Biocryst Pharmaceuticals (BCRX) Stock News

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.

BioCryst Pharmaceuticals (BCRX) has appointed Steve Frank, chairman of global healthcare investment banking at J.P. Morgan, to its board of directors. Frank brings extensive healthcare investment banking experience, having previously served as global group head of worldwide healthcare investment banking at Bear Stearns. He has a notable background in institutional investing, having built State Farm's multi-billion-dollar life science equity portfolio in the 1980s and early 1990s.

The company highlighted its strong position with a commercial product approaching $1 billion in peak sales, a robust cash position independent of capital markets, and a pipeline of potential best-in-class medicines in development. Frank currently serves on Precigen's board and holds a CFA designation, along with degrees from Illinois State University and the University of Chicago.

BioCryst Pharmaceuticals (Nasdaq: BCRX) has announced its participation in three major investor conferences in May 2025:

• Citizens Life Sciences Conference in New York - May 8, 2025, at 9:00 a.m. ET
• Bank of America 2025 Health Care Conference in Las Vegas - May 14, 2025, at 1:40 p.m. ET
• RBC Capital Markets Global Healthcare Conference in New York - May 21, 2025, at 3:05 p.m. ET

Investors and interested parties can access live audio webcasts and replay recordings of these presentations through the Investors & Media section on BioCryst's website at biocryst.com.

BioCryst Pharmaceuticals (Nasdaq: BCRX) has announced it will release its first quarter 2025 financial results on Monday, May 5, 2025. The company will host a conference call and webcast at 8:30 a.m. ET on the same day, featuring management discussion of financial results and a corporate update.

Interested parties can access the live call by dialing 1-844-481-2942 (domestic) or 1-412-317-1866 (international). A live webcast and replay will be available in the investors section at www.biocryst.com.

BioCryst Pharmaceuticals (BCRX) has granted restricted stock units (RSUs) to 10 newly-hired employees as employment inducements. The grants, approved by the compensation committee, cover a total of 65,500 shares of BioCryst common stock and were issued on April 1, 2025.

The RSUs are structured to vest in four equal annual installments, with the first vesting occurring on the one-year anniversary of the grant date. Vesting is contingent upon continued employment with BioCryst. These equity awards were granted under BioCryst's Inducement Equity Incentive Plan and comply with Nasdaq Listing Rule 5635(c)(4).

BioCryst Pharmaceuticals (Nasdaq: BCRX) has announced its upcoming participation in the 24th Annual Needham Virtual Healthcare Conference. The presentation is scheduled for Wednesday, April 9, 2025, at 9:30 a.m. ET.

Investors and interested parties can access both the live audio webcast and a replay of the presentation through the Investors & Media section on BioCryst's official website at http://www.biocryst.com.

BioCryst Pharmaceuticals (BCRX) has announced the granting of restricted stock units (RSUs) to seven newly-hired employees. The compensation committee approved RSUs covering 65,900 shares of BioCryst common stock, granted on March 3, 2025. These inducement grants, issued under Nasdaq Listing Rule 5635(c)(4), will vest over four equal annual installments starting from the one-year anniversary of the grant date. The vesting is contingent upon continued employment with the company. The RSUs are governed by BioCryst's Inducement Equity Incentive Plan and respective RSU agreements.