CAMBRIDGE, Mass. - Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX) has initiated the process to voluntarily discontinue the marketing authorizations for its ALS drug RELYVRIO/ALBRIOZA in the United States and Canada.
The decision follows the topline results from the Phase 3 PHOENIX trial and is being carried out in coordination with the U.S. Food and Drug Administration (FDA) and Health Canada. The company announced today that RELYVRIO/ALBRIOZA will no longer be offered to new patients; however, those currently undergoing treatment will have the option to continue through a free drug program, pending physician consultation.
Despite the setback in its ALS program, Amylyx remains committed to developing treatments for neurodegenerative diseases. The company is advancing its lead asset AMX0035 in clinical trials for Wolfram syndrome and progressive supranuclear palsy (PSP), as well as AMX0114 for ALS. Interim results from the Phase 2 HELIOS trial of AMX0035 for Wolfram syndrome are expected soon, with a presentation scheduled for April 10, 2024.
In response to the recent developments, Amylyx has also announced a restructuring plan aimed at reducing its workforce by approximately 70%. This move is intended to conserve resources and focus on key clinical and preclinical programs. As a result of the restructuring, the company anticipates extending its cash runway into 2026, which aligns with the anticipated data readouts for its ongoing clinical studies.
The PHOENIX Open Label Extension study is ongoing, and topline data from the PHOENIX trial are set to be presented at the American Academy of Neurology Annual Meeting on April 16, 2024. Amylyx is also preparing to initiate a clinical trial for AMX0114 in ALS in the latter half of this year.
The company's decision to withdraw RELYVRIO/ALBRIOZA was made after careful consideration and discussions with regulatory authorities and the ALS community, according to Co-CEOs Joshua Cohen and Justin Klee. Amylyx will continue to collect survival data from the PHOENIX trial as encouraged by ALS specialists.
This strategic pivot allows Amylyx to concentrate on advancing its remaining pipeline, which includes potential treatments for neurodegenerative diseases with limited therapeutic options.
InvestingPro Insights
Amidst the announcement of Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX) discontinuing the marketing authorizations for its ALS drug, the company's financial metrics provide a broader picture of its market position and future prospects. Amylyx's market capitalization, adjusted to $178.27 million, reflects its current valuation in the market. The company's P/E ratio stands at 3.72, with an adjusted P/E ratio for the last twelve months as of Q4 2023 at 4.38, indicating how much investors are willing to pay for a dollar of earnings and suggesting a potentially undervalued stock in comparison to industry peers.
The substantial revenue growth Amylyx has experienced over the past year is noteworthy, with a staggering 1612.94% increase in the last twelve months as of Q4 2023. This growth trajectory, however, must be viewed in the context of the company's recent strategic decisions and the potential impact on future revenue streams. Additionally, the company's gross profit margin stands at 59.66%, which is a strong indicator of its ability to turn revenue into profit.
Investors considering Amylyx may also be interested in the "InvestingPro Tips" that provide deeper insights into the company's financial health and investment potential. For instance, one tip highlights the importance of revenue growth as a signal of a company's potential to scale and capture market share. Another tip might focus on the significance of gross profit margins in assessing a company's operational efficiency. For more comprehensive analysis and additional tips, Amylyx investors can explore the InvestingPro platform, which currently offers PRONEWS24 for an extra 10% off a yearly or biyearly Pro and Pro+ subscription. There are 7 more "InvestingPro Tips" available that can guide investors in making more informed decisions.
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