On May 6, 2026 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the quarter ended March 31, 2026, and provided a business update.

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"We began 2026 with continued strong execution across our business, led by sustained growth of ORLADEYO and solid progress across our pipeline," said Charlie Gayer, President and Chief Executive Officer of BioCryst. "ORLADEYO continues to grow because its differentiated oral profile and high level of attack control meet the needs of an increasing number of people living with hereditary angioedema. At the same time, we remain on track with enrollment in our navenibart and BCX17725 pipeline programs. We are also pleased to partner again with Neopharmed Gentili for European rights to navenibart. This progress underscores our strategy to focus on rare diseases where we have deep expertise, execute efficiently, and allocate capital thoughtfully to drive sustainable value for patients and shareholders."

Business & Corporate Updates

New patient prescriptions in Q1 2026 continued to be strong, driving ORLADEYO revenue of $148.3 million (+11% y-o-y; +21% y-o-y on a comparable basis excluding European revenue).
Patient enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart in hereditary angioedema, is on track to be completed by the end of this June. The program remains on track to support regulatory filing in the US by the end of 2027. Navenibart is an investigational, long-acting plasma kallikrein inhibitor being studied with every three-month and every six-month subcutaneous dosing.
In May, the company announced that it entered into a licensing agreement with an Irish affiliate of Neopharmed Gentili for exclusive rights to commercialize navenibart in Europe for the prophylaxis of hereditary angioedema. BioCryst will receive upfront consideration of $70M and will be eligible to receive up to $275M in future regulatory and sales milestone payments. BioCryst will also receive tiered royalties on net sales ranging from 18% to 30%. Navenibart is an investigational product that has not yet received regulatory approval in the US or Europe.
The company is studying BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, in a Phase 1 trial. The company has begun dosing in Part 4 of this trial, which will enroll up to 12 patients for three months, and expects to report data from this part by the end of 2026.
In Q1 2026, the company ended development of avoralstat, a plasma kallikrein inhibitor for the treatment of diabetic macular edema, to focus the pipeline on rare diseases.
In April, the company appointed Sandeep M. Menon as Chief Research and Development Officer. Dr. Menon brings deep drug development expertise to the leadership team and will lead the company’s R&D efforts with a focused, disciplined, and capital efficient approach.
First Quarter 2026 Financial Results

On January 23, 2026, BioCryst completed the acquisition of Astria Therapeutics, Inc. ("Astria"). The transaction was accounted for as an asset acquisition and as a result, BioCryst recognized a special, non-cash expense of $697.8 million in Q1 2026 related to the acquired in-process research and development asset for navenibart.

The accompanying tables provide GAAP and non-GAAP financial information. Non-GAAP measures include adjustments, as applicable, for the sale of the European ORLADEYO business on October 1, 2025, stock-based compensation, and expenses incurred in connection with the acquisition of Astria, including acquired in-process research and development expense, assembled workforce amortization, severance and retention related costs, and the portion of the Astria stock option payout attributable to post-combination service. Management believes that the presentation of these non-GAAP figures can provide greater transparency into the financial results of core, ongoing operations and improve comparability across reporting periods by excluding items that are non-recurring or other items that may vary significantly from period to period.

BioCryst recorded a GAAP operating loss of $701.6 million for the first quarter of 2026, primarily reflecting the special, non-cash charge related to acquired in-process research and development. On a non-GAAP basis, the company recorded an operating profit of $54.2 million. Additional details on individual adjustments are included in the accompanying financial tables.

Cash, cash equivalents, restricted cash and investments at March 31, 2026, totaled $260.8 million. On a pro-forma basis, including net proceeds of $70 million from the license of European navenibart rights to Neopharmed Gentili after quarter end, cash, cash equivalents, restricted cash and investments at March 31, 2026, totaled $330.8 million.

Financial Outlook for 2026

The company maintained its expectation for full year 2026 global net ORLADEYO revenue to be between $625 million and $645 million and for full year 2026 total revenue, including RAPIVAB (peramivir injection), to be between $635 million and $660 million.

The company also maintained its expectation for full year 2026 non-GAAP operating expenses, excluding stock-based compensation, restructuring, and transaction-related costs, to be between $450 million and $470 million.

Item As of May 6, 2026 As of February 26, 2026
ORLADEYO revenue Unchanged $625 million to $645 million
Total revenue Unchanged $635 million to $660 million
Non-GAAP operating expense Unchanged $450 million to $470 million

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

(Press release, BioCryst Pharmaceuticals, MAY 6, 2026, View Source [SID1234665184])