Ultragenyx, Kyowa Hakko Kirin plan a date with the FDA after positive PhIII for X-linked hypophosphatemia
Shares of Ultragenyx surged about 10% after the biotech reported clearly positive Phase III data for their Kyowa Hakko Kirin-partnered drug for X-linked hypophosphatemia. And now they plan to hustle that data package to regulators at the FDA and EMA.
Researchers recruited 134 patients for the study, and found that 94% of the patients treated with burosumab achieved normal serum phosphorus levels, compared to only 8% in the placebo arm. The drug also hit on a couple of secondary endpoints, rating improvements in stiffness and physical function, but missed statistical significance on the pain score.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.