Cases & investigations

Cases & investigations

Amylyx Pharmaceuticals

Kaskela Law LLC is investigating potential legal claims on behalf of long-term holders of Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx”) common stock.

Recently a federal securities fraud complaint was filed against Amylyx on behalf of certain investors who purchased shares of the company’s stock between November 11, 2022 and November 8, 2023 (the “Relevant Period”).

Aa detailed in the complaint, Amylyx is a commercial-stage biotechnology company that engages in the discovery and development of treatments for amyotrophic lateral sclerosis (“ALS”).  During the Relevant Period the company’s products included AMX0035 (commercially referred to as “Relyvrio” in the U.S.), which was designed for the treatment of ALS in adults in the U.S.

According to the complaint, during the Relevant Period, Amylyx and certain senior executives made a series of materially false and/or misleading statements to investors about the success of Amylyx’s commercial launch of Relyvrio.  Specifically, the defendants are alleged to have made false and/or misleading statements and/or failed to disclose that: (i) at the time, defendants knew that the “significant demand” was due to an initial, temporary bolus of patients that, by this time, had stabilized, offering no meaningful opportunity for further growth, (ii) at the time, contrary to their representations, defendants knew the initial bolus was over within months of the launch, (iii) and thus, there was no growth potential for newly diagnosed patients with ALS in ALS centers, (iv) that there was no opportunity for growth outside the concentrated ALS centers, in the broader neurology community, (v) at the time, defendants already were aware that high, undisclosed discontinuation rates were occurring, undermining the commercial potential for the launch, and (vi) those hidden discontinuations inflated the “runway” left for more, new net patient subscribers.

As further detailed in the complaint, the truth about the launch’s failure was revealed on November 9, 2023, when Amylyx issued a press release announcing disappointing quarterly financial and operational results.  During a subsequent conference call, Amylyx’s management revealed that, despite “a [purported] steady cadence of new prescriptions written” for Relyvrio, Amylyx’s “results were impacted by a number of factors” including a “slowdown in net adds” for Relyvrio during the quarter, which “was primarily driven by increased discontinuations for a variety of reasons.”  Following this news, shares of the company’s stock fell $5.74 per share, or over 31% in value, to close on November 9, 2023 at $12.26 per share, on unusually heavy trading volume.

In light of the foregoing, Kaskela Law’s investigation seeks to determine whether Amylyx’s officers and directors violated the securities laws and/or breached their fiduciary duties in connection with the above alleged misconduct.

Current Amylyx shareholders who purchased or acquired AMLX shares prior to November 9, 2023 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) for additional information about this investigation and their legal rights and options at (484) 229 – 0750, by email at [email protected], or by completing the form on this page.

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