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].

Core Insights - MBX Biosciences, Inc. is focused on developing novel precision peptide therapies for endocrine and metabolic disorders, with a significant emphasis on post-bariatric hypoglycemia (PBH) treatment [1][6] - The company will present findings on MBX 1416 at the American Diabetes Association's 85th Scientific Sessions, highlighting its potential as a once-weekly treatment for PBH [2][1] - MBX 1416 has shown positive results in Phase 1 clinical trials, with a Phase 2 trial expected to start in the latter half of 2025 [2] Company Overview - MBX Biosciences is based in Carmel, Indiana, and utilizes its proprietary PEP™ platform to develop therapies targeting endocrine and metabolic disorders [6] - The company's pipeline includes MBX 2109 for chronic hypoparathyroidism in Phase 2, MBX 1416 for PBH in Phase 1, and an obesity portfolio with an IND filing anticipated in Q2 2025 [6] Product Details - MBX 1416 is an investigational long-acting GLP-1 receptor antagonist designed to prevent severe hypoglycemia in individuals with PBH [4] - PBH is a serious complication following bariatric surgery, characterized by recurrent hypoglycemic episodes, and currently lacks approved pharmacotherapies [5] Upcoming Presentations - Presentations on MBX 1416 will take place on June 22, 2025, during the General Poster Session at the ADA conference, featuring studies on its safety, pharmacokinetics, and effects on blood glucose levels [7]

CARMEL, Ind., May 20, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical- stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, will present at and participate in the following investor conferences: Goldman Sachs Global Healthcare Conference Date: June 9, 2025 Podium Presentation: June 9, 2025, 10:40 a ...

Core Insights - MBX Biosciences is making significant progress in its clinical programs, with topline results for the Phase 2 Avail trial of canvuparatide expected in Q3 2025 and an IND submission for MBX 4291 anticipated in Q2 2025 [2][3][4] Financial Highlights - As of March 31, 2025, MBX Biosciences reported cash, cash equivalents, and marketable securities totaling $240.8 million, which is expected to support operations into mid-2027 [7][16] - Research and development expenses for Q1 2025 were $22.4 million, a significant increase from $11.0 million in Q1 2024, driven by ongoing studies for MBX 4291 and the Phase 2 Avail trial [12][16] - General and administrative expenses rose to $4.1 million in Q1 2025 from $2.3 million in Q1 2024, reflecting increased personnel-related costs [12][16] - The net loss for Q1 2025 was $23.9 million, compared to a net loss of $12.3 million for the same period in 2024 [12][16] Clinical Development Updates - The Phase 2 Avail trial for canvuparatide has completed enrollment with 64 participants, exceeding the original target, and results are expected in Q3 2025 [3][4] - MBX 4291, a GLP-1/GIP co-agonist prodrug, is being developed as a once-monthly treatment for obesity, with an IND application submission on track for Q2 2025 [4][8] - A Phase 2 trial for MBX 1416, targeting post-bariatric hypoglycemia, is expected to begin in the second half of 2025 following successful Phase 1 results [5][8] Corporate Developments - Steve Hoerter has been appointed as an independent director to the board, bringing extensive pharmaceutical leadership and commercialization experience [6][8]

CARMEL, Ind., April 22, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical- stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, will present at and participate in the Citizens Life Sciences Conference on May 7 and the RBC 2025 Global Healthcare Conference on May 21. The Citizens Life Sciences Confere ...