CMRX Chimerix Inc.

6.48
-0.18  -3%
Previous Close 6.66
Open 6.61
52 Week Low 2.22
52 Week High 11.5696
Market Cap $558,649,950
Shares 86,211,412
Float 62,330,747
Enterprise Value $443,355,661
Volume 612,366
Av. Daily Volume 826,316
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Upcoming Catalysts

Drug Stage Catalyst Date
ONC201
H3 K27M-mutant Glioma
Phase 2
Phase 2
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DSTAT (CX-01)
Acute Myeloid Leukemia (AML)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ONC201
Neuroendocrine Tumors
Phase 2
Phase 2
Phase 2 ASCO abstract noted ORR 5/10 (50%).
TEMBEXA (brincidofovir)
Smallpox
Approved
Approved
FDA approval announced June 4, 2021.
DSTAT
Acute lung injury (ALI) in COVID-19
Phase 2
Phase 2
Phase 2 initial data released May 6, 2021. One patients died in DSTAT arm.
Oral Brincidofovir - AdAPT Study
Allogeneic hematopoietic stem cell transplant (HCT) recipients with adenovirus (AdV)
Phase 2
Phase 2
Phase 2 trial discontinued - May 9, 2019.
Brincidofovir - SUPPRESS
Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT)
Phase 3
Phase 3
Phase 3 endpoints not met December 2015
IV Brincidofovir
Adult allo-HCT recipients with Adenovirus
Phase 2
Phase 2
Phase 2 trial discontinued - May 9, 2019.
Brincidofovir - SURPASS
Cytomegalovirus (CMV) infection
Phase 3
Phase 3
Phase 3 discontinued following poor data from SUPPRESS trial
Brincidofovir - SUSTAIN
Cytomegalovirus (CMV) infection
Phase 3
Phase 3
Phase 3 discontinued following poor data from SUPPRESS trial
Brincidofovir - Advise trial
Adenovirus Infection
Phase 3
Phase 3
Phase 3 interim analysis released May 2016. Final data released February 22, 2017.

Latest News

  1. DURHAM, N.C., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that Mike Sherman, Chief Executive Officer, will participate in a panel discussion at the 2021 Wedbush PacGrow Healthcare Conference on Tuesday, August 10, 2021 at 10:55 a.m. ET.

    An audio webcast of the panel discussion will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com, where it will be archived for approximately 90 days.

    About Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact…

    DURHAM, N.C., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that Mike Sherman, Chief Executive Officer, will participate in a panel discussion at the 2021 Wedbush PacGrow Healthcare Conference on Tuesday, August 10, 2021 at 10:55 a.m. ET.

    An audio webcast of the panel discussion will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com, where it will be archived for approximately 90 days.

    About Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is currently in a registrational clinical program for recurrent H3 K27M-mutant glioma and an efficacy analysis by blinded independent central review is expected later in 2021. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the status of Chimerix's oncology programs, and the potential benefits and government procurement of TEMBEXA. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that the current clinical study data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; the ability to generate positive results in a Phase 3 study in acute myeloid leukemia and subsequent approval for DSTAT; risks that Chimerix will not obtain a procurement contract for TEMBEXA in smallpox in a timely manner or at all; Chimerix's reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

    CONTACTS:

            

    Michelle LaSpaluto

    919 972-7115





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Primary Logo

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  2. DURHAM, N.C., July 29, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that it will host a live conference call and audio webcast on Thursday, August 5, 2021 at 8:30 a.m. ET to report financial results for the second quarter ended June 30, 2021, and to provide an operational update.

    To access the live conference call, please dial (877) 354-4056 (domestic) or (678) 809-1043 (international) at least five minutes prior to the start time, and refer to conference ID 6658827. A live audio webcast of the call will also be available on the Investors' section of the Company's website, www.chimerix.com. An archived…

    DURHAM, N.C., July 29, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that it will host a live conference call and audio webcast on Thursday, August 5, 2021 at 8:30 a.m. ET to report financial results for the second quarter ended June 30, 2021, and to provide an operational update.

    To access the live conference call, please dial (877) 354-4056 (domestic) or (678) 809-1043 (international) at least five minutes prior to the start time, and refer to conference ID 6658827. A live audio webcast of the call will also be available on the Investors' section of the Company's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.

