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BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) is a global biotechnology company dedicated to improving the lives of individuals living with rare and serious diseases. Founded in 1986, BioCryst specializes in designing, optimizing, and developing novel small-molecule drugs that block key enzymes involved in infectious and rare diseases. Headquartered in Research Triangle Park, North Carolina, with a discovery center in Birmingham, Alabama, the company harnesses its expertise in drug discovery, clinical development, regulatory affairs, and product commercialization.
BioCryst is known for its flagship product, ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor specifically designed to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older. The efficacy of ORLADEYO has been demonstrated through multiple clinical studies and real-world data, showing significant reductions in HAE attack rates across various patient profiles.
The company's robust pipeline includes several innovative programs such as BCX17725 for Netherton syndrome and avoralstat for diabetic macular edema (DME). BioCryst's research spans multiple scientific disciplines, including biology, computer modeling, and medicinal chemistry, targeting therapeutic areas like acute uncomplicated influenza, hereditary angioedema, filoviruses (Ebola and Marburg), and oncology.
In recent announcements, BioCryst reported strong financial performance with ORLADEYO net revenue experiencing substantial growth. The company also continues to expand globally, with recent approvals of ORLADEYO in major markets, including Brazil and Mexico. Partnerships with organizations such as Pint Pharma help BioCryst extend its reach and bring life-changing treatments to patients worldwide.
BioCryst remains committed to advancing its clinical programs, generating new compounds, and upholding a culture of engagement and accountability. The company's ongoing dedication to developing innovative therapeutics aims to address unmet medical needs and provide better health outcomes for patients suffering from rare and serious conditions.
For more information, please visit www.biocryst.com or follow them on LinkedIn.
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.
BioCryst Pharmaceuticals (BCRX) has received Orphan Drug designation from the FDA for its oral Factor D inhibitor, BCX9930, aimed at treating paroxysmal nocturnal hemoglobinuria (PNH), a rare and severe blood disorder. This designation qualifies BCX9930 for development incentives like tax credits and market exclusivity. Additionally, BCX9930 has also been granted Fast Track designation. Dr. William Sheridan highlighted the unmet medical need BCX9930 addresses, signaling a commitment to advancing this treatment efficiently.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced the grant of inducement stock options for 20 new employees, totaling 290,000 shares, effective July 31, 2020. The options, priced at $4.07 per share, reflect the closing stock price the prior day. Vested over four years, they are part of BioCryst's Inducement Equity Incentive Plan and are valid for a decade. The company focuses on developing novel oral treatments for rare diseases, with products like ORLADEYO™ and RAPIVAB® already in various stages of market approval.
BioCryst Pharmaceuticals (BCRX) is set to release its second quarter 2020 financial results on August 6, 2020. The company will host a conference call and webcast at 8:30 a.m. ET to discuss these results and provide a corporate update. Interested parties can access the call by dialing specific numbers for domestic and international callers and using the designated conference ID. BioCryst focuses on developing oral small-molecule medicines for rare diseases, with ongoing programs for treatments addressing hereditary angioedema, COVID-19, and other serious conditions.
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.