ORIC® Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Updates




ORIC® Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Updates

Reported rinzimetostat (formerly ORIC-944) Phase 1b data that continue to demonstrate potential best-in-class efficacy and safety in mCRPC; selected provisional RP2Ds and initiated dose optimization in combination with AR inhibitors

Presented potential best-in-class enozertinib Phase 1b data demonstrating highly competitive systemic and intracranial activity in NSCLC patients with EGFR exon 20 and EGFR PACC mutations; selected Phase 3 monotherapy dose

Raised $264 million from top-tier healthcare specialist funds; Cash and investments expected to provide runway into 2H 2028 and beyond anticipated primary endpoint readout for rinzimetostat Phase 3 study

Expect to report multiple clinical data readouts for rinzimetostat and enozertinib in 2026, ahead of potential initiation of multiple registrational trials

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Feb. 23, 2026 (GLOBE NEWSWIRE) — ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter and year ended December 31, 2025.

“2025 was a transformational year for ORIC highlighted by clinical data that further demonstrated the potential best-in-class profiles of rinzimetostat in prostate cancer and enozertinib in lung cancer,” said Jacob M. Chacko, M.D., president and chief executive officer. “Those data, along with substantially extended cash runway, position us well for 2026 and beyond as we advance our programs towards registrational studies.”

2025 Key Accomplishments

Rinzimetostat: a potent and selective allosteric inhibitor of PRC2

• Completed Phase 1b dose exploration in prostate cancer and selected provisional recommended Phase 2 doses (RP2Ds) of rinzimetostat to be tested in combination with the approved doses of darolutamide and apalutamide in dose optimization.
• Reported potential best-in-class efficacy and safety dose exploration data in combination with darolutamide and with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Data demonstrated:
  • PSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide.
  • Broad and deep PSA responses that compare favorably to competitor PRC2 inhibitors, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed).
  • Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.
  • Both combination regimens demonstrated a clearly differentiated safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition.
• Presented preclinical data at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics demonstrating potential utility of rinzimetostat combined with AR inhibition in castration-sensitive prostate cancer and combined with KRAS inhibition in KRAS G12C-mutant NSCLC and colorectal cancer models.

Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20 and EGFR PACC mutations

• Reported potential best-in-class efficacy and safety data from a Phase 1b trial of enozertinib at the ESMO Asia Congress 2025 in NSCLC patients with EGFR exon 20 and EGFR PACC mutations. Data demonstrated:
  • Systemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks.
  • Highly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC.
  • Convincing 1L CNS activity, with 100% intracranial ORR in EGFR exon 20 and 100% intracranial ORR in EGFR PACC in patients with measurable CNS disease, including in patients with active brain metastases.
  • Competitive safety profile, with no significant off-target toxicity, resulting in low rate of treatment discontinuations.
• Announced a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate enozertinib in combination with amivantamab and hyaluronidase-lpuj subcutaneous injection (SC amivantamab) for the 1L treatment of NSCLC patients with EGFR exon 20 mutations.
• Announced publication in Cancer Research of preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain penetrance, and antitumor activity across a broad range of EGFR exon 20 and PACC mutant models.

Anticipated Program Milestones:

ORIC anticipates the following upcoming milestones:

• Rinzimetostat in mCRPC:
  • 1Q 2026: Combination dose optimization data with AR inhibitor
  • 1H 2026: Initiate first global Phase 3 registrational trial in mCRPC
  • 2H 2026: Program update
• Enozertinib in NSCLC:
  • 2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab
  • 2H 2026: 1L EGFR PACC monotherapy data

Fourth Quarter and Full Year 2025 Financial Results

• Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $392.3 million as of December 31, 2025, which includes net proceeds of $124.4 million from a private placement financing in May 2025 and $117.6 million from the company’s ATM program in 2025. Subsequent to the quarter ended December 31, 2025, the company raised an additional $20.0 million in net proceeds from a healthcare specialist fund under the ATM program resulting in proforma cash and investments of $412.3 million as of December 31, 2025. The company expects its cash and investments to fund the current operating plan into 2H 2028.
• R&D Expenses: Research and development (R&D) expenses were $25.9 million for the three months ended December 31, 2025, compared to $32.0 million for the three months ended December 31, 2024, a decrease of $6.1 million. For the year ended December 31, 2025, R&D expenses were $109.8 million compared to $114.1 million for the same period in 2024, a decrease of $4.3 million. The decreases were due to lower rinzimetostat drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib.
• G&A Expenses: General and administrative (G&A) expenses were $8.7 million for the three months ended December 31, 2025, compared to $7.6 million for the three months ended December 31, 2024, an increase of $1.1 million. For the year ended December 31, 2025, G&A expenses were $33.2 million compared to $28.8 million for the same period in 2024, an increase of $4.4 million. The increases were primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation.

About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 and EGFR PACC mutations, being developed for NSCLC. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the continued clinical development of rinzimetostat (ORIC-944) and enozertinib; the potential advantages of rinzimetostat and enozertinib; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-class properties of rinzimetostat and enozertinib; the development plans and timelines for rinzimetostat and enozertinib; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational trials; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of rinzimetostat, enozertinib or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on February 23, 2026, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Contact:

Dominic Piscitelli, Chief Financial Officer
dominic.piscitelli@oricpharma.com
info@oricpharma.com

PROCEPT BioRobotics® Announces Updated Dates for 4Q25 Earnings Conference Call and Investor Day




PROCEPT BioRobotics® Announces Updated Dates for 4Q25 Earnings Conference Call and Investor Day

SAN JOSE, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) — PROCEPT BioRobotics Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced that it has updated the timing of its previously announced fourth quarter 2025 earnings conference call and Investor Day due to significant travel disruptions caused by inclement weather.

The Company will report financial results for the fourth quarter of 2025 after market close on Wednesday, February 25, 2026. The Company’s management will host a corresponding conference call beginning at 4:30 p.m. Eastern Time.

The Company also announced it has rescheduled the in-person investor day event to Thursday, February 26, 2026, at the NASDAQ Headquarters in New York City beginning at 8:00am Eastern Time.

