GILEAD SCIENCES SL

Lenacapavir, a twice-a-year HIV prevention injection, reduced infection risk by 96% in a Phase 3 trial, proving 89% more effective than daily Truvada. The trial met key endpoints early, allowing immediate use of lenacapavir. Another trial showed 100% efficacy in women, prompting Gilead to initiate drug approval processes globally.

Regeneron Pharmaceuticals' PE, PB, and PS ratios are low, suggesting potential undervaluation. However, its low ROE indicates lower profitability. High EBITDA and gross profit levels indicate strong financial performance, but low revenue growth may be a concern.

Nivolumab plus gemcitabine/cisplatin chemotherapy significantly improved response rates, overall survival, and progression-free survival in patients with lymph node–only metastatic urothelial carcinoma, according to a post hoc analysis of the CheckMate 901 trial presented at the 2024 ASCO Annual Meeting.

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.