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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 (Nasdaq: BCRX) has initiated the pivotal APeX-P trial, enrolling its first pediatric patient for the oral therapy ORLADEYO® (berotralstat) aimed at treating hereditary angioedema (HAE) in children aged 2 to <12 years. The trial will assess the pharmacokinetics and safety of ORLADEYO, following a 12-week standard-of-care period, leading into an open-label phase of 48 weeks and potentially extending to 144 weeks. The information gathered will support a supplemental New Drug Application (sNDA) for expanding ORLADEYO's use in pediatric patients. ORLADEYO is the first oral preventive therapy approved for HAE attacks in patients aged 12 years and older.
BioCryst Pharmaceuticals (BCRX) announced a collaboration with Swixx BioPharma AG to commercialize ORLADEYO (berotralstat) in Central and Eastern Europe (CEE). This partnership aims to make this oral prophylactic treatment for hereditary angioedema accessible to patients in 15 CEE markets. BioCryst is focused on addressing significant unmet needs in rare diseases, and Swixx brings extensive expertise in this area. The agreement highlights the commercialization efforts for a therapy that is the first oral treatment specifically designed to prevent HAE attacks in adults and children aged 12 and older.
BioCryst Pharmaceuticals (BCRX) reported preliminary ORLADEYO net revenue of $251.6 million for 2022, reflecting a 105% year-over-year increase. The fourth quarter generated $70.7 million in net revenue, a 53% increase from the previous year. Looking ahead, the company projects 2023 revenue to reach at least $320 million and anticipates peak ORLADEYO sales of $1 billion. Company executives noted strong market performance despite slight revenue lag due to seasonal factors.
BioCryst Pharmaceuticals (BCRX) announced promising initial data from its phase 1 trials for BCX10013, a potential best-in-class oral Factor D inhibitor targeting complement-mediated diseases. The trials demonstrated a sustained suppression of the alternative pathway by over 97% following a single dosage, indicating its safety and effectiveness. Plans are set to advance to patient studies for conditions like paroxysmal nocturnal hemoglobinuria (PNH) and immunoglobulin A nephropathy (IgAN). Additionally, the company is expanding its research on oral therapies for other complement pathways.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced its participation in the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 6:00 p.m. ET in San Francisco. The event will feature a presentation from the company, and a live audio webcast will be accessible on their website. BioCryst specializes in developing oral medicines for rare diseases, including its approved product ORLADEYO (berotralstat) and RAPIVAB (peramivir injection). The company is also advancing multiple therapeutic projects, including BCX10013.
BioCryst Pharmaceuticals (BCRX) has announced the discontinuation of its development program for BCX9930 due to recent competitive data presented at the ASH annual meeting, indicating it would not be commercially viable. The focus will now shift entirely to BCX10013, an oral Factor D inhibitor showing promise in clinical trials. This strategic pivot is expected to have a positive financial impact, lowering 2022 operating expenses by about $100 million. Preliminary data on BCX10013 is anticipated in Q1 2023, as BioCryst aims to expand its complement therapeutic program.
BioCryst Pharmaceuticals (BCRX) announced the granting of stock options and restricted stock units (RSUs) to 21 newly-hired employees as an inducement for employment. This grant, effective November 30, 2022, includes options to purchase 134,600 shares at an exercise price of $13.36, equal to the stock's closing price on the grant date. The options and RSUs will vest over four years, contingent upon continued employment. BioCryst focuses on developing small-molecule medicines for rare diseases, including the approved oral treatment ORLADEYO®.
BioCryst Pharmaceuticals (Nasdaq: BCRX) will present virtually at the JMP Securities Hematology & Oncology Summit on December 7, 2022, at 11:40 a.m. ET. The presentation will be accessible via a live audio webcast on their website. The company specializes in developing oral, small-molecule medications for rare diseases, with its product ORLADEYO® (berotralstat) already approved in the U.S. BioCryst also has ongoing clinical programs for oral factor D inhibitors BCX9930 and BCX10013.
BioCryst Pharmaceuticals (BCRX) announced the Israeli Ministry of Health has granted marketing authorization for ORLADEYO® (berotralstat), a once-daily oral therapy for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older. The company plans to partner with Neopharm for its launch in Israel. Clinical trials indicate ORLADEYO was safe and well tolerated, though gastrointestinal reactions were reported, typically resolving over time. This authorization marks a significant stride for HAE patients in Israel, providing a less burdensome treatment option.
BioCryst Pharmaceuticals (BCRX) unveiled new real-world data indicating that patients aged 12 and older using ORLADEYO (berotralstat) for hereditary angioedema (HAE) experience rapid and sustained reductions in attack rates. Presented at the 2022 ACAAI Annual Meeting, the data highlight significant efficacy improvements post-switch from other therapies, with an average attack rate reduction of 80% within the first 90 days. The results suggest ORLADEYO is effective regardless of prior treatment history, with lower adverse event rates compared to clinical trials.
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