A live webcast of both events, as well as an archived recording, will be available on the “Investors” section of the Company’s website at https://ir.procept-biorobotics.com. Each webcast will be archived and available for replay for at least 90 days after the event.

About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics’ mission is to revolutionize BPH treatment globally in partnership with urologists by delivering best-in-class robotic solutions that positively impact patients and drive value. PROCEPT BioRobotics manufactures the AQUABEAM® and HYDROS® Robotic Systems. The HYDROS Robotic System is the only AI-Powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States.

Important Safety Information
All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/

Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com

Carlsmed, Inc. To Participate in the 2026 Canaccord Genuity Musculoskeletal Conference




Carlsmed, Inc. To Participate in the 2026 Canaccord Genuity Musculoskeletal Conference

CARLSBAD, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) — Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced that Mike Cordonnier, CEO and Chairman, will be presenting at the 2026 Canaccord Genuity Musculoskeletal Conference on March 2, 2026 at 11:30 AM CST in New Orleans, LA.  

A live webcast will be available to registered participants. Following the presentation, the webcast replay will be available at https://event.summitcast.com/view/d69xRqMspwymhwGUDdQoes/JC9qqvWhWggYawxGnDNtmz

About Carlsmed, Inc.

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Investor Relations
Caroline Corner, PhD
IR@Carlsmed.com 

Media
LeAnn Burton
Senior Director Brand Marketing
LBurton@Carlsmed.com

Tectonic Therapeutic Appoints François Nader, M.D., as Chair and Independent Director of the Board




Tectonic Therapeutic Appoints François Nader, M.D., as Chair and Independent Director of the Board

WATERTOWN, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced it has appointed François Nader, M.D., MBA, as an independent director to its Board of Directors, effective April 1, 2026, at which time he will also assume the role of Chair of the Board.

Dr. Nader brings more than 30 years of leadership experience across the biotechnology and pharmaceutical industry and currently serves as an Independent Director of Moderna, Inc. (NASDAQ: MRNA), a global biotechnology company. Upon Dr. Nader assuming the role as independent director to the Board of Directors, Terry McGuire will resign from his role as Chair of the Board, a role which Dr. Nader will immediately assume. In order to provide for a smooth leadership transition, Mr. McGuire will remain a member of the Board of Directors until Tectonic’s 2026 Annual Meeting of Stockholders, which is anticipated to be in June 2026.

“We are delighted to welcome François Nader to Tectonic’s Board of Directors. François brings exceptional and broad leadership experience, deep expertise in corporate governance and strategic transactions, and a strong track record of building and scaling innovative biotechnology companies. His perspective will be invaluable as we continue advancing our GPCR-targeted pipeline and positioning Tectonic for long-term growth and shareholder value creation,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. “We would also like to express our sincere appreciation to Terry McGuire for his strong leadership and continued support since Tectonic’s inception, and for his instrumental contributions in helping us build our company.”

“I am excited to join Tectonic at this important stage of its development,” said Dr. Nader. “The company’s approach to targeting GPCR biology has the potential to unlock meaningful therapeutic advances. I look forward to working with the Board and management team to help guide Tectonic’s strategy and support its continued growth.”

“I strongly support the appointment of François Nader to Tectonic’s Board as the company continues to evolve to its next stage of growth,” said Mr. McGuire. “It has been an honor for me to serve as the Chair of Tectonic’s Board, and I’m proud to have been part of the Company’s progress in advancing innovative GPCR-targeted therapies for patients with serious diseases.”

Dr. Nader was appointed as an Independent Director of Moderna in 2019, where he chairs both the Talent & Compensation Committee and the Nominating & Governance Committee. He has served as Chairman, Executive Chairman, and/or Independent Director of numerous biotechnology companies which culminated in significant strategic transactions, including Acceleron Pharma (acquired by Merck), Alexion Pharmaceuticals (acquired by AstraZeneca), Prevail Therapeutics (acquired by Eli Lilly), Clementia Pharmaceuticals (acquired by Ipsen), Advanced Accelerator Applications (acquired by Novartis), Baxalta (acquired by Shire), NPS Pharmaceuticals (acquired by Shire), and Noven Pharmaceuticals (acquired by Hisamitsu). He also previously served as President and Chief Executive Officer of NPS Pharmaceuticals, where he led the company’s transformation into a global rare disease leader. Earlier in his career, he held senior leadership roles spanning medical, regulatory, and commercial functions at Aventis and its predecessor companies. Dr. Nader earned his French Doctorate in Medicine from St. Joseph University in Lebanon and a Physician Executive MBA from the University of Tennessee.

About Tectonic
Tectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit www.tectonictx.com and follow us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the anticipated timing of Tectonic’s 2026 Annual Meeting of Stockholders and the expected changes in board leadership roles. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release. These risks and uncertainties include those that are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed with the SEC for the quarter ended September 30, 2025, and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. 

CONTACT: Contacts:

Investors:
Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

Media:
Kathryn Morris
The Yates Network
kathryn@theyatesnetwork.com
(914) 204-6412

Corvus Pharmaceuticals to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference




Corvus Pharmaceuticals to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference

SOUTH SAN FRANCISCO, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that members of its leadership team will conduct one-on-one meetings with investors and present a corporate overview at Oppenheimer 36th Annual Healthcare Life Sciences Conference which is being held virtually. The presentation will be on Thursday, February 26, 2026 at 2:40pm ET.

A webcast of the presentation will be available live and for 90 days following the event. The webcast may be accessed via the investor relations section of the Corvus website.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of immune diseases and cancer. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is being evaluated in a registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 1 clinical trial for the treatment of atopic dermatitis. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com  

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750

Galapagos Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update




Galapagos Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update

Mechelen, Belgium; February 23, 2026, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today reported its financial results for the full year 2025 and provided an update on the fourth quarter 2025 and its year-to-date performance.

“2025 was a pivotal year for Galapagos, during which our Board of Directors took decisive action to chart a new strategic course for the Company,” said Henry Gosebruch, CEO of Galapagos. “Since assuming the role of Chief Executive Officer in May, our new senior leadership team and I have focused on the Company’s transformation to better position Galapagos for long-term value creation.”

