BioCryst Pharmaceuticals, Inc. develops and commercializes medicines for hereditary angioedema and other rare diseases. Its commercial product ORLADEYO® (berotralstat) is an oral, once-daily plasma kallikrein inhibitor for HAE, and company updates commonly report ORLADEYO revenue, commercial execution, and financial results.
BioCryst news also covers pipeline and portfolio developments, including investigational plasma kallikrein inhibitor navenibart, rare-disease research programs, licensing arrangements, acquisitions, senior R&D leadership changes, investor conference activity, and Nasdaq inducement equity grants tied to new employee hiring.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced findings published in Science Translational Medicine showing that galidesivir demonstrated safety and effective post-exposure prevention against Zika virus in Rhesus macaques. Administered up to 72 hours post-infection, galidesivir reduced viral loads to undetectable levels. The data suggest its potential application against SARS-CoV-2, given the ongoing pandemic. Galidesivir has shown broad-spectrum antiviral activity against over 20 RNA viruses and is currently in a Phase 1 trial for COVID-19 in Brazil.
BioCryst Pharmaceuticals (BCRX) announced the launch of an expanded access program (EAP) for berotralstat, a once-daily oral treatment for hereditary angioedema (HAE). This EAP allows U.S. physicians to request berotralstat for patients unable to access it through clinical trials. The FDA is reviewing a new drug application for berotralstat, with a decision expected by December 3, 2020. BioCryst focuses on developing innovative, oral treatments for rare diseases, with several ongoing drug development programs, including options for COVID-19.
BioCryst Pharmaceuticals (Nasdaq:BCRX) presented findings from patient surveys on hereditary angioedema (HAE) treatments. Results revealed that patients using injectable therapies (Takhzyro®, Haegarda®, Cinryze®) experienced a mean of 0.9 to 1.8 breakthrough attacks in three months. Notably, 85% of respondents reported using preventative medications, with 21% expecting zero attacks within a year. The data was shared at the European Academy of Allergy and Clinical Immunology Digital Congress, indicating a strong demand for new oral treatment options.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced positive data from the APeX-2 and APeX-S clinical trials for berotralstat, an oral treatment for hereditary angioedema (HAE). Over 48 weeks, patients experienced significant reductions in attack frequency and improvements in quality of life scores. In APeX-2, attack rates dropped from 2.9 to 1.0 per month, while in APeX-S, 73% of patients reported zero attacks in the last six months. Berotralstat was well tolerated, with similar adverse events to placebo. The findings were presented at the EAACI Digital Congress.
BioCryst Pharmaceuticals (BCRX) granted inducement options for 147,500 shares to five newly-hired employees on May 29, 2020. The options have an exercise price set at $4.50, matching the stock's closing price before the grant. They vest in four equal annual installments starting one year from the grant date and have a 10-year term in line with BioCryst’s Inducement Equity Incentive Plan. This initiative aligns with NASDAQ Listing Rule 5635(c)(4) and aims to attract talent to advance BioCryst's innovative drug development portfolio.
BioCryst Pharmaceuticals (Nasdaq: BCRX) has successfully completed a public offering of 22,044,447 shares of common stock, generating approximately $115 million in gross proceeds. This includes the full exercise of underwriters’ options for 3,333,334 shares and pre-funded warrants for up to 3,511,111 shares. The funds will be utilized for various purposes, including the development of berotralstat and BCX9930, regulatory activities, and general corporate needs.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced its participation in the Jefferies Virtual Healthcare Conference on June 4, 2020, at 10:30 a.m. ET. The event aims to showcase the company's innovations in treating rare diseases through novel, oral, small-molecule medicines. Noteworthy development programs include berotralstat for hereditary angioedema and BCX9930, an oral Factor D inhibitor. A live audio webcast of the presentation will be available on BioCryst's website for investors.
BioCryst Pharmaceuticals (BCRX) has priced an underwritten public offering of 18,711,113 shares at $4.50 per share, alongside pre-funded warrants for an additional 3,511,111 shares at $4.49 each. The total gross proceeds are expected to reach $100 million before expenses. The offering will close around June 1, 2020, pending customary conditions. Proceeds will support various corporate initiatives, including development of berotralstat and BCX9930, among others. J.P. Morgan and Piper Sandler are managing the offering.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced it will present new data on berotralstat (BCX7353), an oral therapy for hereditary angioedema (HAE), at the upcoming European Academy of Allergy and Clinical Immunology (EAACI) digital congress from June 6-8. Key data include findings from the APeX-S and APeX-2 studies, showcasing berotralstat's long-term safety and significant reduction in HAE attacks. As regulatory approvals approach in the U.S., Japan, and EU, Dr. William Sheridan emphasized berotralstat's potential impact on HAE patients.
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