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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...
Stocks were unable to hold an early advance on Friday, eventually finishing the session lower amid concerns about energy supplies in Europe. An initial rally, sparked by well-received jobs data, proved short-lived, as the Nasdaq recorded its sixth consecutive day of losses. With energy ...
Amylyx Pharmaceuticals ( NASDAQ: AMLX ), a company focused on neurodegenerative diseases, lost ~28% in value on Friday after the FDA posted briefing documents ahead of an advisory committee meeting scheduled for next week on its candidate for amyotrophic lateral sclero...
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 reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to r...
Brainstorm Cell Therapeutics ( NASDAQ: BCLI ), a biotech focused on neurodegenerative diseases, said on Monday that the company would submit a Biologics License Application (BLA) to the FDA seeking approval of its NurOwn therapy for amyotrophic lateral sclerosis (ALS). The p...
Amylyx Pharmaceuticals press release ( NASDAQ: AMLX ): Q2 GAAP EPS of -$0.93 misses by $0.01 . Cash, cash equivalents and short-term investments were $206.7 million For further details see: Amylyx Pharmaceuticals GAAP EPS of -$0.93 misses by $0.01
˗ ALBRIOZA™ (also known as AMX0035) now commercially available in Canada, representing first product launch for Amylyx ˗ FDA Advisory Committee meeting to review new drug application for AMX0035 for the treatment of ALS scheduled for September 7, 2022; ass...
Palm Beach, FL –– August 11, 2022 – FinancialNewsMedia.com News Commentary – Multiple Sclerosis (MS) is an immune-mediated disease affecting the central nervous system. It is characterized by demyelination, inflammation, degenerative changes such as p...
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and t...
Amylyx Pharmaceuticals ( NASDAQ: AMLX ) on Friday said its Albrioza treatment for neurodegenerative disease amyotrophic lateral sclerosis (ALS) was now commercially available for use by patients in Canada. AMLX's Albrioza, also known as AMX0035, is an oral combination ther...
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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...