BioCryst Pharmaceuticals, Inc. is an American pharmaceutical company headquartered in

Durham, North Carolina Durham ( ) is a city in the U.S. state of North Carolina and the county seat of Durham County, North Carolina, Durham County. Small portions of the city limits extend into Orange County, North Carolina, Orange County and Wake County, North Carol ...

. 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. In March 1994, BioCryst became a

public company A public company is a company whose ownership is organized via shares of share capital, stock which are intended to be freely traded on a stock exchange or in over-the-counter (finance), over-the-counter markets. A public (publicly traded) co ...

when it completed an

initial public offering An initial public offering (IPO) or stock launch is a public offering in which shares of a company are sold to institutional investors and usually also to retail (individual) investors. An IPO is typically underwritten by one or more investm ...

by listing its shares on the

NASDAQ The Nasdaq Stock Market (; National Association of Securities Dealers Automated Quotations) is an American stock exchange based in New York City. It is the most active stock trading venue in the U.S. by volume, and ranked second on the list ...

stock exchange. In 2008, the company was named one of the fastest growing companies by

Deloitte & Touche Deloitte is a Multinational corporation, multinational professional services network based in London, United Kingdom. It is the largest professional services network in the world by revenue and number of employees, and is one of the Big Four a ...

in its 2008 list of ''Technology Fast 500''. In October 2010, BioCryst announced its headquarters would move to

, where the company has had an office since 2006. 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. However, BioCryst shareholders voted down the merger in July.

Pipeline

BioCryst’s core development programs include: * Berotralstat (BCX7353), an oral inhibitor of plasma

kallikrein Kallikreins are a subgroup of serine proteases, enzymes capable of cleaving peptide bonds in proteins. In humans, plasma kallikrein (encoded by ''KLKB1 gene'') has no known paralogue, while tissue kallikrein-related peptidases (''KLKs'') encode a f ...

for prevention and treatment of

hereditary angioedema Hereditary angioedema (HAE) is a disorder that results in recurrent attacks of severe swelling. The swelling most commonly affects the arms, legs, face, intestinal tract, and airway. If the intestinal tract is affected, abdominal pain and vo ...

(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. * 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 Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease of the blood characterized by destruction of red blood cells by the complement system, a part of the body's innate immune system. This destructive process ...

(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 Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19, the respiratory illness responsible for the COVID-19 pandemic. The virus previously had the Novel coronavirus, provisional nam ...

(the cause of

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the coronavirus SARS-CoV-2. In January 2020, the disease spread worldwide, resulting in the COVID-19 pandemic. The symptoms of COVID‑19 can vary but often include fever ...

Ebola Ebola, also known as Ebola virus disease (EVD) and Ebola hemorrhagic fever (EHF), is a viral hemorrhagic fever in humans and other primates, caused by ebolaviruses. Symptoms typically start anywhere between two days and three weeks after in ...

Marburg Marburg (; ) is a college town, university town in the States of Germany, German federal state () of Hesse, capital of the Marburg-Biedenkopf Districts of Germany, district (). The town area spreads along the valley of the river Lahn and has ...

, Yellow Fever and

Zika Zika fever, also known as Zika virus disease or simply Zika, is an infectious disease caused by the Zika virus. Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever. Symptoms may include fever, conju ...

. ** 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 Marburg (; ) is a university town in the German federal state () of Hesse, capital of the Marburg-Biedenkopf district (). The town area spreads along the valley of the river Lahn and has a population of approximately 76,000. Having been ...

and potentially for other

filovirus ''Filoviridae'' () is a family of single-stranded negative-sense RNA viruses in the order ''Mononegavirales''. Two members of the family that are commonly known are Ebola virus and Marburg virus. Both viruses, and some of their lesser known rela ...

es, including

Ebola virus ''Orthoebolavirus zairense'' or Zaire ebolavirus, more commonly known as Ebola virus (; EBOV), is one of six known species within the genus ''Ebolavirus''. Four of the six known ebolaviruses, including EBOV, cause a severe and often fatal vira ...

. ** 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. ** 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. 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. The company later made the decision to cease conducting further trials.

References

External links

BioCryst
{{Pharmaceutical companies of the United States American companies established in 1986 Biotechnology companies of the United States Pharmaceutical companies Biotechnology companies established in 1986 Pharmaceutical companies of the United States Pharmaceutical companies established in 1986 Health care companies based in North Carolina 1986 establishments in North Carolina Companies listed on the Nasdaq Life sciences industry Companies based in Durham, North Carolina 1994 initial public offerings