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BioCryst Pharmaceuticals, Inc. Message Board

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  • BARDA Oct 16
    Clinical trials are under way with other experimental vaccines. NIAID currently is supporting Phase 1 clinical trials that examine an investigational Ebola vaccine developed by GlaxoSmithKline and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. Phase 2 clinical efficacy trials for these vaccine candidates are expected in 2015.
    BARDA also continues to explore how its Centers for Innovation in Advanced Development and Manufacturing, its Fill Finish Manufacturing Network, or other measures can accelerate the manufacturing time for Ebola therapeutics and vaccines.
    The agency is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013

  • Drug and Vaccine Research

    USAMRIID is leading the evaluation of several promising Ebola medical countermeasure candidates, including therapeutics and vaccines, according to scientific director Sina Bavari, Ph.D.

    Bavari, an expert at building public-private partnerships, says the current outbreak offers researchers an opportunity to accelerate the development of medical products to prevent and treat the disease through collaboration with pharmaceutical companies and other government agencies.

    Among the products being evaluated by USAMRIID are four potential therapies, including synthetically made, small-molecule drugs that have shown efficacy against a broad range of viral diseases, according to Bavari. One of these drugs, known as BCX4430, has been tested in animal models at USAMRIID; its parent company is in the process of filing an Investigational New Drug application with the FDA to begin Phase I clinical trials in humans.

  • Suspected Ebola case on Air France flight in Madrid

  • Reply to

    NIH Meeting: Oct. 22: BCRX

    by maphere 17 hours ago

    "BCRX is the only publicly traded company at this meeting, others are universities or govt." I like that. "Our " company is in the flow of information and will be recognized as a solution to the consequences of viral infections. At least the government is reacting to the threat of pandemic chaos that evolved from one patient with Ebola.

    "There are higher rates of influenza-associated hospitalization in 2013-14 in persons 18-64 years of age than during the past several seasons
    There were higher numbers of influenza deaths in the 122 Cities Mortality Surveillance System in 2013-14 in persons 25-64 years than during the past several seasons".

    Flu is airborne and easily transmissible. Killing young people is not the norm for flu. I hope the government is waking up to the facts. FUD works on governments as well. Vaccines are nice. A treatment for a viral infection is invaluable...for flu or Ebola. I hope they see the need to be "ready" for a pandemic flu. To be PROACTIVE versus REACTIVE, as in the case of the Ebola CRISIS caused by one patient. Look at the far ranging effects and costs.

  • Reply to

    NIH Meeting: Oct. 22: BCRX

    by maphere 17 hours ago

    BCRX is the only publicly traded company at this meeting, others are universities or govt.

    Samuel L. Stanley, M.D.
    NSABB Chair
    President, Stony Brook University

    Mary E. Groesch, Ph.D.
    Executive Director, NSABB
    Senior Policy Advisor, Program on Biosecurity and Biosafety Policy, Office of the
    Director, National Institutes of Health

    Lawrence A. Tabak, D.D.S., Ph.D.
    Principal Deputy Director
    National Institutes of Health

    Mary E. Groesch, Ph.D.

    Andrew M. Hebbeler, Ph.D.
    Assistant Director for Biological and Chemical Threats

    Nicole Lurie, M.D., M.S.P.H.
    Assistant Secretary for Preparedness and Response
    U.S. Department of Health and Human Services

    Paul Duprex, Ph.D.
    Associate Professor of Microbiology, and Director of Cell and Tissue Imaging, NEIDL
    Institute
    Boston University

    Marc Lipsitch, Ph.D.
    Professor of Epidemiology
    Harvard School of Public Health

    David B. Resnik, J.D., Ph.D.
    Bioethicist and IRB Chair
    National Institute of Environmental Health Sciences

    Discussants
    W. Ian Lipkin, M.D.
    John Snow Professor of Epidemiology, Professor of Neurology and Pathology, and
    Director of the Center for Infection and Immunity
    Columbia University
    Yoshi Kawaoka, D.V.M., Ph.D.
    Professor of Virology
    University of Wisconsin- Madison
    Michael Osterholm, Ph.D., M.P.H.
    McKnight Presidential Chair of Public Health, Director of the Center for Infectious
    Disease Research and Policy (CIDRAP),Professor of Environmental Health Sciences,
    School of Public Health
    University of Minnesota3
    October 17, 2014
    Janet Peterson, CBSP
    Senior Biosafety Officer
    University of Maryland
    Stacey Schultz-Cherry, Ph.D.
    Member
    St. Jude Children's Research Hospital
    Bill Sheridan, M.B., B.S.
    Senior Vice President and Chief Medical Officer
    BioCryst Pharmaceuticals Inc.
    Daniel Perez, Ph.D.
    Professor of Virology
    University of Maryland
    Tom Inglesby M.D.
    CEO and Director, UPMC Center for Health Security
    Associate Professor of Medicine and Public Health, University of Pittsburgh
    Arturo Casadevall, M.D. Ph.D.

  • Third UN employee dies from Ebola

  • Not sure, it could be an older slide, but the presentation as a whole is current.

