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 its Q3 2020 financial results, reporting revenues of $6.1 million, up from $1.8 million in Q3 2019. The increase was primarily attributed to higher collaboration revenue and peramivir sales. R&D expenses rose to $30.2 million, and SG&A expenses increased to $17.2 million, reflecting costs associated with the upcoming launch of ORLADEYO. The net loss for the quarter was $46.1 million, or $0.26 per share, compared to a loss of $37.6 million or $0.34 per share a year earlier. The company expects full-year 2020 net operating cash use between $150 million and $165 million.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced the grant of inducement stock options to nine new employees, totaling 163,000 shares. The options, issued on October 30, 2020, have an exercise price of $3.82 per share, matching the closing stock price on the grant date. Vesting occurs in four equal annual installments starting after one year, subject to the employees' continued service. This issuance aligns with Nasdaq Listing Rule 5635(c)(4) and reflects BioCryst's commitment to attracting talent essential for its ongoing development programs targeting rare diseases.
BioCryst Pharmaceuticals (BCRX) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted a positive scientific opinion for berotralstat through the Early Access to Medicines Scheme (EAMS). This allows hereditary angioedema (HAE) patients aged 12 and older in the UK to access berotralstat for routine prevention before European Commission marketing authorization. The EAMS identifies medicines meeting high unmet needs, and berotralstat offers a significant advantage for HAE treatment. The European Medicines Agency is currently reviewing its marketing authorization application.
BioCryst Pharmaceuticals (BCRX) announced its participation in the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) from November 13-15, 2020. The company will present five abstracts, including a Distinguished Industry Oral Abstract on the APeX-2 trial, highlighting berotralstat's effectiveness in reducing attacks in patients with Hereditary Angioedema (HAE).
Additional presentations will focus on patient-reported quality of life, satisfaction, and treatment burden related to HAE. E-posters will be available online on November 13.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will announce its third quarter 2020 financial results on November 5, 2020. The management team plans to host a conference call and webcast at 8:30 a.m. ET to discuss the results and provide an update on corporate developments.
Investors can join the call at 877-303-8027 for domestic callers and 760-536-5165 for international callers, using conference ID # 3766784. A live webcast will be accessible on the company’s website.
BioCryst Pharmaceuticals has reported significant efficacy results from the APeX-2 trial of berotralstat, a potential oral treatment for hereditary angioedema (HAE). Over 24 weeks, both 110 mg and 150 mg doses of berotralstat notably reduced HAE attack rates compared to placebo, with the 150 mg dose showing superior results. The findings, published in the Journal of Allergy and Clinical Immunology, highlight berotralstat's safety and tolerability. The FDA is set to decide on the new drug application by December 3, 2020.
BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options to 12 new employees totaling 213,000 shares. The options, exercisable at $3.44 per share, were awarded on September 30, 2020, in line with Nasdaq Listing Rule 5635(c)(4). They will vest in four annual installments, subject to continued employment, and have a 10-year term. This initiative highlights BioCryst's commitment to attracting talent necessary for advancing its drug development programs, including treatments for rare diseases and COVID-19.
BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options to 22 new employees. A total of 333,000 shares were allocated at an exercise price of $4.15, equal to the stock's closing price prior to the grant date. The options will vest over four years, starting one year after the grant, and have a 10-year term. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract and retain talent critical for BioCryst's growth, particularly as it advances its novel treatments for rare diseases.
BioCryst Pharmaceuticals (BCRX) announced the U.S. Department of Health and Human Services (HHS) will purchase 10,000 additional doses of RAPIVAB (peramivir injection) for approximately $7 million. This order supports the Strategic National Stockpile amid concerns over the influenza season during the COVID-19 pandemic. The purchase is part of a broader $34.7 million contract from 2018, allowing procurement of up to 50,000 doses over five years. RAPIVAB is approved for treating acute uncomplicated influenza in patients aged 2 and older.
BioCryst Pharmaceuticals (BCRX) announced a $44 million contract from NIAID and an additional $3 million to further develop galidesivir, a broad-spectrum antiviral. The funds will support ongoing clinical trials, including a phase 2 trial for non-hospitalized COVID-19 patients and a trial assessing dosing for patients with renal impairment. Galidesivir has shown effectiveness against various RNA viruses, and the company is accelerating its manufacturing to increase supply. The contract reflects continued government investment in combating COVID-19 and future viral threats.