MBX

Results from Phase 2 trial of once-weekly canvuparatide accepted for oral presentation at ENDO in June 2026 Phase 3 trial of once-weekly canvuparatide on track to initiate in Q3 2026 Appointment of Mark Soued as Chief Commercial Officer adds launch and commercialization expertise Company to host Obesity Day on May 11th featuring initial blinded data from ongoing MBX 4291 Phase 1 trial and update on expanding obesity portfolio $440.0 million in cash and investments expected to support operations into 2029 CARMEL, Ind. and BURLINGTON, Mass., May 07, 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 reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate progress. “We continue to make excellent progress across our pipeline in 2026, including advancement toward initiation of our Phase 3 trial of once-weekly canvuparatide following a successful End-of-Phase 2 meeting with the FDA,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Now we look forward to presenting our full Phase 2 Avail™ results, including one-year open-label extension data for canvuparatide, while continuing to advance a growing obesity pipeline enabled by our Precision Endocrine Peptide (PEP™) platform. With a world-class leadership team and a strong balance sheet, we are well positioned to execute on our goal of delivering improved, long-acting and well-tolerated peptide therapies for patients.” First Quarter 2026 and Corporate Highlights Once-Weekly Canvuparatide for Hypoparathyroidism Presentation of Phase 2 results and one-year follow-up data in June: Results from the 12-week AvailTM trial of once-weekly canvuparatide have been accepted for oral presentation at the Endocrine Society’s ENDO 2026 annual meeting in Chicago on Saturday, June 13, 2026. In addition, MBX will present one-year open-label extension (OLE) data for once-weekly canvuparatide at the 3rd Parathyroid Summit during the ENDO 2026 annual meeting in Chicago on Friday, June 12, 2026. Phase 3 trial of once-weekly canvuparatide on track to initiate in Q3 2026: Following a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administra...

MISSISSAUGA, ON / ACCESS Newswire / March 26, 2026 / Microbix Biosystems Inc. (TSX:MBX)(OTCQB:MBXBF) ("Microbix®" or the Company"), a life sciences innovator, manufacturer, and exporter, announces the voting results from the Annual Meeting of Shareholders of the Company (the "Meeting") which was held on March 25, 2026. At the Meeting, 27.44% of the issued and outstanding shares were represented. Shareholders voted in favour of all resolutions brought before the Meeting. Details of all resolutions that were voted upon are set out in the Management Information Circular (the "Circular") dated February 6, 2026. The Circular is available on the Company's website (https://www.microbix.com) and on SEDAR+ (https://www.sedarplus.ca). All of the board of directors nominees listed in the Circular were re-elected as directors of Microbix. Results of the vote were as follows: Shareholders also approved a resolution re-appointing the Company's auditors, Ernst & Young LLP, with 96.66% of the votes cast in favour. The slides of management's presentation at the Meeting have been posted at https://www.microbix.com. About Microbix Biosystems Inc. Microbix Biosystems Inc. creates proprietary biological products for human health, with over 120 skilled employees and revenues of C$ 18.6 million in its latest fiscal year (2025). It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) and reference materials (QUANTDx™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs or QUANTDx are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides IVDR-compliant CE marked products. Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots and reagents t...

Phase 3 trial of once-weekly canvuparatide remains on track to initiate in Q3 2026 following recently completed, successful End-of-Phase 2 meeting with FDA 12-week MAD Phase 1 data from MBX 4291 for obesity anticipated in Q4 2026 Planned nomination of amycretin and GLP-1/GIP/glucagon receptor triple-agonist development candidates for obesity expected in Q2 and Q3 2026 $459.1 million in pro forma cash and investments as of December 31, 2025, including $85.4 million in net proceeds from top-tier institutional investors through ATM program; expected to support operations into 2029 CARMEL, Ind., March 12, 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 reported financial results for the fourth quarter and full year ended December 31, 2025, and highlighted recent corporate progress. “2025 was a year of continued growth and execution for MBX, highlighted by the clinical validation of our Precision Endocrine Peptide (PEP™) platform,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Following a successful End-of-Phase 2 meeting with the FDA, we now have a clear path to initiate our Phase 3 trial of once-weekly canvuparatide. We are also advancing a growing obesity pipeline, built on our clinically validated PEPTM platform and designed for once-monthly dosing and improved tolerability. We look forward to a data-rich year ahead and to continuing our pursuit of bringing differentiated and best-in-class medicines to patients.” Fourth Quarter 2025 and Recent Corporate Highlights Once-Weekly Canvuparatide for Hypoparathyroidism (HP) End-of-Phase 2 FDA meeting for once-weekly canvuparatide completed: FDA feedback supported advancement into a Phase 3 trial and trial design elements have now been selected, including the number of patients, primary endpoint and key secondary endpoints, as well as dose selection, titration schedule and duration of the study. Initiation of the Phase 3 program remains on track for Q3 2026. EU Orphan Drug Designation granted for canvuparatide: The European Medicines Agency granted orphan drug designation to canvuparatide for the treatment of chronic hypoparathyroidism, supporting its continued clinical de...

