Biocryst Pharmaceuticals (BCRX) Stock News

BioCryst Pharmaceuticals announced that ORLADEYO (berotralstat) has received reimbursement approval in the Netherlands for preventing hereditary angioedema (HAE) attacks in patients 12 years and older. This milestone completes ORLADEYO's reimbursement coverage across all major European countries, marking significant progress for the first oral, once-daily preventive therapy for HAE. The approval follows a positive recommendation from Zorginstituut Nederland and builds upon the European Commission's marketing authorization granted in April 2021. ORLADEYO is now commercially available in over 30 countries, representing a major advancement in HAE treatment accessibility.

BioCryst Pharmaceuticals (BCRX) has granted restricted stock units (RSUs) to seven newly-hired employees as employment inducements. The compensation committee approved RSUs covering 47,250 shares of BioCryst common stock, effective June 2, 2025. These equity awards, granted under Nasdaq Listing Rule 5635(c)(4), will vest over four years in equal annual installments, starting from the one-year anniversary of the grant date. The vesting is contingent upon continued employment with BioCryst. The RSUs are governed by BioCryst's Inducement Equity Incentive Plan and individual RSU agreements.

BioCryst Pharmaceuticals (BCRX) announced it will present new data on ORLADEYO (berotralstat), its oral once-daily treatment for hereditary angioedema (HAE), at the 2025 EAACI meeting in Glasgow. The company will showcase four abstracts highlighting different aspects of ORLADEYO's effectiveness: a pooled analysis of quality of life data from APeX-2 and APeX-J trials, patient perceptions from focus groups, long-term prophylaxis findings from the Berolife study, and interim results from APeX-P showing reduced HAE attacks in pediatric patients. The presentations are scheduled for June 14-15, 2025.

BioCryst Pharmaceuticals presented new data at the 14th C1-inhibitor Deficiency & Angioedema Workshop demonstrating ORLADEYO's (berotralstat) effectiveness in reducing hereditary angioedema (HAE) attacks across all age groups. The APeX-P trial showed significant symptom reduction in young children, with angioedema symptoms decreasing from 11% to 4% over 12 weeks. The Italian expanded access program revealed improved disease control and quality of life scores, while the Berolife study demonstrated sustained attack rate reduction in adolescents from 1.8 to 0.55 attacks per month. The drug showed consistent safety profiles across all age groups, with common side effects including nasopharyngitis, upper respiratory tract infection, and headache. The data supports ORLADEYO as an effective oral, once-daily prophylactic treatment option for HAE patients of all ages.

BioCryst Pharmaceuticals (NASDAQ: BCRX) has announced its participation in two major upcoming investor conferences. The company will present at the Jefferies Global Healthcare Conference in New York on June 4, 2025, at 4:55 p.m. ET, and at the Goldman Sachs 46th Annual Global Healthcare Conference in Miami on June 9, 2025, at 8:40 a.m. ET. Investors can access live audio webcasts and replays of both presentations through the Investors & Media section of BioCryst's website.

BioCryst Pharmaceuticals (BCRX) presented new real-world evidence demonstrating the effectiveness of ORLADEYO® (berotralstat) in treating Hereditary Angioedema (HAE) at ISPOR 2025. The study analyzed data from December 2020 to January 2024, focusing on two patient groups: 1. Severe HAE Patients (56 patients): - Baseline: 7.78-8.23 attacks/month - After ORLADEYO: 1.24-1.90 attacks/month - At 18 months: 6.43 fewer attacks/month 2. Adolescent Patients (99 patients aged 12-17): - Baseline: 2.07-2.30 attacks/month - After ORLADEYO: 0.36-0.76 attacks/month - At 18 months: 1.85 fewer attacks/month The results demonstrate significant and sustained reductions in HAE attack rates through 18 months of treatment, showing ORLADEYO's effectiveness across different patient populations.

The FDA has accepted BioCryst Pharmaceuticals' (BCRX) New Drug Application for ORLADEYO® oral granules to treat hereditary angioedema (HAE) in children aged 2-11 years. The FDA granted Priority Review with a PDUFA target date of September 12, 2025.

The application is based on positive interim data from the APeX-P clinical trial, showing ORLADEYO was well-tolerated with sustained reductions in monthly attack rates. The trial revealed HAE symptoms typically onset at age two, indicating a significant early disease burden. If approved, ORLADEYO would become the first targeted oral prophylactic therapy for HAE patients under 12 years old.

BioCryst has also filed for approval in Europe, with plans for additional submissions in Japan and Canada. ORLADEYO is currently approved for patients 12 years and older in over 30 countries since December 2020.

BioCryst Pharmaceuticals reported strong Q1 2025 financial results, with ORLADEYO net revenue reaching $134.2 million, a 51% year-over-year increase. The company raised its full-year 2025 ORLADEYO revenue guidance to $580-600 million, up from $535-550 million. Total revenues were $145.5 million, up 56.8% year-over-year. BioCryst achieved profitability ahead of schedule, now expecting net income and positive cash flows for full year 2025. The company paid down $75 million in debt, saving approximately $23.5 million over the loan's life. Key developments include an NDA submission for ORLADEYO oral granules for children with HAE aged 2-11, and FDA clearance of the IND for BCX17725 for Netherton syndrome. The percentage of ORLADEYO patients on paid drug increased to 84%, and U.S. HAE patients showing strong preference for oral prophylaxis therapy rose to 70%.

BioCryst Pharmaceuticals (BCRX) has granted restricted stock units (RSUs) to seven newly-hired employees, covering a total of 48,000 shares of common stock. The RSUs were awarded on May 1, 2025 as employment inducements and comply with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years in equal annual installments, beginning one year from the grant date, contingent on continued employment. These grants are governed by BioCryst's Inducement Equity Incentive Plan and individual RSU agreements.