Advisory Committee on Cell Therapy Deramiocel (CAP-1002) Scheduled for Jul 29

研报英文原文证据摘录

Advisory Committee on Cell Therapy Deramiocel (CAP-1002) Scheduled for Jul 29

Update

June 26, 2026 03:47 PM GMT

Morgan Stanley MUFG Securities Co., Ltd.+MNippon Shinyaku (4516) | Japan Jaeheon Lee

Equity Analyst

Advisory Committee on Cell Jaeheon.Lee@morganstanleymufg.comShinichiro Muraoka +81 3 6836-8443

Shinichiro.Muraoka@morganstanleymufg.com +81 3 6836-5424

Therapy Deramiocel (CAP-

1002) Scheduled for Jul 29

Key Takeaways Nippon Shinyaku (4516.T, 4516 JT)

FDA's Advisory Committee is scheduled for Jul 29, 2026. Pharmaceuticals | Japan

Stock Rating Underweight

The PDUFA date remains Aug 22, 2026. Industry View In-Line

Price target ¥2,600

Capricor's share price fell 12-13% (as at 23:30 JST). Shr price, close (Jun 26, 2026) ¥4,049

Mkt cap, curr, basic (bn) ¥272.7

Avg daily trading value (bn) ¥1.7

No surprise, but minor negative: It is reasonable to expect the market to price in a

certain degree of risk regarding FDA approval of Deramiocel following the

announcement of the Advisory Committee. While the Advisory Committee does not

necessarily signal either a good or bad outcome, uncertainty remains high,

particularly around the content of discussions. The next key focus will likely be the

FDA review documents released several days before the Advisory Committee. We

would expect a positive tone to provide reassurance over FDA approval, whereas a

negative tone would likely heighten existing unease and concerns around this. We

do not hold significant concerns regarding efficacy or the safety profile in Ph3 trials,

but we do see a need for continued caution over CMC (production)-related issues

raised in the Complete Response Letter (CRL) issued in Jul 2025. That said, we

believe Nippon Shinyaku's share price currently reflects only limited expectations for