Securities – Fraud

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Where a securities fraud complaint has been filed against the defendant manufacturer of a drug used for the treatment of amyotrophic lateral sclerosis (ALS), a motion to dismiss the complaint should be denied because the plaintiffs have adequately alleged material misrepresentations with respect to forward-looking statements from May and August 2023 that discuss growth opportunities within the ALS community.

“This is a putative securities class action brought pursuant to the Securities Exchange Act of 1934 (‘Exchange Act’) on behalf of individuals who purchased or otherwise acquired the common stock of Amylyx Pharmaceuticals, Inc. (‘Amylyx’) between November 11, 2022, and November 8, 2023, (‘the Class Period’). …

“‘AMX0035’ or ‘Relyvrio’ is a drug produced by Amylyx and used for the treatment of ALS in adults. …

“This Court finds that plaintiffs have adequately alleged material misrepresentations with respect to forward-looking statements made in May and August, 2023, that discuss growth opportunities within the ALS community. …

“Taking all well-pled factual allegations as true, 9,000 patients had been prescribed Relyvrio by the time of the peak of the bolus. Assuming that was sometime between the end of March, 2023 (3,000 net subscribers) and the end of June, 2023 (3,800 net subscribers), more than 5,000 of the total 9,000 subscribers had discontinued treatment. This represents a discontinuation rate of over 50% and indicates that there was significantly less potential for new subscribers. The omission of this data could therefore be found to have rendered defendants ‘ assertions regarding Relyvrio’s growth potential materially misleading.

“Accordingly, the Court finds that the amended complaint adequately states a claim with respect to statements made between May and August, 2023, related to Relyvrio’s growth potential.”

Shih v. Amylyx Pharmaceuticals, Inc. et al. (Lawyers Weekly No. 02-557-25) (12 pages) (Gorton, J.) (Civil Action No. 24-12068-NMG) (Sept. 30, 2025).

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