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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) announced multiple data presentations at the EAACI Hybrid Congress from July 10-12, 2021. Key presentations include:
- Phase 3 APeX-2 Study: Durable reduction in hereditary angioedema (HAE) attack rates with berotralstat.
- APeX-S Subgroup Analysis: Low attack rates in adolescent patients.
- Reduction in On-Demand Medications: Berotralstat's efficacy in HAE treatment.
ORLADEYO (berotralstat) is approved for prophylaxis of HAE attacks in patients 12 years and older.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has secured a crucial partnership with Neopharm Ltd. for the exclusive commercialization of ORLADEYO in Israel. The Israeli Ministry of Health has accepted the regulatory submission for ORLADEYO, which is aimed at preventing recurrent attacks in patients with hereditary angioedema aged 12 and older, and has granted an accelerated review. This collaboration will leverage Neopharm's expertise in rare diseases to enhance market access and support commercialization efforts in Israel and the Palestinian Authority.
BioCryst Pharmaceuticals (BCRX) announced the availability of ORLADEYO™ (berotralstat) in Germany for patients with hereditary angioedema (HAE). The European Medicines Agency approved the drug on April 30, 2021, for preventing recurrent HAE attacks in individuals aged 12 and above. BioCryst aims to meet the significant demand for targeted oral therapies in Europe, with plans for further launches across the continent. ORLADEYO is the first oral therapy specifically designed for HAE prevention and is available in multiple regions, including the U.S. and Japan.
BioCryst Pharmaceuticals (Nasdaq:BCRX) will present at two virtual healthcare conferences: the Jefferies Virtual Healthcare Conference on June 2, 2021, at 2:30 p.m. ET, and the JMP Securities Life Sciences Conference on June 17, 2021, at 1:30 p.m. ET. Investors can access live audio webcasts and replays via the Investors section on BioCryst's website. The company focuses on developing oral medications for rare diseases, including ORLADEYO™ for HAE attack prevention and other investigational therapies.
BioCryst Pharmaceuticals (BCRX) announced that the UK’s MHRA has granted marketing authorization for ORLADEYO™ (berotralstat) as the first oral therapy for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older. This approval marks a significant step in providing patients with a convenient treatment option, potentially improving their quality of life. Clinical trial data showed ORLADEYO reduced HAE attack rates significantly, from 2.9 to 1.0 attacks per month over 48 weeks. The NICE and SMC decisions for NHS use are expected in Q4 2021.
BioCryst Pharmaceuticals reported Q1 2021 net revenue of $10.9 million from ORLADEYO, marking a strong launch for its oral treatment for hereditary angioedema (HAE) in the U.S. The drug is now approved in the U.S., Japan, and the EU. Total revenues reached $19.1 million, up from $4.8 million a year earlier. R&D expenses increased to $42.4 million, reflecting investments in the BCX9930 program. The net loss widened to $64.3 million, or $0.36 per share. With $244.4 million in cash, the company expects its resources to last into 2023.
BioCryst Pharmaceuticals (Nasdaq:BCRX) announced its participation in two upcoming virtual healthcare conferences. The company will present at the Bank of America 2021 Healthcare Conference on May 12, 2021, at 12:30 p.m. ET, and at the 2021 RBC Capital Markets Global Healthcare Conference on May 19, 2021, at 1:20 p.m. ET. Interested parties can access links to live audio webcasts and replays in the Investors section of BioCryst’s website.
BioCryst focuses on discovering novel, oral medicines for rare diseases.
BioCryst Pharmaceuticals (BCRX) announced that the European Commission has approved ORLADEYO™ (berotralstat) for preventing recurrent hereditary angioedema (HAE) attacks in patients aged 12 and older. This approval marks ORLADEYO as the first targeted oral prophylactic therapy in Europe, catering to a significant unmet need. The company plans to launch ORLADEYO in Germany this quarter, with other European markets to follow. In trials, ORLADEYO significantly reduced attack rates and was well tolerated, prompting optimism about its market acceptance and potential impact on patient care.
BioCryst Pharmaceuticals, Inc. (BCRX) will report its first quarter 2021 financial results on May 6, 2021. A conference call and webcast will occur at 8:30 a.m. ET to discuss the results and provide corporate updates. Interested parties can access the call via phone or through a live webcast on BioCryst's investor website. BioCryst focuses on developing oral, small-molecule medicines for rare diseases, with products like ORLADEYO™ approved for HAE attacks and several ongoing development programs.
BioCryst Pharmaceuticals announced that Japan's National Health Insurance (NHI) system has approved ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE), making it the first approved medication of its kind in the country. The NHI price listing will trigger a $15 million milestone payment to BioCryst from its partner Torii Pharmaceutical.
Additionally, BioCryst will receive tiered royalties on net sales in Japan. The medication has shown effectiveness in clinical trials, meeting primary endpoints for reducing HAE attacks.
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