GILEAD SCIENCES SL

Gilead Sciences' Phase III PURPOSE 2 study shows twice-yearly lenacapavir injection reduced HIV infections by 96%, outperforming daily Truvada for HIV prevention. The study's interim analysis recommended offering open-label lenacapavir to all participants. Gilead plans global regulatory filings by end of 2023, aiming for a 2025 launch.

Gilead Sciences' lenacapavir, an HIV treatment repurposed as a twice-yearly preventive shot, reduced HIV infection risk by 96% in a trial involving over 3200 individuals. The drug's high cost as a treatment ($3450/month) raises concerns about its affordability as PrEP. Gilead plans to submit lenacapavir for FDA approval by end of 2024, aiming to make it accessible globally.

Marengo Therapeutics and Gilead collaborate on a Phase I/II study combining STAR0602 (Invikafusp alfa) with Trodelvy for metastatic HR+/HER2- breast cancer and TNBC, aiming to explore a novel therapeutic strategy.

99.9% of participants in the lenacapavir group did not acquire HIV in the PURPOSE 2 trial, with 2 incident cases among 2,180 participants. The trial demonstrated lenacapavir's 96% reduction in HIV infections compared to background incidence and its superiority to once-daily Truvada. Gilead will offer open-label lenacapavir to all participants and plans regulatory filings by end of 2024.

Twice-yearly lenacapavir injections reduced HIV infections by 96% in a phase 3 trial, outperforming daily PrEP pills. Gilead plans global regulatory filings by end of 2024 for potential 2025 launch.

OmRx Oncology, a biopharmaceutical venture with investment from Scripps Research, launched with the in-licensing of OX-4224, an oral checkpoint inhibitor from Gilead Sciences, targeting PD-1/PD-L1 pathway for non-small cell lung cancer. The company aims to improve access to immunotherapy in low and middle-income countries, where biologics are unaffordable and unavailable. OX-4224 will be studied in a Phase 2 program in India, offering a potentially more affordable and accessible option compared to traditional antibody checkpoint inhibitors.

Lenacapavir, a long-acting HIV-prevention drug requiring dosing every six months, showed 89% more effectiveness than daily oral medication in preventing HIV among gay, bisexual, and transgender individuals, and 100% effectiveness in cisgender women. Despite its potential to significantly reduce HIV infections, concerns over its high cost may hinder widespread adoption.

Lenacapavir, an HIV treatment, reduced infection risk by 96% in a Phase 3 trial, proving 89% more effective than Truvada. The trial's success led to early unblinding, allowing all participants access to lenacapavir. Gilead plans to use trial data for drug approval in multiple countries by year-end, prioritizing high-incidence, low-resource regions.