Wedbush analyst Yun Zhong does not believe the Phase 2 top-line data that MBX Biosciences (MBX) announced from a Phase 2 study in hypoparathyroidism could support canvuparatide, a once-weekly therapy, to be a real competitor to Ascendis Pharma’s (ASND) Yorvipath. The 79% responder rate at 6 months is numerically comparable to what Yorvipath demonstrated in the Phase 3 study at week 26, but the placebo response at Week 12 was high, leading to a relatively low statistical significance. Moreover, data from each dose level show that only the highest dose of 800microgram met statistical significance, and the AE rates in canvuparatide cohorts also showed a dose response and were higher than the placebo cohort, including higher rates of hypercalcemia, causing one urgent care visit in a patient that received the 800ug dose, the firm notes. MBX has not disclosed the dose to be evaluated in the planned Phase 3 study, and overall, Wedbush does not see a compelling clinical profile in canvuparatide to be competing with Yorvipath in HP. The firm has an Outperform rating on Ascendis with a price target of $220.
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