“The wind-down of our cell therapy activities is underway, and we have strengthened our leadership team with the capabilities required for our next phase. Our focus is on building sustainable long-term growth through transformative business development, leveraging our unique position and strengths as well as our collaboration with Gilead. We are pleased with the momentum we have built to date and will continue to apply a selective approach in pursuing the right opportunities and the right transactions. Through disciplined capital allocation, we aim to build a pipeline of novel therapeutics that can deliver meaningful benefits for patients and create long-term value for shareholders. We are off to a strong start, and I am excited about what lies ahead,” concluded Gosebruch.

Aaron Cox, CFO of Galapagos, added, “At year-end, Galapagos remained robustly capitalized, with approximately €3.0 billion in cash and financial investments as of December 31, 2025. This strong financial position underpins our ability to act decisively and allocate capital in a disciplined manner as we evaluate business development opportunities. Following completion of the wind-down of the cell therapy activities, we continue to expect to be cash flow neutral to positive by the end of 2026 excluding any business development activities and currency fluctuations, and anticipate a 2026 year-end cash position in the range of €2.775 billion to €2.850 billion.”

Post-period events

• The Board of Directors appointed Paulo Fontoura as Non-Executive Independent Director by way of cooptation, replacing Dr. Susanne Schaffert, who stepped down effective November 1, 2025.
• On January 5, 2026, Galapagos announced that the works council consultation process regarding the wind-down of cell therapy activities had been completed and that its Board of Directors decided to initiate the wind-down of the Company’s cell therapy activities. The wind-down remains on schedule and is expected to be substantially completed by the end of the third quarter of 2026.
• The remaining Galapagos organization expects to be a lean organization of approximately 35-40 employees by the end of 2026, repositioned for long-term growth through transformational business development, while maintaining a dedicated presence at its headquarters in Mechelen, Belgium and its U.S. hubs in Chicago, IL and San Francisco, CA.
• With the wind-down progressing on schedule, Galapagos is now fully focused on pursuing transformative business development opportunities aligned with areas of high unmet medical need. 

Fourth Quarter 2025 Business Update
CORPORATE

• Continued to strengthen and enhance the management team to drive implementation of Galapagos strategy by appointing Fred Blakeslee as Executive Vice President and General Counsel, effective October 16, 2025, succeeding Ms. Valeria Cnossen. Additionally, Ms. Missotten, Chief Human Resource officer, ceased to be a member of the Executive Committee as of December 31, 2025. To ensure continuity, she will continue to serve the Company until June 30, 2026.
• Enhanced governance by appointing Dr. Neil Johnston and Devang Bhuva by way of co-optation as Non-Executive Independent Director and Non-Executive Non-Independent Director, respectively, effective November 1, 2025. In connection with these co-optations, Non-Executive Independent Directors Dr. Elisabeth Svanberg, and Non-Executive Non-Independent Director and current CFO of Gilead, Andrew Dickinson, stepped down.

IMMUNOLOGY SMALL MOLECULE PIPELINE

• In December 2025, we announced topline Phase 2 results for TYK2 inhibitor, GLPG3667, in patients with dermatomyositis (DM) and systemic lupus erythematosus (SLE), which are summarized as follows:
  • The GALARISSO DM study met its primary endpoint, showing that GLPG3667, administered once daily at 150 mg (N=21) in addition to standard-of-care therapy, achieved a statistically significant clinical benefit in the Total Improvement Score (TIS)¹ at Week 24 (p=0.0848; Δ: 14.26), compared to placebo (N=19). The pre-specified threshold of statistical significance was set at 10% (α=0.1). GLPG3667 also showed meaningful clinical improvements compared to placebo on several secondary endpoints of disease activity, including TIS20, TIS40, TIS60 and m-CDASI-A². GLPG3667 demonstrated a favorable safety and tolerability profile throughout the 24-week treatment period.
  • In the GALACELA SLE study, GLPG3667, administered once daily at 75 mg (N=59) and 150 mg (N= 64) in addition to standard-of-care therapy, the primary endpoint analysis of dose-response on SLE responder index (SRI)-4 at Week 32 did not meet statistical significance. However, GLPG3667 showed numerical improvements over placebo (N=63) on several secondary endpoints, particularly on skin-related outcomes. The safety profile was consistent with previous studies with GLPG3667. The GALACELA study is currently ongoing, and the final Week 48 data, expected in the second quarter of 2026, will be essential to assess the totality of the evidence and determine potential next steps for the SLE program.
• As part of our ongoing efforts to maximize the value of this program for both patients and Galapagos, we are evaluating all strategic options. These include potential partnership and business development opportunities to accelerate development of GLPG3667 in DM. Additionally, we continue to explore opportunities to expand into other severe autoimmune diseases with significant unmet medical need. 

ONCOLOGY CAR-T CELL THERAPY UPDATE

• As noted above, the Company announced in January 2026 the start of the wind-down of its cell therapy activities to pursue new transformational business development transactions using its available cash resources. In connection with the wind-down, we notified study investigators of the early termination of the Phase 1/2 ATALANTA-1 (CD19 CAR-T candidate GLPG5101) and Phase 1/2 PAPILIO-1 (BCMA CAR-T candidate GLPG5301) studies. Patients from both studies will roll over into the long-term HESPERIA study (NCT06652633) to monitor long-term safety and efficacy. Residual spending associated with these long-term follow-up studies is expected to be minimal.

Financial performance
Full year 2025 key figures (consolidated)
(€ millions, except basic & diluted earnings per share)

DETAILS OF THE FULL YEAR 2025 FINANCIAL RESULTS

Total operating profit from continuing operations amounted to €295.1 million in 2025, compared to an operating loss of €188.3 million in 2024. This operating profit was primarily due to the release in revenue of the remaining deferred income balance allocated to the drug discovery platform for an amount of €1,069.0 million. The operating expenses were negatively impacted for a total of €399.8 million, by 1) the decision to wind down the cell therapy activities with an impact of €275.0 million, consisting of an impairment of the cell therapy activities of €228.1 million (on goodwill and fixed assets), severance costs of €33.3 million, costs for early termination of collaborations of €16.3 million, deal costs of €10.1 million, €1.5 million additional accelerated non-cash cost recognition for subscription right plans and €7.5 million other costs, partly offset by a positive fair value adjustment of the contingent consideration payable of €21.8 million; and by 2) the strategic reorganization related to the small molecules business announced in January 2025, for €124.8 million. The latter was reflected in severance costs of €47.7 million, costs for early termination of collaborations of €46.1 million, impairment on fixed assets related to small molecules activities of €9.5 million, deal costs of €14.8 million, €4.6 million additional accelerated non-cash cost recognition for subscription right plans and €2.1 million other operating expenses.

