GILEAD SCIENCES SL

U.S. Congress to vote on BIOSECURE Act, impacting global drug development and Chinese pharma firms. The Act, initially stalled, now has high likelihood of passage, potentially causing drug shortages and increased costs. Companies must communicate the patient care impact to stakeholders.

Livdelzi® (seladelpar), a PPARδ agonist, treats primary biliary cholangitis (PBC) in adults, either with UDCA or as a monotherapy for UDCA-intolerant patients. Gilead Sciences acquired CymaBay Therapeutics, expanding its liver portfolio with seladelpar in 2024. The FDA granted accelerated approval in August 2024, based on the Phase III RESPONSE study, showing 62% of Livdelzi recipients achieved the primary endpoint of composite biochemical response, compared to 20% on placebo. Livdelzi also normalized ALP levels and reduced pruritus significantly. The drug is available in 10mg capsules and is under review by the EMA and UK MHRA.

Autolus Therapeutics' obe-cel, an autologous CAR-T cell therapy for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia, awaits FDA approval on November 16, 2024. The therapy targets CD-19 and has shown a 78% ORR in the FELIX study, with potential peak revenues of ~$300m. Despite a 25% share price drop, Autolus holds $700m in cash and has partnerships with BioNTech, Moderna, and Bristol Myers Squibb, positioning it for future growth.

Arie Belldegrun, MD, launches Symbiotic Capital, a global life sciences credit firm with over $600 million in capital, to fund startups needing cash amidst sluggish equity markets. Symbiotic extends non-dilutive senior secure term loans, focusing on stability and maturity of companies, with investments ranging from $20 million to $200 million. The firm is disease agnostic and diversifies across life sciences sectors, aiming to align with companies' success through equity conversion and warrant positions.

In TROPHY-U-01 study, sacituzumab govitecan showed activity in cisplatin-ineligible patients with advanced urothelial cancer post-ICI therapy, with 32% objective response rate and manageable toxicity. Further evaluation is warranted.

Poland emerges as a leading hub for clinical research, the FDA approves the first nasal spray for severe allergic reactions, lenacapavir offers 100% protection against HIV, Novartis' Leqvio significantly reduces LDL-C, alarming trends in men's cancer incidence are projected to 2050, Duality Biotherapeutics initiates Hong Kong IPO to fund cancer drug trials, Omny Health launches a GLP-1 data resource, an adaptive brain pacemaker improves Parkinson’s symptoms, Alzheimer’s drug Lecanemab slows cognitive decline, and AI tool AIM-MASH enhances liver disease trials.

Avenzo Therapeutics and Gilead Sciences partner to assess a combination treatment regimen of AVZO-021 (CDK2 inhibitor) and Trodelvy (Trop-2 ADC) for HR+, HER2- breast cancer. Gilead supplies Trodelvy, while Avenzo conducts and sponsors the study, maintaining all rights for their assets.

The FDA approved Gilead Sciences' Livdelzi for treating primary biliary cholangitis (PBC), a liver disease affecting mainly women. Priced at $12,606 for 30 days, it's expected to boost Gilead's liver drug portfolio. A study showed 62% improvement in biochemical response with Livdelzi and UDCA combination, and it significantly reduces itching, a common PBC symptom.

FDA approved Compugen's IND for COM503, targeting solid tumors, triggering a $30m payment from Gilead. A Phase I trial, evaluating COM503's safety and efficacy alone and with zimberelimab, is set for Q4. The deal could total $848m, including milestones and royalties.

The precision medicine market, valued at $73.11 billion in 2023, is projected to grow to $118.08 billion by 2028, driven by rising cancer prevalence and strategic collaborations. It segments by technology, application, and end-use, with major players including Roche, Pfizer, and Novartis.