Reported positive topline results from the Phase 2 Avail™ trial of once-weekly canvuparatide in hypoparathyroidism (HP) Completed upsized public offering, raising approximately $200 million in gross proceeds $391.7 million in cash, cash equivalents and marketable securities as of September 30, 2025; expected to support operations into 2029 Updated 2026 corporate milestones include clinical data for three Precision Endocrine Peptide™ (PEP) programs and initiation of a Phase 3 trial in HP CARMEL, Ind., Nov. 06, 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 reported financial results for the third quarter ended September 30, 2025, and highlighted recent corporate progress. “The third quarter of 2025 marked another quarter of significant execution as we reported positive topline results from our Phase 2 Avail™ trial of once-weekly canvuparatide,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “These strong results support our belief that canvuparatide has the potential to be best-in-class in hypoparathyroidism, an estimated multibillion dollar market. We are preparing for meetings with US and EU regulatory agencies, initiation of our Phase 3 trial and future commercialization. With a clinically validated PEP™ platform, and cash runway into 2029, MBX is well positioned to execute on our value-creating milestones in 2026 across our pipeline and become a leading, fully integrated endocrine and metabolic disease biopharma company.” In November 2025, the Company's board of directors appointed Steve Hoerter to serve as executive chairperson, to support the Company’s executive team with his perspective and commercialization experience, as the Company prepares for the start of a Phase 3 trial and begins pre-commercial activities. Mr. Hoerter joined the Company’s board of directors earlier this year, bringing more than 30 years of pharmaceutical commercialization and executive leadership experience, most recently as President and Chief Executive Officer of Deciphera Pharmaceuticals until its $2.4 billion acquisition by Ono Pharmaceutical in 2024. Jim Cornelius also retired from the board as of October 31, 2025, after more than five years of valu...

On September 22, 2025, MBX Biosciences announced positive topline results from its Phase 2 Avail trial, with once-weekly canvuparatide achieving the primary endpoint with statistical significance and a high responder rate at 6 months in adults with chronic hypoparathyroidism. An impressive 94% of patients who completed the study chose to enter the open-label extension, highlighting ongoing patient engagement and interest in the therapy’s long-term potential. We'll explore how the advancement to a Phase 3 trial for canvuparatide factors into MBX Biosciences' evolving investment narrative. Uncover the next big thing with financially sound penny stocks that balance risk and reward. For shareholders of MBX Biosciences, the big picture focuses on believing in the company’s ability to transition promising clinical results, like the recent Phase 2 win for canvuparatide, into an eventual commercial product. The strong efficacy and patient retention reported in the latest trial are likely to be a meaningful short-term catalyst, boosting optimism ahead of the planned Phase 3 trial in 2026. The company’s follow-on equity offering alongside these results also signals an intention to secure additional funding, which may impact existing shareholders in the near term but could strengthen the balance sheet for next-phase development efforts. However, risks persist, including the ongoing lack of revenue, continued net losses, a new management team, and a need to outperform established competitors if canvuparatide is eventually approved. Those factors are now seen in a new light, as positive clinical progress could support market confidence, but execution risks remain central to the MBX story. But, with no operating revenue, funding needs should remain front of mind for investors. Our valuation report here indicates MBX Biosciences may be overvalued. Among two Simply Wall St Community fair value estimates, views stretch from US$5.34 to a peak of US$53.43 per share. This wide range shows how differently market participants view MBX’s future as clinical milestones unfold, especially as funding requirements and execution risk become more prominent. Explore these viewpoints to weigh how optimism and uncertainty may affect performance. Explore 2 other fair value estimates on MBX Biosciences - why the stock might be worth less than half the current price! Disagree with this assessm...

CARMEL, Ind., Sept. 19, 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 it will provide topline results from its Phase 2 clinical trial of potential once-weekly canvuparatide for patients with chronic hypoparathyroidism (HP) and host an investor webcast on Monday, September 22. The Company will host a conference call and webcast at 8 am ET on Monday, September 22 to discuss the results from the Avail™ Phase 2 trial. Those who would like to participate may access the live webcast here or dial 1-877-407-0779 (US) or 1-201-389-0914 (international). The live and archived webcast of the call and slide presentation will be available in the Investors section of the Company’s website at https://investors.mbxbio.com/news-events/events. About MBX Biosciences MBX Biosciences is a biopharmaceutical company focused on the discovery and development 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. To learn more, please visit the Company website at https://mbxbio.com/ and follow it on LinkedIn. Media Contact: Katie Beach Oltsik Inizio Evoke Comms [email protected] (937) 232-4889 Investor Contact: Jim DeNike MBX Biosciences [email protected]

