Amylyx Pharmaceuticals, Inc. ($AMLX) Investor Settlement

Amylyx Pharmaceuticals has reached a tentative settlement to resolve investor claims that it misled the market about Relyvrio’s launch, demand, discontinuations, and commercial growth prospects.

Outline:

On September 29, 2022, the FDA approved Relyvrio for ALS, and Amylyx launched the drug on October 24, 2022. Through March, May, and August 2023, the company kept describing the launch as strong and said demand and room for growth remained high. Investors say growth had already slowed after an initial wave of patients and that discontinuations were higher than the market knew. On November 9, 2023, Amylyx disclosed a slowdown in net adds driven by discontinuations, $AMLX fell 31.89%, and the case has now moved to a tentative settlement.

Timeline:

• September 29, 2022: The FDA approved Relyvrio for the treatment of ALS in adults in the United States.

• October 24, 2022: Amylyx commercially launched Relyvrio in the United States.

• March 13, 2023: Amylyx said about 1,300 people were on Relyvrio at year-end 2022 and projected strong continued growth.

• May 11, 2023: Amylyx said roughly 3,000 people were on Relyvrio and described the launch as continuing to perform strongly.

• August 10, 2023: Amylyx said roughly 3,800 people were on Relyvrio and again pointed to growth opportunities ahead.

• November 9, 2023: Amylyx disclosed that growth had slowed and said increased discontinuations were a key reason.

• November 9, 2023: $AMLX fell 31.89% to close at $12.26.

Background:

Amylyx built much of its near-term story around Relyvrio, its ALS treatment. After the drug won FDA approval in September 2022 and launched in October, the company promoted it as an important new option in a disease area with few treatments and high unmet need.

As the launch unfolded, Amylyx repeatedly told investors that demand was strong and that the drug still had meaningful room to expand. The company highlighted growth in the number of patients on therapy and pointed to continued opportunity both within major ALS centers and beyond them.

Investors say that the picture was misleading. They claim the launch was boosted early by an initial wave of patients who had been waiting for the drug, but that this demand faded within months and did not support the broader growth story Amylyx kept presenting.

The dispute also centers on discontinuities. Investors say patients were stopping treatment earlier and at higher rates than the market understood, which made the reported net-growth story look stronger than it really was.

That issue came into clearer view on November 9, 2023, when Amylyx said growth in net patient adds had slowed and that increased discontinuations were a major factor. Shares fell 31.89% that day. The matter has now moved to a tentative settlement.

What Can Investors Expect Now?

Amylyx Pharmaceuticals has reached a tentative settlement to resolve investor claims that it misled the market about Relyvrio’s launch, demand, discontinuations, and commercial growth prospects.

If you were damaged due to this situation, you can file for a payout and get your share of the settlement. You can check if you are eligible and other details in the FAQ section.