    BCRX PR on Aug. 29 said the NHP trials are anticipated to start in a few weeks....we're well passed a few weeks.

    FORBES said this on Aug. 29th:

    BioCryst Pharmaceuticals, Inc. announced this morning that their small-molecule, nucleoside analogue, BCX-4430, would be entering a dose ranging efficacy study in non-human primates within the next few weeks.

    This study could potentially meet all of the criteria for FDA’s Animal Rule, a path by which drugs tested in animals could move to emergency treatment of humans while human safety trials proceed concomitantly.

  • Thanks Map. Interesting.
    The BCX 4430 slide seemed to indicate that NHP testing for EBOLA hadn't started yet (though who knows when this was actually filmed, even though it was uploaded just a couple days ago).'

    ww*.youtube.c*m/watch?v=inIL5Zf97gY

  • Reply to

    FDA go ahead ?

    by dinepat203 18 hours ago

    Favipiravir is chemically totally different from BCX4430.

  • Reply to

    FDA go ahead ?

    by dinepat203 18 hours ago

    Seeing some activity in hepatitis C, an RNA virus, prompted BioCryst scientists to pursue tests of BCX4430 against other RNA viruses. That’s what led the company to filoviruses, the family of viruses that cause viral hemorrhagic fevers. Both Ebola and Marburg are filoviruses.

  • NATIONAL SCIENCE ADVISORY BOARD
    FOR BIOSECURITY
    National Institutes of Health Bldg. 31, 6C, Room 6 Bethesda, MD
    October 22, 2014
    MEETING AGENDA

    Session 1: Benefits, Risks, and Ethical Considerations Associated with Gain-of-Function Studies Involving Pathogens with Pandemic Potential

    Discussants (BCRX 1 of 9)

    Bill Sheridan, M.B., B.S.
    Senior Vice President and Chief Medical Officer BioCryst Pharmaceuticals Inc.

  • $BCRX Favipiravir is the japanese antivaral drug which may had helped the ebola pacient in spain. similar product has BCRX!

  • Reply to

    HAE - $$$$$

    by david_not_a_doc64 19 hours ago

    National Institute of Allergy and Infectious Diseases (NIAID) has exercised two additional options under its contract, which provides for GMP drug substance and drug product manufacture of BCX4430. Exercise of these options includes up to a $2.0 million increase to the existing development contract.

  • Reply to

    HAE - $$$$$

    by david_not_a_doc64 19 hours ago

    Thanks Husky.....a four-bagger on HAE alone will work just fine

    Throw in those other BCRX assets, and we have a party

  • Reply to

    HAE - $$$$$

    by david_not_a_doc64 19 hours ago

    44 bucks a share…

    it's been a loooong time since opus 1 ended. makes me think something might be in the works. 4+ months for designing a trial that will have no more than 50 people? probably at the same place?

  • For a minute.... forget 4430 and Ebola, forget Pami approval and stockpile, forget the world-class Babu platform and the new molecule they've been hinting about, and forget the fact that big pharma covets companies like biocryst.

    If HAEII trials are successful, what is a blockbuster HAE drug worth next year?

  • Maybe the wait for approval will have a benefit. Hospitals are looking to see a surge of ER activity for the flu this year (thanks to Ebola) from people that would have normally stayed home. Insurance companies are worried that admissions will be up because hospitals hurt by Obama care will try to make some money back.

    Sounds like a .... more positive back drop for RAPIVAB and maybe a larger company to peddle the stuff.

    Sentiment: Buy

  • any mention of sarepta's avi drug?

  • Peter Jahrling, PhD, Chief Scientist, NIAID Integrated Research Facility October 15, 2014

    Therapeutic Considerations start at 9:10

    My general review, listen for greater details:

    ZMapp...good preclinical results, difficult to make, ~20 doses available by Dec.
    T-705..."bottom line, up front, it doesn't work"
    TKM-Ebola Clinical trial likely to come off hold, but lower dose likely.
    BCX4430... IND expected in Nov.
    CMRX...looking to do guinea pig test and move into NHP testing

  • Trademark Events
    Event DateEvent Description
    2013-12-16 NEW APPLICATION ENTERED IN TRAM
    2013-12-26 NEW APPLICATION OFFICE SUPPLIED DATA ENTERED IN TRAM
    2014-03-21 ASSIGNED TO EXAMINER
    2014-03-21 NON-FINAL ACTION WRITTEN
    2014-03-21 NON-FINAL ACTION E-MAILED
    2014-03-21 NOTIFICATION OF NON-FINAL ACTION E-MAILED
    2014-09-12 TEAS RESPONSE TO OFFICE ACTION RECEIVED
    2014-09-12 CORRESPONDENCE RECEIVED IN LAW OFFICE
    2014-09-13 TEAS/EMAIL CORRESPONDENCE ENTERED
    2014-09-13 APPROVED FOR PUB - PRINCIPAL REGISTER
    2014-09-25 ASSIGNED TO LIE
    2014-09-30 LAW OFFICE PUBLICATION REVIEW COMPLETED

BCRX
11.60+0.02(+0.17%)Oct 20 4:00 PMEDT

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