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BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) is a global biotechnology company dedicated to improving the lives of individuals living with rare and serious diseases. Founded in 1986, BioCryst specializes in designing, optimizing, and developing novel small-molecule drugs that block key enzymes involved in infectious and rare diseases. Headquartered in Research Triangle Park, North Carolina, with a discovery center in Birmingham, Alabama, the company harnesses its expertise in drug discovery, clinical development, regulatory affairs, and product commercialization.
BioCryst is known for its flagship product, ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor specifically designed to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older. The efficacy of ORLADEYO has been demonstrated through multiple clinical studies and real-world data, showing significant reductions in HAE attack rates across various patient profiles.
The company's robust pipeline includes several innovative programs such as BCX17725 for Netherton syndrome and avoralstat for diabetic macular edema (DME). BioCryst's research spans multiple scientific disciplines, including biology, computer modeling, and medicinal chemistry, targeting therapeutic areas like acute uncomplicated influenza, hereditary angioedema, filoviruses (Ebola and Marburg), and oncology.
In recent announcements, BioCryst reported strong financial performance with ORLADEYO net revenue experiencing substantial growth. The company also continues to expand globally, with recent approvals of ORLADEYO in major markets, including Brazil and Mexico. Partnerships with organizations such as Pint Pharma help BioCryst extend its reach and bring life-changing treatments to patients worldwide.
BioCryst remains committed to advancing its clinical programs, generating new compounds, and upholding a culture of engagement and accountability. The company's ongoing dedication to developing innovative therapeutics aims to address unmet medical needs and provide better health outcomes for patients suffering from rare and serious conditions.
For more information, please visit www.biocryst.com or follow them on LinkedIn.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that data on ORLADEYO™ (berotralstat) will be presented at the 2021 American Academy of Allergy, Asthma & Immunology annual meeting, from February 26 to March 1, 2021. Key presentations include:
- Berotralstat Reduces Use of On-demand Medication in HAE Patients
- Despite Prophylactic Treatments, Break-through Attacks Continue
- Berotralstat Demonstrates Reductions in Attack Frequency in HAE
ORLADEYO is the first oral therapy specifically designed to prevent HAE attacks in patients 12 and older.
BioCryst Pharmaceuticals (BCRX) announced that the FDA has approved a supplemental new drug application for RAPIVAB (peramivir injection). This approval expands RAPIVAB's indication to treat acute uncomplicated influenza in patients aged six months and older, symptomatic for no more than two days. Previously, the drug was only indicated for patients two years and older. The FDA approval is a significant milestone, enhancing RAPIVAB's market potential and patient accessibility.
BioCryst Pharmaceuticals, Inc. (BCRX) announced marketing approval for ORLADEYO (berotralstat) in Japan for the prophylactic treatment of hereditary angioedema in patients aged 12 and older. It is the first oral HAE medication approved in the country. The product will be marketed by Torii Pharmaceutical Co., Ltd., pending pricing negotiations with Japan’s National Health Insurance. Following this approval, BioCryst is set to receive a $15 million milestone payment and tiered royalties of 20-40% on net sales. Approval is supported by recent clinical trials demonstrating efficacy and safety.
BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options to 10 newly-hired employees on December 31, 2020, allowing the purchase of 240,500 shares at $7.45 each, equal to the stock’s closing price on the grant date. These options vest in four equal annual installments, subject to continued service. The initiative complies with Nasdaq Listing Rule 5635(c)(4), aiming to attract talent and align incentives with the company’s growth strategy.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 11:40 a.m. ET via a virtual event. Interested parties can access a live audio webcast and replay through the Investors section of BioCryst’s website. The company focuses on developing oral medicines for rare diseases, with products like ORLADEYO™ approved in the U.S. for HAE prevention and others in development, including BCX9930 and galidesivir for various conditions.
BioCryst Pharmaceuticals (BCRX) announced the results of part 1 of a clinical trial for its antiviral drug, galidesivir, targeting SARS-CoV-2. The trial demonstrated that galidesivir was safe and well tolerated among patients, although it did not show clinical efficacy compared to placebo. The company will refocus its efforts on galidesivir for biodefense against diseases like Marburg virus, discontinuing its COVID-19 indication. The trial, conducted in Brazil, involved 24 patients and revealed a rapid decline in viral RNA levels with no safety concerns.
BioCryst Pharmaceuticals (BCRX) announced positive results from a Phase 1 clinical trial of BCX9250, an oral ALK-2 inhibitor for fibrodysplasia ossificans progressiva (FOP). The trial demonstrated safety and tolerability at all doses studied, supporting once-daily administration. No serious adverse events occurred, and pharmacokinetics showed dose-proportional exposure. With no current treatments available for FOP, these results provide hope for patients. BioCryst plans further discussions with physicians and regulators to advance BCX9250 development.
BioCryst Pharmaceuticals (BCRX) has initiated direct shipments of ORLADEYO™ (berotralstat), the first oral once-daily prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older. Following FDA approval on December 3, 2020, Optime Care, the exclusive specialty pharmacy, has commenced shipments. The EMPOWER Patient Services program provides streamlined access and financial support to HAE patients, aiming for a comprehensive treatment journey. ORLADEYO is designed to reduce plasma kallikrein activity, preventing HAE attacks, but should not be used for acute attack treatment.
BioCryst Pharmaceuticals (BCRX) will present at the JMP Securities Hematology Summit on December 15, 2020, at 3:30 p.m. ET. This virtual event allows investors to access a live audio webcast of the presentation through the company's website. BioCryst focuses on developing oral, small-molecule medicines for rare diseases. Its approved product, ORLADEYO™, prevents HAE attacks and is currently under review in Japan and the EU. The company has several ongoing programs, including treatments for COVID-19 and other serious diseases.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has secured $325 million in funding, including $250 million at closing, to bolster the launch of ORLADEYO™ (berotralstat) for hereditary angioedema (HAE) and advance its oral Factor D inhibitor, BCX9930. The financing comprises a $125 million upfront payment from Royalty Pharma with an 8.75% royalty structure on sales up to $350 million, and a $200 million credit facility from Athyrium Capital. The funds will also enable BioCryst to repay existing debt and expand its clinical trials amid promising early data for BCX9930.
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