Shionogi to Present RADICAVA^® (edaravone) ORS and Digital Health Analyses in ALS at AAN 2026

FLORHAM PARK, NJ, April 16, 2026 — Shionogi Inc. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced two presentations highlighting research in amyotrophic lateral sclerosis (ALS) at the American Academy of Neurology (AAN) 2026 Annual Meeting, taking place April 18-22 in Chicago, Illinois, and online. Both presentations will feature encore analyses sharing previously presented findings.

“We look forward to sharing these analyses at AAN and contributing to the ongoing scientific dialogue around ALS,” said Gustavo A. Suarez Zambrano, M.D., Vice President, Medical Affairs, Rare Disease, Shionogi. “These analyses explore a potential ALS prognostic biomarker and examine emerging digital health tools aimed at advancing monitoring and understanding of disease progression.”

An analysis will be presented assessing neutrophil-to-lymphocyte ratio (NLR) changes in response to edaravone oral suspension-treated patients with ALS and examining the predictive value of baseline NLR compared with propensity score-matched PRO-ACT placebo controls. These results further examine the potential of NLR as a prognostic biomarker in ALS.

A study will be presented evaluating smartphone-based telespirometry as an at-home tool for ALS monitoring. In a six-month prospective study of patients receiving edaravone, ALSFRS-R decline differed based on non-invasive ventilation (NIV) status. Further analyses highlight the importance of incorporating NIV use into clinical study design and interpretation of respiratory and functional endpoints.

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 22,000 people with ALS, with over 2.8-million days of therapy, and have been prescribed by over 2,800 HCPs.^2-4

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

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.

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.

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.

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

To report suspected adverse reactions or product complaints, contact Tanabe Pharma America, 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.

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.

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, CNS disorders and cardiovascular diseases. 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.

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