Welcome to our dedicated page for Rafael Holdings news (Ticker: RFL), a resource for investors and traders seeking the latest updates and insights on Rafael Holdings stock.
Rafael Holdings, Inc. reports developments as a biotechnology company focused on pharmaceutical development and interests in clinical-stage and early-stage pharmaceutical and medical device companies. Its lead program is Trappsol® Cyclo™, a hydroxypropyl-beta-cyclodextrin product candidate evaluated for Niemann-Pick Disease Type C1, with additional cyclodextrin-related work in neurodegenerative disease.
Recurring company news covers clinical development of Cyclo Therapeutics programs, scientific presentations, patent and licensing activity, quarterly and annual financial results, and governance changes. Updates also address the company’s consolidated expenses following the Cyclo Therapeutics acquisition and its portfolio interests in healthcare and medical-device development.
Rafael Pharmaceuticals has announced the enrollment of over 150 patients in its Phase 3 clinical trial (ARMADA 2000) for relapsed or refractory acute myeloid leukemia (AML). This multicenter trial evaluates the efficacy of CPI-613® (devimistat) in combination with specific chemotherapy drugs. The company recently achieved FDA fast-track designation for this treatment, highlighting its potential in addressing the urgent need for effective AML therapies. Experts emphasize the significance of this milestone in improving outcomes for patients suffering from this challenging cancer.
Rafael Holdings, Inc. (NYSE: RFL) reported Q2 FY 2021 revenue of $1.0 million, down from $1.2 million year-over-year, primarily due to the sale of a building. Loss per share increased to $0.50, influenced by a $7.0 million impairment related to Altira. Ameet Mallik will assume the CEO role on May 1, 2021. The firm holds 51% of Rafael Pharmaceuticals, which has received FDA Fast Track designation for its lead compound, CPI-613® (devimistat), aimed at treating various cancers. The company continues its focus on oncology through strategic investments and partnerships.
Rafael Holdings, Inc. (NYSE: RFL) has appointed Ameet Mallik as its new Chief Executive Officer, effective May 1, 2021, succeeding founder Howard Jonas who remains Chairman. Bill Conkling joins as Chief Commercial Officer on March 15, 2021. Mallik, previously from Novartis, brings extensive experience in oncology, crucial as Rafael conducts multiple clinical studies. The leadership expansion aims to enhance the company's ability to develop innovative cancer therapies across its subsidiaries, including Rafael Pharmaceuticals and LipoMedix.
LipoMedix announced that its lead compound, Promitil®, will be manufactured in the U.S. by ForDoz Pharma. Promitil® utilizes a pegylated liposomal delivery system for targeted cancer treatment, encapsulating a new chemical entity, Mitomycin-c lipidic prodrug (MLP), which has shown efficacy against various cancer types in studies. LipoMedix aims for Phase II clinical studies with the drug, expecting improved treatment options for patients. The partnership with ForDoz is intended to overcome manufacturing challenges in nanotechnology.
Rafael Pharmaceuticals will present at the B. Riley Securities Virtual Oncology Investor Conference on January 20, 2021, outlining its progress in cancer metabolism therapeutics. CEO Sanjeev Luther and Co-CMO Tim Pardee will discuss clinical trial launches and FDA Fast Track designations. Specific achievements include FDA approval for pivotal Phase 3 trials in pancreatic cancer and acute myeloid leukemia using their lead compound CPI-613® (devimistat), which enhances cancer cell sensitivity to treatments.
Rafael Pharmaceuticals announced that CEO Sanjeev Luther will present at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021. The presentation will cover significant milestones from 2020, including two FDA Fast Track designations for CPI-613 (devimistat), targeting metastatic pancreatic cancer and acute myeloid leukemia. Luther aims to highlight achievements and discuss future directions for tackling hard-to-treat cancers. The event will be accessible via webcast, with replays available on their website.
Rafael Holdings, Inc. (NYSE: RFL) announced a licensing agreement with Princeton University for exclusive rights to the SHMT inhibitor program, a part of their cancer drug development initiative through the Barer Institute. The SHMT inhibitors target metabolic pathways critical in various cancers, positioning the company for potential commercial drug development. Professor Joshua Rabinowitz expressed enthusiasm for collaborating with the Barer Institute in turning research findings into effective therapies, underscoring the importance of SHMT inhibitors in advancing cancer treatment.
Rafael Holdings (NYSE: RFL) reported Q1 FY 2021 revenue of $1.1 million, down from $1.2 million year-over-year. The company recorded a loss per share of $0.09, improving from $0.10 in Q1 FY 2020. The decline in revenue was partially offset by gains from commercial real estate sales. The company acquired a 33.33% interest in Altira, enhancing its royalty rights. Notably, CPI-613® received Fast Track designation from the FDA for treating metastatic pancreatic cancer and acute myeloid leukemia. Total cash and cash equivalents stood at $7.2 million as of October 31, 2020.
Rafael Pharmaceuticals announced that the FDA granted Fast Track designation for its lead compound, CPI-613® (devimistat), for treating acute myeloid leukemia (AML). This designation aims to expedite development and review processes due to the urgent need for new AML therapies. Rafael's President, Sanjeev Luther, emphasized the significance of this achievement amid COVID-19 challenges. The company had previously received Fast Track designation for devimistat in treating metastatic pancreatic cancer and achieved other regulatory milestones throughout the year.
Rafael Pharmaceuticals announced that the FDA has granted Fast Track designation to its lead compound, CPI-613® (devimistat), for treating acute myeloid leukemia (AML). This designation reflects the urgent need for new treatments for this aggressive disease. The company previously received Fast Track designation for devimistat in treating metastatic pancreatic cancer and has achieved several milestones, including Orphan Drug Designation for soft tissue sarcoma. The compound targets cancer cell metabolism, aiming to improve the effectiveness of chemotherapy while reducing side effects.