Weekly international regulatory approvals, licensing collaborations, M&A activities, clinical developments, and financial performance of top global pharmaceutical companies — May 11–17, 2026

• Astellas: On May 12, Astellas announced post-hoc analyses of the pivotal GATHER1 and GATHER2 studies, demonstrating that IZERVAY reduced the risk of progression to loss of driving eligibility over 24 months versus sham procedure in patients with geographic atrophy secondary to age-related macular degeneration. The results were presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in the United States. At 24 months, the risk of progression to loss of driving eligibility was 12.6% in the monthly or every-other-month IZERVAY dosing groups versus 20.1% in the sham group—a 41% relative risk reduction. Similar results were observed among patients switched from monthly to every-other-month dosing. When analyzing only the monthly-dose group versus sham, the risk of progression to loss of driving eligibility was 15.1% for IZERVAY versus 20.1% for sham—a 35% relative risk reduction. Driving eligibility was defined as best-corrected visual acuity ≥70 ETDRS letters. Extended GATHER2 study data showed that IZERVAY sustainedly slowed the growth rate of retinal lesions, with earlier intervention yielding more pronounced protection of healthy retinal tissue. Among participants who switched to monthly dosing after 3.5 years of monthly or every-other-month IZERVAY, the mean change in lesion area from Month 24 to Month 42 was 40.5% lower than expected in the sham group; among those previously on sham and then switched to monthly IZERVAY, the reduction versus sham was 37%. • Biogen: On May 14, Biogen announced key preliminary results from the Phase 2 CELIA trial evaluating diranersen (BIIB080), a novel tau-targeting antisense oligonucleotide therapy for early Alzheimer’s disease. The data demonstrated that tau-directed therapy not only significantly impacted biomarkers but also conferred cognitive benefits in early Alzheimer’s patients. Disease progression was slowed across all dose levels—most notably in patients receiving the lowest dose (60 mg every 24 weeks). Significant reductions in cerebrospinal fluid tau protein and tau pathology—as measured by positron emission tomography—were observed across all doses and sustained throughout treatment. However, at Week 76, CELIA did not meet its primary dose–response endpoint, the Clinical Dementia Rating Scale. Diranersen is an investigational antisense oligonucleotide designed to target mRNA encoding microtubule-associated protein tau, thereby reducing tau protein production. Abnormal accumulation of tau in the brain is a hallmark feature of Alzheimer’s disease associated with neurodegeneration and cognitive decline. In December 2019, Biogen exercised its license option with Ionis Pharmaceuticals to obtain exclusive worldwide development and commercialization rights, including royalty obligations. • Servier: On May 12, Servier announced that the U.S. FDA granted Emi-Le Breakthrough Therapy Designation.

How should we view Merck, the pharmaceutical company?

Core Business Merck & Co., Inc. is a global healthcare company comprising two main divisions: human health (pharmaceuticals) and animal health. Pharmaceutical Business Human Health Medicines: Merck develops and markets medicines across therapeutic areas including oncology, acute hospital care, immunology, neuroscience, virology, cardiovascular disease, and diabetes. Key brands include Keytruda, Bridion, Adempas, Lagevrio, Belsomra, Simponi, and Januvia. Vaccines: Merck offers a broad portfolio of preventive vaccines for children, adolescents, and adults. Major vaccine brands include Gardasil/Gardasil 9, ProQuad, M-M-R II, Varivax, RotaTeq, Live Oral, Vaxneuvance, Pneumovax 23, and Vaqta. Animal Health Business Veterinary Medicines and Vaccines: Merck develops, manufactures, and markets veterinary pharmaceuticals and vaccines, and provides integrated health management solutions and services—including digitally connected identification, traceability, and monitoring products. Collaborations and Agreements Merck collaborates with Daiichi Sankyo to co-develop three deruxtecan-based antibody–drug conjugate (ADC) candidates for multiple solid tumors. It jointly develops and commercializes Lynparza with AstraZeneca for multiple cancer types, and Koselugo for multiple indications. Additional partnerships exist with Eisai Co., Ltd., Bayer AG, Ridgeback Biotherapeutics LP, and Moderna, Inc. Historical Development 19th Century 1891: Merck & Co. was founded in Rahway, New Jersey, USA, by George Merck as a U.S. subsidiary of the German Merck Group. 20th Century 1917: During World War I, due to hostilities between the U.S. and Germany, Merck & Co. was legally separated from its German parent and became an independent American company. 1925: Merck merged with Powers-Weightman-Rosengarten, expanding its pharmaceutical and chemical manufacturing capacity. 1933: Merck merged with Sharp & Dohme, further strengthening its R&D and marketing capabilities. 1940s: Merck’s R&D team developed several landmark drugs, including streptomycin—the first effective antibiotic against tuberculosis. 1950s–1960s: Merck continued making breakthroughs in drug discovery, including antihypertensive agents for heart disease and anti-inflammatory drugs. 1980s: Merck launched Mevacor, the first statin for treating high cholesterol—ushering in an entirely new class of therapeutics. 21st Century 2000: Merck’s widely prescribed drug Vioxx was withdrawn from the market in 2004 due to increased cardiovascular risks, delivering a major blow to the company.

Germany's Merck raises 2026 guidance for third time

14 hours ago

German drugmaker Merck KGaA raised its 2026 core profit guidance to €6.2-6.4 billion EBITDA, driven by strong Q3 performance and the Bio-Techne acquisition. The company highlighted growth in biomanufacturing and semiconductor materials supporting AI applications.

reuters

2026-06-25

Merck KGaA to Acquire Bio-Techne for $11.3 Billion

2026-06-26

Merck to Acquire US-Based Life Sciences Firm Bio-Techne for $11.3 Billion

2026-09-09

Merck KGaA Buys PostEra’s Oral Fertility Molecules

2026-10-19

Merck KGaA Acquires Silence Therapeutics for $1.3 Billion

2026-11-11

Germany's Merck raises 2026 guidance for third time

Germany's Merck raises 2026 guidance for third time

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