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 (Nasdaq:BCRX) announces its participation in two upcoming virtual healthcare conferences. The first is the Cowen 41st Annual Healthcare Conference on March 4, 2021, at 12:10 p.m. ET, followed by the Barclays Annual Healthcare Conference on March 11, 2021, at 8:00 a.m. ET. Interested investors can access live audio webcasts and replays via the investors section of BioCryst’s website.
BioCryst focuses on developing novel oral medicines for rare diseases, with key products like ORLADEYO™ and RAPIVAB® for treating various conditions.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will announce its fourth quarter and full year 2020 financial results on February 25, 2021. Management will host a conference call at 8:30 a.m. ET to discuss these results and provide a corporate update. The call can be accessed by dialing 877-303-8027 for domestic and 760-536-5165 for international callers. Additionally, BioCryst's lead product, ORLADEYO™, is under regulatory review in the European Union, while ongoing developments include treatments for rare diseases and viral infections.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that data on ORLADEYO™ (berotralstat) will be presented at the 2021 American Academy of Allergy, Asthma & Immunology annual meeting, from February 26 to March 1, 2021. Key presentations include:
- Berotralstat Reduces Use of On-demand Medication in HAE Patients
- Despite Prophylactic Treatments, Break-through Attacks Continue
- Berotralstat Demonstrates Reductions in Attack Frequency in HAE
ORLADEYO is the first oral therapy specifically designed to prevent HAE attacks in patients 12 and older.
BioCryst Pharmaceuticals (BCRX) announced that the FDA has approved a supplemental new drug application for RAPIVAB (peramivir injection). This approval expands RAPIVAB's indication to treat acute uncomplicated influenza in patients aged six months and older, symptomatic for no more than two days. Previously, the drug was only indicated for patients two years and older. The FDA approval is a significant milestone, enhancing RAPIVAB's market potential and patient accessibility.
BioCryst Pharmaceuticals, Inc. (BCRX) announced marketing approval for ORLADEYO (berotralstat) in Japan for the prophylactic treatment of hereditary angioedema in patients aged 12 and older. It is the first oral HAE medication approved in the country. The product will be marketed by Torii Pharmaceutical Co., Ltd., pending pricing negotiations with Japan’s National Health Insurance. Following this approval, BioCryst is set to receive a $15 million milestone payment and tiered royalties of 20-40% on net sales. Approval is supported by recent clinical trials demonstrating efficacy and safety.
BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options to 10 newly-hired employees on December 31, 2020, allowing the purchase of 240,500 shares at $7.45 each, equal to the stock’s closing price on the grant date. These options vest in four equal annual installments, subject to continued service. The initiative complies with Nasdaq Listing Rule 5635(c)(4), aiming to attract talent and align incentives with the company’s growth strategy.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 11:40 a.m. ET via a virtual event. Interested parties can access a live audio webcast and replay through the Investors section of BioCryst’s website. The company focuses on developing oral medicines for rare diseases, with products like ORLADEYO™ approved in the U.S. for HAE prevention and others in development, including BCX9930 and galidesivir for various conditions.
BioCryst Pharmaceuticals (BCRX) announced the results of part 1 of a clinical trial for its antiviral drug, galidesivir, targeting SARS-CoV-2. The trial demonstrated that galidesivir was safe and well tolerated among patients, although it did not show clinical efficacy compared to placebo. The company will refocus its efforts on galidesivir for biodefense against diseases like Marburg virus, discontinuing its COVID-19 indication. The trial, conducted in Brazil, involved 24 patients and revealed a rapid decline in viral RNA levels with no safety concerns.
BioCryst Pharmaceuticals (BCRX) announced positive results from a Phase 1 clinical trial of BCX9250, an oral ALK-2 inhibitor for fibrodysplasia ossificans progressiva (FOP). The trial demonstrated safety and tolerability at all doses studied, supporting once-daily administration. No serious adverse events occurred, and pharmacokinetics showed dose-proportional exposure. With no current treatments available for FOP, these results provide hope for patients. BioCryst plans further discussions with physicians and regulators to advance BCX9250 development.
BioCryst Pharmaceuticals (BCRX) has initiated direct shipments of ORLADEYO™ (berotralstat), the first oral once-daily prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older. Following FDA approval on December 3, 2020, Optime Care, the exclusive specialty pharmacy, has commenced shipments. The EMPOWER Patient Services program provides streamlined access and financial support to HAE patients, aiming for a comprehensive treatment journey. ORLADEYO is designed to reduce plasma kallikrein activity, preventing HAE attacks, but should not be used for acute attack treatment.