ACADIA Pharmaceuticals Inc. (ACAD) Up On FDA Ruling

ACADIA Pharmaceuticals Inc. (ACAD) Up On FDA Ruling
ACADIA Pharmaceuticals Inc.

ACADIA Pharmaceuticals Inc. is up 8 percent on a favorable FDA ruling on a company drug. Analysts have a more mixed view of the news.

Play Quizzes 4

ACADIA Pharmaceuticals Inc. sell side analysts react

Panel in a nutshell. In line with our expectations, all three voting questions at yesterday’s AdCom went in favor of Nuplazid (12-2 on substantial evidence of efficacy; 11-3 on adequate characterization of safety; 12-2 on benefit outweighing risk). We believe that to the extent that one can extrapolate on approvability, yesterday’s AdCom was as positive as it gets for a new drug in a new indication. Overall, we expect the agency to approve Nuplazid by the May 1st PDUFA. Meanwhile, in our view, the open question coming out of the AdCom was not the approvability of the drug, but instead: (1) whether the agency will elect to further qualify the label indication (from “psychosis associated with PD” to “psychosis associated with PD treated with dopaminergic agents”); and (2) whether the agency will attach a black box warning to the label. We believe that both are likely albeit not material developments. We have previously guided that a boxed warning was a high likelihood, but that it would not significantly impact the uptake of the drug. Following yesterday’s AdCom endorsement of Nuplazid, and in anticipation of the May 1st PDUFA, we reiterate our Buy rating and $50 PT.

JPMorgan states:

ValueWalk’s June 2022 Hedge Fund Update: Tiger Global’s Losses Total 44% In 2022

investWelcome to our latest issue of issue of ValueWalk’s hedge fund update. Below subscribers can find an excerpt in text and the full issue in PDF format. Please send us your feedback! Featuring Tiger Global's losses total 44% in 2022, Allianz Global's $5.8bn SEC settlement, and commodity funds draw in cash. Q1 2022 hedge fund Read More

We expect BULLS to focus on the fact that Nuplazid is a wholly owned CNS drug that’s now highly likely to be approved (thus significant scarcity value); given that it will be the only drug indicated for PDP it can still sell well even if label is restricted; plus still have optionality with pending ADP data. Conversely, BEARS may assume label will spook docs/patients and subsequent launch will struggle, which hurts strategic value; and ADP is very high risk.

Today the bulls are winning, but only time will tell who is correct at the end of the day!

Updated on

Sheeraz is our COO (Chief - Operations), his primary duty is curating and editing of ValueWalk. He is main reason behind the rapid growth of the business. Sheeraz previously ran a taxation firm. He is an expert in technology, he has over 5.5 years of design, development and roll-out experience for SEO and SEM. - Email: sraza(at)
Previous article Lululemon Athletica inc. (LULU) Up 10 Percent On Earnings
Next article Investing Mistakes Part 1: Owning Your Most Valuable Asset

No posts to display