MBX Biosciences Inc.
01/12/2026 | Press release | Distributed by Public on 01/12/2026 10:30
MBX Biosciences to Provide 2026 Outlook and Business Update at 44th Annual J.P. Morgan Healthcare Conference (Form 8-K)
MBX Biosciences to Provide 2026 Outlook and Business Update at 44th Annual J.P. Morgan Healthcare Conference
One-year follow-up data from Phase 2 trial of once-weekly canvuparatide, a potential best-in-class therapy for hypoparathyroidism, anticipated in Q2 2026; Phase 3 initiation on track for Q3 2026
12-week data from Phase 1 trial of MBX 4291, a dual GLP-1/GIP co-agonist prodrug with potential for once-monthly dosing and improved tolerability for obesity, anticipated in Q4 2026
Nomination of two additional obesity candidates expected in 2026: an amycretin prodrug and a GLP-1/GIP/GCGR triple agonist, each designed for once-monthly dosing
Strong cash position: preliminary unaudited cash, cash equivalents and marketable securities of approximately $373.7 million as of December 31, 2025, expected to fund operations into 2029
CARMEL, Ind., January 11, 2026 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced it will provide an update on its clinical programs, expanding obesity pipeline, and outlook for 2026 during the Company's presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026, at 3:45 pm PT (6:45 pm ET). The live webcast can be accessed in the events section of the MBX Biosciences website at https://investors.mbxbio.com/news-events/events.
"The Phase 2 success with once-weekly canvuparatide in chronic hypoparathyroidism sets the stage for our upcoming pivotal Phase 3 trial, while underscoring the broad clinical utility of our Precision Endocrine Peptide (PEP™) platform," said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. "We look forward to a catalyst-rich 2026, including the nomination of new development candidates in our expanding obesity portfolio and highly anticipated clinical data from MBX 4291, which holds the promise of potential once-monthly dosing with improved tolerability. With a strong cash position extending into 2029, we are well positioned to execute our strategy and continue to invest in long-term pipeline growth."
Once-weekly Canvuparatide for Hypoparathyroidism (HP)
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The Phase 2 Avail™ trial (Avail) achieved its primary endpoint, demonstrating strong clinical proof-of-concept for canvuparatide with high responder rates and once-weekly dosing that was generally well-tolerated.
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MBX plans to share the full 12-week dataset from Avail and one-year follow-up data at a medical conference in Q2 2026.
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An FDA End-of-Phase 2 meeting is planned for Q1 2026, as MBX continues to prepare for initiation of its Phase 3 confirmatory trial in Q3 2026.
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Primary market research supports canvuparatide's potential as a best-in-class therapy and new standard of care for patients with HP.
MBX 4291 and Early Pipeline Programs for Obesity
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MBX 4291, a glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP) co-agonist prodrug with potential for once-monthly dosing, continues to progress through Phase 1 evaluation, with 12-week multiple ascending dose data expected in Q4 2026.
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MBX expects to expand its obesity portfolio in 2026 with two additional candidates designed to address the full spectrum of needs for patients with obesity, each with once-monthly dosing. These include an amycretin prodrug and a GLP-1/GIP/glucagon receptor (GCGR) prodrug candidate, with nominations anticipated in Q2 and Q3 2026.
Long-acting Imapextide (MBX 1416) for Post-Bariatric Hypoglycemia (PBH)
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Results from the ongoing Phase 2a STEADI™ trial of potential once-weekly imapextide are expected in Q2 2026, including effects on post-prandial glucose regulation and related metabolic parameters.
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Results from primary research conducted by MBX indicate that the majority of patients and endocrinologists surveyed prefer the convenience of a once-weekly injection over a once-daily injection in PBH.
Strong Cash Position
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Preliminary unaudited cash, cash equivalents and marketable securities of approximately $373.7 million as of December 31, 2025, are expected to fund operations into 2029.
About MBX Biosciences
MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company's pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism (HP) preparing for Phase 3 development; an obesity portfolio that includes MBX 4291 in Phase 1 development, as well as multiple discovery and pre-clinical obesity candidates; and imapextide (MBX 1416) for the treatment of post-bariatric hypoglycemia (PBH) in Phase 2 development. The Company is based in Carmel,
Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
About MBX's Proprietary Precision Endocrine Peptide (PEP™) Platform
MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.
Forward-Looking Statements
MBX Biosciences Inc. published this content on January 12, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on January 12, 2026 at 16:31 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]