Nipocalimab-aahu

2026 Third-Quarter reported sales growth of 5.9% to $25.4 Billion with operational growth of 6.0%* and adjusted operational growth of 6.1%* 2026 Third-Quarter earnings per share (EPS) of $0.09 reflects a one-time special charge for the proposed talc litigation resolution, the acquisition of Firefly Bio, Inc., and the strategic collaboration with Sail Biomedicines; adjusted EPS* of $2.59 also reflects the impact of these M&A deals Strong operational performance results in the Company increasing 2026 guidance with estimated reported sales of $101.2 Billion or 7.4% at the midpoint and increasing adjusted EPS* guidance by $0.06 to $11.10 or 2.9% at the midpoint Significant innovation including the market authorization of OTTAVA as the world’s first table-integrated soft tissue robotic system, approval of IMAAVY in warm autoimmune hemolytic anemia (wAIHA), and priority review for RYBREVANT FASPRO for advanced head and neck cancer NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2026. “Johnson & Johnson’s strong third-quarter performance and increased sequential growth reflect the accelerating momentum of our focused portfolio,” said Joaquin Duato, Chairman and Chief Executive Officer. “In the third quarter, we advanced breakthroughs that will redefine care for patients, from delivering one of our most transformative MedTech innovations with OTTAVA to reporting positive Phase 3 results in multiple myeloma. This progress, together with strategic investments in high-growth areas, gives us clearer line of sight to double-digit growth by the end of the decade.” Overall financial results Q3 ($ in Millions, except EPS) 2026 2025 % Change Reported Sales $25,399 $23,993 5.9% Net Earnings $210 $5,152 (95.9)% EPS (diluted) $0.09 $2.12 (95.8)% Q3 Non-GAAP* ($ in Millions, except EPS) 2026 2025 % Change Operational Sales 1,2 6.0% Adjusted Operational Sales 1,3 6.1% Adjusted Net Earnings 1,4 $6,339 $6,801 (6.8)% Adjusted EPS (diluted) 1,4 $2.59 $2.80 (7.5)% Free Cash Flow 5,6 ~$15,100 $14,226 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Non-GAAP financial measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 6 Third-quarter YTD 2026 is estimated as of October 13, 2026 Note: values may have been rounded Regional sales results Q3 % Change ($ in Millions) 2026 2025 Reported Operational 1,2 Currency Adjusted Operational 1,3 U.S. $14,959 $13,708 9.1% 9.1 - 9.1 International 10,440 10,285 1.5 1.8 (0.3) 1.9 Worldwide $25,399 $23,993 5.9% 6.0 (0.1) 6.1 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Segment sales results Q3 % Change ($ in Millions) 2026 2025 Reported Operational 1,2 Currency Adjusted Operational 1,3 Innovative Medicine $16,757 $15,563 7.7% 7.9 (0.2) 8.0 MedTech 8,642 8,430 2.5 2.5 0.0 2.5 Worldwide $25,399 $23,993 5.9% 6.0 (0.1) 6.1 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Third-Quarter 2026 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 7.9%*, with divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by TREMFYA and new products within Other in Immunology, DARZALEX, CARVYKTI, TECVAYLI, RYBREVANT/LAZCLUZE, and ERLEADA in Oncology, and SPRAVATO and CAPLYTA in Neuroscience. Growth was partially offset by STELARA (an approximate 690 basis points impact), SIMPONI/SIMPONI ARIA, and REMICADE in Immunology, as well as OPSUMIT/OPSYNVI in Pulmonary Hypertension, and IMBRUVICA in Oncology. MedTech MedTech worldwide operational sales grew 2.5%*. Growth was primarily driven by electrophysiology products and Shockwave in Cardiovascular, contact lenses in Vision, as well as trauma in Orthopaedics. Full-year 2026 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) October 2026 July 29, 2026 Adjusted Operational Sales 1,2 Change vs. Prior Year / Mid-point 6.4% – 6.8% / 6.6% 6.2% – 6.8% / 6.5% Operational Sales 2 / Mid-point Change vs. Prior Year / Mid-point $100.5B – $100.9B /$100.7B 6.7% – 7.1% / 6.9% $100.3B – $100.9B / $100.6B 6.5% – 7.1% / 6.8% Estimated Reported Sales 3 / Mid-point Change vs. Prior Year / Mid-point $101.0B – $101.4B / $101.2B 7.2% – 7.6% / 7.4% $100.8B – $101.4B / $101.1B 7.0% – 7.6% / 7.3% Adjusted Operational EPS (Diluted) 2,4 / Mid-point Change vs. Prior Year / Mid-point $10.95 – $11.05 / $11.00 1.5% – 2.4% / 2.0% $10.86 – $11.01 / $10.94 0.7% – 2.1% / 1.4% Adjusted EPS (Diluted) 3,4 / Mid-point Change vs. Prior Year / Mid-point $11.05 – $11.15 / $11.10 2.4% – 3.3% / 2.9% $10.96 – $11.11 / $11.04 1.6% – 3.0% / 2.3% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: October 2026 = $1.15 and July 2026 = $1.15 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items Note: percentages may have been rounded Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at , or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News , as well as Innovative Medicine Newsroom , MedTech News & Events , and . Regulatory Johnson & Johnson Receives CE Marking for ACUVUE OASYS MAX Reusable Contact Lenses 1 Press Release FDA approves IMAAVY ® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients Press Release Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer Press Release Johnson & Johnson Receives FDA Market Authorization in the U.S. for its OTTAVA™ Robotic Surgical System Press Release Johnson & Johnson Announces MONARCH™ QUEST 3, Advancing the Latest in Robotically-Assisted Bronchoscopy Press Release Data Releases New Johnson & Johnson ICOTYDE ® (icotrokinra) long-term data demonstrate robust 2- year results in the treatment of adults and adolescents with plaque psoriasis 1 Press Release Johnson & Johnson announces new ICOTYDE™ (icotrokinra) data in difficult-to-treat plaque psoriasis with proven durability through 2-years, affirming its use as a powerful first line systemic therapy 1 Press Release Johnson & Johnson presents new data reinforcing sustained disease control and improved daily function achieved with IMAAVY ® (nipocalimab-aahu) in generalized myasthenia gravis (gMG) Press Release Johnson & Johnson announces TREMFYA ® (guselkumab) is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis (PsA) study Press Release Single infusion of CARVYKTI ® (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma Press Release New model-based analysis further supports the potential of TECVAYLI ® (teclistamab-cqyv) plus DARZALEX FASPRO ® (daratumumab and hyaluronidase-hj) to redene long-term survival expectations in early line relapsed/refractory multiple myeloma Press Release CAPLYTA ® (lumateperone) shows significant and rapid improvement in bipolar mania in pivotal Phase 3 study Press Release RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE ® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026 Press Release Johnson & Johnson's RYBREVANT ® (amivantamab-vmjw) plus chemotherapy delivers longest reported median overall survival in EGFR exon 20 insertion mutation-positive lung cancer Press Release Johnson & Johnson spotlights new neuropsychiatry data across bipolar mania, depression and schizophrenia at Psych Congress 2026 Press Release TECVAYLI ® + TALVEY ® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma Press Release Other New Global Survey by Johnson & Johnson Finds Most Women Don’t Connect Eye Health Changes with Menopause 1 Press Release Johnson & Johnson’s Executive Vice President Jennifer Taubert to Retire; Tom Cavanaugh Appointed EVP, Worldwide Chairman Innovative Medicine Effective September Press Release Johnson & Johnson Completes Acquisition of Firefly Bio, Inc. to Advance Next-Generation Oncology Innovation Press Release Johnson & Johnson Announces Collaboration with Sail Biomedicines to Advance in vivo CAR-T Programs and Transform Autoimmune Disease Through Immune Reset Press Release Johnson & Johnson Announces a Proposed Resolution of Ovarian Talc Litigation Press Release 1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations . About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results . Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results . These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results . Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; and the Company's ability to successfully separate the Company's Orthopaedics business and realize the anticipated benefits from the planned separation. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , investor.jnj.com , or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) THIRD QUARTER NINE MONTHS Percent Change Percent Change 2026 2025 Total Operations Currency 2026 2025 Total Operations Currency Sales to customers by segment of business Innovative Medicine U.S. $ 10,447 9,402 11.1 % 11.1 - $ 29,297 26,655 9.9 % 9.9 - International 6,310 6,161 2.4 3.0 (0.6 ) 19,270 17,983 7.2 3.6 3.6 16,757 15,563 7.7 7.9 (0.2 ) 48,567 44,638 8.8 7.4 1.4 MedTech U.S. 4,512 4,306 4.8 4.8 - 13,525 12,902 4.8 4.8 - International 4,130 4,124 0.1 0.1 0.0 12,679 12,089 4.9 2.2 2.7 8,642 8,430 2.5 2.5 0.0 26,204 24,991 4.9 3.5 1.4 U.S. 14,959 13,708 9.1 9.1 - 42,822 39,557 8.3 8.3 - International 10,440 10,285 1.5 1.8 (0.3 ) 31,949 30,072 6.2 3.0 3.2 Worldwide $ 25,399 23,993 5.9 % 6.0 (0.1 ) $ 74,771 69,629 7.4 % 6.0 1.4 Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) THIRD QUARTER NINE MONTHS Percent Change Percent Change 2026 2025 Total Operational Currency 2026 2025 Total Operational Currency Sales to customers by geographic area U.S. $ 14,959 13,708 9.1 % 9.1 - $ 42,822 39,557 8.3 % 8.3 - Europe 5,405 5,440 (0.6 ) 1.0 (1.6 ) 16,979 15,937 6.5 2.3 4.2 Western Hemisphere excluding U.S. 1,385 1,231 12.5 8.0 4.5 3,987 3,604 10.6 4.5 6.1 Asia-Pacific, Africa 3,650 3,614 1.0 1.0 0.0 10,983 10,531 4.3 3.6 0.7 International 10,440 10,285 1.5 1.8 (0.3 ) 31,949 30,072 6.2 3.0 3.2 Worldwide $ 25,399 23,993 5.9 % 6.0 (0.1 ) $ 74,771 69,629 7.4 % 6.0 1.4 Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) THIRD QUARTER 2026 2025 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) Sales to customers $ 25,399 100.0 $ 23,993 100.0 5.9 Cost of products sold 8,097 31.9 7,303 30.4 10.9 Gross Profit 17,302 68.1 16,690 69.6 3.7 Selling, marketing and administrative expenses 6,285 24.7 5,922 24.7 6.1 Research and development expense 4,652 18.3 3,672 15.3 26.7 In-process research and development impairments 339 1.4 - - Interest (income) expense, net 31 0.1 18 0.1 Other (income) expense, net 5,780 22.8 (478 ) (2.0 ) Restructuring 181 0.7 63 0.3 Earnings before provision for taxes on income 34 0.1 7,493 31.2 (99.5 ) (Benefit from)/Provision for taxes on income (176 ) (0.7 ) 2,341 9.7 (107.5 ) Net earnings $ 210 0.8 $ 5,152 21.5 (95.9 ) Net earnings per share (Diluted) $ 0.09 $ 2.12 (95.8 ) Average shares outstanding (Diluted) 2,448.6 2,428.6 Effective tax rate (517.6 ) % 31.2 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 7,672 30.2 $ 8,436 35.2 (9.1 ) Net earnings $ 6,339 25.0 $ 6,801 28.3 (6.8 ) Net earnings per share (Diluted) $ 2.59 $ 2.80 (7.5 ) Effective tax rate 17.4 % 19.4 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) NINE MONTHS 2026 2025 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) Sales to customers $ 74,771 100.0 $ 69,629 100.0 7.4 Cost of products sold 24,254 32.4 22,288 32.0 8.8 Gross Profit 50,517 67.6 47,341 68.0 6.7 Selling, marketing and administrative expenses 18,751 25.1 16,923 24.3 10.8 Research and development expense 11,832 15.8 10,413 15.0 13.6 In-process research and development impairments 375 0.5 - - Interest (income) expense, net 136 0.2 (62 ) (0.1 ) Other (income) expense, net 6,405 8.6 (7,692 ) (11.1 ) Restructuring 247 0.3 144 0.2 Earnings before provision for taxes on income 12,771 17.1 27,615 39.7 (53.8 ) Provision for taxes on income 1,792 2.4 5,927 8.6 (69.8 ) Net earnings $ 10,979 14.7 $ 21,688 31.1 (49.4 ) Net earnings per share (Diluted) $ 4.49 $ 8.94 (49.8 ) Average shares outstanding (Diluted) 2,445.8 2,424.8 Effective tax rate 14.0 % 21.5 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 24,153 32.3 $ 24,635 35.4 (2.0 ) Net