Amylyx Pharmaceuticals (AMLX) 2025 Conference September 03, 2025 08:00 AM ET Company ParticipantsJustin Klee - Co-Founder, Co-CEO & DirectorJosh Cohen - Co-Founder, Co-CEO & DirectorJustin KleeThree years on average after the bariatric surgery, people will develop this very persistent symptomatic hypoglycemia. What does that mean? When we're talking about this sort of severe hypoglycemia, the medical term is neuroglycopenia. It means that the blood sugar gets to a level where the nervous system stops functi ...

Core Insights - Amylyx Pharmaceuticals presented new exploratory analyses of avexitide at the Endocrine Society's annual meeting, focusing on its potential to treat post-bariatric hypoglycemia (PBH) [1] Group 1: Clinical Trials and Efficacy - The Phase 2b trial of avexitide showed a 64% reduction in moderate to severe hypoglycemic events with a 90 mg once-daily dose, and over half of participants experienced no such events during treatment [2] - The ongoing Phase 3 LUCIDITY trial is evaluating avexitide's safety and efficacy in approximately 75 patients with PBH following Roux-en-Y gastric bypass surgery, with a primary endpoint of reducing Level 2 and 3 hypoglycemic events [3] - Previous trials demonstrated consistent, dose-dependent reductions in hypoglycemic events, with the 90 mg dose showing sustained 24-hour GLP-1 receptor inhibition [4] Group 2: Safety Profile and Future Prospects - Across five clinical trials, avexitide has shown statistically and clinically meaningful efficacy with a favorable safety profile [5] - LUCIDITY is expected to complete enrollment in 2025, with top-line results anticipated in the first half of 2026 and a potential commercial launch in 2027 [5] Group 3: Market Impact - Following the presentation of these findings, AMLX stock increased by 7.55%, reaching $8.26 [5]

Core Viewpoint - Guggenheim Partners has initiated coverage on Amylyx Pharmaceuticals, highlighting the potential of post-bariatric hypoglycemia (PBH) as a significant market opportunity for the company [1][2]. Company Overview - Amylyx Pharmaceuticals is positioned as a first-to-market player in the PBH space, which is estimated to be a $2 billion+ market opportunity [2]. - The company's lead drug, avexitide, is advancing towards pivotal Phase 3 results in the LUCIDITY study, expected to read out in the first half of 2026 [3]. Market Potential - Guggenheim estimates that there are 50,000 to 100,000 individuals in the U.S. suffering from moderate to severe uncontrolled symptoms of PBH [4]. - The global market for GLP-1 antagonists to treat PBH could exceed $2 billion by 2035, with projections of $1.8 billion in the U.S. and $410 million internationally, assuming a 60% peak market share among patients with severe PBH [4]. Competitive Landscape - The main competitor in the PBH market is MBX Biosciences, which is developing a once-weekly GLP-1 antagonist called MBX 1416 [5]. - Analyst estimates suggest that a once-weekly competitor could launch by 2031, while Amylyx's life cycle management strategy may enhance its market position [5]. Stock Performance - As of the last check, Amylyx Pharmaceuticals' stock (AMLX) has increased by 24.5%, reaching $6.25 [5].