Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2025




Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2025

Long-term LEQEMBI treatment suggests potential to delay disease progression from Mild Cognitive Impairment (MCI) to moderate Alzheimer’s disease by up to 8.3 years in low-amyloid group who started treatment at an early stage

New safety and efficacy data presented at scientific symposium on subcutaneous formulation for LEQEMBI initiation treatment, which is under regulatory review in the United States

TOKYO and CAMBRIDGE, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the latest findings on time savings with continued treatment with humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab (generic name, U.S. brand name LEQEMBI^®) were presented at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference. Additionally, a scientific symposium was held on the subcutaneous formulation (SC-AI), which was approved for maintenance treatment in the United States in August 2025, and the rolling supplemental Biologics License Application (sBLA) for initiation treatment was completed in November 2025. The application for a subcutaneous injectable formulation in Japan was submitted in November 2025.

Alzheimer‘s disease (AD) is a progressive, relentless disease with Aβ and tau as hallmarks, that is caused by a continuous underlying neurotoxic process driven by protofibrils* (PF) that begins before amyloid plaque removal and continues afterward.^1,2,3 Only LEQEMBI fights AD in two ways – targeting both PF and amyloid plaque, which can impact tau downstream.

Estimating the 10-Year Time-Savings Benefits of Lecanemab Treatment (Presentation: December 3, 2:40 PM PT)
This analysis used data from the Clarity AD open-label extension (OLE) and 16 clinical studies of monoclonal antibodies for AD to estimate long-term AD progression over 10 years and the slowing effect of continued lecanemab treatment. The analysis evaluated estimated “time savings” (slowing of disease progression) compared to natural decline based on ADNI** (Alzheimer’s Disease Neuroimaging Initiative) data (untreated group), using Clinical Dementia Rating – Sum of Boxes (CDR-SB). These results suggest that early initiation and long-term lecanemab treatment may continue to slow AD progression and help maintain cognitive function over a longer period.

Findings from each group:

• Time Savings from Mild Cognitive Impairment (MCI) Due to AD to Mild AD
  • The time to progression from MCI due to AD to mild AD was 7.2 years in the untreated group, whereas with continued LEQEMBI treatment to the onset of moderate AD, progression to mild AD took 9.7 years, indicating a time savings of 2.5 years.
  • In the low-amyloid group (patients who started treatment at an early stage: amyloid PET <60 centiloids), the time to progression from MCI to mild AD was 13.2 years with continued LEQEMBI treatment to the onset of moderate AD, suggesting a time savings of 6.0 years.
• Time Savings from MCI due to AD to Moderate AD
  • The time to progression from MCI due to AD to moderate AD was 10.1 years in the untreated group, whereas with continued LEQEMBI treatment to the onset of moderate AD, progression to moderate AD took 13.6 years, indicating a time savings of 3.5 years.
  • In the low-amyloid group, the time to progression with continued LEQEMBI treatment to the onset of moderate AD was 18.4 years, suggesting a time savings of 8.3 years.

These findings indicate that earlier initiation of LEQEMBI treatment may provide a greater delay in disease progression. Furthermore, each additional year on LEQEMBI could further delay disease progression compared to stopping treatment, even long after plaque is expected to have been cleared.

Lecanemab Subcutaneous Formulation for Treatment Initiation in Early Alzheimer’s Disease: Optimizing Patient Care with a Potential New Option (Symposium Presentation: December 3, 3:10 PM PT)
In this symposium, the latest data from the lecanemab subcutaneous clinical development program were presented focusing on treatment initiation, including results from the subcutaneous (SC) formulation subcohort (n=273) in the Clarity AD trial OLE. It was shown that weekly administration of lecanemab SC-AI at 500 mg (two 250 mg injections) demonstrated bioequivalence in drug exposure compared to intravenous (IV) dosing of 10 mg/kg every two weeks (exposure ratio: 104%, 90% CI: 99.1%–109%).

Based on clinical data and modeling analysis, the effect on amyloid removal in the brain and safety (ARIA-E incidence) was shown to be independent of the route of administration and explained by exposure, suggesting that weekly 500 mg SC dosing provides similar efficacy and safety to biweekly 10 mg/kg IV dosing. Additionally, ARIA-E incidence was also predicted to be comparable between SC and IV administration (12.4% overall, 30.9% in ApoE4 homozygotes).

