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Acadia Pharmaceuticals Inc: DAYBUE (trofinetide) Receives Positive CHMP Opinion: EU Approval Pending

发布日期: 2026-06-26研究机构: Morgan Stanley公司 / 股票: ACAD.OQ报告页数: 10原文语言: 英语证据页码: 1

研报英文原文证据摘录

Acadia Pharmaceuticals Inc: DAYBUE (trofinetide) Receives Positive CHMP Opinion: EU Approval Pending

Idea

June 26, 2026 11:57 AM GMT

Morgan Stanley & Co. LLCMAcadia Pharmaceuticals Inc | North America Sean Laaman, Ph.D.

Equity Analyst

DAYBUE (trofinetide) Receives Sean.Laaman@morganstanley.comMichael H Riad, Ph.D. +1 212 761-4947

Research Associate

Michael.Riad@morganstanley.com +1 212 761-1309

Positive CHMP Opinion: EU Katherine Sun

Katherine.Sun@morganstanley.com +1 212 761-5968

Approval Pending Natasha Arya

Natasha.Arya@morganstanley.com +1 212 761-6294

CHMP recommends EU approval of DAYBUE for Rett syndrome

neurobehavioral symptoms, positioning Acadia to expand Acadia Pharmaceuticals Inc (ACAD.O, ACAD US)

beyond the U.S. market. Approval would establish first-in-class Biotechnology | United States of America

Stock Rating Equal-weight

status in EU, reinforcing commercial durability and rare disease Industry View Attractive

Price target $26.00

franchise value. Shr price, close (Jun 25, 2026) $23.72

Mkt cap, curr (mm) $4,067

52-Week Range $28.35-19.69

Key Takeaways Enterprise Value, For Consensus $3,029

(12/26e) (mm)**

CHMP positive opinion (post re-exam) sharply de-risks EU approval; EC decision

** = Based on consensus methodology

expected in coming months.

Fiscal Year Ending 12/25 12/26e 12/27e 12/28e

Phase 3 LAVENDER data shows statistically significant benefit on RSBQ and CGI-I Revenue, net ($mm) 1,071 1,242 1,466 1,620

(clinically meaningful outcomes). EBITDA ($mm)** 106 53 159 208

Net income ($mm)** 391 70 156 196

First approved EU therapy for Rett neurobehavioral symptoms would unlock EPS ($)** 2.33 0.40 0.91 1.14

Prior EPS ($)** - - - -

meaningful ex-U.S. revenue and lifecycle durability. P/E 11.5 58.7 26.1 20.9

EPS ($)§ 0.81 0.39 0.82 1.44

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