Tag: Amylyx Pharmaceuticals (AMLX)

Acumen Pharmaceuticals: New Effort to Treat Alzheimer’s Disease Granted FDA Fast Track Designation

Acumen Pharmaceuticals Product ACU193 On October 23, 2022, Acumen Pharmaceuticals (ABOS) announced that the first clinical-stage monoclonal antibody ACU193 - an anti-amyloid beta oligomer antibody, which selectively targets toxic soluble amyloid beta oligomers (AβOs), has been granted  FDA Fast Track designation for the treatment of early Alzheimer . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Treating Untreatable Disease – NASH

Prohost Letter #452 Treating Untreatable Disease - NASH Non Alcoholic Steatohepatitis  The efforts spent on treating Non Alcoholic Steatohepatitis (NASH) have reached a promising stage where clinical trial data from the clinical-stage and revenue-generating biotech firms have demonstrated capability of treat NASH. The most promising of these firms we believe, are clinical-stage firms, especially those firms that have already demonstrated capability of regressing fibrosis in …

Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO™ for of ALS Leading to a Weird Stock Market Reception

Amylyx Pharmaceuticals in the NEWS Amylyx Pharmaceuticals (AMLX) announced that the U.S. FDA has approved RELYVRIO™ (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). The product, RELYVRIO, (previously known as AMX0035 in the U.S.) has significantly slowed the loss of physical function in people living with ALS in a randomized, placebo-controlled . . . This content is for paid …

Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for ALS

Amylyx Pharmaceuticals in the News Amylyx Pharmaceuticals (AMLX): The U.S. FDA Peripheral and Central Nervous System Drugs Advisory Committee has voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035 (sodium phenylbutyrate and taurursodiol ) for the treatment of amyotrophic lateral sclerosis (ALS). The advisory committee’s decision was based on a review . . . This content is …

The FDA Advisory Committee Will Soon Review the NDA of Amylyx Pharmaceuticals’ Product AMX0035 for ALS  

On September 7th the FDA Will Review Amylyx Pharmaceuticals NDA for ALS Treatment Amylyx Pharmaceuticals (AMLX) announced that the U.S. FDA Peripheral and Central Nervous System Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol known also as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS

Health Canada Approved Amylyx Pharmaceuticals’ Product ALBRIOZA for Amyotrophic Lateral Sclerosis

The Great News from Amylyx Pharmaceuticals On Jun. 13, 2022, Amylyx Pharmaceuticals (AMLX) announced that Health Canada has approved ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for amyotrophic lateral sclerosis (ALS). The important thing to learn from Amylyx Pharmaceuticals' press release is that the clinical data demonstrated a . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Amylyx Pharmaceuticals: Continuing to Offer Promising Results in Treating ALS

Amylyx Pharmaceuticals Updated Plans to Advance AMX0035 Amylyx Pharmaceuticals, Inc. provided an update on its plans to advance AMX0035 through the clinical development process for the treatment of amyotrophic lateral sclerosis (ALS). The company intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021. And, as …
Amylyx Pharmaceuticals: Clinical Trial Results Demonstrate Statistically Significant Treatment Benefit in Lou Gehrig’s Disease Patients

Amylyx Pharmaceuticals: Clinical Trial Results Demonstrate Statistically Significant Treatment Benefit in Lou Gehrig’s Disease Patients

Amylyx Pharmaceuticals With the advancement of biological sciences, and increased information about the pathways of diseases, we are getting more interested in biotech firms that are focused on treating life-threatening diseases as the risk of failure is decreasing.  The successful outcome of trials would tremendously boost the values of these firms as we have witnessed in many small biotech firms that became large firms and …