BioInvent plunges on negative regulatory news

The US Food and Drug Administration has put a full clinical hold (ie, no further dosing of patients) has been placed on the current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma, according to Sweden’s BioInvent International (STO: BINV), whose shares plummeted as much as 22% on the news.

BioInvent has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA informed BioInvent that the clinical hold is due to an adverse cardiopulmonary event in the clinical study.

The clinical study is being conducted by BioInvent in collaboration with investigators at the University of Pennsylvania in the USA and aims to document the ability of BI-505 to deepen therapeutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan BI-505 is the company’s lead investigational drug candidate.

BioInvent will analyse the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report.