In this sub-cohort which had prior exposure to lecanemab, safety evaluation showed systemic infusion reactions occurred in 0% of patients receiving 500 mg SC, all of whom had previously received IV lecanemab, and 1.4% of patients who initiated on 720 mg SC by vial, which is favorable compared to systemic infusion reactions in the IV group (26.4%). Immunogenicity assessment indicated a low incidence of anti-drug antibodies (ADA) at 1.4%.

These results indicate that the subcutaneous formulations of lecanemab, designed with consideration for the convenience of patients and their care partners, maintains efficacy with a low incidence of systemic infusion reactions, and is otherwise equivalent to conventional IV administration.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

* Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.³ The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.⁴

** ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD.

INDICATION
LEQEMBI^® is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

Amyloid-Related Imaging Abnormalities
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.

Incidence of ARIA
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.

Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.

Risk Factors of ARIA and ICH

ApoE ε4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.

Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.

The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.

Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.

Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.

Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.

Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.

Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).

Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.

Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.

Infusion-Related Reactions (IRRs)
IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.

IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.

ADVERSE REACTIONS

• The most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%)
• Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity)

LEQEMBI (lecanemab-irmb) is available:

• Intravenous infusion: 100 mg/mL
• Subcutaneous injection: 200 mg/mL

Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

Notes to Editors

1. About lecanemab (generic name, brand name: LEQEMBI^®)
   Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

   Lecanemab has been approved in 51 countries and regions including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 9 countries. LEQEMBI received manufacturing and marketing approval in Japan in September, 2023 for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S., China, the United Kingdom, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted.

   Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

2. About the Collaboration between Eisai and Biogen for AD
   Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
   Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Co., Ltd.
   Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

   In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

   For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

5. About Biogen
   Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

   The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (LEQEMBI); the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance”, “hope,” ”intend,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realised in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosures
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

1. Iwatsubo T, Irizarry M, van Dyck C, Sabbagh M, Bateman RJ, Cohen S. Clarity AD: a phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer’s disease. Presented at: CTAD Conference; November 29-December 2, 2022; San Francisco, CA.
2. Hampel H, Hardy J, Blennow K, et al. The amyloid-β pathway in Alzheimer’s disease. Mol Psychiatry. 2021;26(10):5481-5503.
3. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
4. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2025




Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2025

Long-term LEQEMBI treatment suggests potential to delay disease progression from Mild Cognitive Impairment (MCI) to moderate Alzheimer’s disease by up to 8.3 years in low-amyloid group who started treatment at an early stage

New safety and efficacy data presented at scientific symposium on subcutaneous formulation for LEQEMBI initiation treatment, which is under regulatory review in the United States

TOKYO and CAMBRIDGE, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the latest findings on time savings with continued treatment with humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab (generic name, U.S. brand name LEQEMBI^®) were presented at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference. Additionally, a scientific symposium was held on the subcutaneous formulation (SC-AI), which was approved for maintenance treatment in the United States in August 2025, and the rolling supplemental Biologics License Application (sBLA) for initiation treatment was completed in November 2025. The application for a subcutaneous injectable formulation in Japan was submitted in November 2025.

Alzheimer‘s disease (AD) is a progressive, relentless disease with Aβ and tau as hallmarks, that is caused by a continuous underlying neurotoxic process driven by protofibrils* (PF) that begins before amyloid plaque removal and continues afterward.^1,2,3 Only LEQEMBI fights AD in two ways – targeting both PF and amyloid plaque, which can impact tau downstream.

Estimating the 10-Year Time-Savings Benefits of Lecanemab Treatment (Presentation: December 3, 2:40 PM PT)
This analysis used data from the Clarity AD open-label extension (OLE) and 16 clinical studies of monoclonal antibodies for AD to estimate long-term AD progression over 10 years and the slowing effect of continued lecanemab treatment. The analysis evaluated estimated “time savings” (slowing of disease progression) compared to natural decline based on ADNI** (Alzheimer’s Disease Neuroimaging Initiative) data (untreated group), using Clinical Dementia Rating – Sum of Boxes (CDR-SB). These results suggest that early initiation and long-term lecanemab treatment may continue to slow AD progression and help maintain cognitive function over a longer period.

