MBX Biosciences Inc Stock Price, News & Analysis

MBX Biosciences (Nasdaq: MBX) announced significant positive results from its Phase 2 Avail™ trial of once-weekly canvuparatide for chronic hypoparathyroidism (HP). The trial achieved its primary endpoint with a 63% responder rate at 12 weeks compared to 31% for placebo (p=0.042), and demonstrated a 79% responder rate at 6 months in the open-label extension (OLE).

Key highlights include 100% patient retention through the 12-week study, with 94% entering the OLE. The drug showed positive effects on bone and kidney biomarkers, with a 48% reduction in urine calcium in treated patients. The treatment was well-tolerated with no serious adverse events or discontinuations. Based on these results, MBX plans to initiate a Phase 3 trial in 2026.

MBX Biosciences (Nasdaq: MBX) has announced it will release topline results from its Phase 2 clinical trial of canvuparatide, a potential once-weekly treatment for chronic hypoparathyroidism (HP). The company will host an investor webcast and conference call on Monday, September 22 at 8 AM ET to discuss the Avail™ Phase 2 trial results.

Investors can access the presentation through a live webcast or by dialing 1-877-407-0779 (US) or 1-201-389-0914 (international). The webcast and slide presentation will be available on the company's investor relations website.

MBX Biosciences (Nasdaq: MBX) has initiated its Phase 1 clinical trial of MBX 4291, a novel Precision Endocrine Peptide™ (PEP™) designed for obesity treatment. The drug candidate is a GLP-1/GIP co-agonist prodrug aiming to provide once-monthly dosing with improved weight loss efficacy and better gastrointestinal tolerability.

The trial consists of three parts: a Single Ascending Dose (SAD) study with 5 cohorts, a 4-week Multiple Ascending Dose (MAD) study with 3 cohorts, and a planned 12-week dosing evaluation with up to two larger cohorts. The company expects to report topline results in 2027.

MBX Biosciences (Nasdaq: MBX) has reported its Q2 2025 financial results and pipeline updates. The company maintains a strong financial position with $224.9 million in cash and equivalents, expected to fund operations into mid-2027. Key clinical developments include anticipated Phase 2 Avail™ trial topline results for canvuparatide in hypoparathyroidism in Q3 2025.

The company is advancing multiple clinical programs, including imapextide's Phase 2a trial for post-bariatric hypoglycemia and MBX 4291's Phase 1 trial for obesity, both set to begin in Q3 2025. Q2 financial results showed R&D expenses of $17.7 million (up from $14.4M in Q2 2024) and a net loss of $19.4 million (compared to $15.9M in Q2 2024).

MBX Biosciences has appointed Dr. Andreas Moraitis as Senior Vice President of Clinical Development. Dr. Moraitis, a board-certified endocrinologist, brings extensive experience in leading clinical development programs for endocrine and metabolic conditions. He previously spent over a decade at Corcept Therapeutics overseeing endocrine clinical development and supporting the NDA filing of relacorilant. At MBX, he will lead clinical development for canvuparatide, the company's lead product candidate for hypoparathyroidism. Dr. Moraitis's background includes serving as Clinical Assistant Professor at the University of Michigan's Endocrine Oncology Program and completing a fellowship at the National Institutes of Health. His appointment strengthens MBX's leadership team as they advance their pipeline of obesity and rare disease treatments.

MBX Biosciences (Nasdaq: MBX) has submitted an Investigational New Drug (IND) application to the FDA for MBX 4291, a novel long-acting GLP-1/GIP receptor co-agonist prodrug designed for obesity treatment. The drug candidate aims to be administered once monthly, leveraging MBX's proprietary PEP platform technology. Upon IND clearance, the company plans to initiate Phase 1 trials in healthy overweight volunteers during Q3 2025. MBX 4291 is being developed as a potential best-in-class treatment, with anticipated benefits including less frequent dosing and improved gastrointestinal tolerability, which could lead to better patient adherence and enhanced weight loss outcomes. The company is also advancing multiple early-stage obesity candidates using their precision peptide platform.

MBX Biosciences announced two presentations at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025. The presentations focus on MBX 1416, a Glucagon-Like Peptide-1 Receptor Antagonist, showcasing its safety, pharmacokinetics, and pharmacodynamics in healthy volunteers from a Phase 1 trial, as well as its effects on blood glucose in rats. The findings demonstrate MBX 1416's potential as a once-weekly treatment for post-bariatric hypoglycemia (PBH). The company previously reported positive topline results from a Phase 1 SAD/MAD trial and plans to initiate a Phase 2 trial in the second half of 2025.

MBX Biosciences (Nasdaq: MBX), a clinical-stage biopharmaceutical company specializing in precision peptide therapies for endocrine and metabolic disorders, has announced its participation in two major investor conferences in June 2025. CEO Kent Hawryluk will present at the Jefferies Global Healthcare Conference in New York on June 4 at 2:00 p.m. ET, and at the Goldman Sachs Global Healthcare Conference in Miami on June 9 at 10:40 a.m. ET. Live webcasts will be available on the company's investor website, with replays accessible for approximately 90 days after the events.

MBX Biosciences reported Q1 2025 financial results and corporate updates. The company has $240.8 million in cash and equivalents, expected to fund operations into mid-2027. Key highlights include:

- Phase 2 Avail trial for canvuparatide in hypoparathyroidism completed enrollment with 64 participants, with topline results expected in Q3 2025

- IND submission for MBX 4291, a once-monthly GLP-1/GIP co-agonist prodrug for obesity treatment, planned for Q2 2025

- Phase 2 trial for MBX 1416 in post-bariatric hypoglycemia to begin in H2 2025

Financial results show R&D expenses increased to $22.4 million (vs $11.0M in Q1 2024), G&A expenses rose to $4.1 million (vs $2.3M), with a net loss of $23.9 million (vs $12.3M).