BioCryst Lowers 2026 OpEx Guidance to $420–$440M, Closes Birmingham Lab
BCRX•BioCryst will discontinue internal discovery programs and close its Birmingham research facility by year-end 2026 to prioritize external innovation. The company completed Phase 3 ALPHA-ORBIT enrollment, resolved ORLADEYO pellet delays with availability in early August, and lowered its 2026 non-GAAP operating expense guidance to $420–$440 million.
1. Strategic Shift and Facility Closure
BioCryst will wind down its internal discovery programs and close the Birmingham Discovery Center of Excellence by the end of 2026. The move follows a strategic review that concluded external partnerships and licensing will be more capital efficient for building a sustainable rare disease pipeline beyond current clinical assets.
2. Phase 3 ALPHA-ORBIT Enrollment Completed
Enrollment in the ALPHA-ORBIT pivotal Phase 3 trial for navenibart, a long-acting plasma kallikrein inhibitor for hereditary angioedema, has been completed. This study, the largest HAE trial to date, will assess both 3- and 6-month dosing with topline efficacy data expected in Q3 2027.
3. ORLADEYO Pellet Delay Resolved
A previously disclosed manufacturing delay for ORLADEYO oral pellets intended for patients aged 2 to under 12 years has been resolved. The company expects the pediatric formulation to be available in early August 2026, restoring full market supply.
4. Updated 2026 Financial Outlook
BioCryst narrowed its full-year 2026 non-GAAP operating expense guidance from $450–$470 million to $420–$440 million, reflecting cost savings from the research facility wind-down. The company reaffirmed its ORLADEYO revenue guidance of $625–$645 million and total revenue guidance of $635–$660 million.
