BioCryst Pharmaceuticals explained

BioCryst Pharmaceuticals, Inc.
Type:	Public
Traded As:	NASDAQ: Russell 2000 Component
Location:	Durham, North Carolina, US
Key People:	Jon P. Stonehouse (president and CEO)
Industry:	Healthcare
Products:	RABIVAP
Revenue:	$49 million (2019)^[1]
Num Employees:	110
Homepage:	www.biocryst.com

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 peramivir (Rapivab) was approved by FDA in December 2014. It has also been approved in Japan, Korea, and China.

History

The company was founded in 1986 by Charles E. Bugg and John A. Montgomery.^[2] 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.^[3]

In October 2010, BioCryst announced its headquarters would move to Durham, North Carolina, where the company has had an office since 2006.^[4] In January 2018, BioCryst signed a definitive merger agreement with Idera Pharmaceuticals, with plans for the combined company to change its name and move to Pennsylvania.^[5] However, BioCryst shareholders voted down the merger in July.^[6]

Pipeline

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.^{[7] [8]}
• 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.^[9]
  • 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.^[10]
  • 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.^[11]
  • 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.^[12] 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.^[13] The company later made the decision to cease conducting further trials.^[14]

External links

1. BioCryst

Notes and References

1. Web site: BioCryst Pharmaceuticals Revenue 2006-2021 | BCRX.
2. Web site: About us . July 17, 2023.
3. Web site: BioCryst named 29th fastest growing tech firm . Birmingham Business Journal . November 26, 2008 .
4. News: BioCryst moving HQ to Durham. Ranii. David. News & Observer. October 14, 2010. October 14, 2010. dead. https://web.archive.org/web/20101017043235/http://www.newsobserver.com/2010/10/14/739369/biocryst-moving-hq-to-durham.html. October 17, 2010. mdy-all.
5. News: Patchen . Tyler. BioCryst Pharmaceuticals to merge with Pennsylvania pharmaceutical company . 7 April 2021 . The Business Journals . 23 January 2018.
6. Web site: BioCryst stockholders call off merger with Idera Pharmaceuticals. Hale . Conor . 11 July 2018. Fierce Biotech . 9 April 2021.
7. Web site: FDA Approves Berotralstat as First Oral Hereditary Angioedema Prophylaxis. 2021-01-09. HCPLive. December 4, 2020 .
8. Web site: Orladeyo (berotralstat) FDA Approval History. 2021-01-09. Drugs.com. en.
9. Web site: BioCryst Oral Drugs for Viruses Galidesivir. 2021-01-09. BioCryst Pharmaceuticals. en.
10. Web site: 2014-03-03. Broad-Spectrum Antiviral Effective Against Ebola, MERS-CoV. 2021-01-09. Global Biodefense. en-US.
11. Web site: HHS Contracts with BioCryst Pharmaceuticals to Develop New Ebola Drug. 2021-01-09. Infection Control Today. March 31, 2015 .
12. Web site: BioCryst starts COVID-19 trial of broad-spectrum antiviral. 2021-01-09. FierceBiotech. April 10, 2020. en.
13. Web site: A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever or COVID-19 - Full Text View - ClinicalTrials.gov. 2021-01-09. clinicaltrials.gov. en.
14. News: Halford . Bethany. To conquer COVID-19, create the perfect pill . 22 June 2021 . Chemical & Engineering News . 20 May 2021.