earnings $ 20,034 26.8 $ 20,206 29.0 (0.9 ) Net earnings per share (Diluted) $ 8.19 $ 8.33 (1.7 ) Effective tax rate 17.1 % 18.0 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measures Third Quarter Nine Months Ended (Dollars in Millions Except Per Share Data) 2026 2025 2026 2025 Net Earnings, after tax- as reported $210 $5,152 $10,979 $21,688 Pre-tax Adjustments Litigation related 5,519 15 6,116 (6,894 ) Intangible Asset Amortization expense 1,240 1,048 3,732 3,435 Restructuring related 1 195 168 533 302 Orthopaedics separation related 369 - 746 - Acquisition, integration and divestiture related (34 ) 97 142 475 (Gains)/losses on securities 10 (387 ) (262 ) (327 ) IPR&D impairments 339 - 375 - Other - 2 - 29 Tax Adjustments Tax impact on special item adjustments 2 (1,677 ) (168 ) (2,469 ) 826 Tax legislation and other tax related 168 874 142 672 Adjusted Net Earnings , after tax $6,339 $6,801 $20,034 $20,206 Average shares outstanding (Diluted) 2,448.6 2,428.6 2,445.8 2,424.8 Adjusted net earnings per share (Diluted) $2.59 $2.80 $8.19 $8.33 Operational adjusted net earnings per share (Diluted) $2.61 $8.04 Notes: 1 In the fiscal second quarter of 2026, the Company initiated a supply chain restructuring program primarily in the Innovative Medicine segment to exit certain manufacturing locations as part of its optimization efforts to streamline operations. The program is expected to be substantially completed by the end of fiscal year 2029 with estimated costs between $650 - $750 million, and include site and supplier exit costs, decommissioning and asset impairment costs. Restructuring expenses of $74 million in the fiscal third quarter of 2026 ($274 million Q3 2026 YTD), were primarily related to asset impairments and exit costs. In fiscal 2025, the Company initiated a restructuring program of its Surgery franchise within the MedTech segment to simplify and focus operations by exiting certain non-strategic product lines and optimize select sites across the network. Restructuring expenses of $80 million were recorded in the fiscal third quarter of 2026 ($194 million Q3 2026 YTD) and $128 million in the fiscal third quarter of 2025 ($157 million Q3 2025 YTD) primarily includes costs related to product exits. This program is expected to be substantially completed by the end of fiscal year 2026. In fiscal 2023, the Company initiated a restructuring program of its Orthopaedics franchise within the MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The restructuring expenses of $41 million in the fiscal third quarter of 2026 ($65 million Q3 2026 YTD) and $40 million in the fiscal third quarter of 2025 ($145 million Q3 2025 YTD) includes costs related to market and product exits. This program will be completed as of Q4 2026 at a total cost of approximately $1 billion. 2 The tax impact related to special item adjustments reflects the current and deferred income taxes associated with the above pre-tax special items in arriving at adjusted earnings. Contacts Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com Read full story here

—Supports BioCryst’s evolution toward a more disciplined R&D model centered on external innovation— RESEARCH TRIANGLE PARK, N.C., Oct. 05, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the formation of a Scientific Advisory Board (SAB) comprising seven accomplished scientific and industry leaders with deep expertise across rare disease research and drug development. The SAB will provide independent scientific and strategic guidance as the Company advances its research and development strategy and builds a high value novel drug pipeline. “The formation of BioCryst’s Scientific Advisory Board marks an important step in the evolution of our new R&D model,” said Dr. Sandeep Menon, BioCryst’s Chief Research and Development Officer. “External innovation is increasingly central to how we build our pipeline, and guidance from leading scientists and physicians will sharpen our thinking and