00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
17:53 , Aug 3, 2018 |  BC Week In Review  |  Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) revealed that it and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) sold a rare pediatric disease Priority Review voucher during 2Q18 to an undisclosed company for $80.6 million. Ultragenyx spokesperson Danielle Keatley...
17:45 , Jul 31, 2018 |  BC Extra  |  Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) revealed that it and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) sold a rare pediatric disease Priority Review voucher during 2Q18 to an undisclosed company for $80.6 million. Ultragenyx spokesperson Danielle Keatley...
14:24 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

Ultragenyx's Crysvita meets in Phase III for pediatric XLH

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said Crysvita burosumab-twza (KRN23, UX023) met the primary endpoint of improving rickets compared with conventional therapy in the Phase III PIXLES trial to treat...
16:32 , Apr 20, 2018 |  BC Week In Review  |  Clinical News

Ultragenyx gains rare disease approval, voucher

FDA approved Crysvita burosumab-twza (KRN23, UX023) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat X-linked hypophosphatemia in patients aged one year and older. FDA said Crysvita is the...
19:57 , Apr 17, 2018 |  BC Extra  |  Company News

Ultragenyx gains rare disease approval, voucher

FDA approved Crysvita burosumab-twza (KRN23, UX023) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat X-linked hypophosphatemia in patients aged one year and older. FDA said Crysvita is the...
18:40 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

Kyowa XLH therapy approved in EU

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission granted conditional approval to an MAA for Crysvita burosumab (KRN23, UX023) to treat X-linked hypophosphatemia with radiographic evidence of...
20:30 , Feb 23, 2018 |  BC Extra  |  Company News

XLH therapy burosumab gains EU approval

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission granted conditional approval to an MAA for Crysvita burosumab (KRN23, UX023) to treat X-linked hypophosphatemia with radiographic evidence of...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
00:13 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

Kyowa's XLH candidate Crysvita gets nod from EMA's CHMP

EMA's CHMP recommended conditional approval of Crysvita burosumab (KRN23, UX023) from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children ages one and up and...