All articles tagged with #merck
Topline results from a large trial show Moderna and Merck’s cancer vaccine, intismeran autogene, reduced recurrence or spread of surgically removed melanoma, signaling a milestone after years of doubt and pandemic-related hurdles—though some scientists urge waiting for fuller data and longer follow-up before declaring a definitive breakthrough.
Moderna and Merck reported a personalized mRNA cancer vaccine used with Keytruda that reduced melanoma recurrence and spread in a trial of more than 1,000 patients, with five-year data from earlier results showing about a 50% drop in recurrence and a 59% drop in spread versus Keytruda alone; if approved, thousands of melanoma patients could benefit in the first years, and trials in other cancers (lung, bladder, kidney, pancreatic, stomach) are ongoing with results expected in the coming years.
Moderna’s personalized mRNA cancer vaccine Intismeran Autogene, developed with Merck, showed Phase 3 melanoma trial success when paired with Keytruda, triggering a roughly 176% stock rally and making Moderna the S&P 500’s second-best performer this year as analysts boost bets on its cancer pipeline, though the magnitude of benefit and potential launches remain under review.
Moderna and Merck reported that their experimental mRNA cancer vaccine, intismeran, when combined with Merck’s Keytruda, produced a clinically meaningful improvement in high-risk melanoma across more than 1,100 patients, with safety consistent with prior studies; the trial could pave the way for a commercial launch next year and signals potential for an expanded mRNA cancer platform, triggering a sharp rally in Moderna’s stock and a solid gain for Merck.
Broadcom fell about 4.7%, dragging the Nasdaq lower early in the session due to its index-heavy weight, while the Dow and S&P 500 advanced on gains in Moderna and Merck and a favorable rotation in tech led by Marvell’s deal with Google. