Nippon Shinyaku (4516): AdCom vote increases uncertainty about Nippon Shinyaku’s medium- to long-term outlook

Research evidence excerpt

Nippon Shinyaku (4516): AdCom vote increases uncertainty about Nippon Shinyaku’s medium- to long-term outlook

J P M O R G A N Asia Pacific Equity Research

30 July 2026

Nippon Shinyaku (4516) Neutral

4516.T, 4516 JP

AdCom vote increases uncertainty about Nippon Price (29 Jul 26):¥3,550

Shinyaku’s medium- to long-term outlook Price Target (Dec-26):¥4,000

The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (AdCom) Japan Equity Research

has voted 9-3 that there is not sufficient evidence of efficacy to recommend

Biotechnology & Pharmaceuticals/

approval for deramiocel in treating cardiomyopathy in patients with Duchenne Medical Technologies & Services

muscular dystrophy (DMD). We believe this result, along with the negative view AC Seiji Wakao, Ph.D.

expressed by the FDA in its review materials, significantly reduces the likelihood

(81-3) 6736-8612

that deramiocel will obtain FDA approval (PDUFA date: August 22). seiji.wakao@jpmorgan.com

Yugo R. Kamimura, Ph.D.

For Nippon Shinyaku, deramiocel is an important pipeline product that is expected (81-3) 6736-8635

to support profit growth after the Uptravi patent cliff (LOE: 2027). Now that it is yugo.kamimura@jpmorgan.com

difficult to factor in an earnings contribution from deramiocel, we believe Nippon Naoko Saito

Shinyaku’s medium- to long-term profit growth scenario has become much less (81-3) 6736-8693

likely. While the share price had already fallen in response to the announcement naoko.saito@jpmorgan.com

of the FDA review materials, we think it is likely to come under further downward JPMorgan Securities Japan Co., Ltd.

pressure as a result of the AdCom vote.

The majority of AdCom members judged that not enough evidence is available to

show that deramiocel is effective in treating cardiomyopathy.