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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER