GILEAD SCIENCES SL

Niven R. Narain emphasizes that AI investments in drug development require robust data and validation. GEN's A-List highlights 10 AI-based drug discovery leaders, including BPGbio, which focuses on cancer energy generation. Other notable companies include Nvidia and Palantir Technologies, though not on the A-List. The list includes specifics on companies like Anima Biotech, Atomwise, and Nimbus Therapeutics, detailing their AI platforms and drug development progress.

The biotech sector is advancing with AI, gene editing, precision medicine, and biomanufacturing, driving drug development and treatment options. Key stocks like Amgen Inc. (AMGN), Gilead Sciences (GILD), and Biogen Inc. (BIIB) are capitalizing on these trends, focusing on oncology, neurological disorders, and infectious diseases. The global biotechnology market is expected to grow at a CAGR of 11.5% to $4.61 billion by 2033. AMGN, BIIB, and GILD are highlighted for their innovations, financial performance, and market prospects.

Kelun-Biotech's sacituzumab tirumotecan (sac-TMT) receives NMPA approval in China for triple-negative breast cancer, competing with Gilead's Trodelvy. The drug, also under review for EGFR-mutant NSCLC, is partnered with MSD, potentially worth up to $1.4 billion. Phase 3 study results showed a 47% reduction in death risk.

Gilead Sciences' Phase III PURPOSE 2 trial showed lenacapavir reduced HIV infections by 96%, with only two cases among 2,179 participants, indicating a 99.9% success rate. The trial, conducted across 88 sites in seven countries, supports global regulatory filings for lenacapavir for PrEP, expected by year-end.

Obe-cel (Aucatzyl) CAR T-cell therapy demonstrated durable remissions in 77% of patients with relapsed or refractory B-cell ALL in the FELIX trial, with 55% achieving complete remission. Median event-free survival was 11.9 months, and overall survival was 15.6 months. Obe-cel showed low severe toxicity, supporting its safety and efficacy.

FDA issues Complete Response Letter for Applied Therapeutics' govorestat NDA for classic galactosemia, citing deficiencies in clinical study results. APLT plans to request a meeting with the FDA to discuss next steps. Shares dropped 77.3% post-announcement.

The Gene Switch Market is projected to grow from USD 0.78 Bn in 2024 to USD 1.78 Bn by 2031, with a CAGR of 11.6%. CoherentMI's report provides a comprehensive analysis of market trends, competitive landscape, and key players like Novartis, Pfizer, and Gilead Sciences.

Twice-yearly lenacapavir (Sunlenca) reduced HIV infection by 89% in the PURPOSE 2 trial compared to daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF, Truvada), with no safety concerns. The trial, funded by Gilead Sciences, was stopped early due to superior efficacy of lenacapavir, which offers an efficacious choice for HIV prevention, potentially increasing PrEP uptake.

Advanz Pharma's Ocaliva (obeticholic acid) for PBC loses EU market access as EC revokes conditional marketing authorisation, leaving limited second-line options for patients. Advanz CEO criticizes court's ruling for not assessing patient impact. Ocaliva remains available in the US under accelerated approval.

Roche's Phase 3 trial SKYSCRAPER-01 showed tiragolumab did not improve survival in advanced lung cancer, failing to meet primary goals. Despite earlier promising data, final analysis indicated no sustained benefit. Roche will review tiragolumab's development, while other companies continue TIGIT drug research, hoping for breakthroughs.