Positive; Detailed Announcement of Domestic Ph3 Outcomes for KP-001 in Vascular Malformation

Research evidence excerpt

Positive; Detailed Announcement of Domestic Ph3 Outcomes for KP-001 in Vascular Malformation

Update

July 17, 2026 11:54 AM GMT

Morgan Stanley MUFG Securities Co., Ltd.+MKaken Pharmaceutical (4521) | Japan Jaeheon Lee

Equity Analyst

Positive; Detailed Jaeheon.Lee@morganstanleymufg.comShinichiro Muraoka +81 3 6836-8443

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

Announcement of Domestic

Ph3 Outcomes for KP-001 in

Vascular Malformation

Kaken Pharmaceutical (4521.T, 4521 JP)

Pharmaceuticals | Japan

Key Takeaways Stock Rating Overweight

Industry View In-Line

Kaken issued a post-close press release regarding KP-001 Ph3 results after its Price target ¥5,300

Shr price, close (Jul 17, 2026) ¥3,860

conference presentation in the morning of Jul 17, and held a small meeting from Mkt cap, curr, basic (bn) ¥147.3

5:30pm. Avg daily trading value (bn) ¥0.5

Efficacy is positive; more or less on par with Ph2 (Ex.1), with a 31% response rate

based on change in target lesion volume (assessed via MRI) at 24 weeks.

Safety: Grade 3 events were observed in 17% and Grade 4 events in 6% of trial

subjects, confirming risk mainly of elevated kidney function test values. The

impression is not good, but nor do concerns appear to be major.

In terms of differentiation vs. rivals, as well as good efficacy, we would view the

safety profile as relatively clean, especially in terms of limited side effects

stemming from immunosuppressive effects.

We envisage domestic launch in Japan in summer/fall 2027. Ph3 trials in the US

are currently underway and we expect data to be available in about mid-2028.

Minor positive: In terms of efficacy, we would put the results as broadly in line with

the base case we set out in our Jul 14 CDI. On the other hand, materialization of side