• Total net revenues amounted to €1,112.2 million in 2025, compared to €275.6 million last year. The revenue recognition related to the exclusive access rights granted to Gilead under the OLCA³ for the Galapagos’ drug discovery platform amounted to €1,069.0 million in 2025, compared to €230.2 million in 2024. It was assessed based on the intention to wind down and on the facts and circumstances on December 31, 2025, that the deferred income balance allocated to the Company’s drug discovery platform is no longer justified in the 2025 IFRS financial statements, leading to full recognition of the deferred income at December 31, 2024, as revenue. For the avoidance of doubt, the OLCA remains in effect. Royalty income from Gilead for Jyseleca^® amounted to €12.2 million in 2025 (€10.6 million in 2024).
• Cost of sales amounted to €29.7 million in 2025 as compared to €34.8 million in 2024 and related to the supply of Jyseleca^® to Alfasigma under the transition agreement. The related revenues are reported in total net revenues.
• R&D expenses in 2025 amounted to €459.4 million, compared to €335.5 million in 2024. Subcontracting costs increased by €72.8 million from €160.1 million in 2024 to €232.9 million in 2025 primarily driven by costs for the early termination of collaboration programs and costs for the cell therapy programs in oncology. Depreciation and impairment costs in 2025 increased to €42.4 million, compared to €35.4 million in 2024, due to impairments on fixed assets related to small molecules programs. Personnel costs increased from €87.7 million in 2024 to €147.2 million in 2025 primarily due to severance costs.
• S&M and G&A expenses amounted to €153.4 million in 2025, compared to €134.4 million in 2024. The increase in S&M and G&A expenses was mainly due to higher personnel costs, which increased from €59.2 million in 2024 to €81.0 million in 2025 due to increased severance costs.
• Impairment of the cell therapy activities is a result of the Company’s previously announced strategic alternatives process for the cell therapy activities whereby the Company assessed the cell therapy activities associated assets’ recoverable amount in accordance with IAS 36. The recoverable amount was estimated lower than the assets’ carrying value. As a result, the Company recognized an impairment loss of €228.1 million, thereby aligning the cell therapy assets’ book value with the Company’s strategic decision to wind down the cell therapy activities, which resulted in a full impairment of both the associated goodwill and intangible assets and a partial impairment of property, plant and equipment.
• Other operating income of €40.8 million in 2024 increased to €53.5 million in 2025, mainly driven by the fair value adjustment of the contingent consideration payable of €21.8 million, partly offset by lower grant and R&D incentives income.

Net financial income in 2025 amounted to €5.8 million, compared to net financial income of €185.2 million in 2024.

• Fair value adjustments and net currency exchange results amounted to a negative amount of €39.4 million in 2025, compared to fair value adjustments and net currency exchange gains in 2024 of €95.8 million. They were primarily attributable to €18.3 million of negative changes in fair value of current financial investments, and to €44.8 million of unrealized currency exchange losses on cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, partly offset by a positive effect of €22.7 million as consequence of the settlement of a hedging instrument.
• Net other financial income in 2025 amounted to €45.2 million, compared to net other financial income of €89.4 million in 2024. Net interest income amounted to €45.3 million in 2025 compared to €88.5 million of net interest income in 2024, due to a decrease in the interest rates and a shift from investments in term deposits generating financial income to investments in money market funds generating fair value changes. Fair value gains and interest income derived from cash, cash equivalents and financial investments excluding any currency exchange results amounted to €103.0 million in 2025 (compared to €140.4 million in 2024). 

Galapagos had €18.6 million of tax income in 2025, compared to €1.8 million of tax income in 2024. The increase is mainly explained by the reversal of the deferred tax liabilities linked to capitalized intangible assets related to the cell therapy activities, as the Company recorded an impairment on these intangible assets. Galapagos did not incur a current tax liability in 2025 because the profit of the year is fully absorbed by current year tax deductions.

The Company reported a net profit from continuing operations in 2025 of €319.5 million, compared to a net loss from its continuing operations of €1.3 million in 2024.

Net profit from discontinued operations related to Jyseleca^® amounted to €1.4 million, compared to net profit amounting to €75.4 million in 2024. The net result for discontinued operations included €11.7 million of R&D expenses primarily related to the final settlement of disputed expenses with Alfasigma, and €11.9 million of other operating income related to a fair value adjustment of the contingent consideration receivable from Alfasigma as a consequence of an adjusted sales forecast. The operating profit from discontinued operations in 2024, was mainly related to the gain on the sale of the Jyseleca^® business to Alfasigma of €52.3 million.

Galapagos reported a net profit in 2025 of €320.9 million, compared to a net profit of €74.1 million in 2024.

Cash and financial investments
Cash and financial investments totaled €2,998.0 million on December 31, 2025, as compared to €3,317.8 million on December 31, 2024. At December 31, 2025, cash and financial investments included $2,159.0 million held in U.S. dollars ($726.9 million on December 31, 2024) which could generate foreign exchange gains or losses in the financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as the Company’s functional currency is EUR (translated at a rate of 1.175 €/$ at December 31, 2025).

Total net decrease in cash and financial investments amounted to €319.8 million in 2025, compared to a net decrease of €366.7 million in 2024. This net decrease was composed of (i) €189.1 million of operational cash burn (*) including cash in of €111.7 million related to the return on financial investments, (ii) €128.3 million of negative exchange rate differences, positive changes in fair value of current financial investments and variation in accrued interest income, (iii) €20.0 million convertible loan issued to a third party, and (iv) €17.6 million of net cash in related to the sale/acquisition of subsidiaries.

