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 (BCRX) is a biotechnology leader developing innovative therapies for rare diseases and infectious conditions through targeted enzyme inhibition. This news hub provides investors and healthcare professionals with timely updates on clinical developments, regulatory milestones, and strategic initiatives.
Access authoritative reporting on BCRX's pipeline progress, including updates on hereditary angioedema treatments and antiviral therapies. Our curated collection features earnings announcements, research breakthroughs, and partnership disclosures – all essential for tracking this biopharma innovator.
Key updates include FDA decisions, clinical trial results, and scientific publications. Bookmark this page for streamlined access to verified BioCryst news, eliminating the need to monitor multiple sources. Check regularly for developments impacting the company's position in enzyme inhibitor therapeutics and rare disease treatment markets.
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.
