Moderna and Merck’s melanoma mRNA therapy meets Phase 3 endpoints

Moderna Inc. doubled the list price of its RSV vaccine, mRESVIA, to around $640 per dose in the U.S., aiming to reflect mRNA technology value and offset development costs. Shares surged, but analysts warn of potential payer pushback. The vaccine's uptake has lagged behind rivals like GSK and Pfizer, with 2023 sales under $25 million. A European Commission contract for up to 24 million doses offers a lifeline. Moderna targets 10% growth in 2026, with RSV and other respiratory vaccines as key cont

Moderna (MRNA) and Merck (MRK) announced positive Phase 3 trial results for their personalized mRNA cancer vaccine, Intismeran Autogene, combined with Keytruda. The treatment extended survival without melanoma recurrence. MRNA stock surged 177%, MRK rose 12%. The vaccine's personalized nature and high cost may pose insurance coverage challenges. FDA approval is expected in 2027-2028. The treatment is not yet commercially priced, with estimates exceeding $150,000 per patient.

Target reported Q2 earnings with a 5.3% sales increase and 3.8% same-store sales growth, driven by a $994M tariff refund and 20% fundamental EPS growth. The company is focusing on digital sales and price cuts to attract budget-conscious shoppers. Moderna's stock surged 135% following positive Phase 3 trial results for its mRNA-based personalized cancer vaccine, a significant milestone in cancer treatment.

Merck's stock (MRK) is near its 52-week high, closing at $150.33 on Sept. 4, 4% below its peak. The company and Moderna (MRNA) reported positive phase III study results for their cancer therapy combo, meeting primary and key secondary endpoints. Keytruda, Merck's top-selling drug, drives over 55% of pharmaceutical sales and is key to the company's growth strategy. Merck is exploring new combinations and formulations to extend Keytruda's growth.

The FDA approved Moderna's mRNA flu vaccine, citing 26.6% higher efficacy than traditional vaccines. However, an analysis of trial data revealed a statistically significant increase in serious adverse events (SAEs) in the mRNA group. The FDA used pooled data from multiple trials to dilute this safety signal, despite acknowledging potential variations. Concerns also arise from higher mortality rates in mRNA groups across trials.

Merck and Moderna reported positive Phase 3 trial results for a personalized mRNA vaccine targeting melanoma, combined with Merck's Keytruda. The treatment improved recurrence-free survival, marking a potential first FDA-approved mRNA cancer therapy. The vaccine is customized using a patient's tumor DNA and RNA, teaching the immune system to target cancer cells. Costs and production time remain high, but experts anticipate advancements in manufacturing and AI-driven targeting.