BioCryst Announces Approval of ORLADEYO® for Pediatric HAE Patients in Japan
— Expands availability of the first and only oral prophylactic therapy for patients with HAE ages 2 to
Company profile
BioCryst Pharmaceuticals, Inc.
Pipeline5 assets
- ORLADEYO (berotralstat)ORLADEYO / plasma kallikrein / oral small-molecule inhibitor / Rare diseasesHereditary angioedema (HAE) prophylaxisApproved/Commercialmarketed
- ORLADEYO (berotralstat) in PediatricsORLADEYO / plasma kallikrein / oral small-molecule inhibitor / Rare diseasesHereditary angioedema (HAE) prophylaxis, ages 2 to <12Approved/Commercialmarketed
- NavenibartSTAR-0215 / plasma kallikrein / monoclonal antibody inhibitor / Rare diseasesHereditary angioedema (HAE) prophylaxisPhase 3/Pivotalinvestigational
- BCX17725BCX17725 / KLK5 / protein therapeutic / Rare diseasesNetherton syndromePhase 1investigational
- STAR-0310STAR-0310 / OX40 / monoclonal antibody antagonist / Immunology/DermatologyAtopic dermatitisPreclinicalinvestigational; strategic alternatives planned
Latest news17 items
All newsBioCryst Reports Second Quarter 2026 Financial Results
— Total net revenue of $218.3 million and ORLADEYO ® net revenue of $158.2 million — — Operating profit of $98.5 million and Non-GAAP operating profit of $113.2 million — — Maintained Full Year 2026 ORLADEYO revenue guidance of $625 to $645 million and increased total revenue guidance to $690
Enrollment • Phase 3Enrollment completion Tue, Jun 30, 2026
BioCryst to Report Second Quarter 2026 Financial Results on August 5
RESEARCH TRIANGLE PARK, N.C., July 22, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will report its second quarter 2026 financial results on Wednesday, August 5, 2026. BioCryst management will host a conference call and webcast at 8:30 a.m.
BioCryst Appoints David W. Jenkins as Chief Scientific Officer
RESEARCH TRIANGLE PARK, N.C., July 15, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) (“BioCryst” or the “Company”) today announced the appointment of David W. Jenkins, MA, PhD, to the newly created position of Chief Scientific Officer, effective immediately, reporting to
BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
RESEARCH TRIANGLE PARK, N.C., July 02, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst’s board of directors granted nine newly-hired employees stock options to purchase an aggregate of 33,950 shares, and restricted
BioCryst Sharpens Scientific Focus on External Innovation with Wind Down of Internal Discovery Programs and Closure of Birmingham Research Facility
—Advances strategic shift toward a disciplined research model prioritizing external innovation to accelerate rare disease pipeline growth— —Completes enrollment in Phase 3 ALPHA-ORBIT for navenibart, largest pivotal HAE study to date— —Resolves previously disclosed manufacturing delay of ORLADEYO ®
Enrollment • Phase 3Enrollment completion Mon, Jun 29, 2026
BioCryst Presents New Clinical Data and Real-World Evidence Demonstrating Impact of HAE Portfolio at the 2026 European Academy of Allergy and Clinical Immunology Annual Meeting
— Growing body of ORLADEYO ® clinical data and real-world evidence demonstrates consistent reductions in HAE attack burden and healthcare utilization across diverse patient populations — New post hoc analysis of Phase 1b/2 ALPHA-STAR study of investigational navenibart demonstrates consistent
Presentation / Abstract • Phase 1EAACI poster presentation Fri, Jun 12, 2026, 12:00 PM TRT
BioCryst to Present New HAE Data from ORLADEYO® (berotralstat) and Navenibart at the 2026 European Academy of Allergy and Clinical Immunology Annual Meeting
RESEARCH TRIANGLE PARK, N.C., May 27, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present seven abstracts from its hereditary angioedema (HAE) portfolio at the Annual Meeting of the European Academy of Allergy and Clinical Immunology
Presentation / AbstractEAACI poster presentation Fri, Jun 12, 2026, 12:00 PM TRT
BioCryst to Present New Real-World Evidence Underscoring the Ongoing Burden of Pediatric Hereditary Angioedema at ISPOR 2026
RESEARCH TRIANGLE PARK, N.C., May 13, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present new real-world evidence at the 2026 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) conference taking place in
BioCryst Reports First Quarter 2026 Financial Results and Provides Business Update
— Q1 2026 ORLADEYO ® net revenue of $148.3 million (+11% y-o-y; +21% y-o-y on comparable basis excluding European revenue) — — Announced licensing agreement for European commercial rights to navenibart for $70M upfront and milestone payments up to $275M — RESEARCH TRIANGLE PARK, N.C., May 06, 2026
BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
RESEARCH TRIANGLE PARK, N.C., May 05, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst’s board of directors granted six newly-hired employees restricted stock units (RSUs) covering an aggregate of 61,750 shares of
BioCryst Announces European Licensing Agreement with Irish Affiliate of Neopharmed Gentili for Navenibart in Hereditary Angioedema
— BioCryst grants Irish affiliate of Neopharmed Gentili exclusive license to commercialize navenibart for hereditary angioedema in Europe — — BioCryst to receive $70M upfront, up to $275M in future regulatory and sales milestone payments, and royalties on sales ranging from 18 to 30 percent — —
BioCryst to Present at Upcoming Investor Conferences
RESEARCH TRIANGLE PARK, N.C., April 28, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company plans to present at the following conferences: Bank of America Health Care Conference in Las Vegas on Tuesday, May 12, 2026, at 4:40 p.m. ET.
BioCryst to Report First Quarter 2026 Financial Results on May 6
RESEARCH TRIANGLE PARK, N.C., April 15, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will report its first quarter 2026 financial results on Wednesday, May 6, 2026. BioCryst management will host a conference call and webcast at 8:30 a.m.
BioCryst Appoints Sandeep M. Menon Chief Research and Development Officer
— Experienced R&D leader with a track record of advancing innovative therapies from early development to global approval — RESEARCH TRIANGLE PARK, N.C., April 06, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the appointment of Sandeep M.
BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
RESEARCH TRIANGLE PARK, N.C., April 03, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst’s board of directors granted 12 newly-hired employees stock options to purchase an aggregate of 33,950 shares, and restricted
BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
RESEARCH TRIANGLE PARK, N.C., March 04, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the compensation committee of BioCryst’s board of directors granted six newly-hired employees restricted stock units (RSUs) covering an aggregate of 65,850 shares of