Findings from each group:

• Time Savings from Mild Cognitive Impairment (MCI) Due to AD to Mild AD
  • The time to progression from MCI due to AD to mild AD was 7.2 years in the untreated group, whereas with continued LEQEMBI treatment to the onset of moderate AD, progression to mild AD took 9.7 years, indicating a time savings of 2.5 years.
  • In the low-amyloid group (patients who started treatment at an early stage: amyloid PET <60 centiloids), the time to progression from MCI to mild AD was 13.2 years with continued LEQEMBI treatment to the onset of moderate AD, suggesting a time savings of 6.0 years.
• Time Savings from MCI due to AD to Moderate AD
  • The time to progression from MCI due to AD to moderate AD was 10.1 years in the untreated group, whereas with continued LEQEMBI treatment to the onset of moderate AD, progression to moderate AD took 13.6 years, indicating a time savings of 3.5 years.
  • In the low-amyloid group, the time to progression with continued LEQEMBI treatment to the onset of moderate AD was 18.4 years, suggesting a time savings of 8.3 years.

These findings indicate that earlier initiation of LEQEMBI treatment may provide a greater delay in disease progression. Furthermore, each additional year on LEQEMBI could further delay disease progression compared to stopping treatment, even long after plaque is expected to have been cleared.

Lecanemab Subcutaneous Formulation for Treatment Initiation in Early Alzheimer’s Disease: Optimizing Patient Care with a Potential New Option (Symposium Presentation: December 3, 3:10 PM PT)
In this symposium, the latest data from the lecanemab subcutaneous clinical development program were presented focusing on treatment initiation, including results from the subcutaneous (SC) formulation subcohort (n=273) in the Clarity AD trial OLE. It was shown that weekly administration of lecanemab SC-AI at 500 mg (two 250 mg injections) demonstrated bioequivalence in drug exposure compared to intravenous (IV) dosing of 10 mg/kg every two weeks (exposure ratio: 104%, 90% CI: 99.1%–109%).

Based on clinical data and modeling analysis, the effect on amyloid removal in the brain and safety (ARIA-E incidence) was shown to be independent of the route of administration and explained by exposure, suggesting that weekly 500 mg SC dosing provides similar efficacy and safety to biweekly 10 mg/kg IV dosing. Additionally, ARIA-E incidence was also predicted to be comparable between SC and IV administration (12.4% overall, 30.9% in ApoE4 homozygotes).

In this sub-cohort which had prior exposure to lecanemab, safety evaluation showed systemic infusion reactions occurred in 0% of patients receiving 500 mg SC, all of whom had previously received IV lecanemab, and 1.4% of patients who initiated on 720 mg SC by vial, which is favorable compared to systemic infusion reactions in the IV group (26.4%). Immunogenicity assessment indicated a low incidence of anti-drug antibodies (ADA) at 1.4%.

These results indicate that the subcutaneous formulations of lecanemab, designed with consideration for the convenience of patients and their care partners, maintains efficacy with a low incidence of systemic infusion reactions, and is otherwise equivalent to conventional IV administration.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

* Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.³ The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.⁴

** ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD.

INDICATION
LEQEMBI^® is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

Amyloid-Related Imaging Abnormalities
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.

Incidence of ARIA
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.

Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.

Risk Factors of ARIA and ICH

ApoE ε4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.

Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.

The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.

Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.

Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.

Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.

Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.

Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).

Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.

Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.

Infusion-Related Reactions (IRRs)
IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.

IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.

ADVERSE REACTIONS

• The most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%)
• Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity)

LEQEMBI (lecanemab-irmb) is available:

• Intravenous infusion: 100 mg/mL
• Subcutaneous injection: 200 mg/mL

Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

Notes to Editors

1. About lecanemab (generic name, brand name: LEQEMBI^®)
   Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

   Lecanemab has been approved in 51 countries and regions including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 9 countries. LEQEMBI received manufacturing and marketing approval in Japan in September, 2023 for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S., China, the United Kingdom, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted.

   Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

2. About the Collaboration between Eisai and Biogen for AD
   Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
   Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Co., Ltd.
   Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

   In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

   For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

5. About Biogen
   Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

   The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (LEQEMBI); the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance”, “hope,” ”intend,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realised in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosures
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

1. Iwatsubo T, Irizarry M, van Dyck C, Sabbagh M, Bateman RJ, Cohen S. Clarity AD: a phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer’s disease. Presented at: CTAD Conference; November 29-December 2, 2022; San Francisco, CA.
2. Hampel H, Hardy J, Blennow K, et al. The amyloid-β pathway in Alzheimer’s disease. Mol Psychiatry. 2021;26(10):5481-5503.
3. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
4. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

Supernus Pharmaceuticals to Participate in the Bank of America Securities 2025 CNS Therapeutics Virtual Conference




Supernus Pharmaceuticals to Participate in the Bank of America Securities 2025 CNS Therapeutics Virtual Conference

ROCKVILLE, Md., Dec. 03, 2025 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, will present at the Bank of America Securities 2025 CNS Therapeutics Virtual Conference on Monday, December 8, 2025, at 3:20 p.m. ET.

Investors interested in arranging a meeting with company management during the conference should contact the Bank of America conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section of the Supernus Pharmaceuticals website at www.supernus.com. An archived replay of the webcasts will be available for 60 days on the Company’s website following the conference.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders.

For more information, please visit www.supernus.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management’s current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products, and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products, and the products of its subsidiaries; the Company’s ability to commercialize its products, and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

CONTACTS:

Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591

or

INVESTOR CONTACT:
Peter Vozzo
ICR Healthcare
(443) 213-0505
peter.vozzo@icrhealthcare.com

Wake Radiology UNC Health Rex Announces the Retirement of Body Imaging Radiologist Dr. Imre Gaal Jr.




Wake Radiology UNC Health Rex Announces the Retirement of Body Imaging Radiologist Dr. Imre Gaal Jr.

Raleigh, N.C., Dec. 03, 2025 (GLOBE NEWSWIRE) — Wake Radiology UNC Health Rex, the largest outpatient imaging provider in the Triangle, today announced the retirement of distinguished Body Imaging Radiologist Imre Gaal Jr., MD after 25 years of leadership and service. 

Throughout his tenure, Dr. Gaal was instrumental in growing Wake Radiology through his forward-thinking business acumen, his contributions to the training and development of radiologic technologists, and his steadfast commitment to superior patient care. His excellence is reflected in part by his academic training, which included studies at the Massachusetts Institute of Technology, from which he obtained a Bachelor of Science and Master of Science in Electrical Engineering and Computer Science. This was followed by Dartmouth Medical School and then Duke University for a residency in diagnostic radiology. 

“Dr. Gaal’s knowledge and clinical decision-making have been superbly valuable for the care of our community. He has proven time and again to be a trusted consultant for complex body imaging, never hesitating to stop during a busy schedule to review a study,” said Russell Wilson, MD, Wake Radiology Musculoskeletal Radiologist. “Beyond his clinical impact, he sets a powerful example for his younger colleagues, demonstrating the ideal balance between commitment to medical practice and the love of his family. I am grateful for his partnership.”

Following his radiology residency, Dr. Gaal served in the Air Force at David Grant Medical Center, Travis Air Force Base, California, where he was an Attending Radiologist and Associate Director of the Technologist Training Program. While there, he trained radiology residents in GI imaging and numerous radiologic technologists. He continued his love of teaching throughout his career, training a generation of technologists at Wake Radiology and WakeMed. 

While in the Air Force, Dr. Gaal was also involved with the deployment of Picture Archiving and Communication Systems (PACS) when it was in its infancy worldwide. He was also deeply involved with telemedicine at a time when the Department of Defense was heavily investing in the concept. Finally, he completed a formal body imaging fellowship at the University of California, San Francisco before joining Wake Radiology in September 2000. 

Dr. Gaal has consistently shown a passion for radiology and its role in advancing healthcare, as evidenced by his professional dedication to lifelong learning. He attended the Radiological Society of North America (RSNA) Annual Meeting for 26 consecutive years and was also a regular attendant at the European Congress of Radiology in Vienna. He continued to adopt new advanced imaging techniques throughout his career, including Prostate and Rectal MR and Cardiovascular CT and MR.

A key driver of success at Wake Radiology, Dr. Gaal applied his knowledge of IT systems to a complex, interconnected medical environment, ultimately influencing the growth trajectory for the practice. He led the introduction of Multi-Detector CT technology at Wake Radiology in the early 2000s, attending the seminal Stanford meetings and writing articles that introduced the referring community to the technology and its applications. This was followed by the introduction of Dual Source CT cardiovascular applications at WakeMed in the mid-2010s. 