Financial Guidance
In connection with the wind-down of the cell therapy activities, the Company expects an operating cash outflow of up to €50 million in Q1 2026, as well as one-time restructuring cash impact of €125 to €175 million in 2026, a reduction of €25 million compared to the prior guidance of €150 million to €200 million. In addition, Galapagos anticipates cash costs of approximately €35 million to €40 million for final implementation of the restructuring announced in January 2025. Costs related to the ongoing TYK2 program, including completion of the Phase 2 clinical trials in DM and SLE, as well as ongoing support to advance the program toward Phase 3 development, are expected to be up to €40 million in 2026. 

Galapagos expects to be cash flow neutral to positive by the end of 2026, excluding any business development activities or currency fluctuations. Galapagos anticipates it will have approximately €2.775 billion to €2.850 billion in cash and financial investments, at December 31, 2026, based on a constant EUR/U.S. dollar exchange rate of 1.175 €/$ at December 31, 2025.

Annual Report 2025

Galapagos is currently finalizing the financial statements for the year ended December 31, 2025. The Company’s independent auditor has confirmed that its audit procedures in relation to the financial information for the year ended December 31, 2025, in accordance with the International Standards on Auditing are substantially completed and have not revealed any material corrections required to be made to the financial information included in this press release. Should any material changes arise during the audit’s finalization, an additional press release will be issued. The assurance work in relation to the sustainability information is ongoing at this moment and not completed yet. Galapagos aims to publish the fully audited full year 2025 annual report on, or around, March 26, 2026.

Conference call and webcast presentation

Galapagos will host a conference call on February 24, 2026, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call using the access information provided in the e-mail received upon registration or by using the “call me” feature. The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.

Financial calendar 2026

About Galapagos
Galapagos is a biotechnology company built to bring meaningful medicines to patients with serious diseases in therapeutic areas of unmet need. The Company combines world-class deal making expertise with capital to identify, acquire, and advance promising opportunities that have the potential to drive value for patients and shareholders. Applying a modality-agnostic asset selection approach and operational flexibility, Galapagos prioritizes oncology and immunology & inflammation programs with clear clinical proof-of-concept in emerging areas. For more information, visit www.glpg.com or follow us on LinkedIn or X.

For further information, please contact:
Investors
Glenn Schulman, PharmD, MPH
+1 412 522 6239
ir@glpg.com

Media
Katie Morris
+1 952 288 6821
katiemorris@ententeinc.com

Forward-looking statements

This press release contains forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain,’ “explore,” “further” as well as similar expressions. These statements include, but are not limited to, the guidance from management regarding our financial results (including guidance regarding the expected results and operational use of cash for the fiscal year 2026); statements regarding our business development strategy, including statements regarding potential partnering or acquisition opportunities, including any transactions in partnership with Gilead, and the expected benefits of such opportunities and partnership; statements regarding the wind down of our cell therapy activities, including statements regarding the expected costs and benefits of such wind down, the anticipated reduction in work force and related site closure; and statements regarding our product candidates and partnered programs, and any of our future product candidates or approved products, if any, including statements regarding the expected timing, design and readouts of our ongoing and planned preclinical studies and clinical trials, including but not limited to (i) GLPG3667 in SLE and DM, (ii) GLPG5101 in R/R NHL, and (v) GLPG5301 in R/R MM, including recruitment for trials and interim or topline results for trials and studies in our portfolio, statements regarding the potential attributes and benefits of our product candidates, statements regarding our commercialization efforts for our product candidates and any of our future approved products, if any. Galapagos cautions the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause actual events, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if our results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that our expectations and management’s guidance regarding our 2025 results and 2026 operating expenses, cash position and other financial estimates may be incorrect (including because one or more of its assumptions underlying our revenue or expense expectations may not be realized); the risk that we will not be able to execute on our currently contemplated business plan or strategy and/or will revise our business plan or strategy; risks related to our ability to successfully identify, pursue and consummate new transformational business development transactions, including our ability to identify product candidates that will have commercial success and/or be profitable; risks related to our ability to satisfy legal and regulatory requirements (including antitrust requirements related to both us and Gilead), amend our existing agreement with Gilead, and address other factors outside our control that may impact our ability to consummate any potential transaction timely or at all, or if consummated, to realize the benefits of such transaction; the risks related to our ability to successfully implement the wind down of our cell therapy activities within the expected timeframe or at all, or if implemented, will achieve its anticipated economic benefits; risks related to negative impacts of the wind down (whether or not completed) on our stock price, employee retention, business relationships and business generally (including risk of litigation); risks associated with Galapagos’ product candidates and partnered programs, including GLPG5101; the risk that ongoing and future clinical trials may not be completed in the currently envisaged timelines or at all; the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data from Galapagos’ ongoing and planned clinical research programs in DM, SLE, R/R NHL, R/R MM and any other indications or diseases, may not support registration or further development of its product candidates due to safety or efficacy concerns or other reasons); the risk that we may not be able to realize the expected benefits from the appointment (by way of co-optation) of the new Director, the risk that the preliminary and topline data from our studies, including the GALARISSO, GALACELA, ATALANTA-1, PAPILIO-1 and HESPERIA-studies, may not be reflective of the final data; risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead); the risk that the transfer of the Jyseleca^® business will not have the currently expected results for our business and results of operations the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will revise our business plan; and the risk that our estimates regarding the commercial potential of our product candidates (if approved) or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate. A further list and description of these risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20‐F filed with the SEC and our subsequent filings and reports filed with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate, are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release to reflect any change in our expectations or any change in events, conditions or circumstances, unless specifically required by law or regulation.

