Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences' PURPOSE 1 trial, focusing on HIV prevention in young African women and adolescent girls, represents a significant step in inclusive clinical research. The trial studies a PrEP medication administered every six months via injection and is part of the most comprehensive HIV prevention program ever conducted. The study enrolled thousands of cisgender women and girls aged 16-25 in South Africa and Uganda, including pregnant and lactating women - a first for a Phase 3 HIV prevention trial. The initiative addresses the disproportionate impact of HIV on women in sub-Saharan Africa, where approximately 3,100 women acquire HIV weekly. Preliminary results have been encouraging.

Gilead Sciences announced positive interim results from the Phase 3 ASSURE study of Livdelzi (seladelpar) in treating Primary Biliary Cholangitis (PBC). The study showed that 81% of participants achieved composite biochemical response by Month 30, and 41% achieved normalization of alkaline phosphatase levels. The drug demonstrated significant improvements in PBC progression markers with a robust safety profile, with no treatment-related serious adverse events reported. Additionally, Livdelzi reduced pruritus severity, with 27% of participants experiencing near resolution of itch symptoms. The drug received FDA accelerated approval in August 2024 for PBC treatment.

Gilead Sciences (Nasdaq: GILD) has announced the pricing of $3.5 billion in senior unsecured notes through a public offering. The notes are structured in four tranches: $750 million at 4.80% maturing in 2029, $1 billion at 5.10% maturing in 2035, $1 billion at 5.50% maturing in 2054, and $750 million at 5.60% maturing in 2064. The offering is expected to close on November 20, 2024. The company plans to use the proceeds for general corporate purposes, including potential debt repayment. Barclays Capital and BofA Securities are serving as lead joint book-running managers for the offering.

Gilead Sciences presented full results from its Phase 3 PURPOSE 2 trial studying twice-yearly lenacapavir for HIV prevention. The trial showed that lenacapavir reduced HIV infections by 96% compared to background HIV incidence, with only two cases among 2,179 participants. The drug demonstrated 89% higher effectiveness than daily Truvada.

Trial participants showed high adherence to lenacapavir injections, with 91% receiving on-time injections at week 26 and 92.8% at one year. The FDA granted Breakthrough Therapy Designation for lenacapavir for PrEP, and Gilead plans to begin regulatory filings by end of 2024.

Gilead Sciences presented new research data on its HIV treatment portfolio at HIV Glasgow 2024, including four-year outcomes from the BICSTaR study for Biktarvy®. The study demonstrated high long-term efficacy and safety, with 98% virologic suppression in treatment-naïve and 97% in treatment-experienced patients, with no treatment-emergent resistance. New data also highlighted Biktarvy's high barrier to resistance compared to other treatments. The company showcased investigational regimens with varied dosing frequencies, including once-daily, once-weekly, and twice-yearly options, focusing on person-centered drug development to address unmet needs in HIV treatment.

Gilead Sciences (GILD) has announced its executives' participation in three major investor conferences: the Jefferies London Healthcare Conference on November 20 at 9:30 AM GMT, the Piper Sandler Annual Healthcare Conference on December 3 at 11:00 AM ET, and the Annual Evercore ISI HealthCONx Conference on December 4 at 11:40 AM ET.

Live webcasts will be available on the company's investor page, with replays accessible for at least 30 days post-presentation. Gilead Sciences is a biopharmaceutical company focused on developing innovative medicines for HIV, viral hepatitis, COVID-19, and cancer, operating in over 35 countries worldwide.

Gilead Sciences announced the presentation of HIV research findings at HIV Glasgow 2024, featuring data from over 40 studies across HIV treatment and prevention. Key highlights include full results from PURPOSE 2 trial evaluating twice-yearly lenacapavir for HIV prevention, four-year outcomes from BICSTaR study demonstrating Biktarvy's efficacy and safety, and late-breaking data from a Phase 2 study on an investigational once-weekly oral combination treatment of islatravir/lenacapavir. The research spans HIV prevention, treatment options, and pipeline developments, reflecting Gilead's commitment to person-centered drug development strategies.

Gilead Sciences reported strong Q3 2024 results with total revenue increasing 7% to $7.5 billion. Product sales excluding Veklury grew 7% to $6.8 billion, driven by HIV sales up 9% to $5.1 billion. Biktarvy sales rose 13% to $3.5 billion, while Trodelvy sales increased 17% to $332 million. The company reported diluted EPS of $1.00, down from $1.73 in Q3 2023, primarily due to a $1.75 billion IPR&D impairment. Based on strong performance, Gilead raised its full-year 2024 guidance, projecting product sales of $27.8-28.1 billion and non-GAAP diluted EPS of $4.25-4.45.

Kite, a Gilead company, will present 18 studies at ASH 2024, showcasing their CAR T-cell therapy portfolio. Key highlights include positive survival outcomes from both clinical trials and real-world data. The Phase 1 study of anito-cel showed 30.2-month median progression-free survival, while the Phase 2 iMMagine-1 study demonstrated 95% objective response rate. Yescarta® continues to show superior survival rates in the largest real-world analysis for second-line therapy in large B-cell lymphoma. Long-term survival data for both Yescarta® and Tecartus® will be presented from multiple ZUMA studies across various blood cancers.