Earnings summaries and quarterly performance for MBX Biosciences.
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Recent press releases and 8-K filings for MBX.
MBX Details 2026 Clinical Milestones, Including Canvaparatide Phase 3 and Expanded Obesity Pipeline
MBX
New Projects/Investments
Guidance Update
- MBX reported a strong financial position with approximately $375 million in cash at year-end, following a $200 million public offering, which is expected to fund its clinical studies.
- For its lead program, Canvaparatide, a confirmatory Phase 3 trial is set to initiate in Q3, following positive Phase 2 data showing a 63% responder rate at 12 weeks and 79% at six months, with 94% of patients continuing into an open-label extension. One-year open-label extension data is anticipated in Q2.
- MBX is significantly expanding its obesity portfolio, with 12-week MAD data for MBX 4291 expected in Q4, and the selection of Amycretin and triple G agonist candidates planned for Q2 and Q3, respectively. These new candidates aim for potential once-monthly dosing and improved tolerability.
- A Phase 2A proof-of-concept study readout for Imiplexide, a treatment for post-bariatric hypoglycemia, is also expected in Q2.
Jan 13, 2026, 11:45 PM
MBX Provides Updates on Clinical Pipeline and Financial Position at J.P. Morgan Healthcare Conference
MBX
New Projects/Investments
Guidance Update
- MBX plans to initiate a confirmatory Phase 3 trial for Canvaparatide in Q3 of this year, following successful Phase 2 data.
- The company is in a strong financial position with approximately $375 million in cash at year-end, bolstered by a $200 million public offering.
- MBX is expanding its obesity portfolio, with preclinical data for new Amycretin and triple G agonist candidates presented, and Phase 1 12-week data for MBX 4291 expected in Q4.
- A Phase 2A proof-of-concept study readout for imipexide in post-bariatric hypoglycemia is anticipated in Q2.
Jan 13, 2026, 11:45 PM
MBX Biosciences Outlines 2026 Clinical Milestones and Strong Financial Position
MBX
New Projects/Investments
Guidance Update
- MBX Biosciences plans to initiate a confirmatory Phase III trial for canvuparatide in hypoparathyroidism in Q3 of this year, following positive Phase II data that showed a 63% responder rate at 12 weeks and 79% at six months. One-year open-label extension data for canvuparatide is expected in Q2.
- The company is expanding its obesity portfolio, with MBX 4291 (a GLP-1/GIP co-agonist) expected to release 12-week MAD data from its Phase I study in Q4 of this year, aiming for once-monthly dosing and better tolerability.
- MBX is also finalizing the selection of an amycretin (in Q2) and a GGG agonist (in Q3) for its obesity pipeline, with expectations for once-monthly dosing and improved tolerability.
- For imapextide, a GLP-1 antagonist for post-bariatric hypoglycemia, a Phase II-A proof of concept study readout is expected in Q2 of this year.
- MBX Biosciences reported a strong financial position with approximately $375 million in cash at year close, which is sufficient to support all described clinical studies, including the Phase III trial and two Phase I proof-of-concept studies for new obesity candidates.
Jan 13, 2026, 11:45 PM
MBX Biosciences Provides 2026 Outlook and Business Update
MBX
Guidance Update
New Projects/Investments
- MBX Biosciences reported preliminary unaudited cash, cash equivalents, and marketable securities of approximately $373.7 million as of December 31, 2025, which is projected to fund operations into 2029.
- Key clinical data readouts anticipated in 2026 include one-year follow-up data for canvuparatide (Phase 2) in Q2 2026 and 12-week data for MBX 4291 (Phase 1) in Q4 2026.
- The company also expects to nominate two additional obesity candidates in Q2 and Q3 2026 and release results from the Phase 2a trial of imapextide in Q2 2026.
Jan 12, 2026, 11:02 AM
MBX Biosciences Provides Updates on Clinical Pipeline and Financial Position
MBX
New Projects/Investments
Guidance Update
- MBX Biosciences reported strong Phase 2 AVAIL top-line data for MBX 2109 in hypoparathyroidism in September, showing 79% treatment response at six months. The company plans to engage with the FDA and EMA in Q1 for end-of-phase 1 meetings and expects to start a global Phase 3 registration study in Q3.
- The company's GLP-1/GIP agonist, MBX 4291, for obesity, is designed for once-monthly administration with improved tolerability, leveraging its PEP technology. 12-week MAD data from its Phase 1 study is on track to read out in Q4 2026.
- MBX Biosciences also has MBX 1416 for post-bariatric hypoglycemia, a condition with over 125,000 prevalence in the U.S. and no approved pharmacotherapy. Phase 2A data for this program is expected in Q2 2026.
- MBX Biosciences is in a strong financial position, having raised approximately $200 million in gross proceeds last September, providing cash to support operations into 2029. This funding covers the full completion of the Phase 3 registration study for MBX 2109 and pre-commercial activities.