                   

¹ Minimal improvement per ACR/EULAR is defined as a total improvement score (TIS) of >= 20 points. The TIS is a score derived from the evaluation of the results from 6 core set measurements of myositis disease activity.
² M-CDASI-A: Modified Cutaneous Dermatomyositis Disease Area and Severity Index Activity.
³ OLCA: Option, License and Collaboration Agreement
                  

(*) The operational cash burn (or operational cash flow if this liquidity measure is positive) is equal to the increase or decrease in the cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus: 

• the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities
• the net proceeds or cash used, if any, related to the acquisitions or disposals of businesses; the acquisition of financial assets held at fair value through other comprehensive income; the movement in restricted cash and movement in financial investments, if any, the cash advances and loans given to third parties, if any, included in the net cash flows generated from/used in (-) investing activities
• the cash used for other liabilities related to the acquisition or disposal of businesses, if any, included in the net cash flows generated from/used in (-) operating activities.
This alternative liquidity measure is in the view of the Company an important metric for a biotech company in the development stage. The operational cash burn for year 2025, amounted to €189.1 million and can be reconciled to the cash flow statement by considering the increase in cash and cash equivalents of €28.1 million, adjusted by (i) the net sale of financial investments amounting to €219.6 million, (ii) the cash-in related to the sale/acquisition of subsidiaries of €17.6 million, and (iii) the convertible loan issued to a third party of €20.0 million.

ⁱ General and administrative

ⁱⁱ Sales and marketing

Attachments

• Galapagos Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business
• fy25_financial_tables_EN

Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer




Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer

Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab^1,2,3,4,5

SC amivantamab is now authorised across all previously approved IV indications, offering fewer administration-related reactions and new dosing options^1,2,3,4,5,6

BEERSE, BELGIUM, Feb. 23, 2026 (GLOBE NEWSWIRE) — Johnson & Johnson today announced that the European Commission (EC) has approved an extension of the RYBREVANT^®▼ (amivantamab) marketing authorisation to include additional subcutaneous (SC) dosing regimens. With this decision, SC amivantamab is now authorised for use across all previously approved intravenous (IV) amivantamab indications, including:⁶

Every-four-week (Q4W) SC amivantamab dosing regimen:⁶

• in combination with LAZCLUZE^®▼(lazertinib) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations
• as monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy

Every-three-week (Q3W) SC amivantamab dosing regimen in combination with carboplatin and pemetrexed for adult patients with advanced NSCLC:⁶

• with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI)
• with activating EGFR exon 20 insertion mutations, as first-line treatment

“The approval of additional subcutaneous dosing options represents a step forward in how we can deliver amivantamab in clinical practice for EGFR-mutated non-small cell lung cancer,” said Silvia Novello, M.D., Ph.D., Professor of Medical Oncology in the Oncology Department at San Luigi Hospital in Orbassano, University of Turin, Italy.** “Having the option to transition from every-two-week to every-four-week dosing allows us to better align treatment with individual patient needs. These subcutaneous regimens have demonstrated efficacy and safety consistent with the intravenous formulation, while offering practical advantages like reduced time in clinic, and fewer administration-related reactions, making a real difference for both patients and healthcare teams.”

The approval is supported by results from the Phase 2 PALOMA-2 and Phase 1 PALOMA studies, evaluating the feasibility of SC administration, pharmacokinetics, efficacy and safety of SC amivantamab in multiple regimens in patients with locally advanced or metastatic EGFR-mutated NSCLC, including the Q3W and Q4W dosing regimens.^1,2,3,4,5 Results demonstrated that treatment with SC amivantamab resulted in a response rate and safety profile consistent with historical IV amivantamab dosing, but with a significantly reduced incidence of administration-related reactions (ARRs).^1,2,3,4,5 Administration time with SC amivantamab was faster, approximately five minutes compared to five hours for the first IV amivantamab infusion.^1,2,3,4,5 Consistent with IV amivantamab, the most common treatment-emergent adverse events (TEAEs) were EGFR- and MET-related. These included dermatitis acneiform, paronychia, rash, stomatitis, and hypoalbuminemia.^1,2,3,4,5

“The approval of these new subcutaneous dosing regimens marks an important step in Johnson & Johnson’s commitment to transforming the treatment journey for patients with EGFR-mutated non-small cell lung cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “By offering more flexible and convenient options, we aim to reduce the burden of treatment on patients and their caregivers across all approved indications, while maintaining the well-established efficacy of intravenous amivantamab. This milestone reflects our broader mission to deliver therapies that not only extend and improve lives but also prioritise the experience of those receiving them.”

About the PALOMA Study
PALOMA (NCT04606381), is an open-label, multicentre, dose escalation Phase 1b study which assessed the feasibility of SC administration of amivantamab based on safety and pharmacokinetics (PK) in patients with advanced solid tumours who may benefit from EGFR-or MET-directed therapy, to determine a dose, dose regimen and formulation for SC amivantamab delivery.^1,3,7

About the PALOMA-2 Study
PALOMA-2 (NCT05498428) is an open-label Phase 2 study evaluating the efficacy, safety, and PK of first and second-line SC amivantamab (administered via manual injection) as a monotherapy or combined with lazertinib and/or chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC.^2,4,5,8 The primary endpoints are safety and objective response rate (ORR) as assessed by the investigator per RECIST v1.1*.⁸

About Amivantamab 
Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system.^6,9,10,11

The European Commission (EC) has previously approved amivantamab in the following indications:⁶

Intravenous amivantamab: 

• In combination with lazertinib for the first-line treatment of adult patients with advanced non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
• In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI).
• In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations.
• As monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

Subcutaneous amivantamab:  

• In combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. 
• As monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy. 

Subcutaneous (SC) amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE^® drug delivery technology.¹²

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics.⁶

▼ In line with EU regulations for new medicines, amivantamab is subject to additional monitoring.  

About Lazertinib 
In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Lazertinib is an oral, third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.¹³ An analysis of the efficacy and safety of lazertinib from the Phase 3 study LASER301 was published in The Journal of Clinical Oncology in 2023.¹³

In January 2025, the European Commission approved a marketing authorisation for lazertinib, in combination with amivantamab, for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.¹⁴

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using lazertinib, please refer to the Summary of Product Characteristics.¹⁵

▼ In line with EU regulations for new medicines, lazertinib is subject to additional monitoring. 

