AMLX Stock Recent News

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.

Amylyx Pharmaceuticals, a biotech firm focusing on neurodegenerative disorders, has seen impressive Q1 2023 financial performance despite clinical uncertainties around its flagship product, Relyvrio. Relyvrio, an ALS treatment drug, generated $71.4 million in revenue, bolstering predictions of annual revenues surpassing $1 billion.

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX ) Q1 2023 Earnings Conference Call May 11, 2023 6:00 PM ET Company Participants Lindsey Allen - Head of Investor Relations and Communications Justin Klee - Co-Chief Executive Officer and Co-Founder Margaret Olinger - Global Head of Commercial and CCO James Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer and Co-Founder Conference Call Participants Corinne Jenkins - Goldman Sachs Marc Goodman - SVB Securities Ananda Ghosh - H.C. Wainwright Neena Bitritto-Garg - Citi Lindsey Allen Good afternoon and thank you for joining today to discuss our First Quarter 2023 Earnings.