“Dr. Imre Gaal Jr. exemplifies Wake Radiology’s commitment to clinical excellence and patient-first care,” said Dr. Brent Townsend, President and Managing Partner, Wake Radiology. “His quarter century of dedicated service has not only shaped our practice but has also contributed to the positive experience of our patients.”

Beyond patient care, Dr. Gaal is appreciated by his colleagues for his consistently calm demeanor, love of jazz, and helpful tips on travel. His passions also include trekking, photography, film and theater. The entire practice wishes him a long, healthy, and happy retirement.

About Wake Radiology UNC Health Rex

Wake Radiology UNC Health Rex has set the standard for medical imaging excellence and innovation since 1953. Physician-owned and led, our results-driven team of sub-specialized radiologists delivers an unparalleled patient experience rooted in accessible, compassionate and actionable care. As the Triangle’s first and largest outpatient imaging provider, Wake Radiology relies on world-class technology to deliver faster and more accurate imaging services, allowing physicians to elevate patient care and help our communities thrive. Specialties include MRI, CT, X-ray, Ultrasound, Interventional Radiology, Nuclear Medicine, Bone Density and Mammography across 13 area locations. Learn more at WakeRad.com

CONTACT: Rivers Agency: 
publicrelations@riversagency.com 
919-932-9985

Nika Pharmaceuticals, Inc. (NIKA) Progress Update




Nika Pharmaceuticals, Inc. (NIKA) Progress Update

HENDERSON, Nev., Dec. 03, 2025 (GLOBE NEWSWIRE) — Nika Pharmaceuticals, Inc. (OTCQB: NIKA) appeared on The Street Reports podcast where CEO Dimitar Savov shared the progress the company has made thus far and outlined what is expected for 2026, which will be a crucial year for the company. You may listen to the podcast episode here.

Additionally, NIKA’s partner, Nika Europe, is finalizing the technical project for the pharmaceutical factory and expects to begin construction soon. Given that the factory is a “building within a building”, the build up time will be short and the factory is expected to be completed by the end of Q1, 2026. The production line equipment, for which $387,088 has already been paid, is in the final testing stages before it can be shipped for installation in the factory.

“Although the technical project has taken a bit longer to complete than initially expected, that is normal due to the myriads of technical details required to build a state-of-the-art pharmaceutical factory adhering to all GMP standards” explained Savov. “To explain the complexity in simple numerical terms, just the water for injections (WFI) system will cost nearly $ 500,000 pre-tax with the advanced HVAC system costing more than $ 1.1 million pre-tax,” continued Savov. “With the launch of the factory, NIKA will develop into a strong pharmaceutical project, bringing significant value to its shareholders,” concluded Savov.

About Nika Pharmaceuticals, Inc.

Nika Pharmaceuticals, Inc. (NIKA) is a pharmaceutical company, specializing in the treatment of HIV/AIDS, Hepatitis B and C, Rheumatoid Arthritis, Cancer, Diabetes, and all diseases, for which strengthened cell immunity is of vital importance. NIKA’s intellectual property includes six drugs in injection form – two of which have successfully undergone clinical trials with good treatment results – four drugs in tablet form, and eleven dietary supplements. NIKA’s goal is to not only achieve corporate profits, but to provide better and easier access to life-saving medicinal drugs and useful dietary supplements. Find more on www.nikapharmaceuticals.com.

Forward-looking Statement:

This press release contains forward-looking statements. Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements.” These forward-looking statements generally are identified by the words “believes,” “estimates,” “projects,” “intends,” “plan,” “can,” “will,” “would,” and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain.