strengthen the diligence behind each program we evaluate and advance. The Scientific Advisory Board will work closely with me and our Chief Scientific Officer, Dr. David Jenkins, as we shape and execute BioCryst’s R&D strategy.” “Building on our success in developing and commercializing medicines for hereditary angioedema, we are bringing the same rigor to the next generation of BioCryst medicines,” said Charlie Gayer, Chief Executive Officer. “With the expertise of these highly experienced scientific advisors, BioCryst will be better positioned to evaluate emerging opportunities and translate their potential into meaningful benefits for patients.” The SAB will provide strategic guidance across BioCryst’s research and development activities, including pipeline expansion, external innovation opportunities, translational science and clinical development. The board will also offer insights on regulatory strategy and help strengthen connections with leading scientific, medical and patient communities worldwide. "Few companies have demonstrated BioCryst’s ability to translate rigorous science into rare disease medicines that reach patients, and that track record is what makes the Company’s evolution so compelling," said Dr. Anthony Manning, Chair of the Scientific Advisory Board. "The formation of this Board is an important step for BioCryst, and it is a privilege to chair a group with this depth of experience across rare disease drug discovery, translational science and clinical development. I am confident the Company’s decisions about which science to pursue and how to advance it will benefit from the collective judgment of its members." Scientific Advisory Board Members: Anthony (Tony) Manning, PhD, Chair, is Principal at Manning Bio Worldwide, LLC, advising biotechnology companies and academic institutions following a 30-year career in pharmaceutical drug discovery and development. As Chief Scientific Officer at Momenta Pharmaceuticals (now part of Johnson & Johnson), he built a pipeline of first-in-class therapeutics for rare autoantibody-driven diseases, including nipocalimab (IMAAVY), now FDA-approved for generalized myasthenia gravis and warm autoimmune hemolytic anemia, with additional indications in development. Earlier, he led drug discovery efforts at Roche Pharmaceuticals and Biogen Idec, contributing to the approvals of Actemra and Rituxan, and to the development of litifilimab, now in Phase 3 for lupus. Dr. Christine Bulawa, PhD, received a PhD from the University of Wisconsin-Madison and completed postdoctoral studies at Massachusetts Institute of Technology (MIT). As part of her 20+ years in rare disease drug discovery, she was the first employee of FoldRx Pharmaceuticals and instrumental in the preclinical development of tafamidis, the first pharmacological treatment for transthyretin amyloidosis. As a senior leader in Pfizer’s Rare Disease Research Unit, Dr. Bulawa built a pipeline of innovative programs based on rigorously validated targets, spanning portfolio entry to clinical development, with a focus on small molecule and genetic therapies to treat degenerative neurological, neuromuscular and protein aggregation diseases. Dr. Eric A. Hughes, MD, PhD, serves as Executive Vice President, Global Research & Development and Chief Medical Officer at Teva Pharmaceuticals. A physician-scientist who earned his MD and PhD from Yale University, Dr. Hughes brings nearly 20 years of biopharmaceutical industry experience and is helping advance Teva’s transformation into a leading innovative biopharmaceutical company, enabled by a world-class generics business. Prior to Teva, he served in leadership roles at Vertex, Novartis and Bristol Myers Squibb. Dr. Stephanie Noviello, MD, MPH, is Chief Medical Officer at ILiAD Biotechnologies, Inc. She is a clinical development leader with extensive experience across infectious diseases, virology, immunology, rare diseases and skeletal diseases at Novartis, Motif