    About Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA® for the treatment of smallpox as a medical countermeasure. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is currently in a registrational clinical program for recurrent H3 K27M-mutant glioma and a blinded independent central review is expected later in 2021. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, Chimerix's growth and development. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that the current Phase 2 clinical trial data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; risks that Chimerix will not obtain a procurement contract for TEMBEXA in smallpox in a timely manner or at all; Chimerix's reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

    CONTACTS:

    Michelle LaSpaluto

    919 972-7115





    Will O'Connor

    Stern Investor Relations

    212-362-1200



    Primary Logo

    View Full Article Hide Full Article
  3. DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted TEMBEXA® (brincidofovir) tablets and oral suspension approval for the treatment of smallpox. TEMBEXA is approved for adult and pediatric patients, including neonates.

    "We are delighted to report our first FDA approved products for the treatment of smallpox, particularly as the importance of pandemic preparedness has been put into focus over the last year. With this approval in hand, we now look forward to advancing our discussions with the Biomedical Advanced Research and…

    DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted TEMBEXA® (brincidofovir) tablets and oral suspension approval for the treatment of smallpox. TEMBEXA is approved for adult and pediatric patients, including neonates.

    "We are delighted to report our first FDA approved products for the treatment of smallpox, particularly as the importance of pandemic preparedness has been put into focus over the last year. With this approval in hand, we now look forward to advancing our discussions with the Biomedical Advanced Research and Development Authority (BARDA) toward a procurement contract to support national preparedness," said Mike Sherman, Chief Executive Officer of Chimerix.

    Chimerix developed the TEMBEXA oral formulations as medical countermeasures for the treatment of smallpox under an ongoing collaboration with BARDA, part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under contract number HHSO100201100013C.

    TEMBEXA's approval is based on efficacy data in two lethal orthopoxvirus animal models of human smallpox disease, the rabbitpox model (New Zealand White rabbits infected with rabbitpox virus) and the mousepox model (BALB/c mice infected with ectromelia virus). In the pivotal studies in each model, TEMBEXA treatment resulted in statistically significant survival benefit versus placebo following delayed treatment after animals were infected with a lethal viral dose. The FDA's ‘Animal Rule' allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans. The TEMBEXA U.S. Prescribing Information has a BOXED WARNING for increased risk for mortality when used for longer duration; see below for Important Safety Information.

    About Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Most recently, the Company obtained FDA approval for brincidofovir as a medical countermeasure for the treatment of smallpox. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is currently in a registrational clinical program for recurrent H3 K27M-mutant glioma and a blinded independent central review is expected later in 2021. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    About Smallpox

    Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30%. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention (CDC), variola virus is ranked in the highest risk category for bioterrorism agents (Category A) due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption.

    About TEMBEXA

    TEMBEXA is an oral antiviral formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. TEMBEXA is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug's efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.

    TEMBEXA (brincidofovir) is a nucleotide analog lipid-conjugate designed to mimic a natural monoacyl phospholipid to achieve effective intracellular concentrations of the active antiviral metabolite, cidofovir diphosphate. Cidofovir diphosphate exerts its orthopoxvirus antiviral effects by acting as an alternate substrate inhibitor for viral DNA synthesis mediated by viral DNA polymerase.

    IMPORTANT SAFETY INFORMATION Including BOXED WARNING

    WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION



    An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease.

    WARNINGS AND PRECAUTIONS

    Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment.

    Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur. Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA.

    Coadministration with Related Products: TEMBEXA should not be co-administered with intravenous cidofovir.

    Carcinogenicity: TEMBEXA is considered a potential human carcinogen. Do not crush or divide TEMBEXA tablets and avoid direct contact with broken or crushed tablets or oral suspension.

    Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA may irreversibly impair fertility in individuals of reproductive potential.

    ADVERSE REACTIONS

    Common adverse reactions (adverse events assessed as causally related by the investigator in ≥ 2% of subjects) experienced in the first 2 weeks of dosing with TEMBEXA were diarrhea, nausea, vomiting and abdominal pain.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Based on findings from animal reproduction studies, TEMBEXA may cause fetal harm when administered to pregnant individuals. Pregnancy testing should be performed before initiation of TEMBEXA in individuals of childbearing potential to inform risk. An alternative therapy should be used to treat smallpox during pregnancy, if feasible.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the advancement of discussions with BARDA toward a procurement agreement for the sale of TEMBEXA to the SNS and the timing of the confirmatory response rate assessment for ONC201. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that Chimerix will not obtain a procurement contract for TEMBEXA in smallpox in a timely manner or at all; Chimerix's reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

    CONTACT:

    Investor Relations:        

    Michelle LaSpaluto

    919 972-7115





    Will O'Connor

    Stern Investor Relations

    212-362-1200



    Primary Logo

    View Full Article Hide Full Article
  4. DURHAM, N.C., May 25, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that Mike Sherman, Chief Executive Officer of Chimerix, will present a corporate overview at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 10:00 a.m. ET.

