GILEAD SCIENCES SL

Nurix Therapeutics presented preclinical data for NX-5948 (oral BTK degrader) and GS-6791 (IRAK4 degrader, developed with Gilead Sciences) at ACR Convergence 2024, showing potential superiority over kinase inhibitors in inflammatory and autoimmune diseases.

Nurix Therapeutics presented preclinical data on NX-5948 (BTK degrader) and GS-6791 (IRAK4 degrader) at ACR Convergence 2024, highlighting their potential in treating inflammation and autoimmune diseases.

Urothelial carcinoma treatment has evolved with FDA approvals of enfortumab vedotin-ejfv + pembrolizumab and nivolumab + cisplatin/gemcitabine. Personalized therapy is crucial as patients now live longer, but toxicity remains a challenge. Circulating tumor DNA (ctDNA) may help tailor treatment, and ongoing research explores combinations like sacituzumab govitecan + enfortumab vedotin. The landscape is rapidly changing, emphasizing the need for more biomarker research to guide treatment selection.

Michael Yee of Jefferies maintains a Buy rating on Biogen (BIIB) with a $250.00 price target, citing positive developments for Biogen’s Alzheimer’s drug, Leqembi, in the European market. The European Medicines Agency’s approval recommendation, despite limitations, is seen as a significant market opportunity. Challenges include EU pricing and reimbursement processes, logistical issues, and the need for pipeline expansion, but the drug’s potential in specific patient groups supports the Buy recommendation.

Paxlovid remains effective in high-risk vaccinated or previously infected patients, reducing hospitalizations and deaths. GB-0669, a novel monoclonal antibody, shows promise for immune-compromised patients. Obeldesivir, an investigational antiviral, demonstrated efficacy in reducing viral load and infectious titers, though its trial was halted.

Global Organoids Market to grow at a CAGR of ~14% by 2030, driven by personalized medicine, organoid use in drug discovery, and cancer research. North America leads the market, with key players including Thermofisher Scientific Inc., StemCell Technologies Inc., and others. Organoids mimic human organs, aiding in disease modeling and drug testing, but face challenges like high costs and limited vascularization.

Phase III PURPOSE 2 trial results show lenacapavir injections significantly lower HIV infections by 96%, outperforming daily Truvada. Lenacapavir, a long-acting HIV-1 capsid inhibitor, targets multiple stages of HIV-1 lifecycle, with no cross resistance to existing medications. The trial involved over 3,200 participants across 88 sites globally, demonstrating high adherence and safety.

Phase 3 trial results show lenacapavir for PrEP is highly effective, with 99.9% of participants not acquiring HIV, and a 96% risk reduction compared to background incidence. Lenacapavir demonstrated superiority over once-daily Truvada, prompting the Data Monitoring Committee to recommend open-label use. High adherence rates were observed, with 91% receiving timely injections at week 26 and 92.8% at 1 year. The FDA granted lenacapavir PrEP Breakthrough Therapy Designation, and Gilead plans global regulatory filings by end of 2024.

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Gilead Sciences developed TDF and TAF, FDA-approved medicines for HIV treatment. TDF-based medicines were marketed from 2001-2012. TAF research began in the late 1990s but halted in 2004 due to lack of safety improvement over TDF. TAF was revisited in 2010, and after five years of trials, TAF-based medicines were approved for sale in 2015.