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. (RFL) news coverage centers on its activities as a biotechnology company developing pharmaceuticals and managing a portfolio of clinical and early-stage life science and technology businesses. Company press releases highlight progress in its lead program, Trappsol® Cyclo™, an investigational therapy for Niemann-Pick Disease Type C1 (NPC1), as well as updates from its wholly owned subsidiary Cyclo Therapeutics, LLC.
Investors following RFL news can expect regular updates on the pivotal Phase 3 TransportNPC™ clinical trial and related sub-studies of Trappsol® Cyclo™, including interim analyses, Data Monitoring Committee recommendations and presentations of clinical data at scientific meetings. News items also describe regulatory interactions, such as acceptance of statistical analysis plans, and design details of the NPC1 and Alzheimer’s disease trials conducted by Cyclo Therapeutics.
Rafael Holdings’ releases further cover financial results for its fiscal quarters and year, including net loss figures, research and development spending, and the impact of consolidating subsidiaries such as Cyclo Therapeutics, Cornerstone and Day Three Labs. Capital markets activity is another recurring theme, with announcements about a $25 million rights offering of Class B common stock, the associated standby purchase agreement and the issuance and exchange of warrants in connection with the merger with Cyclo Therapeutics, Inc.
Governance and corporate developments also appear in the RFL news flow. Examples include board and management changes, such as the election of new directors, committee appointments, the passing of a lead independent director, and executive transitions including the appointment of a Chief Operating Officer. For readers tracking RFL, this news page provides a consolidated view of clinical, financial, governance and capital structure developments disclosed by Rafael Holdings.
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.
Rafael Pharmaceuticals has announced the initiation of a Phase 2 clinical trial for CPI-613® (devimistat) combined with hydroxychloroquine, targeting clear cell sarcoma. This collaboration involves Sara’s Cure and SARC, focusing on a rare cancer that predominantly affects young adults. The trial, part of Rafael's mission to develop treatments for hard-to-treat cancers, will take place at several U.S. sites, including Cleveland Clinic and University of Michigan. CPI-613® aims to enhance chemotherapy effectiveness while reducing side effects, having already received FDA orphan drug designation for multiple cancers.
Rafael Pharmaceuticals has announced the initiation of a Phase 2 clinical trial for CPI-613® (devimistat) in combination with hydroxychloroquine to treat clear cell sarcoma. This rare cancer primarily affects young adults and has limited treatment options. Collaborating with Sara's Cure and SARC, the trial will enroll patients at several U.S. sites, including Cleveland Clinic and Indiana University. Devimistat targets cancer cell metabolism, enhancing the efficacy of chemotherapy while reducing side effects. The trial aims to provide hope for patients with this challenging disease.
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