Merck announced on Friday, September 18, 2026 that the CHMP recommended approval of Keytruda (pembrolizumab) with Padcev (enfortumab vedotin) as neoadjuvant treatment, continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer; the recommendation also covers subcutaneous Keytruda. In the Phase 3 KEYNOTE-B15 (EV-304) trial, the regimen reduced the risk of an event-free survival event by 47% and the risk of death by 35% versus gemcitabine and cisplatin chemotherapy plus surgery, and the pathologic complete response rate was 55.8% versus 32.5%. Merck said it would be the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for muscle-invasive bladder cancer regardless of cisplatin eligibility in the EU. A European Commission decision is expected by the fourth quarter of 2026, and the FDA approved the combination for this use in July 2026. Merck's partners on the regimen are Astellas and Pfizer.
Moderna (NASDAQ: MRNA) announced Thursday August 27, 2026 a private placement of $2 billion in convertible senior notes due 2032, with proceeds directed to the cancer vaccine business (led by intismeran autogene / mRNA-4157, the individualized neoantigen therapy that encodes up to 34 tumor-specific neoantigen peptides per patient) and to repay existing debt. The raise follows the Wednesday August 19 announcement that the Phase 3 INTerpath-001 melanoma trial of intismeran plus Keytruda met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival, which added roughly $44.5 billion in market cap to MRNA in a single session as shares surged 177%. Moderna is advancing intismeran in nine total Phase 2 and Phase 3 trials across melanoma, NSCLC, bladder cancer, and renal cell carcinoma, and the raise positions the company to accelerate manufacturing scale-out and expansion into new tumor types.
Gilead Sciences (NASDAQ: GILD) received European Commission marketing authorization Monday August 24, 2026 for Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda (pembrolizumab) for first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Approval criteria: PD-L1 combined positive score (CPS) ≥10 and no prior systemic therapy for metastatic disease. Trodelvy mechanism: an antibody-drug conjugate (ADC) with an anti-Trop-2 monoclonal antibody linked to the SN-38 topoisomerase I inhibitor payload; when Trop-2 (trophoblast cell surface antigen 2) is expressed on tumor cells, Trodelvy binds and internalizes to release the cytotoxic SN-38 inside the cancer cell. The Keytruda addition provides checkpoint inhibitor activity against PD-L1-positive tumors. Positioning: the first and only antibody-drug conjugate plus immunotherapy combination approved for first-line metastatic TNBC in the EU's 27 member states, plus Norway, Iceland, and Liechtenstein. The FDA had already approved the same combination in June 2026 based on the same clinical evidence. The approval extends Gilead's ADC commercial franchise. The ADC combination-therapy category (ADC + checkpoint inhibitor, ADC + targeted therapy) has attracted increasing investment across oncology as ADCs establish clinical value across breast, bladder, lung, and other solid tumors; adjacent peptide-drug conjugates (PDCs) with tumor-targeting peptides plus cytotoxic payloads are also expanding as a related modality.
Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) announced Wednesday August 19, 2026 that the Phase 3 INTerpath-001 trial of intismeran autogene (V940 / mRNA-4157, an individualized neoantigen therapy) plus pembrolizumab (Keytruda) met its primary endpoint of recurrence-free survival (RFS) and the key secondary endpoint of distant metastasis-free survival (DMFS) in adults with high-risk (Stage IIB-IV) resected cutaneous melanoma compared to Keytruda alone. Mechanism: intismeran autogene is a personalized mRNA therapy that encodes up to 34 tumor-specific neoantigen peptides selected from the individual patient's tumor mutation signature. The mRNA is delivered as a lipid nanoparticle injection; cells at the injection site translate the mRNA into the neoantigen peptides, which are then presented to the immune system to generate a targeted T-cell response against the patient's tumor. The Phase 3 readout is the first positive Phase 3 for an individualized neoantigen therapy and the first Phase 3 to demonstrate substantial improvement over Keytruda alone in the adjuvant melanoma setting. Trial design: randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 evaluating safety and efficacy of the combination versus Keytruda alone. Phase 2b KEYNOTE-942 five-year follow-up data presented at the 2026 ASCO Annual Meeting had shown a 49% reduction in risk of recurrence or death and a 59% reduction in risk of distant metastasis or death for the combination versus Keytruda alone, and the Phase 3 readout confirms and extends those benefits. The result validates the personalized neoantigen mRNA vaccine platform and opens a substantial commercial pathway for the Merck-Moderna collaboration in adjuvant oncology settings beyond melanoma including non-small-cell lung cancer, renal cell carcinoma, and cutaneous squamous cell carcinoma where INTerpath studies are ongoing.