BioSciences, Bristol-Myers Squibb and Schering-Plough Research Institute. Dr. Shashi Ramaiah, DVM, PhD, DACVP, DABT, is a board-certified Veterinary Pathologist and Toxicologist who spent 18 years at Pfizer, most recently as Vice President and Global Head of Discovery, Investigative and Translational Sciences. He is Founder and CEO of SPECCRO, a drug development advisory firm that helps biotechnology companies and investors de-risk programs and portfolios, drawing on more than 40 senior industry experts and extensive engagement with national and international scientific consortia. Dr. Art Taveras, PhD, is a seasoned biopharmaceutical executive with over 35 years of industry experience, specializing in leading R&D divisions across major public pharmaceutical corporations and biotech firms including Biogen Idec, Transform Therapeutics, X4 Pharmaceuticals, CoMET Therapeutics, ShangPharma ChemPartner, Alantos Pharmaceuticals and Schering-Plough. His strategic expertise as President, CEO, CSO and R&D Leader has advanced robust pipelines and key global R&D partnerships, culminating in over 175 patent application filings, 150 publications, 60 clinical trials, 6 regulatory agency approvals and 5 therapeutic platform technologies across commercial and clinical-stage assets for diseases in neurology, oncology, immunology, metabolism and rare disease. Dr. Ajay Yekkirala, PhD, is an experienced serial entrepreneur who co-founded Superluminal Medicines at RA Capital and built a strong investor syndicate including NVIDIA, Eli Lilly, Insight Partners, Catalio, BVF and Perceptive Advisors. As Chief Scientific Officer, he directs the AI/ML platform build and all pipeline R&D. Prior to Superluminal, Dr. Yekkirala founded Blue Therapeutics to develop non-addictive painkillers. He received his PhD from the University of Minnesota and completed postdoctoral training at Harvard Medical School. He has authored several papers published in high-impact, peer-reviewed journals and advised various committees at the NIH, including EPPIC-NET at NINDS and Medication Development Research Committee at NIDA. About BioCryst Pharmaceuticals BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (HAE) and other rare diseases, driven by its deep commitment to improving the lives of people living with these conditions. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor and is advancing a pipeline of potential first-in-class or best-in-class therapeutics for rare diseases. For more information, please visit or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements, including statements regarding future results, performance, or achievements, expectations regarding BioCryst’s strategic shift to prioritize external innovation, expectations regarding pipeline development, the anticipated role and potential benefits of BioCryst’s Scientific Advisory Board, and statements related to BioCryst’s future operations, prospects and pipeline programs. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst’s ability to successfully progress its pipeline development plans; guidance and recommendations provided by the Scientific Advisory Board may not improve BioCryst’s evaluation or advancement of potential programs or result in the anticipated benefits; the commercial viability of BioCryst’s future rare disease therapies; ongoing and future development of product candidates may take longer than expected and may not have positive results; product candidates, if approved, may not achieve market acceptance; the results of BioCryst’s partnerships with third parties may not meet BioCryst’s current expectations; and BioCryst’s ability to realize the contemplated benefits of its new R&D strategy and model and successfully evaluate and execute external opportunities. This list is not exclusive. To see a more comprehensive list of risks, please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements. Contact: Investors: investorrelations@biocryst.com Media: media@biocryst.com