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 announced a priced public offering of 17,500,000 shares of its common stock at $2.60 per share, aiming for total gross proceeds of $45,500,000. The offering, set to close on December 6, 2021, includes a 30-day option for underwriters to purchase an additional 2,625,000 shares. Proceeds will support clinical development programs, the launch of zandelisib pending FDA approval, and other corporate purposes. Jefferies, Stifel, and Wells Fargo Securities are the joint book-running managers for the offering.
MEI Pharma, Inc. (Nasdaq: MEIP) has announced a public offering of 17,500,000 shares of its common stock. The underwriters have a 30-day option to purchase an additional 15% of the shares. Proceeds will support clinical development programs and the potential commercial launch of zandelisib, pending FDA approval. The offering is subject to market conditions, and the actual size and terms may vary. Jefferies, Stifel, and Wells Fargo Securities are managing the offering.
MEI Pharma announced promising results from the pivotal Phase 2 TIDAL study of zandelisib in patients with relapsed/refractory follicular lymphoma. The study showed a 70.3% objective response rate and a 35.2% complete response rate among 91 patients. The drug was generally well tolerated, with a 9.9% discontinuation rate due to drug-related adverse events. The study is part of ongoing efforts to seek FDA approval for zandelisib, which has already received Fast Track and Orphan Drug designations.
MEI Pharma, Inc. (NASDAQ: MEIP) announced a live investor and analyst webcast scheduled for November 30, 2021. The event will discuss data from the ongoing Phase 2 TIDAL study of zandelisib, a potential treatment for relapsed or refractory follicular lymphoma. The webcast will also cover updates on the zandelisib program. Investors can access the live audio webcast through MEI's website, with a replay available for 30 days post-event. MEI Pharma focuses on developing innovative cancer therapies and has multiple clinical-stage assets.
MEI Pharma (Nasdaq: MEIP) announced the appointment of Sujay Kango to its board of directors, effective November 22, 2021. Kango brings over 25 years of experience in the pharmaceutical industry, notably in commercial operations and product launches. His expertise is expected to aid MEI as it transitions to a commercial-stage company. Additionally, Kevan Clemens, Ph.D., has resigned from the board after several years of service. MEI Pharma focuses on developing innovative cancer therapies and currently has clinical trials underway for its product candidates.
MEI Pharma (NASDAQ: MEIP) reported its Q1 FY2022 financial results, highlighting a cash position of $145.5 million. The company is on track to report data from the TIDAL study by year-end 2021, which evaluates zandelisib for follicular lymphoma. Key developments include the initiation of the Phase 3 COASTAL study and a $20 million milestone payment from Kyowa Kirin. Revenue for the quarter was $13.4 million, up from $3.8 million in Q1 2021, while net loss increased to $11.9 million, or $0.11 per share. MEI plans further pipeline advancements and is positioned to support a New Drug Application.
MEI Pharma has received orphan-drug designation from the FDA for zandelisib, a treatment for follicular lymphoma. This designation provides various incentives, including tax credits and potential seven years of marketing exclusivity upon approval. Zandelisib, a selective PI3Kδ inhibitor, is currently undergoing Phase 2 and Phase 3 trials to assess its efficacy against follicular and marginal zone lymphomas. MEI and Kyowa Kirin are collaborating on its development, with MEI retaining all U.S. sales revenue.
MEI Pharma, Inc. (NASDAQ: MEIP) announced the presentation of three abstracts at the 63rd Annual American Society of Hematology Meeting from December 11 to 14, 2021. The studies include: 1) a Phase 3 trial of zandelisib with rituximab versus standard immunochemotherapy for indolent non-Hodgkin’s lymphoma; 2) ME-344's enhancement of venetoclax activity against acute myeloid leukemia (AML); and 3) a Phase 1 study of voruciclib in B-cell malignancies. The latter showed promising results with no significant toxicities and disease stabilization in heavily treated patients.
MEI Pharma, Inc. (NASDAQ: MEIP) has granted stock options for 133,000 shares to two new employees as an inducement for their acceptance of employment. The options have an exercise price of $2.82 per share, matching the closing price on the grant date. These grants are part of the 2021 Inducement Grant Equity Compensation Plan and were approved by the Compensation Committee. The options will vest 25% after one year, with subsequent monthly vesting over three years. MEI Pharma focuses on developing new cancer therapies and currently has four clinical-stage assets.
MEI Pharma, Inc. (NASDAQ: MEIP) announced the grant of inducement stock options totaling 136,000 shares to three new employees. These options, set at an exercise price of $2.76 reflect the stock's closing price on the grant date. The options have a 10-year term, vesting 25% on the one-year anniversary and 2.0833% monthly thereafter, with potential early vesting in case of a change of control. This grant is part of the company's 2021 Inducement Grant Equity Compensation Plan and aligns with Nasdaq regulations.
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