BioCryst reports Q3 2026 results, ORLADEYO pellet approval, and raises revenue guidance
The company got FDA approval for ORLADEYO oral pellets in patients 12 and older and lifted its full-year total revenue outlook to $715 million to $730 million.
BioCryst Pharmaceuticals reported financial results for the quarter ended September 30, 2026 on November 4, 2026. In October, the FDA approved the company's supplemental New Drug Application for the use of the oral pellet formulation of once-daily ORLADEYO for patients with HAE aged 12 years and older.1 The pellet formulation had already launched in August for patients aged 2 to under 12, with early reimbursement strong and new prescriptions ahead of the company's expectations.1
In August, the company commenced operations with CareMed as its sole-source specialty pharmacy partner for ORLADEYO shipments to patients.1
On the pipeline, the company is studying BCX17725, an investigational KLK5 inhibitor for Netherton syndrome, in a Phase 1 trial, and has enrolled Part 4, with initial data expected by the end of 2026.1 Navenibart, an investigational long-acting plasma kallikrein inhibitor, is being studied in the fully enrolled ALPHA-ORBIT pivotal study and the ORBIT-EXPANSE extension study, with top-line results at six- and twelve-month endpoints expected in Q3 2027.1
The company has discontinued development of STAR-0310, an early-stage atopic dermatitis program acquired through the Astria Therapeutics acquisition, after concluding its exploration of partnering opportunities.1 Birmingham site closure activities remain on track to be substantially complete by year-end, with expected total cash costs of about $10 million and annualized savings of $30 million to $35 million once fully realized.1
Financially, total net revenue was $180.3 million and ORLADEYO net revenue was $174.8 million, with operating profit of $53.3 million.1 The company maintained its full year ORLADEYO revenue outlook of $625 million to $645 million and raised total revenue guidance to $715 million to $730 million, driven mainly by higher revenue from licensing navenibart's European rights and higher RAPIVAB orders.1 Cash, cash equivalents, restricted cash and investments totaled $376.4 million as of September 30, 2026.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.