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 announced the FDA has lifted the partial clinical hold on its BCX9930 program. Enrollment in pivotal trials for paroxysmal nocturnal hemoglobinuria (PNH) and other kidney diseases will resume with a reduced dose of 400 mg twice daily. Previous doses of 500 mg showed elevated serum creatinine levels in some patients. The change aims to prevent crystal formation in kidneys. If successful, BioCryst plans to invest more in BCX9930; if not, they will shift focus to other pipeline candidates.
BioCryst Pharmaceuticals, Inc. (BCRX) will announce its second quarter 2022 financial results on August 4, 2022, followed by a conference call at 8:30 a.m. ET for a corporate update. The live call can be accessed at 866-374-5140 (domestic) or 404-400-0571 (international) using conference ID 68509725#. A webcast and slides will be available on the company's investor website, with a replay accessible afterward.
BioCryst focuses on developing oral treatments for rare diseases, including ORLADEYO (berotralstat) and other pipeline candidates.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will present at the H.C. Wainwright 1st Annual Hereditary Angioedema Virtual Conference on July 20, 2022, at 10:00 a.m. ET. The presentation is accessible via a live audio webcast on the company’s website.
BioCryst focuses on developing oral medicines for rare diseases. Their approved product ORLADEYO (berotralstat) is already available in the U.S. and globally. The company is also advancing several programs, including BCX9930 and galidesivir.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced promising long-term efficacy and safety results for ORLADEYO (berotralstat) in treating hereditary angioedema (HAE). Data from the APeX-2 and APeX-S clinical trials highlight sustained reductions in HAE attack rates and improved quality of life. Notably, patients switching from injectable therapies reported 98 percent attack-free days. Presenting at the EAACI Congress 2022, these findings bolster ORLADEYO's position as a preferred oral prophylactic therapy for HAE.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that it will present data at the EAACI Hybrid Congress 2022 in Prague from July 1-3. Key abstract presentations include:
- Attack-free Status: Patients switching from Lanadelumab to Berotralstat.
- Quality of Life Improvement: Observed in long-term Berotralstat treatment.
- Decreased Injectable Medication Use: After 96 weeks of Berotralstat treatment.
ORLADEYO (berotralstat) is designed to prevent hereditary angioedema attacks in patients aged 12 and older.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has formed an exclusive partnership with Pint Pharma GmbH to promote ORLADEYO® (berotralstat) across the pan-Latin America (LATAM) region. This agreement aims to address the needs of hereditary angioedema (HAE) patients seeking new treatment options. Pint Pharma will handle marketing authorizations and commercialization in LATAM. ORLADEYO, the only oral therapy for HAE prevention, has been successful in several global markets, indicating strong potential for market acceptance in the LATAM region.
BioCryst Pharmaceuticals (BCRX) announced FDA has granted Fast Track designation for BCX9250 aimed at preventing heterotopic ossification in fibrodysplasia ossificans progressiva (FOP) patients. This designation expedites drug development and review for serious conditions with unmet medical needs. BCX9250 targets the ALK-2 enzyme, crucial for FOP, with positive Phase 1 trial results indicating good safety and tolerability. This follows recent PRIME eligibility from EMA, reflecting significant progress in the drug’s development, addressing a critical need in an ultra-rare disease community.
BioCryst Pharmaceuticals (BCRX) announced that Swissmedic has authorized the marketing of ORLADEYO (berotralstat) for preventing recurrent hereditary angioedema (HAE) attacks in patients aged 12 and older in Switzerland. The drug is the first oral, non-steroidal therapy for HAE, enhancing treatment options. Following its European approval last year, BioCryst anticipates launching ORLADEYO in Switzerland after finalizing reimbursement plans. Clinical trials reported gastrointestinal issues which were generally mild and self-resolving.
BioCryst Pharmaceuticals (BCRX) announced the approval of ORLADEYO (berotralstat) by Health Canada for the prevention of recurrent hereditary angioedema (HAE) attacks in patients aged 12 and older. This marks a significant advancement for the Canadian HAE community, offering a much-needed oral prophylactic therapy. ORLADEYO is already approved in multiple global markets, and the company is committed to ensuring timely access for Canadian patients. Clinical trials reported that ORLADEYO was generally well tolerated, with gastrointestinal reactions being the most common adverse effects.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will present at two upcoming healthcare conferences: the Jefferies Healthcare Conference on June 8, 2022, at 9:00 a.m. ET, and the JMP Securities Life Sciences Conference on June 15, 2022, at 12:00 p.m. ET. Investors can access live audio webcasts and replays of these events via the Investors & Media section of BioCryst's website. The company specializes in developing oral small-molecule medicines for rare diseases, with drugs like ORLADEYO® approved in multiple regions, and several ongoing development programs including BCX9930 and galidesivir.