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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 (BCRX) reported its Q4 and full-year 2020 financial results, revealing total revenues of $4.0 million for Q4 and $17.8 million for the full year, down from $39.7 million and $48.8 million in 2019 respectively. The company launched ORLADEYO in the U.S. after FDA approval and received marketing approval in Japan. The financing raised $325 million in December 2020 aids the launch and ongoing development of BCX9930, with cash totaling $303 million expected to last into 2023. The net loss increased to $60.5 million in Q4, reflecting higher R&D and SG&A expenses.
BioCryst Pharmaceuticals (Nasdaq:BCRX) announces its participation in two upcoming virtual healthcare conferences. The first is the Cowen 41st Annual Healthcare Conference on March 4, 2021, at 12:10 p.m. ET, followed by the Barclays Annual Healthcare Conference on March 11, 2021, at 8:00 a.m. ET. Interested investors can access live audio webcasts and replays via the investors section of BioCryst’s website.
BioCryst focuses on developing novel oral medicines for rare diseases, with key products like ORLADEYO™ and RAPIVAB® for treating various conditions.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will announce its fourth quarter and full year 2020 financial results on February 25, 2021. Management will host a conference call at 8:30 a.m. ET to discuss these results and provide a corporate update. The call can be accessed by dialing 877-303-8027 for domestic and 760-536-5165 for international callers. Additionally, BioCryst's lead product, ORLADEYO™, is under regulatory review in the European Union, while ongoing developments include treatments for rare diseases and viral infections.
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.