BioCryst Pharmaceuticals

BioCryst Pharmaceuticals, Inc. is an American pharmaceutical company headquartered in Durham, North Carolina. The company is a late stage biotech company that focuses on oral drugs for rare and serious diseases. BioCryst's antiviral drug RAPIVAB was approved by FDA in December 2014. It has also been approved in Japan, Korea and China.

BioCryst Pharmaceuticals, Inc.
TypePublic
NASDAQ: BCRX
Russell 2000 Component
IndustryHealthcare
Founded1986
HeadquartersDurham, North Carolina, USA
Key people
Jon P. Stonehouse , President and Chief Executive Officer
ProductsRABIVAP
Revenue $49 Million(2019)[1]
Number of employees
110
Websitewww.biocryst.com

History

The company was founded in 1986 by Charles E. Bugg, Ph.D. and John A. Montgomery, Ph.D. In March 1994, BioCryst became a public company when it completed an initial public offering by listing its shares on the NASDAQ stock exchange. In 2008 the company was named one of the fastest growing companies by Deloitte & Touche in its 2008 list of Technology Fast 500.[2]

In October 2010, BioCryst announced its headquarters would move to Durham, North Carolina, where the company has had an office since 2006.[3]

Pipeline

BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst’s core development programs include:

  • Berotralstat (BCX7353), an oral inhibitor of plasma kallikrein for prevention and treatment of hereditary angioedema (HAE).
    • FDA has approved Expanded Access Program for berotralstat for eligible patients in the United States.
    • Berotralstat has a PDUFA date for FDA approval on December 3, 2020.
    • On December 3, 2020, the FDA approved berotralstat as the first oral hereditary angioedema prophylaxis.[4][5]
  • BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases.
    • FDA has granted Fast Track designation for BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
  • BCX9250, an oral ALK-2 inhibitor for treatment of Fibrodysplasia Ossificans Progressiva (FOP).
  • Galidesivir (BCX4430) is a broad-spectrum antiviral in advanced development for the treatment of viruses including SARS-CoV-2 (the cause of COVID-19), Ebola, Marburg, Yellow Fever and Zika.[6]
    • Galidesivir was safe and generally well tolerated in Phase 1 clinical safety and pharmacokinetics trials conducted in 2019 by both intravenous and intramuscular routes of administration in healthy human subjects.
    • In animal studies, galidesivir has demonstrated survival benefits against a variety of serious pathogens, including Ebola, Marburg, Yellow Fever and Zika viruses.
    • BioCryst is developing galidesivir in collaboration with U.S. government agencies and other institutions.
    • In September 2013, NIAID contracted with BioCryst for the development of galidesivir as a treatment for Marburg virus disease and potentially for other filoviruses, including Ebola virus.[7]
    • In March 2015, BioCryst announced that the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health & Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has awarded BioCryst a contract for the continued development of galidesivir as a potential treatment for diseases caused by RNA pathogens, including filoviruses.[8]
    • In April 2020, BioCryst began enrollment of a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19.[9] This clinical trial is (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.[10]

References
  1. https://www.macrotrends.net/stocks/charts/BCRX/biocryst-pharmaceuticals/revenue
  2. BioCryst named 29th fastest growing tech firm Birmingham Business Journal, November 26, 2008
  3. Ranii, David (October 14, 2010). "BioCryst moving HQ to Durham". News & Observer. Archived from the original on October 17, 2010. Retrieved October 14, 2010.
  4. "FDA Approves Berotralstat as First Oral Hereditary Angioedema Prophylaxis". HCPLive. Retrieved January 9, 2021.
  5. "Orladeyo (berotralstat) FDA Approval History". Drugs.com. Retrieved January 9, 2021.
  6. "BioCryst | Oral Drugs for Viruses | Galidesivir". BioCryst Pharmaceuticals. Retrieved January 9, 2021.
  7. "Broad-Spectrum Antiviral Effective Against Ebola, MERS-CoV". Global Biodefense. March 3, 2014. Retrieved January 9, 2021.
  8. "HHS Contracts with BioCryst Pharmaceuticals to Develop New Ebola Drug". Infection Control Today. Retrieved January 9, 2021.
  9. "BioCryst starts COVID-19 trial of broad-spectrum antiviral". FierceBiotech. Retrieved January 9, 2021.
  10. "A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever or COVID-19 - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved January 9, 2021.
  1. BioCryst
  2. BioCryst Drug Pipeline
  3. https://www.biocryst.com/our-program/galidesivir/
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