Amylyx (AMLX) Down on Negative CHMP Opinion for ALS candidate
Amylyx Pharmaceuticals AMLX announced that it received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for conditional marketing authorization of AMX0035. Shares of the company were down almost 7% on Jun 23, following the news.
The conditional marketing authorization application was filed in January 2022, seeking approval for AMX0035, under the brand name Albrioza. AMX0035 is used for treating adults with amyotrophic lateral sclerosis (ALS).
This news came in after the company's earlier announcement in May 2023 that the CHMP was leaning toward a negative opinion.
AMLX plans to request a formal re-examination procedure of the regulatory application.
Shares of Amylyx have lost 37.6% year to date compared with the industry’s 1.9% decline.
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In September 2022, AMX0035 was approved by the FDA under the brand name Relyvrio. In June 2022, the candidate received conditional approval from Health Canada under the brand name Albrioza for treating ALS.
Despite the setback, Amylyx remains confident in the strength of the CENTAUR study data, which is believed to fulfill the criteria for the European Union’s conditional approval. The data also serves as the basis for the abovementioned approvals.
The CENTAUR study was successful in meeting its prespecified primary outcome, making AMX0035 the first ALS therapy.
AMLX is also actively working on completing its global phase III PHOENIX study. The study is evaluating the safety and efficacy of AMX0035 (over 48 weeks) in treating ALS to further support Albrioza’s approval. Results from the study are expected by mid-2024.
In the first quarter of 2023, Relyvrio/Albrioza generated revenues of $71.4 million.
Amylyx Pharmaceuticals, Inc. Price and Consensus
Amylyx Pharmaceuticals, Inc. price-consensus-chart | Amylyx Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Amylyx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Novartis NVS, Akero Therapeutics AKRO and Omega Therapeutics OMGA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The bottom-line estimate for Novartis has dipped to a loss of $6.74 for 2023 from the previous projection of earnings of $6.55 per share in the past 90 days. Shares of Novartis have risen 11% year to date.
NVS’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 5.15%.
The consensus estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have dec;ined 7.3% year to date.
AKRO’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.49 per share to a loss of $2.05 for 2023 in the past 90 days. Shares of the company have rallied 22.9% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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