About Non-Small Cell Lung Cancer
In Europe, it is estimated that 484,306 people were diagnosed with lung cancer in 2022.¹⁶ NSCLC accounts for 85 percent of all lung cancer cases.¹⁷ Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.¹⁶

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.¹⁷  Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.^17,18  EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.^19,20,21,22 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations.²³ The five-year survival rate for all patients with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent and between 25-32 percent of patients receiving the current first-line standard of care, osimertinib, do not survive long enough to reach second-line treatment.^{24,25,26,27,28,29,30} EGFR exon 20 insertion (ex20ins) mutations are the third most prevalent activating EGFR mutation.³¹ Patients with EGFR ex20ins mutations have a real-world five-year OS of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.²⁵

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 https://innovativemedicine.jnj.com/emea/. Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea/.

Cautions Concerning Forward-Looking Statements 
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab or lazertinib. 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 materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s 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 http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.    

**Prof. Novello has served as a consultant to Johnson & Johnson; she has not been paid for any media work.

*RECIST (v1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger. 

References

¹ Minchom AR, et al. Subcutaneous amivantamab (ami) in patients (pts) with advanced solid malignancies: The PALOMA study-Updated safety and identification of the recommended phase 2 dose. ESMO Poster. 2023.

² Lim S, et al. Subcutaneous amivantamab and lazertinib as first-line treatment in patients with advanced EGFR-mutated, non-small cell lung cancer (NSCLC): Interim results from the phase 2 PALOMA-2 study. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024.

³ Leighl NB, Minchom AR, Lee KH, et al. Subcutaneous amivantamab administered every 4 weeks (Q4W) in patients with advanced solid malignancies: the phase 1b PALOMA study. Oral Presentation presented at: European Lung Cancer Congress (ELCC); March 20-23, 2024; Prague, Czech Republic.

⁴ Scott C, et al. PALOMA-2: Subcutaneous Amivantamab Administered Every 4 Weeks Plus Lazertinib in First-Line EGFR-Mutated Advanced NSCLC. Poster Presented at IASLC 2025 World Conference on Lung Cancer.

⁵ Lim S, et al. First-Line Subcutaneous Amivantamab Plus Chemotherapy in EGFR Exon 20 Insertion-Mutated Advanced NSCLC: Results From PALOMA-2. Poster Presented at IASLC 2025 World Conference on Lung Cancer

⁶ European Medicines Agency. Amivantamab Summary of Product Characteristics. February 2026.

⁷ ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (PALOMA). https://clinicaltrials.gov/study/NCT04606381. Accessed: February 2026.

⁸ ClinicalTrials.gov. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PALOMA-2). https://clinicaltrials.gov/study/NCT05498428. Accessed: February 2026.

⁹ Moores SL, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res 2016;76(13)(suppl 27216193):3942-3953.

¹⁰ Grugan KD, et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. Mabs. 2017;9(1):114-126.

¹¹ Yun J, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR–MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion–Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209.

¹² Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.

¹³ Cho, BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217. 

¹⁴ Innovativemedicine.jnj.com/EMEA. European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer. Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-lazcluze-lazertinib-in-combination-with-rybrevant-amivantamab-for-the-first-line-treatment-of-patients-with-egfr-mutated-advanced-non-small-cell-lung-cancer. Accessed: February 2026.

¹⁵ European Medicines Agency. Lazcluze. January 2025. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze. Accessed: February 2026.

¹⁶ Global Cancer Observatory. Cancer Today. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf. Accessed: February 2026

¹⁷ Zappa C, et al. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res. 2016;5(3):288–300.

¹⁸ Wee P & Wang Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers. 2017;9(12):52.

¹⁹ Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 2019;37(2):97-104.

²⁰ Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting (Singapore); January 29, 2021.

²¹ Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985- 78993.

²² Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.

²³ American Lung Association. EGFR and Lung Cancer. Available at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed: February 2026.

²⁴ Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol 2016 Apr;11(4):556-65.

²⁵ Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.

²⁶ Shao J et al. The number of brain metastases predicts the survival of non-small cell lung cancer patients with EGFRR mutation status. Cancer Rep (Hoboken). 2022;5(9): e1550.

²⁷ Achrol A et al. Brain metastases. Nat Rev Dis Primers. 2019;17(5): 5.

²⁸ Rangachari D et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer. 2015;88(1): 108-111.

²⁹ Nieva J, et al. A real-world (rw) observational study of long-term survival (LTS) and treatment patterns after first-line (1L) osimertinib in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive (m) advanced non-small cell lung cancer (NSCLC). Ann Oncol. 2023;34, S774.

³⁰ Girard N, Leighl NB, Ohe Y, et al. Mortality among EGFR-mutated advanced NSCLC patients after starting frontline osimertinib treatment: a real-world, US attrition analysis. Presented at: the European Lung Cancer Congress; March 29-April 1, 2023; Copenhagen, Denmark. Poster 19P.

³¹ Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9. 

CP-561869
February 2026

FOR EUROPEAN MEDICAL AND TRADE MEDIA ONLY

CONTACT: Media contact:
Laura Coughlan 
lcoughl5@its.jnj.com

Investor contact:
Lauren Johnson
investor-relations@its.jnj.com 

Celldex Announces Multiple Upcoming Presentations at AAAAI 2026 Supporting Barzolvolimab’s First-in-Class and Best-in-Disease Profile




Celldex Announces Multiple Upcoming Presentations at AAAAI 2026 Supporting Barzolvolimab’s First-in-Class and Best-in-Disease Profile

HAMPTON, N.J., Feb. 23, 2026 (GLOBE NEWSWIRE) — Celldex (NASDAQ:CLDX) announced today that multiple presentations from the Company’s Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) have been accepted for presentation at the 2026 American Academy of Allergy, Asthma & Immunology’s (AAAAI) Annual Meeting being held in Philadelphia, February 27 – March 2.

New data from the Phase 2 ColdU and SD Open Label Extension (OLE) will be presented as a late breaker, highlighting that retreatment with barzolvolimab leads to rapid improvement in urticaria control after symptom recurrence.

