IR News 2026

KYOTO, Japan, May 8, 2026 - Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Toru Nakai) announces that a lawsuit was filed against Nippon Shinyaku in the Superior Court of New Jersey, Chancery Division, Bergen County, as follows.

1. Date of Complaint

 May 7th, 2026

2. Reasons and Background for the Action

 Capricor Therapeutics, Inc. (Headquarters: California, USA, CEO: Linda Marbán, NASDAQ: CAPR) announced that it has filed a lawsuit against Nippon Shinyaku and its U.S. subsidiary, NS Pharma, Inc., seeking an injunction against the Commercialization and Distribution Agreement for CAP-1002 (deramiocel) (the Agreement). The lawsuit concerns the Nippon Shinyaku’s product distribution rights in the United States in the Agreement. 

CAP-1002 (deramiocel) is currently under the FDA review for approval for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy.

3. Party Who Filed the Complaint

(1) Name: Capricor Therapeutics, Inc.　 

(2) Address: 10865 Road to the Cure, Suite 150, San Diego, CA 92121, United States

 

4. Contents of the Complaint

 A judgement regarding the U.S. distribution rights in the United States, etc.

5. Prospects

 The complaint has not been served, but our understanding is that Capricor appears to be arguing that the amendments to the Agreement regarding the U.S. launch of CAP-1002 (deramiocel), as well as the launch preparations of Nippon Shinyaku and NS Pharma are insufficient. However, we are confident that both Nippon Shinyaku and NS Pharma have responded appropriately and sincerely to ensure treatment reaches DMD patients after approval. While we recognize that Capricor’s claims lack merit, we remain open to discussions with Capricor to maximize the value of CAP-1002 (deramiocel).

Contact:

Public Relations & Investor Relations Dept., Nippon Shinyaku Co., Ltd.

e_mail_kouhou@po.nippon-shinyaku.co.jp