|Over a week ago|
Chimerix appoints Allen Melemed as CMO » 07:0206/2206/22/20
Chimerix (CMRX) announced…
Chimerix (CMRX) announced the appointment of Allen Melemed, M.D., M.B.A., as chief medical officer. Melemed joins Chimerix from Eli Lilly and Company (LLY), where he spent more than 20 years dedicated to the clinical development and approval of oncology medicines across a broad range of tumor types including VERZENIO, CYRAMZA, LARTRUVO, ALIMTA and RETEVMO among others.
|Over a month ago|
Chimerix initiated with a Buy at JonesTrading » 09:2005/2105/21/20
JonesTrading analyst Soumit Roy initiated coverage of Chimerix with a Buy rating and $10 price target. Chimerix's DSTAT blocks four different pathways to block AML cells from hiding in the bone marrow, modulates immune cells to prevent AML stem cell survival and allow for faster immune cell recovery, which Roy believes is a better approach than peer's E-selectin specific approach. He expects a "constant flow of news" from the company's ongoing COVID-19 trial, potentially positive updates from BARDA meetings and interim Phase 3 data in first-line AML in 2022, Roy added.
Fly Intel: Pre-market Movers » 09:1404/2904/29/20
GILD, CMRX, BA, MA, HUM, EAT, DIN, GOOG, GOOGL, NOC, GE, GD, HAS, LH, APRN, F, PLYA
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Chimerix receives FDA clearance for brincidofovir NDA » 08:3504/2904/29/20
Chimerix announced that…
Chimerix announced that the company has received clearance from the FDA for a rolling submission of its new drug application, or NDA, for the approval of brincidofovir, or BCV, as a medical countermeasure for smallpox. The company intends to begin the rolling NDA submission for BCV in May with completion targeted for mid-2020. Chimerix is developing BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority, or BARDA, part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under an ongoing USG contract.
Chimerix initiates Phase 2/3 trial of DSTAT in acute lung injury » 07:2004/2904/29/20
Chimerix announced the…
Chimerix announced the Company's initiation of a Phase 2/3 study of dociparstat sodium in COVID-19 patients with acute lung injury. DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.
|Over a quarter ago|
Chimerix expects to submit BCV NDA for smallpox in mid-2020 » 07:1902/2502/25/20
In January, Chimerix…
In January, Chimerix presented data in support of BCV as a potential treatment for smallpox at the 2020 American Society for Microbiology Biothreats Meeting in Arlington, Virginia. The presentation highlighted independent experiments performed in two lethal animal models of smallpox. In these studies, either rabbits or mice were inoculated with rabbitpox or ectromelia virus, respectively, to determine the survival benefit conferred by BCV treatment in animals acutely infected with these orthopoxviruses. Animals were randomized to receive either placebo or BCV at varying time intervals post infection. In both studies, animals that received BCV, even when administered late post-infection, demonstrated a statistically significant survival advantage relative to placebo. Data from these studies are intended to address the requirement under the FDA Animal Efficacy Rule for two different animal models of efficacy. Chimerix is collaborating with the Biomedical Advanced Research and Development Authority for the development of BCV as a potential medical countermeasure for smallpox. This rule allows for testing the efficacy of investigational drugs in animal models for diseases which cannot be evaluated in human clinical studies. In cooperation with BARDA, Chimerix has scheduled a pre-NDA meeting with FDA to review the final efficacy and safety data in preparation to submit an NDA. Pending the outcome of this meeting, Chimerix intends to submit a BCV NDA for smallpox in mid-2020. The Company's operating and manufacturing plan assumes entering into a procurement contract with BARDA in 2020 and preparation for delivery of BCV into the Strategic National Stockpile in 2021.
