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BioCryst Pharmaceuticals

biocryst.com

Founded Year

1986

Stage

PIPE - III | IPO

Total Raised

$57.43M

Market Cap

1.97B

Stock Price

10.58

About BioCryst Pharmaceuticals

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.

Headquarters Location

4505 Emperor Blvd. Suite 200

Durham, North Carolina, 27703,

United States

205-444-4600

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Expert Collections containing BioCryst Pharmaceuticals

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

BioCryst Pharmaceuticals is included in 1 Expert Collection, including Biopharma Tech.

B

Biopharma Tech

15,535 items

Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.

BioCryst Pharmaceuticals Patents

BioCryst Pharmaceuticals has filed 53 patents.

The 3 most popular patent topics include:

  • Complement system
  • EC 3.4.21
  • Coagulation system
patents chart

Application Date

Grant Date

Title

Related Topics

Status

8/26/2020

1/24/2023

Complement system, Immune system, Immunology, Clusters of differentiation, EC 3.4.21

Grant

Application Date

8/26/2020

Grant Date

1/24/2023

Title

Related Topics

Complement system, Immune system, Immunology, Clusters of differentiation, EC 3.4.21

Status

Grant

Latest BioCryst Pharmaceuticals News

BioCryst Begins Enrollment in Pivotal APeX-P Trial Evaluating ORLADEYO® (berotralstat) in Pediatric Patients with Hereditary Angioedema

Jan 26, 2023

Durham, North Carolina, UNITED STATES RESEARCH TRIANGLE PARK, N.C., Jan. 26, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first patient in the pivotal APeX-P trial evaluating oral, once-daily ORLADEYO® (berotralstat) in pediatric hereditary angioedema (HAE) patients who are 2 to <12 years of age. “Today’s announcement marks a very important step in our continuing efforts to reduce the burden of therapy for people living with HAE around the world with oral, once-daily ORLADEYO. Pediatric patients are a particularly important group where the challenges posed by disease and treatment can be significant to these children and their families, especially given the uncertainty they face as they are newly diagnosed during childhood. It is imperative that we strive to help normalize patients’ lives, as early experiences can have a lasting impact on how HAE is perceived – and managed – for their entire lifetimes. We are excited by the opportunity to introduce this new pediatric formulation of ORLADEYO that could significantly reduce the treatment burden for children and families impacted by HAE,” said Dr. Ryan Arnold, chief medical officer of BioCryst. ORLADEYO is the first and only oral therapy designed specifically to prevent HAE attacks in adult and pediatric patients 12 years and older. First approved by the U.S. Food and Drug Administration (FDA) in December 2020, ORLADEYO is available in many global markets. APeX-P is an open-label trial designed to evaluate the pharmacokinetics (PK) and safety of ORLADEYO in pediatric HAE patients (2 to <12 years of age). The trial will consist of an initial 12-week standard-of-care (SOC) treatment period, followed by a subsequent open-label ORLADEYO treatment period lasting 48 weeks, with continuation up to 144 weeks. Patients will be enrolled into four dose cohorts, with body weight being used to determine assignment to each cohort. Higher weight cohorts (Cohorts 1 and 2) will enroll first and in parallel, and safety assessments and PK modelling from all available PK data will then be used to confirm the weight bands for sequentially enrolling Cohorts 3 and 4. The effectiveness of ORLADEYO in APeX-P will be summarized using descriptive statistical methods. The primary endpoint of APeX-P is the characterization of the PK profile of ORLADEYO in patients aged 2 to <12 years. Following the completion of APeX-P, BioCryst plans to submit a supplemental New Drug Application (sNDA) for the potential expanded use of ORLADEYO for prophylaxis to prevent attacks in pediatric HAE patients. For more information about the APeX-P trial, visit ClinicalTrials.gov and search NCT number NCT05453968. About ORLADEYO® (berotralstat) ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein. U.S. Indication and Important Safety Information INDICATION ORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. Limitations of use The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation. IMPORTANT SAFETY INFORMATION An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent. The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine). Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO. ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO. The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established. There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production. To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or  www.fda.gov/medwatch .

BioCryst Pharmaceuticals Frequently Asked Questions (FAQ)

  • When was BioCryst Pharmaceuticals founded?

    BioCryst Pharmaceuticals was founded in 1986.

  • Where is BioCryst Pharmaceuticals's headquarters?

    BioCryst Pharmaceuticals's headquarters is located at 4505 Emperor Blvd., Durham.

  • What is BioCryst Pharmaceuticals's latest funding round?

    BioCryst Pharmaceuticals's latest funding round is PIPE - III.

  • How much did BioCryst Pharmaceuticals raise?

    BioCryst Pharmaceuticals raised a total of $57.43M.

  • Who are the investors of BioCryst Pharmaceuticals?

    Investors of BioCryst Pharmaceuticals include Royalty Pharma, OMERS Capital Markets, Athyrium Capital Management, TPG Biotech, Kleiner Perkins Caufield & Byers and 8 more.

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