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Rafael Holdings (RFL) is a diversified holding company focused on clinical stage therapeutics, infusion technology, and strategic real estate. This page serves as your centralized source for official news, press releases, and updates across all business segments.
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Rafael Holdings, Inc. (NYSE: RFL) announced disappointing results from two Phase 3 clinical trials of its lead candidate, devimistat (CPI-613®). The AVENGER 500 trial for metastatic pancreatic cancer failed to meet its primary endpoint of improved overall survival (11.1 months vs. 11.7 months). In another trial, ARMADA 2000 for relapsed or refractory acute myeloid leukemia (AML), an independent committee recommended stopping the trial due to lack of efficacy. The company plans to collaborate with Rafael Pharmaceuticals to assess the data further.
Rafael Holdings, Inc. (NYSE: RFL) announced a stock option grant to Dr. Mary Margaret Huizinga for 122,341 shares of Class B common stock, with an exercise price of $30.54, the closing price on October 15, 2021. The options will vest over four years, beginning October 18, 2022. This grant follows Dr. Huizinga's appointment as Chief Development and Medical Officer, intended as an inducement under NYSE Rule 303A.08. Rafael Holdings focuses on developing cancer therapies and has a significant stake in clinical-stage oncology companies.
Rafael Holdings, Inc. (NYSE: RFL) announced plans to report top line data from its AVENGER 500 Phase 3 trial for metastatic pancreatic cancer and submit a merger proposal with Rafael Pharmaceuticals for stockholder voting within the year. The company closed a PIPE financing, securing $97.8 million in August 2021, and appointed new senior pharmaceutical executives to strengthen operations. Financial results show a net loss of $24.8 million for fiscal 2021, reflecting increased R&D and operational expenses as it develops novel oncology therapies through the Barer Institute.
Rafael Holdings, Inc. (NYSE: RFL) announced the appointment of Mary Margaret (Mimi) Huizinga, MD, MPH as Chief Development and Medical Officer, effective October 18, 2021. This strategic move reflects the importance of the company’s late-stage clinical programs in developing cancer metabolism therapies. Huizinga brings extensive experience from her role at Novartis and a proven track record in oncology development. Her leadership is expected to enhance clinical efforts, particularly as the company approaches a critical phase with the Phase 3 trial data readout for CPI-613® in metastatic pancreatic cancer.
Rafael Pharmaceuticals announces the start of its Phase 1 clinical trial involving CPI-613® (devimistat) combined with hydroxychloroquine for patients with clear cell sarcoma, a rare and aggressive cancer. Enrollment will begin at City of Hope, California, with additional sites to follow. The trial aims to address significant unmet medical needs in this challenging sarcoma type. CPI-613® targets mitochondrial functions in cancer cells, potentially improving treatment efficacy with reduced side effects. The FDA has also designated devimistat as an orphan drug for several cancers, signaling strong research support.
Rafael Holdings, Inc. (NYSE: RFL), a pharmaceutical holding company, has appointed Ashok Marin as Chief Legal Officer. The appointment comes as the company anticipates top-line data from Phase 3 trials for CPI-613, a key drug for metastatic pancreatic cancer. Marin, with over 20 years of experience, previously held senior legal roles at Immunomedics, contributing to its $21 billion acquisition by Gilead. Rafael granted Marin options to purchase 34,066 shares at $37.61, vesting over four years, as part of his employment inducement.
On September 17, 2021, Rafael Holdings, Inc. (NYSE: RFL) announced an inducement grant to Patrick Fabbio to purchase 105,602 shares of Class B common stock at an exercise price of $36.32. The options will vest 25% on the first anniversary and monthly thereafter until fully vested by September 17, 2025. This grant is part of Rafael's 2018 Equity Incentive Plan and was approved by the Compensation Committee, aimed at facilitating Fabbio's hiring as Chief Financial Officer on September 13, 2021. This strategic move underscores Rafael's commitment to strengthening its leadership team amid a focus on cancer therapeutics.
On September 14, 2021, Rafael Holdings, Inc. (NYSE: RFL) announced the appointment of Patrick Fabbio as Chief Financial Officer. With over 25 years of extensive experience in financial and operational roles within the life sciences sector, Fabbio aims to enhance the company’s financial strategy as it approaches pivotal clinical trial data for CPI-613®, targeting metastatic pancreatic cancer. CEO Ameet Mallik expressed confidence in Fabbio’s ability to drive growth in oncology therapeutics. Rafael Holdings continues to invest in its pipeline and aims for commercialization of its cancer metabolism therapies.
On August 26, 2021, Rafael Pharmaceuticals announced that CEO Sanjeev Luther will present at the World Orphan Drug Congress. His presentation, titled 'Leveraging Relationships in Ultra-rare Cancers,' will focus on the development of CPI-613® (devimistat) for ultra-rare cancers. Devimistat targets cancer cell metabolism, enhancing the effectiveness of chemotherapy while reducing side effects. The FDA has approved pivotal Phase 3 trials for devimistat in pancreatic cancer and acute myeloid leukemia and granted it orphan drug status for several cancers. More details will be available on Rafael’s website post-congress.
Rafael Pharmaceuticals has successfully completed a Phase 1b clinical trial of CPI-613® (devimistat) combined with gemcitabine and cisplatin for biliary tract cancer. This multicenter study, in collaboration with Michigan Medicine, showed promising results and identified the recommended Phase 2 dose. Phase 2 trials are currently enrolling patients to evaluate the efficacy of devimistat at maximum tolerated doses. Devimistat targets energy metabolism in cancer cells, aiming to improve treatment outcomes for patients with significant unmet medical needs.