MBX Stock Soars Pre-Market After Investigational Hypoparathyroidism Drug Yields Positive Results In Study

MBX Biosciences, Inc. (MBX) said on Monday that its once-weekly Canvuparatide achieved the primary endpoint with statistical significance at week 12 in its mid-stage trial in adult patients with chronic hypoparathyroidism.

Hypoparathyroidism is a rare endocrine disease caused by a deficiency of parathyroid hormone (PTH) released by the parathyroid glands that results in decreased calcium levels in the blood. According to MBX, the disease affects more than 250,000 individuals in the U.S. and Europe.

The company noted that 63% of Canvuparatide-treated patients in the study maintained serum calcium levels within the normal range and were independent of conventional therapy, including active vitamin D and calcium supplements, at week 12, with zero contribution from rescue therapy, compared to 31% in placebo-treated patients, the company stated.

In the open-label extension of the trial, 79% of patients who received treatment achieved these milestones at six months. The company is now preparing to kickstart a late-stage trial of once-weekly Canvuparatide in 2026.

Shares of the company soared 144% in the pre-market session at the time of writing. On Stocktwits, retail sentiment around MBX stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘extremely high’ levels.

Guggenheim subsequently raised its price target on MBX to $84 from $44 while keeping a ‘Buy’ rating on the shares. The results achieved the firm's "bull case," noted the analyst, who increased the firm's view of the odds of success for Canvuparatide to 75% from 50% previously. Guggenheim also argued that the data provides "clear line of sight to blockbuster-plus potential."

CEO Kent Hawryluk said that the company is pleased with the results. “We believe the totality of the data support a once-weekly product profile with continuous infusion-like PTH exposure. These 12-week and 6-month results represent the potential for a meaningful improvement over current treatment options for HP patients and provide a strong foundation for further development,” he said.

All doses of Canvuparatide were generally well-tolerated with no discontinuations related to the drug, and no treatment-related serious adverse events or discontinuations were recorded during the 12-week trial, the company said.

MBX stock is down 46% this year and approximately 55% over the past 12 months.

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