Shionogi to Present New Real-World Data Advancing the Understanding of ALS at the 2026 Annual NEALS Meeting

FLORHAM PARK, NJ, October 26, 2026 - Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.), will present three posters at the 2026 Annual Network of Excellence for Amyotrophic Lateral Sclerosis (NEALS) Meeting, taking place October 27-30 in Clearwater, Florida. Shionogi remains committed to advancing ALS research and expanding the understanding of RADICAVA ORS^® (edaravone), including through real-world evidence and innovative approaches to disease monitoring.

Data being presented at the 2026 Annual NEALS Meeting include analyses evaluating the association of RADICAVA ORS treatment with progression-free survival and functional outcomes in patients with ALS. Additional research explores the role of remote respiratory monitoring and its potential to identify patients at risk of more rapid disease progression.

"ALS is a highly variable disease, which makes it essential to examine potential treatment effects from multiple perspectives," said Gustavo A. Suarez Zambrano, M.D., Vice President, Medical Affairs, Rare Disease, Shionogi Inc. "Shionogi's research brings together real-world analyses and at-home respiratory monitoring to deepen our understanding of disease progression and generate insights that may support more informed care for people living with ALS."

NEALS attendees can visit the Shionogi team during the meeting to learn more about the company's commitment to ALS research and supporting the ALS community.

RADICAVA ORS^® (edaravone) and ALS data posters:

• Poster #187: Association of Edaravone with Improved Progression-Free Survival in Patients with Amyotrophic Lateral Sclerosis: A Propensity Score-Matched Analysis of the Optum Claims Database
• Poster #188: Association of Edaravone Treatment with Slower Functional Decline in a Real-World Cohort of Patients with Amyotrophic Lateral Sclerosis with Elevated Neurofilament Light Chain
• Poster #105: At-Home Telespirometry Identifies Baseline Erect Slow Vital Capacity (eSVC) at ≤80%-Predicted as a Pivotal Benchmark Separating Rapid from Less Rapid Decline in eSVC, Supine SVC and Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Score in an Observational Study (NCT05106569)

About RADICAVA ORS^® (edaravone)

The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS^® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. Each 105 mg (5mL) dose of RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.¹

Edaravone was discovered and developed for ALS by Tanabe Pharma Corporation and commercialized in the U.S. by Tanabe Pharma America, Inc. The Tanabe Pharma group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT^® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021), Australia (February 2023) and Brazil (February 2024). Marketing authorization for RADICAVA^® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT^® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA ORS, along with the previously available IV RADICAVA^® (edaravone), have been used to treat over 22,800 people with ALS, with over 3.0-million days of therapy, and have been prescribed by over 2,850 HCPs.²

Following the completion of Shionogi's acquisition of the global RADICAVA business, Shionogi now holds global rights to RADICAVA ORS and RADICAVA IV.

INDICATION

RADICAVA ORS^® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions

RADICAVA ORS^® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions

RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.

Adverse Reactions

The most common adverse reactions (≥10%) reported in RADICAVA^® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy

Based on animal data, RADICAVA ORS may cause fetal harm.

To report suspected adverse reactions or product complaints, contact Shionogi Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, also available at http://www.RADICAVAORS.com

About ALS

ALS (Amyotrophic Lateral Sclerosis) is a progressive neurodegenerative disease characterized by the selective degeneration and loss of motor neurons, leading to muscle weakness and respiratory impairment. After onset, muscle atrophy gradually progresses, and ultimately respiratory muscle paralysis severely impacts life expectancy. Globally, the annual incidence is estimated at approximately 1-2 cases per 100,000 population, making it a rare disease for which no fundamental cure currently exists.³ Multiple factors, including oxidative stress and glutamate-induced excitotoxicity, are involved in its pathophysiology, and treatment options to slow disease progression remain extremely limited. For this reason, ALS is recognized as a disease with a high level of unmet medical need, and the development and delivery of innovative therapies are strongly required.

About Shionogi in Rare Disease

Shionogi is committed to the research and development of innovative medicines that address unmet medical needs for people worldwide. Rare diseases often have limited treatment options and affect the lives of individuals and families around the world. In the U.S., Shionogi is advancing a rare disease franchise that includes an approved therapy for amyotrophic lateral sclerosis (ALS) as well as clinical programs in Fragile X syndrome, Jordan's Syndrome and Pompe disease. For more information, view our pipeline here: https://www.shionogi.com/us/en/innovation/pipeline.html.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and wellbeing of the patients we serve." The company currently markets products in several therapeutic areas including anti-infectives, pain, and CNS disorders. Shionogi's research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer's disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

For Further Information, Contact:

SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

Shionogi Inc.: [email protected]

References

1. RADICAVA and RADICAVA ORS [package insert]. Florham Park, NJ: Shionogi Inc.

2. Data on file. Shionogi Inc.

3. Xu, et al. Global variation in prevalence and incidence of amyotrophic lateral sclerosis: a systematic review and meta-analysis. J Neurol. 2020 Apr;267(4):944-953. DOI: 10.1007/s00415-019-09652-y