition, strategic collaborations with leading research institutions and oncology experts bolster the company's development capabilities and market positioning.
Financial Condition: MEI Pharma continues to focus on advancing its clinical pipeline while maintaining a prudent financial strategy. The company’s investment in cutting-edge research and clinical trials is supported by strategic funding initiatives, ensuring sustained progress in its mission to combat cancer.
Current Projects: The clinical development of Pracinostat, ME-401, and ME-344 remains at the forefront of MEI Pharma’s efforts. Ongoing clinical trials and research are expected to provide valuable data, guiding future regulatory submissions and potential market approvals.
With a robust pipeline and a clear focus on innovative cancer therapies, MEI Pharma, Inc. stands as a significant player in the oncology sector. For more information, please visit www.meipharma.com.
MEI Pharma, Inc. (NASDAQ: MEIP) has appointed Anne Frese as chief people officer, effective immediately. Frese brings over 30 years of human resources experience from various industries, her most recent position being chief human resources officer at Vyripharm Enterprises. CEO Daniel P. Gold expressed confidence in Frese's ability to enhance team development and align with MEI's mission to improve patient lives. This strategic move aims to strengthen MEI’s organizational culture as it advances its cancer therapies, including zandelisib, currently undergoing clinical trials.
MEI Pharma announced promising data from the zandelisib clinical development program presented at the 2022 European Hematology Association Hybrid Congress. The Phase 2 TIDAL study reported a 70.3% objective response rate and a 35.2% complete response rate in patients with relapsed or refractory follicular lymphoma. Notably, 87.5% of responses occurred within the first two therapy cycles. Adverse events led to a 9.9% discontinuation rate, primarily consisting of Grade 3 AEs. The study aims to continue assessing zandelisib's safety and efficacy as enrollment progresses in additional cohorts.
MEI Pharma and Kyowa Kirin presented data from the ongoing Phase 2 TIDAL study on zandelisib at the ASCO 2022 Annual Meeting. The study showed a 70.3% objective response rate and a 35.2% complete response rate among patients with relapsed or refractory follicular lymphoma. Notably, 87.5% of responses occurred within the first two cycles of therapy. Safety data indicated that 9.9% of patients discontinued for drug-related adverse events, with 83% reporting Grade 3 adverse events primarily in initial treatment cycles. The results support the continued development of zandelisib, particularly in the Phase 3 COASTAL study.
MEI Pharma (NASDAQ: MEIP) has granted stock options for 40,000 shares to a new employee as an inducement for employment. The exercise price is $0.48 per share, equal to the closing stock price on the grant date. Approved by the Compensation Committee, the options will vest over a period of four years, with 25% vesting on the first anniversary and the remaining vesting monthly. This action aligns with the company’s 2021 Inducement Grant Equity Compensation Plan.
MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. announced the presentation of Phase 2 TIDAL study data on zandelisib at the ASCO 2022 Annual Meeting, scheduled for June 3-7, 2022. The study evaluates the efficacy and safety of zandelisib, a PI3Kδ inhibitor for treating B-cell malignancies. The abstract ID is 7511, with a poster discussion led by Dr. Andrew David Zelenetz on June 4. MEI Pharma focuses on developing innovative cancer therapies, aiming for FDA approvals for its clinical-stage assets.
MEI Pharma, Inc. (Nasdaq: MEIP) reported third-quarter results for FY 2022, highlighting $169 million in cash. Following an FDA meeting, the company will not pursue an accelerated FDA application for zandelisib based on single-arm TIDAL data but will continue with the randomized COASTAL study. The net loss for Q3 was $8.7 million, or $0.07 per share, a notable improvement from a $25.6 million loss in the previous year. R&D expenses increased to $22.3 million, driven by zandelisib studies. Revenue rose to $9.7 million, attributed to the Kyowa Kirin partnership.
MEI Pharma will participate in the H.C. Wainwright Global Investment Conference 2022, presenting a company overview and business update starting May 24, 2022, at 7:00 a.m. Eastern Time. The presentation will be available for on-demand listening for 90 days. MEI Pharma focuses on developing innovative therapies for cancer, with its clinical-stage assets including zandelisib, which is under FDA review. Interested parties can access the presentation on MEI Pharma's website.
MEI Pharma (NASDAQ: MEIP) and Kyowa Kirin (Tokyo: 4151) announced that two abstracts regarding zandelisib, a PI3Kδ inhibitor for B-cell malignancies, will be presented at the European Hematology Association (EHA) 2022 Hybrid Congress from June 9-17, 2022. Oral presentation on June 11 will focus on the efficacy and safety of zandelisib in relapsed or refractory follicular lymphoma, while a poster on June 10 will discuss results from a multi-arm Phase 1b study. These presentations may support future FDA marketing approvals.
MEI Pharma, Inc. (NASDAQ: MEIP) has granted inducement stock options totaling 100,000 shares to two new employees as a condition of employment. The options, priced at $0.49 per share, align with the company's stock's closing price on the grant date. These options have a 10-year term and will vest at specified intervals, including an initial 25% vesting after one year. The grant complies with Nasdaq Listing Rule 5635(c)(4), which necessitates immediate disclosure of such inducements.
MEI Pharma, Inc. (NASDAQ: MEIP) announced preclinical data presentations at the AACR Annual Meeting 2022 for zandelisib, a PI3K inhibitor, and ME-344, a mitochondrial inhibitor. Zandelisib demonstrated immunomodulatory effects in CLL models, improving overall survival. ME-344 enhanced venetoclax activity against AML, targeting metabolic vulnerabilities. Continuing clinical trials include the Phase 2 TIDAL study for zandelisib and a Phase 2 study for ME-344 with Avastin. These developments aim to progress MEI's pipeline and offer new cancer treatment options.
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