Gilead and Galapagos are ending all studies of an experimental drug for lung disease after independent reviewers determined its benefits do not outweigh the risks.
The decision to end research on ziritaxestat, which was being tested as a treatment for idiopathic pulmonary fibrosis, marks a second major failure for the Gilead-Galapagos partnership. In August, the Food and Drug Administration unexpectedly rejected filgotinib, a rheumatoid arthritis drug that was central to the 10-year, $5 billion pact the companies inked in mid-2019.
Galapagos and Gilead didn’t provide details of the issues with ziritaxestat in a Wednesday release. Rather, they said data would be presented at future medical meetings. The monitoring board acted in part because of mortality trends observed among patients, Mizuho Securities analyst Salim Syed wrote in a note to investors, citing a statement he received from Gilead. Galapagos shares tumbled 18% Wednesday. READ MORE
by Kristin Jensen
Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company, announced a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.
Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures. If approved, efgartigimod will be the first neonatal Fc receptor (FcRn) blocker for the treatment of adults in Europe living with rare neuromuscular disease generalized myasthenia gravis (gMG).
Galapagos CEO Paul Stoffels, M.D., has finally taken the plunge on M&A. The newly minted chief executive has signed not one but two deals in an attempt to right the ship, bringing two small biotechs aboard for a combined 239 million euros ($251.4 million).