Chimerix to initiate Phase 3 trial of DSTAT w/ chemotherapy mid-year » 07:1802/2502/25/20
Chimerix recently conducted an end of Phase 2 meeting with the U.S. Food and Drug Administration related to the Company's development of DSTAT in AML. Following that meeting, Chimerix incorporated FDA's feedback on key elements of the Phase 3 clinical trial and has since submitted a full protocol for final FDA review. Chimerix plans to initiate a Phase 3 trial mid-year of DSTAT in combination with standard chemotherapy in newly diagnosed AML patients. The proposed Phase 3 trial will be a randomized, double-blind trial of approximately 570 newly diagnosed AML patients. The trial will include patients 60 years of age or older who have an intermediate or adverse genetic risk profile. It will also include patients between 18 and 60 years of age who have an adverse genetic risk profile. Patients will be randomized 1:1 to receive DSTAT in combination with standard of care cytarabine plus anthracycline induction and cytarabine consolidation chemotherapy or to receive standard of care induction and consolidation chemotherapy alone. Patients with FLT-3 mutations will be allowed in the study and will be eligible to receive midostaurin. The primary endpoint of the proposed trial will be overall survival. In addition, FDA has indicated that event-free survival, using complete response with hematologic recovery to define induction success, is acceptable as an endpoint for regulatory approval. Other endpoints to be evaluated in the proposed trial include minimal residual disease, relapse-free survival, time to hematologic recovery, and induction response. In order to supplement the previously reported data from the pilot and Phase 2 trials and provide additional evidence of DSTAT's mechanism of action, the proposed Phase 3 trial includes an early assessment of comparative CR and MRD rates among the first 80 evaluable patients. This data is expected to be unblinded, reported publicly, and available for ongoing analysis of later endpoints. Prior to potential unblinding, this data will be reviewed by an independent Data Monitoring Committee. The DMC will have the discretion to maintain blinding of the data from this early assessment in the event the DSTAT arm shows exceptional advantages to the control arm on CR and/or MRD, at certain pre-specified thresholds, which would allow inclusion of these patients in the final analysis. The Company expects to incur approximately $15M in clinical trial expenses up to and including this early assessment.
Chimerix reports Q4 EPS (6c), two est. (17c) » 07:1602/2502/25/20
Reports Q4 revenue $6.8M,…
Reports Q4 revenue $6.8M, two est. $750,000. "The transformation and progress we made in 2019 has laid the foundation for Chimerix to achieve a number of value-creating milestones in 2020," said Mike Sherman, Chief Executive Officer of Chimerix. "The team has continued to execute extremely well as we plan to file our first New Drug Application for brincidofovir as a medical countermeasure for smallpox and advance our promising dociparstat sodium program into pivotal Phase 3 clinical development as a front-line treatment for acute myeloid leukemia."
Chimerix appoints Pratik Multani to board of directors » 08:1902/2402/24/20
Chimerixannounced the appointment of Pratik S. Multani, M.D., to its Board of Directors, effective immediately. Dr. Multani currently serves as Chief Medical Officer of ORIC Pharmaceuticals. He replaces Jim Daly, who recently stepped down from the Board of Directors.
Chimerix presents data supporting brincidofovir as potential smallpox treatment » 08:0201/2901/29/20
Chimerix announces that…
Chimerix announces that data in support of brincidofovir as a potential treatment for smallpox were highlighted in an oral presentation and poster at the 2020 American Society for Microbiology Biothreats Meeting taking place January 28-30, 2020 in Arlington, Virginia. Chimerix is developing BCV as a medical countermeasure against smallpox. The poster titled, "Brincidofovir Treatment Efficacy in Two Well Characterized Orthopoxvirus Infection Models of Smallpox," can be accessed on the Investor page of the Chimerix corporate website. Independent experiments were performed in two lethal animal models of smallpox. In these studies, either rabbits or mice were inoculated with rabbitpox or ectromelia virus, respectively, to determine the survival benefit of BCV in animals acutely infected with these orthopoxviruses. These animal models are being studied in connection with the FDA Animal Rule to determine the utility of BCV as a medical countermeasure against the human orthopoxvirus disease, smallpox. Animals were randomized to receive either placebo or BCV treatment at varying intervals post infection. In both studies, animals that received BCV, regardless of time post-infection, demonstrated a statistically significant survival advantage relative to placebo.