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 Peramivir (trade name Rapivab) is an antiviral drug developed by BioCryst Pharmaceuticals for the treatment of influenza. Peramivir is a neuraminidase inhibitor, acting as a transition-state analogue inhibitor of influenza neuraminidase and th ...

(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 stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange ( ...

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 investme ...

by listing its shares on the NASDAQ stock exchange. In 2008, the company was named one of the fastest growing companies by

Deloitte & Touche Deloitte Touche Tohmatsu Limited (), commonly referred to as Deloitte, is an international professional services network headquartered in London, England. Deloitte is the largest professional services network by revenue and number of profession ...

in its 2008 list of ''Technology Fast 500''. In October 2010, BioCryst announced its headquarters would move to Durham, North Carolina, 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 Berotralstat, sold under the brand name Orladeyo, is a medication used to prevent attacks of hereditary angioedema (HAE) in people aged twelve years and older. The most common side effects include abdominal pain, vomiting, diarrhea, back pain, ...

(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 ...

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 vomitin ...

(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 occu ...

(PNH). * BCX9250, an oral ALK-2 inhibitor for treatment of

fibrodysplasia ossificans progressiva Fibrodysplasia ossificans progressiva (; FOP; also called Münchmeyer disease and formerly called myositis ossificans progressiva or Stoneman disease) is an extremely rare connective tissue disease in which fibrous connective tissue such as mus ...

(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. ** 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 virus disease (MVD; formerly Marburg hemorrhagic fever) is a viral hemorrhagic fever in humans and primates caused by either of the two Marburgviruses: Marburg virus (MARV) and Ravn virus (RAVV). Its clinical symptoms are very similar t ...

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 re ...

es, including

Ebola virus ''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 hemorrhagic fever in humans and o ...

. ** 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
{{DEFAULTSORT:Biocryst Pharmaceuticals American companies established in 1986 Biotechnology companies of the United States Biopharmaceutical 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