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Gilead's Bold Ambition of Transforming Triple-Negative Breast Cancer Treatment to Be Highlighted With New Data at SABCS

ASCENT Subgroup Analysis Provides Insights on Treatment Outcomes for Black Patients with Metastatic TNBC –

Separate ASCENT Post Hoc Analysis Examines Outcomes in Patients Who Discontinue Treatment Due to Progressive Disease

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Trodelvy® Granted European Commission Marketing Authorization for Treatment of Metastatic Triple-Negative Breast Cancer in Second Line

-- Marketing Authorization Based on Phase 3 ASCENT Study Showing Trodelvy Significantly Improved Overall Survival vs. Physician's Choice of Chemotherapy in Metastatic Triple-Negative Breast Cancer --

-- Trodelvy Offers an Important New Treatment Option for People with this Aggressive Type of Metastatic Breast Cancer --

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Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta

-- If Approved, Bulevirtide Will Be the First Treatment Option for Adult Patients in the U. S. With Chronic Hepatitis Delta Virus Infection With Compensated Liver Disease --

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA. Bulevirtide is an investigational agent in the U.S. and the safety and efficacy have not been established. The BLA submission is supported by data from completed and ongoing Phase 2 studies and the ongoing Phase 3 MYR301 study which supports the safety and efficacy of bulevirtide 2 mg once daily after 24 weeks of therapy. In Europe, Hepcludex ® (bulevirtide) has been granted Conditional Marketing Authorization by the European Commission and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency (EMA), as the first approved treatment in Europe for adults with chronic HDV infection with compensated liver disease.

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