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Amylyx Pharmaceuticals said on Friday the European Union medicines regulator for the second time declined to recommend a marketing authorisation for the company's drug to treat amyotrophic lateral sclerosis (ALS).
Growth stocks have wilted under an avalanche of macro headwinds in late 2023. This broad sell-off, though, may have created some incredible bargains.
Amylyx Pharmaceuticals, Inc. (AMLX) came out with quarterly earnings of $0.31 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to loss of $0.93 per share a year ago.
Clinical trials can be like a tightrope over a minefield for biotech investors. Only a fraction of drugs even succeed through clinical trials to receive FDA approval.
Amylyx focuses on neurodegenerative diseases. After launching its first product in September, the company turned its first profitable quarter.
Amylyx's (AMLX) shares plunge on getting a negative opinion from the Committee for Medicinal Products for Human Use for the marketing authorization of AMX0035, used to treat amyotrophic lateral sclerosis.
Amylyx Pharmaceuticals and Viking Therapeutics have been on fire over the past year. Even so, both companies still look incredibly undervalued relative to their long-term growth potential.
Shares have lost a third of their value year to date. Relyvrio launch in ALS has produced promising metrics out of the gate and the company will be generating positive cash flow going forward. The confirmatory readout from PHOENIX trial in 2024 is a key concern, as in the worst-case scenario Relyvrio could be pulled off the market if no benefit is observed.
Amylyx Pharmaceuticals Inc said on Tuesday the European drug regulator was likely to reject its amyotrophic lateral sclerosis (ALS) drug, sending its shares down 8.5% in premarket trading.
The biotech sector is notoriously volatile, populated with plenty of unprofitable companies that soar on optimism about clinical trials. Those same stocks can later plummet on poor trial results, or a delay when it comes to regulatory approval.