MBX Doses First Patient in Pivotal Phase 3 Trial for Once-Weekly Hypoparathyroidism Drug
MBX has more than doubled off its 52-week low of $9.63 on light trading volume (0.3× avg).
Summary
MBX Biosciences has dosed the first patient in its pivotal Phase 3 oPTimize trial for once-weekly canvuparatide in adults with chronic hypoparathyroidism. The trial will enroll approximately 160 patients randomized 3:1 to drug or placebo over a 26-week double-blind period, followed by a 78-week open-label extension. This marks the start of the registrational program, building on positive Phase 2 data and one-year extension results reported in June. The primary endpoint is a composite responder measure at Week 26, including normal serum calcium, independence from active vitamin D, and reduced calcium supplementation. With $418.6M in cash and runway into 2029, the company is well-funded to complete this trial. The initiation of Phase 3 is a major de-risking event for the lead asset and positions canvuparatide as a potential best-in-class PTH replacement therapy.
At the time of this announcement, MBX was trading at $66.50 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3.2B. The 52-week trading range was $9.63 to $72.64. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.