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) has received FDA orphan drug designation for BCX9250, aimed at treating fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder. This designation offers benefits like tax credits, user fee exemptions, and potential market exclusivity. BioCryst is also preparing for trials in FOP patients next year following earlier Fast Track and EMA PRIME designations for BCX9250. The drug demonstrated safety and tolerability in Phase 1 trials, supporting once-daily dosing. The upcoming American Society for Bone and Mineral Research meeting will feature data from BCX9250 studies.
BioCryst Pharmaceuticals announced promising results for its oral Factor D inhibitor, BCX9930, in patients with C3 glomerulopathy (C3G). The study demonstrated over 99% suppression of the alternative pathway (AP) of the complement system, maintained for 24 hours after dosing. The drug achieved rapid suppression of C3a levels and was generally safe and well-tolerated. These findings support further development of BCX9930 for treating C3G and other complement-mediated diseases. The data will be presented at the 18th European Meeting on Complement in Human Disease in Bern, Switzerland.
On August 25, 2022, BioCryst Pharmaceuticals (BCRX) announced a contract extension with the U.S. Department of Health and Human Services (HHS) to supply an additional 10,000 doses of its antiviral drug, RAPIVAB (peramivir injection), valued at approximately $7 million. This order fulfills the final requirement under a $34.7 million contract for 50,000 doses over five years, aimed at enhancing pandemic preparedness. RAPIVAB is approved for treating acute influenza in patients over six months old, with administration via intravenous infusion.
BioCryst Pharmaceuticals (BCRX) announced that the Saudi Food and Drug Authority has approved ORLADEYO® (berotralstat) for the prevention of hereditary angioedema attacks in patients aged 12 and older. This approval highlights the demand for new HAE treatment options in Saudi Arabia. ORLADEYO is the first oral therapy specifically designed for HAE prophylaxis. BioCryst also has distribution agreements with NewBridge Pharmaceuticals for the GCC region. The drug demonstrated safety and tolerability in clinical trials, with some common adverse reactions noted.
BioCryst Pharmaceuticals (BCRX) reported Q2 2022 net revenue of $65.2 million, a 129% increase year-over-year. The company anticipates FY 2022 ORLADEYO net revenue of $255 million to $265 million and projects peak global sales of ORLADEYO nearing $1 billion. Growth continues in patient prescriptions, with a significant portion from key HAE treaters. However, R&D expenses rose to $62.0 million, and net losses increased to $58.9 million. The company has lifted the clinical hold on BCX9930 and expects increased focus on its development.
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.
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