GILEAD SCIENCES SL

FDA granted Breakthrough Therapy Designation to Gilead's Trodelvy for ES-SCLC patients progressing after platinum-based chemotherapy, based on Phase II TROPiCS-03 study results. Trodelvy showed 41.9% ORR, 83.7% disease control rate, and median DOR of 4.7 months. ES-SCLC represents 70% of SCLC cases, with limited treatment options post-first-line therapy.

EMA's CHMP recommended Gilead Sciences' seladelpar for EU approval as a second-line PBC treatment, either with UDCA or alone for non-UDCA responders/intolerants. The European Commission is expected to decide by early 2025. Seladelpar, already U.S.-approved as Livdelzi, targets PPAR-delta to manage liver inflammation and symptoms like itching, based on Phase 3 RESPONSE trial data showing significant improvement in liver damage markers and itch relief. An ongoing Phase 3 AFFIRM trial tests its efficacy in PBC patients with compensated cirrhosis.

The Chronic Hepatitis B Market Forecast-2034 report provides insights into epidemiology, market trends, and treatment advancements in the 7MM. It highlights the growing market size, emerging therapies, and clinical trials aimed at revolutionizing treatment. Key companies and therapies are identified, with the US leading in market size and prevalence. The report underscores the high global burden of CHB and the potential of innovative treatments to drive market growth.

Gilead's Trodelvy, a Trop-2-directed antibody-drug conjugate, received a second FDA Breakthrough Therapy designation for treating extensive-stage small cell lung cancer (ES-SCLC) post-platinum chemotherapy. Previously approved for certain breast cancers, Trodelvy showed promising antitumor activity in ES-SCLC, supporting further research. Lung cancer, a leading cause of cancer deaths, sees 15% as SCLC, with 70% diagnosed at an extensive stage, underscoring the need for effective treatments.

Genesis Therapeutics, founded in 2019 by Evan Feinberg, PhD, leverages AI for drug discovery, notably through its GEMS platform. With over $300M raised, including a $200M Series B, and collaborations with Nvidia and biopharma giants like Gilead, Eli Lilly, and Genentech, Genesis focuses on oncology and immunology, aiming to drug challenging targets with advanced AI and neural network technologies.

Gilead Sciences announced FDA granted Breakthrough Therapy Designation to Trodelvy for treating extensive-stage small cell lung cancer based on Phase 2 TROPiCS-03 study results. Trodelvy is approved in over 40 countries for multiple breast cancer types and urothelial cancer.

Wesley Sundquist's research on HIV's protein shell led to the development of lenacapavir, a long-lasting HIV prophylactic providing protection for six months, named Breakthrough of the Year by 'Science'. Lenacapavir's clinical trials showed 100% efficacy in preventing HIV transmission.

Gilead Sciences announced FDA granted Breakthrough Therapy Designation to Trodelvy for extensive-stage small cell lung cancer, based on Phase 2 TROPiCS-03 study results. Trodelvy showed promising antitumor activity and consistent safety profile, supporting further investigation in a Phase 3 trial.

Hepatitis B, a significant global health challenge, is expected to see market growth due to increasing prevalence and awareness. Key companies like Gilead Sciences and Brii Biosciences are advancing treatments through clinical trials. The market, driven by antiviral medications, anticipates a surge with new pipeline products. Vaccination remains the most effective prevention method.