    A live audio webcast of the chat will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com, where it will be archived for approximately 90 days.

    About Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the…

    DURHAM, N.C., May 25, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that Mike Sherman, Chief Executive Officer of Chimerix, will present a corporate overview at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 10:00 a.m. ET.

    A live audio webcast of the chat will be available on the Investor Relations section of Chimerix's website at ir.chimerix.com, where it will be archived for approximately 90 days.

    About Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. The Company's three most advanced clinical-stage development programs are brincidofovir (BCV), ONC201 and dociparstat sodium (DSTAT). BCV is an antiviral drug candidate developed as a potential medical countermeasure for smallpox and is currently under review for regulatory approval in the United States. ONC201 is currently in a registrational clinical program for recurrent H3 K27M-mutant glioma and a blinded independent central review is expected later this year. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

    CONTACT:

    Investor Relations:

    Michelle LaSpaluto

    919 972-7115





    Will O'Connor

    Stern Investor Relations

    212-362-1200



    Primary Logo

    View Full Article Hide Full Article
  5. DURHAM, N.C., May 19, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced upcoming oral and poster presentations at the American Society of Clinical Oncology 2021 Annual Meeting, which will be held virtually June 4-8, 2021.

    Two titles have been accepted for oral presentations as follows:

    Title: Serial plasma and CSF cell-free tumor DNA (cf-tDNA) tracking in diffuse midline glioma patients undergoing treatment with ONC201
    Abstract Number: 2012
    Date and Time: June 4, 2021 at 9:00 AM EDT
    Presenter: Evan Cantor, M.D., University of Michigan
    Session Title: CNS Targeting: From Delivery to Biomarker Assessment…

    DURHAM, N.C., May 19, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced upcoming oral and poster presentations at the American Society of Clinical Oncology 2021 Annual Meeting, which will be held virtually June 4-8, 2021.

    Two titles have been accepted for oral presentations as follows:

    Title: Serial plasma and CSF cell-free tumor DNA (cf-tDNA) tracking in diffuse midline glioma patients undergoing treatment with ONC201

    Abstract Number: 2012

    Date and Time: June 4, 2021 at 9:00 AM EDT

    Presenter: Evan Cantor, M.D., University of Michigan

    Session Title: CNS Targeting: From Delivery to Biomarker Assessment

    Title: Phase 2 study of DRD2 antagonist/ClpP agonist ONC201 in neuroendocrine tumors

    Abstract Number: 3002

    Date and Time: June 4, 2021 from 11:00 AM - 2:00 PM EDT

    Presenter: Peter M. Anderson, M.D., Ph.D., Cleveland Clinic

    Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

    One title has been accepted as a poster presentation as follows:

    Title: First-in-human dose escalation and food effect study of oral ONC206 in adults with recurrent primary CNS neoplasms

    Abstract Number: TPS2072

    Date and Time: June 4, 2021 at 9:00 AM EDT

    Presenter: Brett J. Theeler, M.D., Walter Reed National Military Medical Center

    Session Title: Central Nervous System Tumors

    About Chimerix

    Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Our three most advanced clinical-stage development programs are brincidofovir (BCV), ONC201 and dociparstat sodium (DSTAT). BCV is an antiviral drug candidate developed as a potential medical countermeasure for smallpox and is currently under review for regulatory approval in the United States. ONC201 is currently in a registrational clinical program for recurrent H3 K27M-mutant glioma and a blinded independent central review is expected later this year. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia and as a potential treatment for acute lung injury in hospitalized COVID-19 patients.

    CONTACT:

    Investor Relations:        

    Michelle LaSpaluto

    919 972-7115





    Will O'Connor

    Stern Investor Relations

    212-362-1200





    Primary Logo

    View Full Article Hide Full Article
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