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FDA Advisory Committee Meeting to Discuss NDA for AMX0035 for the Treatment of ALS Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that Nasdaq has halted trading of the company’s common stock. The U.S. Food and Drug Administration’s (FDA) Periph...
Amylyx has a crucial adcomm tomorrow. The FDA has been generally negative in its briefing docs. I'm expecting the outcome will be for Amylyx to complete the confirmatory phase 3 trial. For further details see: Amylyx: Crucial Advisory Committee Meet Tomorrow, Approval Ch...
Wednesday is going to be a very big day for folks with neurodegenerative disorders and a clinical-stage biopharmaceutical company called Amylyx Pharmaceuticals (NASDAQ: AMLX) . On March 30, the FDA is meeting with independent neurologists to discuss the company's experimental treatm...
A late-day surge allowed the major U.S. equity averages to end an otherwise lackluster trading session with respectable gains. A drop in oil prices helped give stocks a boost. Amid the overall advance, cryptocurrency stocks performed extremely well. A general rally in the crypto complex suppo...
Citi detailed why the selloff of Reata Pharmaceuticals (NASDAQ:RETA -17.0%) was overdone after the clinical-stage biopharma company fell on Monday in reaction to negative views cited by the FDA on amyotrophic lateral sclerosis therapy, AMX0035. Developed by Amylyx Pharmaceuticals (A...
Following a sharp decline, the clinical-stage pharma company, Amylyx (NASDAQ:AMLX -41.3%) pared losses after Evercore ISI issued favorable views on the briefing documents released by the U.S. regulators on the company’s candidate for amyotrophic lateral sclerosis, AMX0035. Ahead of an ...
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Reata Pharmaceuticals (RETA -31.4%) are struggling today, likely as a result of U.S. FDA briefing documents on Amylyx Pharma's (AMLX -55.3%) AMX0035, the company's amyotrophic lateral sclerosis therapy. Those documents raised concerns about the statistical significance of a pivotal trial...
Shares of Amylyx Pharmaceuticals (NASDAQ: AMLX) , a clinical-stage biopharmaceutical company, are tanking in response to comments from the FDA regarding the company's lead candidate. The stock was down 53.7% at 11:49 a.m. ET on Monday. Amylyx has one new drug candidate in clinic...
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the March 30, 2022 Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) ...
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- Avexitide is a novel, first-in-class GLP-1 receptor antagonist with the potential to treat hyperinsulinemic hypoglycemia - FDA Breakthrough Therapy Designation granted for avexitide for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism - Acquisition builds on Am...
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that Amylyx’ management team will host a conference call and webcast tomorrow, Wednesday, July 10, 2024, at 8:00 a.m. ET to discuss the acquisition of avexitide from Eiger ...
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that management will participate in a fireside chat presentation at the Goldman Sachs 45th Annual Global Healthcare Conference. The conference is being conducted in-person in Miam...