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Gainers: Turning Point Therapeutics (TPTX) +116%. Amylyx Pharmaceuticals (AMLX) +27%. Yumanity Therapeutics (YMTX) +11%. Amarin (AMRN) +9%. Galecto (GLTO) +8%. Losers: Novavax (NVAX) -13%. Rallybio (RLYB) -13%. Invitae (NVTA) -9%. Spruce Bioscience...
The U.S. Food and Drug Administration (FDA) extended its the review period by three months for Amylyx Pharmaceuticals' (NASDAQ:AMLX) amyotrophic lateral sclerosis (ALS) medicine AMX0035 to have more time to review additional analyses of data. The FDA will now make a decisi...
New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has extended the ...
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) announced today that a new post hoc analysis measuring substantial individual response to AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) w...
As neurology-focused biotech Acadia Pharma (NASDAQ:ACAD) prepares for an AdCom meeting next month on its marketing application for pimavanserin in Alzheimer’s disease psychosis (ADP), Citi argued on Thursday that the company shares could even double with a positive vote. The antipsycho...
Adding to previously reported overall functional and survival benefit data for AMX0035, these findings support effect of AMX0035 on disease progression in ALS Randomization to AMX0035 resulted in a lower occurrence of death or tracheostomy/permanent assisted ventilat...
Amylyx Pharmaceuticals press release (NASDAQ:AMLX): Q1 GAAP EPS of -$0.93 misses by $0.19. “We are encouraged by the overall progress Amylyx made over the first quarter of 2022. We are continuing to engage with regulators throughout the review process to move AMX0035 toward potential r...
˗ Final stages of commercial launch readiness underway to support the launch of AMX0035 for the treatment of ALS in the U.S. and Canada, if approved - Data published in Muscle & Nerve further demonstrate significant benefit of AMX0035 on survival in Phase 2 CENTAUR ...
An analysis using the rank-preserving structural failure time model (RPSFTM), a method frequently employed in oncology to account for placebo crossover, estimated a 10.6-month longer median survival duration for AMX0035 participants Participants randomized to receive AMX0035...
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...
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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...