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Problems with the trial design make it difficult to determine the effectiveness of Amylyx's AMX0035 against ALS. AMX0035 combines two compounds - sodium phenylbutyrate and tauroursodeoxycholic acid - that inhibit and scavenge peroxynitrite. This may be the key to the treatment of seve...
- Summary of data from CENTAUR and PEGASUS showed AMX0035 was safe and well tolerated in clinical trials in amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD) - Majority of treatment-emergent adverse events (TEAEs) associated with AMX0035 were gastroin...
On March 30, FDA's advisory committee voted 6 No to 4 Yes, to the question if AMLX's single phase 2 trial data established its effectiveness in treating ALS. The PDUFA day for AMLX's application is on June 29. While the ultimate decision rests on the FDA alone, I take a look at AL...
Arcadia Biosciences (RKDA) -25% on Q4 results. UiPath (PATH) -19% on Q4 results. Clarus Therapeutics (CRXT) -18% on Q4 results. Sharecare (SHCR) -15% on Q4 results. InflaRx (IFRX) -13% vilobelimab fails to show statistical significance in seve...
Amylyx Pharmaceuticals press release (NASDAQ:AMLX): FY GAAP EPS of -$13.35 beats by $4.80. Revenue of $0.28M (-56.9% Y/Y) misses by $0.25M. For further details see: Amylyx Pharmaceuticals GAAP EPS of -$13.35 beats by $4.80, revenue of $0.28M misses by $0.25M
˗ Preparations underway to support potential commercial launch of AMX0035 for the treatment of ALS in the U.S. and Canada, if approved ˗ FDA assigned PDUFA action date of June 29, 2022 Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” ...
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the Company&...
An advisory committee of the U.S. Food and Drug Administration (FDA) on Wednesday voted against the approval of AMX0035, an investigational therapy for amyotrophic lateral sclerosis, developed by Amylyx Pharmaceuticals (NASDAQ:AMLX). Four panelists have reportedly voted for its approval while...
Biogen and Ionis just dropped an antisense drug candidate because of a complete miss on its clinical trial endpoints. Amylyx has completed its trial and believes that it has shown evidence of efficacy. As we have seen in the past, the FDA is completely capable of approving this dr...
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...
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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...