Cambridge, Massachusetts-based Amylyx Pharmaceuticals has encountered a regulatory obstacle in Europe for its ALS treatment, AMX0035, also known as Albrioza or Relyvrio. The European Medicines Agency (EMA) has expressed a negative opinion about the drug, reiterating an earlier unfavorable stance. This news was announced on Friday.
Amylyx Pharmaceuticals, which operates with a moderate level of debt, has seen its stock fare poorly over the last month with a 1 Month Price Total Return of -21.9% according to InvestingPro data. The company's market cap stands at 20.7B USD, and it is trading near its 52-week low, with the price at 69.58% of the 52-week high.
Despite the setback in Europe, the pharmaceutical firm remains undeterred and continues with its Phoenix phase 3 clinical trial. The goal of this trial is to further substantiate the drug's efficacy and safety, with hopes of accelerating approval within the European Union.
Notably, AMX0035 has already garnered approvals elsewhere. The drug received conditional approval from Health Canada and a full endorsement from the U.S. Food and Drug Administration (FDA), where it is known under the alternative name Relyvrio.
The company anticipates results from the ongoing Phoenix phase 3 trial to be available in mid-2024. These results could potentially influence future decisions by the EMA regarding the approval of AMX0035.
While Amylyx's revenue growth has been accelerating, with a growth of 39.94% as per InvestingPro data, the company has been facing a declining trend in earnings per share. In fact, analysts do not anticipate the company will be profitable this year. Despite this, Amylyx's liquid assets exceed its short-term obligations, suggesting a strong financial position.
For more insights on Amylyx Pharmaceuticals, readers can refer to InvestingPro Tips, which provides valuable tips based on real-time metrics. There are a total of 10 additional tips listed in InvestingPro, providing a comprehensive view of the company's financial health and market performance.
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