CONTACT: CONTACT Clifford Redekop, Secretary
COMPANY Nika Pharmaceuticals, Inc.
PHONE (702)-326-3615
EMAIL info@nikapharmaceuticals.com
WEB www.nikapharmaceuticals.com

4D Path’s Physics-Inspired QPOR™ Platform Predicts Neoadjuvant Chemotherapy Response from Routine Biopsy Images in Early-Stage Triple-Negative Breast Cancer from Phase II TBCRC-030 Trial




4D Path’s Physics-Inspired QPOR™ Platform Predicts Neoadjuvant Chemotherapy Response from Routine Biopsy Images in Early-Stage Triple-Negative Breast Cancer from Phase II TBCRC-030 Trial

Prospective-trial analysis published in the Journal of the National Cancer Institute predicts residual cancer burden from baseline H&E slides using fully automated, treatment predictive platform

NEWTON, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) — 4D Path, a company dedicated to personalizing cancer care through a novel, physics-inspired approach to predicting tumor response to therapy, today announced that the company’s Q-Plasia OncoReader (QPOR™) platform has successfully predicted treatment response in patients with early-stage triple-negative breast cancer (TNBC) using digitized baseline biopsy images. Analysis conducted within the Translational Breast Cancer Research Consortium (TBCRC) 030 clinical trial represents the first demonstration of a statistical physics and tumor biology-based computational biomarker predicting post-treatment outcomes from pre-treatment tissue alone, without any clinical or molecular inputs.

Results, published in the Journal of the National Cancer Institute (JNCI), establish a new framework for baseline digital image–based prediction of chemotherapy response and lay the groundwork for future chemo-immunotherapy applications for early-stage TNBC. The multi-institutional collaboration, led by investigators from Dana-Farber Cancer Institute, included researchers from Harvard Medical School, Brigham and Women’s Hospital, 4D Path Inc., and other leading academic centers.

The TBCRC 030 trial previously evaluated Myriad Genetics’ HRD biomarker as a predictor of response to either cisplatin or paclitaxel in TNBC. In this follow-up analysis, investigators applied 4D Path’s QPOR™ algorithm to pre-treatment core biopsies to evaluate tumor-infiltrating lymphocytes (TILs) and computational immune–cell-cycle biomarkers (CmbI, also known as the complex immune response index CIRi), in addition to visual examination (VE) by a pathologist. All assessments were blinded and independently performed on digitized hematoxylin and eosin (H&E) slides.

Key findings include:

• 9X Increased Response Odds of Image-Only Prediction in the Paclitaxel Arm: CmbI predicted RCB 0/1 in paclitaxel-treated patients (OR 9.17, p=0.009; AUC 0.74) using H&E only; CA-TILs and IHI did not.
• Immune Biology Matters: Both visual and computational assessments correlated with response, underscoring the prognostic and predictive role of immune infiltration in TNBC.
• BRCA-Proficient Cohort, Overall Association: In TBCRC 030 (BRCA1/2-proficient), visually assessed-TILs and CmbI associated with response overall; by arm, the signal localized to paclitaxel, not cisplatin.

QPOR’s CmbI is designed to capture the baseline complex immune response as a predictor of post-operative residual cancer burden (RCB) after neoadjuvant chemotherapy. Computed directly from H&E, it integrates—the tumor’s proliferative state, the spatial heterogeneity of immune infiltrates in conjunction with a cell cycle G1/S deregulation signature. This mechanism aligns with the predictive capacity observed with paclitaxel in TBCRC 030 and, importantly, the predictive capacity was also observed in TBCRC 031 (germline BRCA–mutated, HER2-negative breast cancer), where CmbI predicted response to neoadjuvant doxorubicin–cyclophosphamide (AC) and cisplatin monotherapy (ASCO 2024). Together, these observations support potential generalizability of the assay.

“These findings show the complex immune response—a key ingredient of tumor-response biology—can be quantitatively captured directly from routine biopsy slides using first-principles computation as a predictive biomarker of neoadjuvant chemotherapy response, and that G1/S cell-cycle deregulation signatures can be leveraged for a comprehensive quantification of the complex immune response,” said Dr. Satabhisa Mukhopadhyay, Co-founder and Chief Scientific Officer of 4D Path. “It opens the possibility of baseline treatment predictive modeling for treatment selection, trial design, and testing future therapeutic strategies.”

“This is a prospective evaluation of a computational biomarker derived from standard histology that, much like expert visual assessment of TILs, predicts post-treatment response,” said Dr. Erica Mayer, principal investigator of TBCRC 030, and director of breast cancer clinical research at Dana-Farber Cancer Institute. “Developing reproducible predictive signatures from clinical trial pre-treatment biopsies could ultimately improve selection of therapies to optimize patient care.”

