FDA Grants Traditional Approval to Merck's Keytruda for TMB-H Tu

RBC Capital reiterated a Sector Perform rating and $145 price target for Merck (MRK) after melanoma trial data showed a recurrence-free survival hazard ratio of 0.58. The stock is near its 52-week high, up 76% year-to-date. Analysts expect regulatory filings in the U.S. and Europe, with FDA approval anticipated in 2027. Merck is set to announce earnings on October 29, with mixed analyst expectations.

Merck and Moderna reported that their combined mRNA cancer vaccine and immunotherapy reduced melanoma death or recurrence risk by 42% in a Phase 3 trial. Moderna shares fell 17% despite prior gains, while Merck shares dropped 1.8%. The vaccine, tested with Keytruda, showed significant efficacy, with 82.2% of patients cancer-free after two years. The companies plan to seek US approval and launch in 2027.

Moderna's shares fell 25.2% to $183.88, losing $24B in market value, after late-stage trial data for its melanoma vaccine showed a 42% reduction in cancer recurrence or death. Analysts attributed the drop to a 'sell-the-news' reaction. Merck, its partner, saw a 1% decline. Both companies plan to discuss results further at an oncology meeting.

Moderna's stock fell 25% on Thursday despite positive leaked data showing its cancer vaccine, developed with Merck, reduced melanoma recurrence risk by over 40% when combined with Keytruda. The vaccine also reduced cancer spread risk by 38%. Moderna's stock has risen over 500% this year on vaccine expectations. The trial focused on personalized treatment for melanoma, with experts calling it a landmark in cancer research.

Merck (MRK) reported positive Phase 3 trial results for its mRNA-based therapy intismeran autogene combined with KEYTRUDA, showing reduced risk of recurrence or death in melanoma patients. The company has a 2.41% dividend yield but a high payout ratio of 1.11, raising sustainability concerns. MRK's GF Score is 79/100, with strong profitability but weak momentum. Insiders have sold $71.4M in shares, and gurus are trimming positions. The stock is trading 22.5% above its GF Value of $121.00.

Merck (MRK) gains investor attention after Phase 3 INTerpath-001 trial shows promising recurrence-free survival data for intismeran autogene in melanoma treatment. Wells Fargo maintains an Overweight rating with a $165 price target. Merck's dividend yield is 2.41%, but its payout ratio is high at 111%, raising sustainability concerns. The stock trades 22.5% above its intrinsic value of $121, indicating modest overvaluation.