Short answer
MBX Biosciences, Inc. (MBX) filed an 8-K current report with the SEC on June 12, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). One-year Phase 2 Avail and open-label extension data for once-weekly canvuparatide in chronic hypoparathyroidism.
MBX Biosciences, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- One-year Phase 2 Avail and open-label extension data for once-weekly canvuparatide in chronic hypoparathyroidism
- Sustained treatment benefit positions canvuparatide as a potential PTH replacement therapy
- Management webcast scheduled June 12, 2026 at 8:00 a.m. ET to discuss clinical results
- Exhibit 99.1 contains the press release; Exhibit 99.2 contains the investor presentation
Item 8.01 · Other Events
- One-year responder rate 57% (31/54), with no rescue-therapy contribution during the final treatment week
- 12-week primary endpoint: 63% (30/48) versus 31% placebo (5/16), p=0.042
- Pharmacokinetics support once-weekly dosing, with peak-to-trough ratio approximately 1.3
- Calcium, urinary calcium, eGFR and bone-turnover measures remained consistent with physiologic PTH replacement
- Generally well tolerated through one year; no treatment-related serious adverse events and 10% injection-site reactions
Item EX-99.1 · Exhibit EX-99.1
- One-year responder rate 57% (31/54), broadly comparable to 63% (30/48) at Phase 2 Week 12
- Sustained calcium normalization, reduced urine calcium, improved eGFR, and physiologic bone-remodeling markers support PTH replacement potential
- 90% of OLE entrants remained in treatment at one year, indicating strong retention for once-weekly dosing
- No new safety signals; no treatment-related serious adverse events, with injection-site reactions in 10% of OLE patients
- Phase 3 pivotal trial remains on track to initiate in Q3 2026, advancing MBX’s lead program toward registrational development
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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