The future of Alnylam Pharmaceuticals Inc.'s RNAi candidate for respiratory syncytial virus (RSV), ALN-RSV01, could be either continued development or total termination, according to CEO John Maraganore, following the drug's failure to hit its primary endpoint in a Phase IIb trial against progressive bronchiolitis obliterans syndrome (BOS) in lung transplant patients.
Vertex Pharmaceuticals Inc.'s stock slid more than 10 percent Tuesday following a release of corrected clinical data for a Phase II trial of Kalydeco (ivacaftor) with VX-809, showing that only 35 percent of cystic fibrosis (CF) patients with the F508del mutation experienced an absolute improvement in lung function (FEV1) of 5 percent or more, rather than the 46 percent as reported previously.
Sangart Inc. added $50 million in additional equity financing through its existing investor, Leucadia National Corp. The funding was made upon exercise of Series G preferred stock warrants held by Leucadia, and brings the total amount raised by the company to $280 million.
A Phase IIb trial intended to show the benefit of MediciNova Inc.'s asthma candidate, MN-221, failed to meet its primary endpoint of improved forced expiratory volume in one second (FEV1) compared to placebo, sending the company's stock plummeting 43.3 percent Thursday.
InterMune Inc. agreed to sell its rights to Actimmune (interferon gamma-1b) to Vidara Therapeutics International Ltd. for $55 million in cash plus royalties for two years. InterMune's CEO Dan Welch said divesting Actimmune would free up capital for development and registration of Esbriet (perfenidone) in Europe and other territories, and support other research and development activities.
Osiris Therapeutics Inc. won a double victory today with the first ever marketing approval for a manufactured stem cell product and the first therapy for graft-vs.-host disease (GvHD). Health Canada issued marketing authorization for Osiris's stem cell therapy Prochymal (remestemcel-L) for GvHD in children.
Sosei Group Corp. reported that NVA237 beat placebo at improving lung function, symptom relief and quality of life among sufferers of chronic obstructive pulmonary disease (COPD) in its Phase III GLOW2 trial.
Oncomed Pharmaceuticals Inc. filed an initial public offering (IPO), hoping for about $115 million to support its antibody therapies targeted at cancer stem cells (CSCs).
GlaxoSmithKline plc's $2.6 billion acquisition offer for Rockville, Md.-based Human Genome Sciences Inc. (HGS) turned hostile recently when GSK announced that it would not participate in a strategic alternatives review process with HGS, and that it would instead commence its tender offer for all outstanding shares for $13 per share in cash, which it first put forward April 11.
Cellzome AG, of Heidelberg, Germany, will soon become GlaxoSmithKline plc's newest platform technology asset, subsequent to the pharma's acquisition of all outstanding shares of Cellzome for £61 million (US$99 million) in cash. GSK currently owns 19.98 percent of Cellzome.