Dec 2, 2025, 9:00 PM
MBX Biosciences Provides Updates on Clinical Programs and Financial Outlook
MBX
New Projects/Investments
Guidance Update
- MBX Biosciences reported strong Phase II AVAIL top-line data for canvuparatide (MBX 2109) in hypoparathyroidism, showing a 63% response rate at 12 weeks and 79% at 6 months in the open-label extension. The company plans to engage with the FDA and EMA in Q1 2026 and aims to start a global Phase III study in Q3 2026.
- The company is developing MBX 4291, a GLP-1/GIP agonist for obesity, designed for a once-monthly product profile with improved tolerability using its PEP technology. 12-week MAD data is anticipated in Q4 2026.
- MBX Biosciences also has MBX 1416 for post-bariatric hypoglycemia, with Phase IIa data expected in Q2 2026.
- The company is in a strong financial position, with a cash runway into 2029 following a $200 million raise in September, supporting all current clinical programs.
Dec 2, 2025, 9:00 PM
MBX Biosciences Provides Updates on Clinical Programs and Financial Position
MBX
New Projects/Investments
Guidance Update
Product Launch
- MBX Biosciences reported strong Phase 2 AVAIL top-line data for once-weekly canbuparatide in hypoparathyroidism, showing 63% response at 12 weeks and 79% in the open-label extension. The company plans to start a global Phase 3 registration study in Q3 2026 after Q1 2026 regulatory meetings.
- Physicians surveyed indicated they would consider MBX's canbuparatide profile as best-in-class, with 94% of AVAIL patients opting into a two-year open-label extension. One-year open-label extension data is expected in Q2 2026.
- The company's GLP-1/GIP agonist, MBX 4291 for obesity, is being developed as a once-monthly product with 12-week MAD data anticipated in Q4 2026.
- MBX 1416, targeting post-bariatric hypoglycemia, has Phase 2A data expected in Q2 2026 from a 39-day study in 10 adult patients.
- MBX Biosciences is in a strong financial position, having raised approximately $200 million last September, providing cash to support operations into 2029 and fund pivotal programs.
Dec 2, 2025, 9:00 PM
MBX Biosciences Provides Pipeline Update, Highlights Obesity Program
MBX
New Projects/Investments
Revenue Acceleration/Inflection
- MBX Biosciences is advancing three clinical-stage programs in endocrine and metabolic disease, utilizing its Precision Endocrine Peptide (PEP) platform technology.
- The company's obesity candidate, MBX 4291, a potential once-monthly GLP-1 GIP co-agonist prodrug, is expected to release 12-week MAD results in the target population in Q4 2026, with a focus on achieving better tolerability.
- MBX has funding secured into 2029 and anticipates a catalyst-rich year in 2026, including end of Phase 2 meetings for canvuparatide in Q1 2026 and Phase 3 initiation in Q3 2026.
- Their once-weekly PTH replacement therapy, canvuparatide, achieved 79% positive results in its open-label extension and is positioned as a best-in-class treatment for hypoparathyroidism.
Nov 24, 2025, 3:00 PM
MBX Biosciences Outlines Key Clinical Milestones for 2026 and Funding into 2029
MBX
New Projects/Investments
Guidance Update
- MBX Biosciences anticipates a catalyst-rich year in 2026 with key milestones across its three clinical-stage programs in endocrine and metabolic diseases.
- For its once-weekly canvuparatide program in hypoparathyroidism, MBX expects end of Phase II meetings with the FDA and EMA in Q1 2026, followed by the presentation of Avail Phase II results and one-year follow-up data in Q2 2026, and the initiation of a Phase III registration study in Q3 2026. The program reported a 79% responder rate in Phase II.
- The company's potential once-monthly obesity candidate, MBX 4291, a GLP-1/GIP co-agonist prodrug, is expected to release 12-week Multiple Ascending Dose (MAD) results in the target population in Q4 2026. Non-human primate studies demonstrated nearly 20% weight lowering after four once-weekly doses.
- MBX Biosciences has funding secured into 2029, which is intended to support these upcoming catalysts, including Phase III completion and pre-commercial activities for its hypoparathyroidism program.
Nov 24, 2025, 3:00 PM
MBX Biosciences Provides 2026 Catalyst Outlook and Funding Update
MBX
New Projects/Investments
Guidance Update
- MBX Biosciences is advancing three clinical-stage programs, with outstanding phase two top-line results reported in September for its once-weekly canvuparatide, a potential PTH replacement therapy for hypoparathyroidism.
- The company anticipates significant catalysts in 2026, including end-of-phase two meetings with the FDA and EMA for canvuparatide in Q1 2026, and top-line results for its obesity and post-bariatric hypoglycemia (PBH) candidates in Q2 2026.
- MBX Biosciences reported $392 million in cash and equivalents at the end of the last quarter, providing funding to support operations into 2029, which includes completing the phase three study for canvuparatide and pre-commercial activities.
Nov 19, 2025, 4:00 PM
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