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Amylyx Pharmaceuticals, Inc. today announced that the donated clinical data from the placebo arm of the CENTAUR clinical trial that evaluated the safety, efficacy, and survival benefits of AMX0035 in adult participants with amyotrophic lateral sclerosis (ALS) are now available in the Po...
Amylyx Pharmaceuticals (NASDAQ: AMLX) is up more than 100% over the past three months. The stock surged again on Sept. 7 after a Food and Drug Administration (FDA) advisory panel changed their minds to say they now think that Albrioza (sodium phenylbutyrate and taurursodiol...
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the publication of preclinical data showing the effect of sodium phenylbutyrate (PB) and taurursodiol (TURSO, also known as ursodoxicoltaurine) on the transcriptomic and m...
In the field of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, there aren't yet any approved treatments that address the disease itself. This will most likely change by the end of September. A panel of independent advisors to the Food and Drug Administration, meeti...
Shares of the clinical-stage biotech Amylyx Pharmaceuticals (NASDAQ: AMLX) were up by a jaw-dropping 65% on heavy volume as of 10:02 a.m. ET Thursday morning. The drugmaker's shares are skyrocketing in response to a positive advisory committee vote for its amyotrophic lateral sc...
InvestorPlace - Stock Market News, Stock Advice & Trading Tips Source: Moab Republic / Shutterstock Apple (NASDAQ: AAPL ) stock is a hot topic on Thursday following the tech giant’s latest event showing off new products. Let’s go over all of the biggest anno...
Amylyx Pharmaceutical ( NASDAQ: AMLX ) is trading 81% higher premarket after a panel of experts to the U.S. Food and Drug Administration voted in favor to recommend approval of the drug, AMX0035, to treat neurodegenerative disease amyotrophic lateral scl...
- FDA Advisory Committee voted 7:2 that the available evidence of effectiveness is sufficient to support approval of AMX0035 for the treatment of ALS - If approved, AMX0035 will be the first treatment in ALS that has demonstrated a significant slowing of disease progre...
A U.S. Food and Drug Administration (FDA) advisory committee on Wednesday voted in favor to recommend approval of Amylyx Pharmaceuticals' ( NASDAQ: AMLX ) treatment for neurodegenerative disease amyotrophic lateral sclerosis (ALS). The FDA's Peripheral and Central Nervo...
Summary An FDA Advisory Committee will today look at fresh data presented by ALS drug developer Amylyx as it attempts to secure accelerated approval on Sept. 29. Last time out, the AdComm voted 6-4 against in answer to the question as to whether there was sufficient data to approv...
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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...