Merck (NYSE: MRK) reported Q2 2026 earnings Tuesday August 4, 2026 before market open with quarterly revenue of $16.61 billion (+5% year-over-year), beating analyst consensus of $16.36 billion. Keytruda (pembrolizumab) generated $8.37 billion in Q2 sales (+5% YoY), exceeding analyst expectations of $8.27 billion; the total includes $463 million from the newly-launched more convenient injectable Keytruda formulation. Merck highlighted the July 16, 2026 LIPFENDRA (enlicitide) FDA approval as the first once-daily oral macrocyclic peptide PCSK9 inhibitor in the class, priced at $315 per month with peak sales potential of $5 billion by 2034. Full-year 2026 revenue guidance was raised to $66.3-67.3 billion from the prior $65.8-67 billion range, but adjusted EPS guidance was cut to $2.66-2.76 to reflect a one-time $5.7 billion ($2.31 per share) charge tied to the Terns Pharmaceuticals acquisition that closed in H1 2026. Merck shares rose 0.6% in early trading to $128.54. Broader pipeline highlights include continued growth of Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma), and Capvaxive (pneumococcal vaccine), plus the integration of Terns and Cidara acquisitions. Merck has beaten consensus in each of the trailing four quarters.
Merck (NYSE: MRK) Q2 2026 earnings pre-day positioning ahead of the Tuesday August 4, 2026 before-market-open report. Zacks analyst consensus: $16.33 billion revenue, $1.36 diluted EPS (down 36.2% year-over-year from $2.13 in Q2 2025). Analyst focus areas: Keytruda (pembrolizumab) sales trajectory (Zacks estimate $8.06 billion Q2, driven by earlier-stage indication uptake and continued metastatic-setting momentum) ahead of the 2028 US patent cliff that ends Keytruda exclusivity; the initial commercial ramp of LIPFENDRA (enlicitide) oral macrocyclic peptide PCSK9 inhibitor following the July 16, 2026 FDA approval, with peak sales potential estimated at $5 billion by 2034 and analyst commentary describing the safety label as 'the cleanest in the class'; contribution from Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma), and Capvaxive (pneumococcal vaccine); and the integration of the Terns Pharmaceuticals and Cidara Therapeutics acquisitions closed in H1 2026. Merck has beaten earnings expectations in each of the trailing four quarters with a 7.75% average earnings surprise; analyst attention also on potential FY 2026 revenue guidance revision from the prior $65.8-67 billion range and non-GAAP EPS guidance from $5.04-5.16.
Merck (NYSE: MRK) reports Q2 2026 earnings Tuesday August 4, 2026 before market open with Zacks analyst consensus at $16.33 billion revenue and $1.36 diluted EPS (-36.2% year-over-year from $2.13 in Q2 2025). Analyst focus areas: Keytruda (pembrolizumab) sales trajectory with the Zacks estimate at $8.06 billion Q2, driven by earlier-stage indication uptake and continued metastatic-setting momentum ahead of the 2028 US patent cliff; the initial commercial launch of LIPFENDRA (enlicitide) macrocyclic peptide oral PCSK9 inhibitor following the July 16, 2026 FDA approval at $315/month list price ($10.50 per tablet), with peak sales potential estimated at $5 billion by 2034; the emerging contribution of Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma and VHL disease), and Capvaxive (pneumococcal vaccine); and pipeline signal from the Terns Pharmaceuticals and Cidara Therapeutics acquisitions completed in H1 2026. Merck has beaten earnings expectations in each of the trailing four quarters with a 7.75% average earnings surprise. Beyond Q2 specifically, analyst attention will focus on the FY 2026 revenue guidance ($65.8-67 billion range on the prior call) and non-GAAP EPS guidance ($5.04-5.16 range) for revisions.
Bloomberg reported May 6 that Eli Lilly's Mounjaro displaced Merck's Keytruda as the world's best-selling pharmaceutical in Q1 2026 — $8.66B Mounjaro Q1 sales vs Keytruda's $7.9B Q1 sales. The Mounjaro+Zepbound combined tirzepatide platform generated $36.5B in 2025, outpacing Keytruda's $31.6B. Keytruda had held the #1 ranking since Q1 2023, when it displaced AbbVie's Humira. The shift is the first time a peptide therapeutic has taken the top spot since the historical run of insulin biosimilars. The narrative also frames Lilly's $4.5B Lebanon Indiana manufacturing recommitment and the broader $21B Indiana capital plan as the supply-chain answer to demand at that scale.
Evaxion's AI-designed personalized neoantigen peptide vaccine EVX-01 combined with Keytruda produced a 75% objective response rate at 2 years in advanced melanoma patients, with 86% of vaccine targets triggering de novo T-cell responses. Data were presented April 22 at AACR 2026; 3-year follow-up expected in H2 2026. The 86% target-hit rate demonstrates AI-designed peptide neoantigen selection maturing for cancer vaccines.