All presentations will be posted on the Celldex website at the dates/times listed below. Presentation details are as follows:

Trial: Phase 2 ColdU and SD Study
Presentation: Treatment with Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Inducible Urticaria
Session Date / Time: 2/27/2026, 2:45 pm – 3:45 pm
Title: Allergic Skin Diseases
Type: Poster Session
Poster Number: 072
Location: Convention Center, Level 2, Hall E

Trial: Phase 2 CSU Study
Presentation: Prolonged Off-Treatment Efficacy of Barzolvolimab in Chronic Spontaneous Urticaria
Session Date / Time: 2/27/2026, 2:45 pm – 3:45 pm
Title: Allergic Skin Diseases
Type: Poster Session
Poster Number: 075
Location: Convention Center, Level 2, Hall E

Trial: Phase 2 ColdU and SD Study
Presentation: Retreatment with Barzolvolimab Leads to Rapid Improvement in Urticaria Control After Symptom Recurrence in Chronic Inducible Urticaria
Session Date / Time: 3/1/2026, 9:45 am – 10:45 am
Title: Late Breaking Poster Session II
Type: Poster Session LB
Poster Number: L41
Location: Convention Center, Level 2, Hall E

About Barzolvolimab
Barzolvolimab is a humanized monoclonal antibody with a completely novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first in class and best in disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future.

About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders.
Visit www.celldex.com.

Forward Looking Statement
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com

Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com

Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer




Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer

• U.S. Fast Track designation of ART6043 underpinned by promising clinical data to date and high unmet need in gBRCA-mutated HER2-negative breast cancer
• Artios is launching a global randomized Phase 2 study to evaluate ART6043 in patients with BRCA-mutant HER2-negative breast cancer who are eligible to receive a PARP inhibitor

CAMBRIDGE, United Kingdom and NEW YORK, February 23, 2026 – Artios Pharma Limited (“Artios”), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its potentially first-in-class DNA polymerase theta (Polθ) inhibitor, ART6043, in combination with the PARP inhibitor, olaparib, for the treatment of adult patients with germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor.

“Breast cancer remains the second leading cause of cancer death in women in the United States. Granting of U.S. Fast Track designation is an important recognition of ART6043’s clinical profile to treat gBRCAm HER2-negative breast cancer and supports our mission to rapidly deliver potential first-in-class therapies to patients who have limited treatment options,” said Mike Andriole, Chief Executive Officer of Artios. “Importantly, breast cancer patients with a BRCA mutation often develop resistance to treatment with a PARP inhibitor alone. There remains a significant need to improve clinical outcomes and rates of survival through inhibition of Polθ.”

The designation was granted based on data from the ongoing, first-in-human, Phase 1/2a study (NCT05898399), evaluating ART6043 in combination with olaparib in patients with advanced solid tumors harboring mutations in DDR pathways, including gBRCAm HER2-negative breast cancer. In data presented at the European Society for Medical Oncology (ESMO) Congress 2025, ART6043 demonstrated an attractive tolerability profile, expected PK/PD activity, and promising clinical signals.

“gBRCA-mutated HER2-negative breast cancer presents significant treatment challenges due to its frequently aggressive nature and high risk of recurrence, often due to BRCA reversions, with patients requiring intensive therapy,” said Ian Smith, Chief Medical Officer of Artios. “In our ongoing Phase 1/2a study, ART6043, in combination with olaparib, has shown encouraging clinical activity in the relevant genetic background, together with a favorable tolerability and pharmacology profile. These early results support ART6043 as a potential new targeted therapy capable of removing a cancer cell’s reliance on Polθ as a DNA repair mechanism to enhance anti-tumor activity in a well-defined patient population.”

“Our experiments to date with ART6043 have been rationally designed following our team’s pioneering work with the industry’s first PARP inhibitor and recognizing that inhibition of Polθ may enhance the cancer cell killing effects of PARP inhibition and overcome key mechanisms of resistance to improve survival in these patients,” added Graeme Smith, Chief Scientific Officer of Artios.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review and accelerated approval if relevant criteria are met. This designation will enable Artios to interact more frequently and earlier with the FDA to discuss ART6043’s development path.

About ART6043
ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology-mediated end joining (MMEJ) to exploit tumor dependence on error-prone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA‑damaging modalities. Artios’ differentiated approach is to evaluate ART6043 with olaparib in molecularly defined solid tumors, including settings with BRCA variants and PARP inhibitor resistance, to enhance target engagement and anti-tumor activity while maintaining tolerability.

About Artios Pharma Ltd.
Artios’ mission is to develop new classes of medicines that harness DNA Damage Response (DDR) pathways, targeting DNA replication stress and synthetic lethality, to deliver meaningful survival benefits for patients with cancer. Its three potentially first-in-class programs, each with a novel mechanism of action, include ATR inhibitor alnodesertib, the DNA polymerase theta (Polθ) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells’ survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at www.artios.com to learn more about Artios.

For more information, please contact:
Trophic Communications
Jacob Verghese or Verena Schossmann
Tel: +49 151 7441 6179
Email: artios@trophic.eu

Cerevance to Participate in the TD Cowen 46th Annual Health Care Conference




Cerevance to Participate in the TD Cowen 46th Annual Health Care Conference

BOSTON, Feb. 23, 2026 (GLOBE NEWSWIRE) — Cerevance, a clinical-stage biopharmaceutical company advancing targeted therapies for neurodegenerative diseases and obesity, today announced participation in one-on-one meetings with investors at the TD Cowen 46th Annual Health Care Conference being held from March 2-4 in Boston.

About Cerevance
Cerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative diseases and obesity. Our proprietary platform, Nuclear Enriched Transcript Sort sequencing (NETSseq), allows us to identify targets that are expressed at very low levels, that are present in rare cell types, or that change over time as a disease progresses. Our most advanced investigational treatment, solengepras, is currently in Phase 3 development and has the potential to be a first-in-class, oral non-dopaminergic therapy for both motor and non-motor symptoms of Parkinson’s disease. Our second investigational treatment, CVN293, is a highly selective investigational oral inhibitor targeting potassium two pore domain channel subfamily K member 13 (KCNK13). CVN293 represents a potentially novel intervention point for neurodegenerative disorders and obesity. For more information, please visit www.cerevance.com and follow us on LinkedIn and X.

Contacts 

Cerevance: 
Johnna Simões, ir@cerevance.com

Media:
April Dovorany, adovorany@realchemistry.com