
Amicus Therapeutics, Inc. (FOLD)
Whether directors and officers of Amicus Therapeutics, Inc. (FOLD) breached their fiduciary duties to the company and its shareholders.
Investigation
04/25/2022
Initial Lawsuit
05/13/2022
Lawsuit Progression
07/12/2022
The U.S. Food and Drug Administration identified chemistry, manufacturing, and controls (CMC) issues during a review of the company’s New Drug Application (NDA) for its AXS-07 product candidate for the acute treatment of migraine are unresolved. This investigation focuses on whether the issues were known to management prior to submitting the NDA, thereby impacting the communicated timeline.
This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.
A lawsuit was subsequently filed. We will update this post as it unfolds.
04/25/2022
Axsome Therapeutics, Inc. discloses that the U.S. Food and Drug Administration has found chemistry, manufacturing, and controls (CMC) issues identified during the FDA’s review of the company’s New Drug Application (NDA) for its AXS-07 product candidate for the acute treatment of migraine are unresolved.
“Based upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$30.5 | $39.1 | $-8.6 | -21.99% |
This is a federal securities class action on behalf of a class consisting of all persons and entities other than defendants that purchased or otherwise acquired Axsome securities between December 30, 2019 and April 22, 2022, both dates inclusive.
According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:
(i) Axsome’s chemistry, manufacturing, and control (CMC) practices were deficient with respect to AXS-07 and its manufacturing process;
(ii) as a result, Axsome was unlikely to submit the AXS-07 New Drug Application (NDA) on its initially represented timeline;
(iii) the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA;
(iv) accordingly, the FDA was unlikely to approve the AXS-07 NDA;
(v) as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and
(vi) as a result, the company’s public statements were materially false and misleading at all relevant times.
The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses
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