The computational analysis produced a quantitative, fully deterministic, and reproducible biomarker predictive of treatment response—by design, intrinsically free of observer variability and machine-learning bias. The study underscores the potential of computational pathology and oncology to complement traditional visual methods, expand biomarker access globally, and facilitate standardized clinical trial workflows.

By relying solely on H&E images, the QPOR™ platform offers a scalable, cost-effective, and interpretable alternative to conventional AI-driven models that require large, annotated datasets. Additionally, this approach provides a foundation for treatment predictive modeling in chemotherapy, potentially applicable to chemoimmunotherapy, and supports the use of physics-based algorithms as complementary tools for patient selection, treatment de-escalation, or early therapy switching decisions.

For additional information, access the full article, “Prognostic value of visually and computationally-assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030),” in the Journal of the National Cancer Institute.

About 4D Path
4D Path has created a groundbreaking platform, the patented Q-Plasia OncoReader (QPOR™), designed to directly measure and quantify cell cycle deregulation and tumor immune microenvironment dynamics to predict a patient’s response to therapy. This unprecedented view into tumor dynamics creates new pathways from clinical use to research and development applications— bringing more effective, personalized therapies to patients. 4D Path is focused on a bold vision where every person impacted by cancer is diagnosed quickly and accurately and receives the best, most personalized treatment plan to beat cancer and live a longer, healthier life.

For additional information, please visit www.4dpath.com or follow 4D Path on LinkedIn.

CONTACT: PR Contact
Jordan Bouclin / Jill Anderson
SVM PR & Marketing Communications
Jordan.bouclin@svmpr.com / Jill.anderson@svmpr.com
(401) 490-9700

NMDP Hires New Philanthropic Leader to Accelerate Financial Giving and Research




NMDP Hires New Philanthropic Leader to Accelerate Financial Giving and Research

MINNEAPOLIS, Dec. 03, 2025 (GLOBE NEWSWIRE) — NMDP^SM, a global nonprofit leader in cell therapy, hired Jessica Kowal as chief philanthropy officer to lead the NMDP Foundation^SM, which expands access to blood stem cell transplants by providing financial assistance to patients and advancing cutting-edge research. Kowal will play a critical role in creating a multiyear strategy and amplifying the impact of financial supporters to advance NMDP’s vision of creating a world where every patient can receive their life-saving cell therapy.

“Jess is a visionary and impactful leader who will help NMDP unlock possibilities we’ve never pursued before,” said Erica Jensen, senior vice president of Strategy and Advancement, NMDP. “Her proven ability to galvanize stakeholders around ambitious goals will elevate how we engage supporters—whether that’s by removing financial barriers to transplant for patients and families in need or funding groundbreaking research like the Donor for All initiative to help all patients survive and thrive.”

In its fiscal year ending September 30, 2025, the NMDP Foundation provided over $7 million in financial assistance to 3,405 families, helping overcome the heavy financial toll that transplant places on patients and caregivers. Charitable giving programs supported by individuals, corporations and other groups helped relieve financial pressures such as transportation, time off from work and medical bills.

Kowal will helm the NMDP Foundation at a critical time. The Foundation also fuels the next generation of scientific discovery through the NMDP Amy Strelzer Manasevit Research Program, one of the nation’s most respected early-career investigator awards in transplant and cell therapy. Since the program’s launch in 1998, the Foundation has invested nearly $12.5 million to support 51 scholars, who have collectively gone on to secure more than $250 million in research investment—driving breakthroughs that improve survival rates and quality of life measures for transplant patients.

Kowal brings over 16 years of experience directing comprehensive fundraising programs across academic, health care and R1 Big Ten institutions—the highest classification of research output within academia. Drawing on her past roles at the University of Minnesota’s School of Public Health, Inspira Healthcare and Stockton University, she brings expertise in all facets of advancement operations, including principal, major and planned giving; gift fund administration; foundation and corporate relations; signature events and more.

Most recently, Kowal served as assistant dean for Institutional Advancement at the University of Minnesota’s Carlson School of Management, where she guided campaigns from inception to execution. Specifically, she led the implementation of a strategic growth plan, which drove a 45% growth in gift production. Kowal has been recognized by the Association of Healthcare Philanthropy as a Top 40 Under 40 recipient and by the Council for Advancement and Support of Education as Professional of the Year. She joined NMDP on November 24.