Topline results for the Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism on track for Q3 2025 Imapextide (MBX 1416) Phase 2a trial initiation in patients with post-bariatric hypoglycemia anticipated in Q3 2025 MBX 4291 Phase 1 trial initiation in obesity anticipated in Q3 2025 $224.9 million in cash, cash equivalents and marketable securities as of June 30, 2025; expected to support operations into mid-2027 CARMEL, Ind., Aug. 07, 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 reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress. “We are pleased to report continuous clinical development progress across our entire pipeline of Precision Endocrine Peptide (PEP) product candidates with a number of value-creating milestones anticipated in the second half of this year,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “We look forward to sharing topline results from our Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism this quarter. In addition, we are on track to initiate a Phase 2a clinical trial for imapextide, a peptide therapy for the treatment of post-bariatric hypoglycemia, and a Phase 1 trial evaluating MBX 4291 in patients with obesity, both in this quarter.” Second Quarter 2025 and Recent Corporate Highlights Hypoparathyroidism (HP): Canvuparatide (MBX 2109) Phase 2 topline data from Avail trial expected in Q3 2025. Topline results from the Phase 2 Avail trial of canvuparatide, a potential long-acting, once-weekly parathyroid hormone (PTH) peptide prodrug candidate, are on track to be reported in the third quarter of 2025. Post-bariatric Hypoglycemia (PBH): Imapextide (MBX 1416) Patient screening underway in Phase 2a trial: The Company has completed an end-of-Phase 1 meeting and a Phase 2a clinical trial evaluating imapextide, a long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist for the treatment of PBH, is expected to begin in the third quarter of 2025. Obesity: MBX 4291 Phase 1 trial to initiate Q3 2025: MBX 4291, a GLP-1/glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug is being developed as a once-monthly treatment f...

Topline results for the Phase 2 Avail™ evaluating canvuparatide in patients with hypoparathyroidism expected in 3Q 2025 Investigational New Drug submission for MBX 4291 on track for 2Q 2025 $240.8 million in cash, cash equivalents and marketable securities as of March 31, 2025; expected to support operations into mid-2027 CARMEL, Ind., May 12, 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 reported financial results for the first quarter ended March 31, 2025, and highlighted recent corporate progress. “We’ve followed up on our strong execution in 2024 with excellent progress on all our programs enabled by a strong balance sheet and cash position,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Following full enrollment of the Phase 2 Avail trial investigating canvuparatide for the treatment of hypoparathyroidism, we look forward to reporting top line results in the third quarter of 2025. We’re also on track to submit our investigational new drug (IND) application this quarter for MBX 4291, a novel glucagon-like peptide 1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug for treating obesity. In addition to these milestones, we also expect to begin a Phase 2 trial for MBX 1416 in post-bariatric hypoglycemia patients in the second half of this year and share further details on our additional obesity candidates currently in pre-clinical development.” First Quarter 2025 and Recent Corporate Highlights Hypoparathyroidism (HP): Canvuparatide (MBX 2109) Phase 2 topline data from Avail trial expected in 3Q 2025. MBX completed enrollment of 64 participants, exceeding its original enrollment target, in the Phase 2 Avail trial of canvuparatide, a potential long-acting parathyroid once-weekly hormone peptide prodrug candidate, in the first quarter of 2025. Topline results are expected in the third quarter of 2025. Obesity: MBX 4291 IND application submission on track for Q2 2025: MBX 4291, a GLP-1/GIP co-agonist prodrug, is being developed as a once-monthly treatment for obesity. The Company expects to submit an IND application for MBX 4291 this quarter. Post-bariatric Hypoglycemia (PBH): MBX 1416 Phase 2 trial expec...

Enrollment complete in Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism; topline results on track for Q3 2025 MBX 1416 Phase 2 trial in patients with post-bariatric hypoglycemia expected to begin in 2H 2025 Investigational New Drug submission anticipated in Q2 2025 for MBX 4291 in obesity $262.1 million in cash, cash equivalents and marketable securities as of December 31, 2024; expected to support operations into mid-2027 CARMEL, Ind., March 17, 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 reported financial results for the fourth quarter and full year ended December 31, 2024, and highlighted recent corporate progress. “MBX is entering 2025 with strong momentum following significant and transformational progress in 2024,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “We are poised to deliver Phase 2 clinical data on our lead program in hypoparathyroidism, canvuparatide, with topline results from our Avail™ trial anticipated in the third quarter of 2025. Additionally, we are well-positioned to enter the clinic with our first obesity candidate later this year, pending clearance of our investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA). Finally, we look forward to initiating a Phase 2 trial evaluating MBX 1416 in post-bariatric hypoglycemia (PBH) patients in the second half of 2025.” Fourth Quarter 2024 and Recent Corporate Highlights Hypoparathyroidism (HP): Canvuparatide (MBX 2109) Completed Enrollment in Phase 2 Avail Trial in HP patients: In March 2025, MBX announced the completion of enrollment of 64 patients with HP in the Phase 2 Avail trial of canvuparatide, the Company’s potential long-acting parathyroid once-weekly hormone (PTH) peptide prodrug. Topline results from the randomized, double-blind, placebo-controlled 12-week trial are anticipated in the third quarter of 2025. Published Phase 1 Trial Results: In December 2024, MBX announced the publication of a peer-reviewed article highlighting results from the Phase 1 study of canvuparatide titled “MBX 2109, a Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-in-Human, Randomized Trial” in The Jou...