Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences celebrates the Israeli Ministry of Health's new universal HIV screening policy for pregnant women, announced in September 2022. This policy makes HIV testing a routine procedure for all pregnant women, a significant shift from previous guidelines that only tested high-risk groups. The change aims to prevent mother-to-child transmission of HIV, with early treatment reducing transmission risk to as low as 0.3%. Gilead's partnership with the Israel AIDS Task Force and other organizations has been pivotal in advocating for this long-awaited policy. The coalition expects this policy will lower the incidence of children born with HIV in Israel.

Gilead Sciences continues its efforts against COVID-19 by mobilizing teams of virologists as 'variant hunters' to monitor new strains. Gilead has tested over 15 variants of SARS-CoV-2 since the pandemic began. Upon identifying a 'variant of concern,' the company coordinates with the CDC and global collaborators to collect samples and assess the effectiveness of existing therapeutics. Recent developments include utilizing engineered variants, or 'replicons,' to accelerate testing processes as new variants emerge. This proactive approach aims to ensure that COVID-19 treatments remain effective.

Gilead Sciences supports community outreach efforts by Equal Hope, focusing on breast cancer education for underserved women in Chicago. Founded to address disparities in cancer mortality rates, particularly for Black women, Equal Hope mobilizes health workers in local spaces to engage with the community. The COVID-19 pandemic disrupted timely screenings, increasing the risk of late-stage cancer detection. With Gilead's assistance, Equal Hope aims to enhance outreach and ensure that preventative breast health screenings remain a priority.

Gilead Sciences has entered into a collaboration and licensing agreement with EVOQ Therapeutics to exclusively license EVOQ's NanoDisc technology for the development of immunotherapy products targeting rheumatoid arthritis and lupus. This agreement enables Gilead to pursue clinical development and commercialization of these therapies, with potential payments to EVOQ reaching up to $658.5 million plus royalties. The collaboration aims to address significant unmet needs in autoimmune disease treatment.

Gilead Sciences announced the validation of a Type II variation Marketing Authorization Application for Trodelvy (sacituzumab govitecan-hziy) by the European Medicines Agency. This application is aimed at treating adults with HR+/HER2- metastatic breast cancer who have undergone previous therapies. The approval is based on positive survival data from the Phase 3 TROPiCS-02 study, which showed improved progression-free and overall survival compared to standard chemotherapy. The FDA has also accepted a related supplemental application under priority review.

Gilead Sciences (GILD) has amended its license agreement with Jounce Therapeutics (JNCE) to buy out remaining financial obligations associated with GS-1811, an anti-CCR8 antibody designed for solid tumors. Jounce will receive $67 million and will forfeit up to $645 million in potential future payments. Gilead assumes full responsibility for GS-1811’s global development and commercialization, aiming to enhance its oncology portfolio. The buyout is expected to lower Gilead’s GAAP and non-GAAP EPS by approximately $0.04 in 2022.

Gilead Sciences (Nasdaq: GILD) announced its participation in the J.P. Morgan Healthcare Conference on January 9, 2023, at 10:30 a.m. PT. The event will be accessible via live webcast on the company's investor page. A replay will be available for 30 days post-presentation. Gilead Sciences is a biopharmaceutical leader focused on innovative therapies for HIV, viral hepatitis, and cancer, operating in over 35 countries with headquarters in Foster City, California.

Kite Pharma, a Gilead Company, and Daiichi Sankyo announced that Japan's Ministry of Health has approved Yescarta for treating relapsed/refractory large B-cell lymphoma (R/R LBCL). The approval is based on the ZUMA-7 study, which showed Yescarta provided a four-fold increase in event-free survival compared to standard care (8.3 vs. 2 months). Moreover, patients treated with Yescarta were 2.5 times more likely to be alive after two years without disease progression. This marks a significant advancement for patients in Japan, where this cancer type is prevalent.

Sunlenca (lenacapavir) has received FDA approval as the first capsid inhibitor for HIV-1 treatment in adults experiencing multi-drug resistant HIV infections. This drug, distinguished by its unique multi-stage action, offers a twice-yearly treatment option, addressing a critical gap for patients with limited therapy choices. The approval is based on the CAPELLA trial, which demonstrated an 83% success rate in achieving undetectable viral loads at Week 52. Sunlenca’s long-acting properties and broad application potential mark it as a significant advancement in HIV treatment.