AstraZeneca

AstraZeneca and Amgen's Tezspire met primary endpoint in Phase III WAYPOINT study, showing significant efficacy in chronic rhinosinusitis with nasal polyps. Tezspire reduced nasal polyps size and congestion with a consistent safety profile. Analysts note potential regulatory risks due to single study evaluation, contrasting with Sanofi and Regeneron's Dupixent, which had two pivotal studies. AstraZeneca and Amgen plan to share data with regulatory authorities and present at a medical congress.

J.P.-G. consults for Lilly, Roche, Eisai, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Gilead, MSD; receives travel compensation from Roche; employed by MEDSIR. G.A. receives honoraria from MEDSIR. M.G. receives travel support and honoraria from AstraZeneca, Gilead Sciences, Roche, Pfizer. A.L.-C. receives research support, consults, speaks, and travels for Roche, Lilly, Pfizer, Novartis, Merck Sharp & Dohme, Gilead, Daiichi Sankyo; owns MEDSIR, Initia-Research. J.C. consults, receives honoraria, research funding, stock, travel expenses, and patents for Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies; holds patents for pharmaceutical combinations.

Trump's impact on pharma, Novo's semaglutide success in NASH, AstraZeneca's clinical trial leadership, Viking's weight loss data, and expediting MLR reviews.

Daiichi Sankyo and AstraZeneca awarded 2024 Prix Galien USA for Enhertu, a HER2-directed ADC. Enhertu, developed jointly, is transforming HER2+ solid tumour treatment. The Galien Foundation recognizes impactful FDA-approved treatments, honoring medical innovation.

Alteogen Inc. entered an exclusive license agreement with Daiichi Sankyo to use ALT-B4, a novel hyaluronidase, for developing a subcutaneous version of ENHERTU®, a HER2-directed ADC. Alteogen will receive upfront and milestone payments, plus royalties on sales, and will supply ALT-B4 for clinical and commercial use.

Alteogen Inc. and Daiichi Sankyo enter an exclusive license agreement for ALT-B4, enabling subcutaneous ENHERTU® development. Alteogen to receive upfront and milestone payments, plus royalties on sales.

AstraZeneca's oral GLP-1 agonist AZD5004 showed similar efficacy to injected versions in a Phase I trial, with plans for Phase IIb obesity and diabetes studies by late 2025. The drug aims to enter the lucrative obesity market, competing with Novo Nordisk's injectables. AZD5004, licensed from Eccogene, is expected to generate $800 million in sales by 2032 if successful.

Recent breakthroughs in myelodysplastic syndromes (MDS) include the VERONA and SELECT-MDS-1 trials, potentially shifting MDS treatment. FDA actions in October 2024 included approvals for acalabrutinib, priority review for Enhertu, and Cologuard Plus launch. DESTINY-Breast06 shows Enhertu's potential in HER2-low/ultra-low breast cancer. KEYNOTE-522 demonstrated improved survival with pembrolizumab in early-stage triple-negative breast cancer. LEAP-012 showed significant PFS improvement with lenvatinib/pembrolizumab in intermediate HCC. The 19th Annual NY Lung Cancers Symposium will focus on early-stage lung cancer treatment strategies.

Viking Therapeutics (VKTX) aims to compete with Eli Lilly and Novo Nordisk in the weight loss drug market, with its oral candidate showing promising results. Despite a 28% drop from its peak, the stock has gained over 260% this year. The market for weight loss drugs is expected to reach $100 billion by 2030, offering potential for Viking to carve out a share.

Goodwin's two-part series on Greater China's life sciences sector highlights stable M&A activity in pharmaceutical/biotech despite market fluctuations. Notable 2024 deals include Fosun Pharma's $1.71B acquisition of Shanghai Henlius Biotech and Johnson & Johnson's $850M acquisition of Proteologix, Inc. Trends indicate a shift towards CAR-T cell therapies and large molecule/biologics, with medical devices also playing a significant role. Factors driving recovery include regulatory changes, market readjustments, and the maturing of early-stage investments.