Amylyx Pharmaceuticals Inc
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Amylyx Pharmaceuticals Inc
Amylyx Pharmaceuticals, Inc. operates as a biopharmaceutical company, which provides disease-modifying solutions for neurodegenerative diseases. The company is headquartered in Cambridge, Massachusetts and currently employs 205 full-time employees. The company went IPO on 2022-01-07. The firm is developing therapies for treatment paradigm for amyotrophic lateral sclerosis (ALS), and range of neurodegenerative diseases by keeping neurons alive. The firm is pursuing commercialization of its product candidate, AMX0035. AMX0035 is an investigational product comprised of two complementary active agents, sodium phenylbutyrate (PB) and taurursodiol (TURSO) also known as ursodoxicoltaurine. AMX0035 is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases. AMX0035 keep neurons alive under a variety of different conditions and stresses, including in in vitro models of neurodegeneration, endoplasmic reticulum stress, mitochondrial dysfunction, oxidative stress and disease-specific models of a variety of other conditions, as well as in vivo models of Alzheimer’s Disease (AD) and multiple sclerosis.
Amylyx Pharmaceuticals, Inc. operates as a biopharmaceutical company, which provides disease-modifying solutions for neurodegenerative diseases. The company is headquartered in Cambridge, Massachusetts and currently employs 205 full-time employees. The company went IPO on 2022-01-07. The firm is developing therapies for treatment paradigm for amyotrophic lateral sclerosis (ALS), and range of neurodegenerative diseases by keeping neurons alive. The firm is pursuing commercialization of its product candidate, AMX0035. AMX0035 is an investigational product comprised of two complementary active agents, sodium phenylbutyrate (PB) and taurursodiol (TURSO) also known as ursodoxicoltaurine. AMX0035 is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases. AMX0035 keep neurons alive under a variety of different conditions and stresses, including in in vitro models of neurodegeneration, endoplasmic reticulum stress, mitochondrial dysfunction, oxidative stress and disease-specific models of a variety of other conditions, as well as in vivo models of Alzheimer’s Disease (AD) and multiple sclerosis.
Enrollment Delay: Amylyx now expects to complete recruitment for the LUCIDITY Phase III trial in Q1 2026, a modest delay from the prior target of end-2025, with top-line data now anticipated in Q3 2026.
Launch Timeline Unchanged: Despite the enrollment delay, the company still expects to be prepared for a potential avexitide launch in 2027, pending FDA approval.
Strong Cash Position: The company ended Q3 with $344 million in cash, strengthened by a recent public offering, supporting operations and the planned avexitide launch into 2028.
Reduced Operating Expenses: Total operating expenses fell 53% year-over-year, mainly due to one-time acquisition costs last year.
PBH Market Confidence: Amylyx remains confident in its estimate of 160,000 people in the US with post-bariatric hypoglycemia (PBH) not controlled by diet, based on claims analysis and field research.
Pipeline Progress: The AMX0035 pivotal trial for Wolfram syndrome is expected to start in the second half of 2026, and early data from the AMX0114 ALS study will focus on safety, with biomarker data expected in 2026.
