Gilead Sciences, Inc. - GILD STOCK NEWS

Gilead Sciences (GILD) presented new data from its HIV treatment portfolio at AIDS 2024, emphasizing the long-term efficacy and safety of Biktarvy® and investigational treatments. Five-year data showed Biktarvy maintained high virologic suppression in Hispanic/Latine patients (100% undetectable status) and 98.1% in non-Hispanic/Latine patients. The BICSTaR study confirmed Biktarvy's effectiveness in older adults with comorbidities, with a 96% viral suppression rate at two years. ARTISTRY-1 study outcomes showcased the potential of bictegravir + lenacapavir combination for complex treatment regimens. New investigational treatments, GS-4182 and GS-1720, indicate promising once-weekly dosing options. Additionally, lenacapavir with bNAbs demonstrated sustained viral suppression with twice-yearly dosing. These comprehensive findings reinforce Gilead's commitment to innovative, person-centered HIV treatment solutions.

Gilead Sciences (GILD) announced full efficacy and safety results from its Phase 3 PURPOSE 1 trial for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for HIV prevention. Key findings include:

- Zero HIV infections and 100% efficacy in the lenacapavir group
- Superior prevention compared to daily oral Truvada
- High adherence (>90%) to lenacapavir injections
- Generally well-tolerated with no serious injection site reactions
- First adult pivotal HIV prevention trial to include pregnant women and adolescents

If approved, lenacapavir would be the first twice-yearly PrEP option, potentially improving uptake and adherence. Gilead is prioritizing swift access in high-incidence, resource- countries. Results from the PURPOSE 2 trial are expected in late 2024/early 2025.

Gilead Sciences (GILD) and the Elton John AIDS Foundation have extended their RADIAN partnership for five more years, investing $25 million to address the growing HIV crisis in Eastern Europe and Central Asia (EECA). The initiative aims to support local organizations and expand its geographic focus to help communities impacted by the Ukraine conflict. RADIAN has already reached over 271,000 people with HIV services and provided more than 114,000 HIV tests since 2019. The partnership will continue to tackle structural drivers of the epidemic, strengthen HIV health systems, and enhance local organizations' capacities. It will also introduce an innovation fund to support creative solutions in the region.

Gilead Sciences (Nasdaq: GILD) has announced that Chief Medical Officer Merdad Parsey, MD, PhD, will leave the company in early 2025. Dr. Parsey will continue in his role until Q1 2025 and assist with the transition. During his five-year tenure, Dr. Parsey played a important role in strengthening and diversifying Gilead's portfolio, which has more than doubled under his leadership.

The company now has 54 ongoing clinical trials across virology, oncology, and inflammation. Dr. Parsey's contributions include advancing market-leading treatments in virology and establishing Gilead's oncology pipeline. CEO Daniel O'Day praised Dr. Parsey's significant contributions and expressed confidence in the company's future growth based on the strong, diverse clinical pipeline developed during his tenure.

Gilead Sciences (GILD) announced its program for the 25th International AIDS Conference (AIDS 2024), highlighting advancements in HIV prevention, treatment, and cure research. Key highlights include:

1. Full data from the PURPOSE 1 trial on lenacapavir, a twice-yearly HIV prevention medicine.

2. Week 48 outcomes from ARTISTRY-1 study on a single-tablet regimen of bictegravir and lenacapavir.

3. Two-year outcomes from BICSTaR study on Biktarvy®.

4. New data on GS-1720 and GS-4182 for potential once-weekly oral HIV treatments.

5. Resistance analyses for lenacapavir + teropavimab + zinlirvimab combination.

Gilead will also host symposia on addressing barriers to HIV care and prevention, and showcase initiatives aimed at improving HIV awareness and care.

Gilead announced a significant enhancement to its employee benefits by introducing AccessHope, a cancer care support program, to its U.S. employees and their families. This initiative provides access to a network of oncology professionals offering treatment information and emotional support. Jim Candler, a Senior Director at Gilead, shared his positive experience with AccessHope after being diagnosed with prostate cancer. He emphasized the program's role in helping him and his wife navigate treatment options. Additionally, Gilead's efforts in cancer care caught the attention of President Biden's Cancer Moonshot initiative, leading to an invitation to the White House to discuss employer-led cancer screening practices. This initiative highlights Gilead's commitment to employee wellbeing and innovative cancer treatment options.

Gilead Sciences (Nasdaq: GILD) announced interim Phase 3 trial results showcasing the 100% efficacy of its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for HIV prevention in cisgender women. The PURPOSE 1 trial concluded with zero HIV infections, demonstrating lenacapavir’s superiority over daily oral Truvada and background HIV incidence. Based on these findings, the independent Data Monitoring Committee advised halting the blinded phase and transitioning all participants to open-label lenacapavir. The trial included over 5,300 cisgender women and adolescent girls across 28 sites in South Africa and Uganda. Lenacapavir was generally well-tolerated with no new safety concerns. Gilead plans to present more detailed data at a future conference and continues additional trials under the PURPOSE program, aiming to end the HIV epidemic globally.

Gilead Sciences and Kite Pharma celebrated Pride Month by raising Pride Month flags at their campuses, showcasing their support for LGBTQ+ communities worldwide. This initiative aligns with Gilead's commitment to inclusion and diversity, which is integral to their mission of creating a healthier world. Gilead Sciences is a biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for unmet medical needs, particularly life-threatening illnesses. Headquartered in Foster City, California, Gilead operates in over 35 countries globally.

Gilead's Kite announced new data for Yescarta® (axicabtagene ciloleucel) in treating relapsed/refractory large B-cell lymphoma (R/R LBCL). Key findings indicate that using Yescarta as a second-line treatment improves manufacturing success rates by 2.60% compared to third-line treatments, achieving a 95.08% success rate in second-line therapies. Additionally, second-line treatments showed double the median percentage of naïve-like T-cells in patients, enhancing potential outcomes.

Preliminary results from the ZUMA-24 study suggest that outpatient administration of Yescarta is feasible, with safety data consistent with prior studies. These findings will be presented at the 2024 European Hematology Association Annual Congress.