About NMDP^SM 

At NMDP^SM, we believe each of us holds the key to curing blood cancers and disorders. As a global nonprofit leader in cell therapy, NMDP creates essential connections between researchers and supporters to inspire action and accelerate innovation to find life-saving cures. With the help of blood stem cell donors from the world’s most diverse registry and our extensive network of transplant partners, physicians and caregivers, we’re expanding access to treatment so that every patient can receive their life-saving cell therapy. NMDP. Find cures. Save lives. Learn more at nmdp.org.

Media Contact:

Erin Bix

ebix@nmdp.org

Carl H. Sharperson III Joins MATTER Board of Directors




Carl H. Sharperson III Joins MATTER Board of Directors

MINNEAPOLIS, MN , Dec. 03, 2025 (GLOBE NEWSWIRE) — MATTER, a Minnesota-based global NGO, today announced the appointment of Carl H. Sharperson III to its Board of Directors.

Sharperson currently serves as a Senior Corporate Account Executive at GitHub, a subsidiary of Microsoft, where he helps companies modernize their software engineering practices with artificial intelligence. He holds a BBA in Marketing from Savannah State University in Savannah, Georgia, and an MBA in Finance from the University of Miami Herbert Business School.

Carl’s connection to MATTER began in 2023 when he traveled to Victoria Falls, Zimbabwe, to visit the MATTER Career Readiness Institute. During that trip, he worked with students on interview skills and career readiness, an experience that deepened his passion for creating opportunities for young people to thrive where they live. Each year, he participates in an overseas short-term mission trip, with past travel including Istanbul (Turkey), the Comoros Islands in East Africa, Yogyakarta (Indonesia), Madrid (Spain), Limassol (Cyprus), Varanasi (India), and Cairo (Egypt). Carl also serves as a deacon at River Valley Church’s City campus in Minneapolis.

“I am honored to join the MATTER Board of Directors,” said Sharperson. “Having seen firsthand the impact of MATTER’s work in Zimbabwe, I am inspired by their commitment to innovation, sustainability, and empowering local leaders. I’m excited to bring my experience in technology, business, and global missions to help MATTER expand its impact around the world.”

“Carl brings a powerful blend of corporate expertise, global perspective, and a heart for people that fits perfectly with where MATTER is headed,” said Quenton Marty, CEO of MATTER. “His passion for equipping the next generation and his experience at the intersection of technology and innovation will be a tremendous asset as we continue to grow MATTER’s social enterprise engine and advance projects that improve communities around the world.”

Carl Sharperson III

About MATTER

MATTER, a Minnesota-based global NGO, brings together the best companies, experts, problem solvers and above all, doers, to launch projects that improve communities. This collaborative movement has inspired solutions in health access, providing beneficial meals for children and families, regenerative agriculture, and student-centered education, collectively impacting more than 54 million lives. MATTER’s guiding belief is encapsulated in the simple yet powerful expression, YOU MATTER. 

Press inquiries

MATTER
https://www.matter.ngo
Brian Numainville
brian@matter.ngo
612-467-9141 

Kestra Medical Technologies, Ltd. to Report Second Quarter Fiscal 2026 Financial Results




Kestra Medical Technologies, Ltd. to Report Second Quarter Fiscal 2026 Financial Results

KIRKLAND, Wash., Dec. 03, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced that it will report second quarter fiscal 2026 financial results on Thursday, December 11. Management will host a corresponding conference call at 4:30 p.m. Eastern Time.

A live and archived webcast of the conference call will be available in the “Events” section of the investor relations website. Participants are encouraged to register on the website 10 minutes prior to the start of the conference call.

About Kestra
Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com.

CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com

Kestra Medical Technologies, Ltd. to Report Second Quarter Fiscal 2026 Financial Results




Kestra Medical Technologies, Ltd. to Report Second Quarter Fiscal 2026 Financial Results

KIRKLAND, Wash., Dec. 03, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced that it will report second quarter fiscal 2026 financial results on Thursday, December 11. Management will host a corresponding conference call at 4:30 p.m. Eastern Time.

A live and archived webcast of the conference call will be available in the “Events” section of the investor relations website. Participants are encouraged to register on the website 10 minutes prior to the start of the conference call.

About Kestra
Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com.

CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com