- MBX Biosciences announced **positive Phase 2 results for once-weekly Kaniparutide** for hypoparathyroidism, reporting a **79% responder rate at six months** and **94% of patients electing to enroll in a two-year open-label extension study**.  **[1776111_2162449_1]**  The company plans to advance to a Phase 3 registration study.  **[1776111_2162449_1]** 
- The company is progressing with **MBX 1416**, a GLP-1 antagonist for post-bariatric hypoglycemia, which is currently in a **Phase 2a study** with data anticipated in **2026**  **[1776111_2162449_1]** ,.  **[1776111_2162449_5]** 
- MBX's obesity program, featuring **MBX 4291** (a dual GLP-1/GIP co-agonist prodrug with potential for once-monthly dosing), is in a **Phase 1 study** with full data expected in **2027**  **[1776111_2162449_1]** ,  **[1776111_2162449_2]** ,.  **[1776111_2162449_3]**  MBX plans to **partner these obesity programs**.  **[1776111_2162449_4]** 
- MBX Biosciences reported a **pro forma cash position of approximately $412 million as of June 30, 2025**, following a recent follow-on offering, which is projected to extend its operating runway **into 2029**.  **[1776111_2162449_1]**

MBX Biosciences Updates on Clinical Pipeline and Financial Outlook

- MBX Biosciences, Inc. entered into an Underwriting Agreement on **September 24, 2025**, for an underwritten public offering of **11,108,055** shares of common stock.  **[1776111_0001193125-25-220432_mbx-20250924.htm:1]** 
- The shares were offered at a price of **$18.00** per share, and the company granted the underwriters a 30-day option to purchase up to an additional **1,666,208** shares.  **[1776111_0001193125-25-220432_mbx-20250924.htm:1]** **[1776111_0001193125-25-220432_mbx-ex1_1.htm:37]** 
- The offering closed on **September 26, 2025**, resulting in approximately **$187.5 million** in net proceeds for MBX Biosciences, Inc..  **[1776111_0001193125-25-220432_mbx-20250924.htm:1]** 
- The net proceeds are primarily intended to advance the development of its three clinical-stage programs, fund discovery research and development activities, additional clinical development, and for general corporate purposes, working capital, and capital expenditures.  **[1776111_0001193125-25-220432_mbx-20250924.htm:1]** **[1776111_0001193125-25-220432_mbx-ex1_1.htm:24]**

MBX Biosciences Closes Public Offering

- MBX Biosciences announced that its once-weekly canvuparatide achieved the primary endpoint in its Phase 2 Avail™ trial for chronic hypoparathyroidism, demonstrating a **63% responder rate at 12 weeks**.  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]** 
- The responder rate further improved to **79% at 6 months** in the open-label extension (OLE).  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]** 
- The therapy was generally well tolerated, with **no treatment-related serious adverse events or discontinuations** reported during the 12-week trial.  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]** 
- Based on these positive results, MBX Biosciences plans to initiate a **Phase 3 clinical trial in 2026**.  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]**

MBX Biosciences Announces Positive Phase 2 Trial Results for Canvuparatide

- MBX Biosciences announced **positive top-line results** from its AVAIL Phase II trial for once-weekly candiparatide, a treatment for hypoparathyroidism, with **63% of patients** achieving the primary composite endpoint at week 12 compared to **31% on placebo**.  **[1776111_2152469_1]** 
- In the ongoing open-label extension study, overall responder rates increased to **79% at six months**, with **90% of patients** gaining independence from active vitamin D and **81%** from therapeutic doses of oral calcium.  **[1776111_2152469_1]** **[1776111_2152469_5]** 
- Once-weekly candiparatide was **well tolerated** in the 12-week trial, with no treatment-related serious adverse events or discontinuations.  **[1776111_2152469_1]** **[1776111_2152469_6]**  The most commonly reported adverse events included headaches, hypercalcemia, arthralgia, and nausea.  **[1776111_2152469_6]** 
- The company plans to advance candiparatide into **Phase III development** in **2026**, following an end-of-Phase II meeting with the FDA.  **[1776111_2152469_1]** **[1776111_2152469_7]**

MBX Biosciences Reports Positive Phase II Results for Once-Weekly Candiparatide

- MBX Biosciences announced positive top-line results from its Phase 2 Avail trial and Open-Label Extension (OLE) for **once-weekly Canvuparatide** in adults with hypoparathyroidism on **September 22, 2025**.  **[1776111_2152850:0]** **[1776111_2152850:4]** 
- At Week 12, **63%** of patients receiving once-weekly canvuparatide achieved the primary endpoint compared to **31%** on placebo (p<0.05).  **[1776111_2152850:4]** **[1776111_2152850:9]** 
- The responder rate further increased to **79%** at 6 months in the OLE.  **[1776111_2152850:4]** **[1776111_2152850:12]** **[1776111_2152850:15]** 
- The treatment was **well-tolerated**, with no treatment-related serious adverse events or discontinuations during the 12-week trial.  **[1776111_2152850:4]** **[1776111_2152850:13]** 
- These results support the advancement of once-weekly Canvuparatide into **Phase 3** development, with a global Phase 3 trial planned for **2026**.  **[1776111_2152850:4]** **[1776111_2152850:15]**

MBX Biosciences (MBX)