Welcome to our dedicated page for Biocryst Pharmaceuticals news (Ticker: BCRX), a resource for investors and traders seeking the latest updates and insights on Biocryst Pharmaceuticals stock.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) is a global biotechnology company focused on hereditary angioedema (HAE) and other rare diseases, and its news flow reflects this specialization. Company press releases frequently highlight regulatory milestones, clinical data, commercial performance, and strategic transactions related to its flagship product ORLADEYO® (berotralstat) and its broader rare disease pipeline.
Investors following BCRX news can expect regular updates on ORLADEYO, described as the first oral, once-daily plasma kallikrein inhibitor for prophylaxis to prevent HAE attacks. Recent announcements have covered U.S. Food and Drug Administration approval of an oral pellet formulation for pediatric patients aged 2 to <12 years, interim data from the APeX-P pediatric trial showing early and sustained reductions in attack rates, and presentations at major allergy and immunology congresses on the burden of HAE in children and caregivers.
BioCryst also issues news on its financial outlook and operating performance, including preliminary ORLADEYO net revenue, total revenue guidance that incorporates RAPIVAB® (peramivir injection), and non-GAAP operating expense expectations. These releases often explain how structural changes, such as the sale of the European ORLADEYO business, affect the company’s revenue mix and cost base.
Strategic and corporate developments are another major theme in BCRX news. The company has announced a definitive agreement to acquire Astria Therapeutics, Inc., with updates on regulatory clearances such as early termination of the Hart-Scott-Rodino waiting period and expected closing timelines. Additional news items include leadership changes, inducement equity grants under Nasdaq Listing Rule 5635(c)(4), and planned presentations at high-profile investor conferences.
For readers tracking BCRX, this news stream offers insight into BioCryst’s commercial execution in HAE, progress of its rare disease pipeline, evolving capital allocation, and key corporate events. Regularly reviewing these updates can help contextualize movements in BCRX stock and provide a clearer picture of the company’s strategic direction.
BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options for 12 new employees, totaling 222,500 shares. The options were issued on July 30, 2021, with an exercise price of $16.12, equal to the closing stock price on that date. Options will vest in equal annual installments over four years, contingent on the employees' continued service. This action follows Nasdaq Listing Rule 5635(c)(4), aimed at enhancing employee incentives and aligning their interests with shareholders.
BioCryst Pharmaceuticals (BCRX) has appointed Vincent Milano, a leader in hereditary angioedema (HAE) and rare diseases, to its board of directors. Milano brings extensive experience from his tenure as CEO of Idera Pharmaceuticals and ViroPharma, where he successfully launched the HAE treatment, Cinryze. His appointment is expected to enhance BioCryst's strategic direction, especially in commercializing its oral HAE treatment, ORLADEYO, and advancing its pipeline products, including BCX9930. The company focuses on developing innovative therapies for rare diseases.
BioCryst Pharmaceuticals (BCRX) will report its Q2 2021 financial results on August 5, 2021. The conference call at 8:30 a.m. ET will provide insights into the company's performance and future outlook. BioCryst is known for its development of oral medicines for rare diseases, including ORLADEYO for HAE prevention. The company also has ongoing projects like BCX9930 for complement-mediated diseases and galidesivir for Marburg virus treatment, showcasing a strong commitment to addressing significant medical needs.
BioCryst Pharmaceuticals (BCRX) announces pivotal trials REDEEM-1 and REDEEM-2 for its oral Factor D inhibitor, BCX9930, targeting paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 will compare BCX9930 monotherapy to C5 inhibitors, while REDEEM-2 will evaluate BCX9930 against placebo in treatment-naïve patients. Primary endpoint: change in hemoglobin over 12-24 weeks. Both trials begin patient enrollment in H2 2021. Previous trials showed BCX9930 increased hemoglobin by 3.2 g/dL and was well-tolerated. FDA granted Fast Track and Orphan Drug Designation for BCX9930.
BioCryst Pharmaceuticals (BCRX) announced significant findings from the APeX-2 trial for ORLADEYO (berotralstat), demonstrating an 80% average reduction in monthly hereditary angioedema (HAE) attacks. The treatment was well-tolerated, with 81% of patients completing the trial. Additional presentations at the EAACI Congress revealed a 78-85% reduction in the use of on-demand medications for patients with significant attack rate reductions. Long-term data underscores the drug's efficacy and safety, crucial for patient demand as therapy shifts from injectables to oral solutions.
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.
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