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) announced that its abstract on Voruciclib, a CDK9 inhibitor, was selected for an E-Poster Session at the AACR Annual Meeting 2021, set for April 10, 2021. Voruciclib targets KRAS mutant cancers by downregulating MYC, which is crucial for cancer cell proliferation. Preclinical studies demonstrated reduced cell viability and significant tumor growth inhibition. MEI is also conducting additional studies to evaluate Voruciclib's synergistic effects with other KRAS inhibitors. This positions Voruciclib as a potential therapeutic option for challenging KRAS-driven cancers.
MEI Pharma (NASDAQ: MEIP) has confirmed its participation in the virtual H.C. Wainwright Global Life Sciences Conference 2021. The event will feature a company overview and business update, available for on-demand listening starting March 9, 2021, at 7:00 a.m. Eastern Time. This presentation will be archived for 90 days on MEI Pharma's website. The company is focused on developing new cancer therapies, including zandelisib, which is currently in a Phase 2 clinical trial potentially supporting FDA approval.
MEI Pharma (NASDAQ: MEIP) reported its financial results for the quarter ending December 31, 2020, showing significant developments in its zandelisib program. Cash and equivalents stood at $180.1 million, aided by $20.9 million from a tax refund. Revenue increased to $9.2 million from $1.0 million year-over-year, mainly due to a licensing agreement with Kyowa Kirin. Research and development expenses rose to $22.2 million, with a net loss of $11.5 million, improving from $20.2 million the previous year. The company anticipates important milestones for zandelisib in 2021.
MEI Pharma, Inc. (NASDAQ: MEIP) announced the completion of the safety evaluation phase in its Phase 1b trial for zandelisib, a selective PI3K delta inhibitor, in combination with zanubrutinib for B-cell malignancies. The Safety Review Committee recommended expanding into disease-specific cohorts, confirming the treatment was well tolerated. MEI also updated its 2021 pipeline milestones, including anticipated enrollment completion in the Phase 2 TIDAL study and initiation of further studies for zandelisib, voruciclib, and ME-344. The company has sufficient cash runway through 2023.
MEI Pharma, Inc. (NASDAQ: MEIP) reported its Q1 FY2021 results, highlighting a cash position of $176.1 million with no debt and a net loss of $2.1 million, or $0.02 per share. Revenues increased to $3.8 million from $1.2 million YoY, mainly due to a license agreement with Kyowa Kirin. R&D expenses rose to $13.0 million, driven by zandelisib development. The TIDAL study for follicular lymphoma is on track for enrollment completion by Q1 2021, with additional studies planned for expansion. The company remains committed to advancing its clinical pipeline amid the ongoing pandemic.
MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on cancer therapies, announced its participation in two upcoming virtual investor conferences. The conferences include the Stifel 2020 Virtual Healthcare Conference on November 16, 2020, at 4:40 p.m. ET and the Evercore ISI HealthCONx Conference on December 3, 2020, at 11:45 p.m. ET. Webcasts for both presentations will be available on their website. MEI's portfolio features zandelisib, currently in a Phase 2 trial, which may support FDA accelerated approval.
MEI Pharma announced that the first patient has been dosed in the pivotal Phase 2 study of zandelisib for treating indolent B-cell non-Hodgkin's lymphoma (iNHL) in Japan. This multicenter, open-label study will assess zandelisib as a monotherapy for patients who have undergone at least two prior systemic therapies. The primary endpoint is the objective response rate with a sample size of 60 patients, aiming for completion by September 2024. This marks a significant step in the global development program for zandelisib, following a global licensing agreement with Kyowa Kirin.
Kyowa Kirin and MEI Pharma announced that the first patient has been dosed in a pivotal Phase 2 study of zandelisib in Japan. This multicenter, open-label trial aims to evaluate zandelisib as a monotherapy for patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma (iNHL). In partnership, both companies seek to expand zandelisib's global development, with Kyowa Kirin holding exclusive rights outside the U.S. The study will include 60 patients, primarily measuring the objective response rate, and is expected to conclude by September 2024.
MEI Pharma, Inc. (NASDAQ: MEIP) has appointed Brian T. Powl as Senior Vice President of Marketing, effective immediately. Mr. Powl, previously with Celgene Corporation, brings extensive experience in commercial strategy for cancer therapies. His role will be pivotal as MEI prepares for the potential launch of zandelisib, a drug currently in Phase 2 trials that could receive FDA accelerated approval. COO David Urso emphasized the importance of Powl's leadership in enhancing MEI's commercialization capabilities and achieving long-term growth objectives.
MEI Pharma, Inc. (NASDAQ: MEIP) reported its fiscal year 2020 results, highlighting progress in its cancer treatment zandelisib. The company entered a global collaboration with Kyowa Kirin, receiving a $100 million upfront payment and potential milestones of $582.5 million. Zandelisib showed an 83% response rate in a Phase 1b study for B-cell malignancies. Financially, MEI ended the year with $182.6 million in cash, but reported a net loss of $46 million, or $0.51 per share. As of June 30, 2020, shares outstanding rose to 111,513,689 from 73,544,576 year-over-year.
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