Cornerstone Pharmaceuticals announces orphan drug designation for CPI-613 » 11:1105/2405/24/22
Cornerstone Pharmaceuticals announced that the European Medicines Agency has granted orphan drug designation to CPI-613 for the treatment of advanced unresectable biliary tract cancer. Also known as cholangiocarcinoma, biliary tract cancer is an extremely rare and hard to treat cancer, affecting just over 2,000 people in the UK annually with incidents steadily increasing every year.
|Over a week ago|
Rafael Pharmaceuticals announces name change to Cornerstone Pharmaceuticals » 09:1105/1905/19/22
Rafael Pharmaceuticals announced that it is changing its name to Cornerstone Pharmaceuticals, its original company name. All company branding, including the website and logo have been updated accordingly. The company's clinical trials in Burkitt's lymphoma, biliary tract cancer and clear cell sarcoma are continuing to meet enrollment and data milestones. To date, the U.S. Food and Drug Administration has designated devimistat as an orphan drug for the treatment of Burkitt's lymphoma, biliary tract cancer and soft tissue sarcoma. The European Medicines Agency has granted orphan drug designation to devimistat for Burkitt's lymphoma. New trials in the pipeline for hematologic and solid tumors will launch in Q2 and Q3 2022.
|Over a quarter ago|
Rafael Holdings files to sell 2.83M shares of Class B common stock for holders 17:0102/1502/15/22
Rafael Holdings terminates merger agreement with Rafael Pharmaceuticals » 07:4202/0302/03/22
In a regulatory filing…
In a regulatory filing last night, Rafael Holdings disclosed that on February 2, the company delivered a letter to Rafael Pharmaceuticals pursuant to which the company terminated their previously announced merger agreement, effective immediately. "As previously disclosed on a current report filed on June 17, 2021, Rafael Holdings entered into an agreement and plan of merger, by and among the company, certain subsidiaries of the company and Rafael Pharmaceuticals, Inc. The merger agreement provided for Pharma to become a wholly-owned subsidiary of the company and for holders of capital stock of Pharma other than the company and its controlled affiliates to receive shares of company Class B common stock in exchange for their interests in Pharma... As of October 31, 2021, based on information available to the company, the company and its subsidiaries held capital stock of Pharma representing 51% of the outstanding capital stock of Pharma and 41% on a fully diluted basis, excluding the remainder of a warrant held by the company to acquire shares of Pharma and other interests held by the company that may be convertible into equity securities of Pharma. The company may seek to enter into discussions with Pharma regarding the relationship between the companies in light of the termination of the merger agreement," the filing stated.
Rafael announces William Conkling to assume role of CEO » 07:0301/2101/21/22
Rafael Holdings (RFL)…
Rafael Holdings (RFL) announced several changes to its leadership team. William Conkling will remain with the company and assume the responsibilities of Chief Executive Officer from Ameet Mallik as of February 1, 2022. Conkling has over 20 years of experience specializing and currently serves as Rafael's Chief Commercial and Business Officer. Dr. Rick Ewing has recently taken on the role of Head of Drug Discovery and will be responsible for expanding the research and development team and advancing our early-stage pipeline. Prior to joining Rafael Holdings, Dr. Ewing spent 21 years at Bristol Myers Squibb (BMY). Mimi Huizinga, Chief Medical Officer, will be leaving the company as of January 31, 2022, to pursue other opportunities. Ameet Mallik will remain a member of the company's Board of Directors and Chair the recently established Transition Committee.
Rafael announces enrollment, additional sites for Phase 2 trial of CPI-613 » 08:4501/1801/18/22
Rafael Pharmaceuticals announced the ongoing successful enrollment rate of its Phase 2 clinical trial for CPI-613 in combination with gemcitabine and cisplatin in patients with biliary tract cancer. The multicenter trial is for patients with locally advanced unresectable or metastatic biliary tract cancer who have had no prior treatment. "We are pleased that our Phase 2 trial has continued to see a positive enrollment rate, demonstrating devimistat's ability to serve as a catalyst for hope and potential relief to families affected by this harrowing condition," said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. "We are happy to report a continuation of safety within the trial, as the wellbeing of our patients is our top priority."
Rafael announces completion of dose escalation with no DLT in trial of CPI-613 » 08:3401/0601/06/22
Rafael Pharmaceuticals announced the completion of the first cohort of dose escalation with no dose-limiting toxicity, DLT, in the APOLLO 613 Phase 1/2 clinical trial of CPI-613 in combination with hydroxychloroquine in patients with relapsed clear cell sarcoma. Rafael is also launching additional sites for the trial at Seattle Children's and Atrium Health Wake Forest Baptist. Existing sites already enrolling patients include City of Hope in Duarte, California, Cleveland Clinic Children's, University of Michigan's Rogel Cancer Center and Vanderbilt University Medical Center. "The success of our first cohort of dose escalation increases our optimism that devimistat may help address the gaps for efficacious treatment methods for relapsed clear cell sarcoma," said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. "There is a significant unmet need in treatments for clear cell sarcoma and other rare cancers, and as such, patients and physicians in the rare disease community are incredibly hopeful of devimistat's capabilities."
Rafael Holdings options imply 5.6% move in share price post-earnings » 14:4912/1412/14/21
Pre-earnings options volume in Rafael Holdings is normal with calls leading puts 19:1. Implied volatility suggests the market is anticipating a move near 5.6%, or 30c, after results are released. Median move over the past eight quarters is 3.5%.
Rafael Holdings options imply 6.4% move in share price post-earnings » 13:3412/1312/13/21
Pre-earnings options volume in Rafael Holdings is normal with calls leading puts 8:7. Implied volatility suggests the market is anticipating a move near 6.4%, or 34c, after results are released. Median move over the past eight quarters is 3.5%.
Rafael Pharmaceuticals announces published data on CPI-613 » 10:4612/1312/13/21
Rafael Pharmaceuticals announced a publication on its Phase 2 clinical trial of CPI-613 for the treatment of relapsed or refractory Burkitt lymphoma/leukemia or high-grade B-cell lymphoma at the American Society of Hematology, ASH, Annual Meeting and Exposition. Highlights from the published study, "Complete Remission with Devimistat in Refractory Burkitt Lymphoma," include a patient with four prior therapies, who had a near complete metabolic remission after four cycles of devimistat, and complete remission after cycle seven. As of July 2021, he was in cycle eleven. Typically, such patients have no viable treatment options. The ongoing study is currently recruiting at MD Anderson Cancer Center, City of Hope, Memorial Sloan Kettering Cancer Center and Massachusetts General Hospital. Rafael plans to open four additional sites at key institutions across the United States in Q1 2022.