GILEAD SCIENCES SL

Merck announced positive Phase 3 results for doravirine/islatravir in HIV-1 trials, showing non-inferiority to current therapies and consistent safety.

CAR-T therapy can benefit patients excluded from pivotal trials, according to Daniel Goyco Vera, MD. His study of 61 lymphoma patients found effective treatment despite exclusion criteria, highlighting the need for diverse trial recruitment to build trust and ensure generalizable results.

Lenacapavir, a Gilead Sciences drug approved in 2022 for multi-drug-resistant HIV, shows potential in HIV prevention. In PURPOSE 1 trial with over 5,000 women and girls in South Africa and Uganda, no participants receiving lenacapavir were infected.

2024 saw breakthroughs in gene therapies for sickle cell disease, at-home flu vaccines, mind-controlled prosthetics, non-opioid pain medicine, AI medical scribes, fruit fly brain mapping, clinical-grade hearing aids, new schizophrenia drugs, brain-computer interfaces, HIV prevention meds, cervical cancer screening alternatives, maternal health apps, AI protein structure prediction, VR for mental health, screen time reduction tools, gene therapy for deafness, women's health research, self-serve vision tests, blood tests for colorectal cancer, and potential lupus cures.

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.

Gilead's Trodelvy granted second Breakthrough Therapy designation by FDA for extensive-stage small cell lung cancer, following promising phase II TROPiCS-03 study results.

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.

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.