UCB: shares resist after negative CHMP opinion
(CercleFinance.com) - Belgian drugmaker UCB's shares resisted in morning trading on Monday, despite a European panel ruling against the approval of its Evenity drug for the treatment of severe osteoporosis.
Late on Friday UCB and US partner Amgen announced that they have been informed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorisation application for Evenity.
The companies said they intend to submit a written notice for a re-examination by the CHMP.
Analysts, however, say that the US, and not Europe, remains the largest potential market for Evenity.
As a reminder, Evenity has been approved by the US Food and Drug Administration (FDA) in April 2019 for the treatment of osteoporosis in postmenopausal women at high risk of fractures.
UCB shares are currently up 1.1% on Euronext Brussels.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
Late on Friday UCB and US partner Amgen announced that they have been informed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorisation application for Evenity.
The companies said they intend to submit a written notice for a re-examination by the CHMP.
Analysts, however, say that the US, and not Europe, remains the largest potential market for Evenity.
As a reminder, Evenity has been approved by the US Food and Drug Administration (FDA) in April 2019 for the treatment of osteoporosis in postmenopausal women at high risk of fractures.
UCB shares are currently up 1.1% on Euronext Brussels.
Copyright (c) 2019 CercleFinance.com. All rights reserved.