Shares of Gilead Sciences, Inc. (NASDAQ:GILD) ended Monday session in red amid volatile trading. The shares closed down -0.11 points or -0.15% at $72.64 with 8.18 million shares getting traded. Post opening the session at $72.54, the shares hit an intraday low of $72.31 and an intraday high of $73.46 and the price vacillated in this range throughout the day. The company has a market cap of $95.45 billion and the numbers of outstanding shares have been calculated to be 1.32 billion shares.
Gilead Sciences, Inc. (GILD) announced that it is stopping its combined Phase 2/3 clinical study of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis. This decision follows a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC) after the first 150 patients of a planned 1600-patient trial were treated for an 8-week induction duration. The DMC recommended that the study be terminated early due to meeting the pre-specified futility and efficacy criteria. No safety concerns were noted in this interim analysis. Gilead has also reviewed the data and determined that there is insufficient evidence of a treatment benefit in the group of patients randomized to receive either one of two doses of GS-5745.
Separately, a Phase 3 study of GS-5745 is ongoing in patients with gastric cancer, as well as a Phase 2 study in patients with gastric cancer in combination with nivolumab and additional Phase 2 studies in moderately to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis. These studies will continue as planned.
Shares of Bristol-Myers Squibb Co (NYSE:BMY) ended Monday session in red amid volatile trading. The shares closed down -0.43 points or -0.86% at $49.34 with 11.58 million shares getting traded. Post opening the session at $49.69, the shares hit an intraday low of $49.10 and an intraday high of $49.79 and the price vacillated in this range throughout the day. The company has a market cap of $81.67 billion and the numbers of outstanding shares have been calculated to be 1.66 billion shares.
Bristol-Myers Squibb Co (BMY) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
“We recognize the enormous challenges facing classical Hodgkin lymphoma patients who do not respond to or who progress following currently available treatments, and we are dedicated to helping these patients in their fight against this devastating disease,” said Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb. “CHMP positive opinion marks an important milestone in applying our Immuno-Oncology science to delivering a treatment option for patients with this hematologic malignancy. If approved by the European Commission, Opdivo will become the first PD-1 inhibitor approved to treat a hematologic malignancy in the European Union, further building on our established heritage in blood cancer care.”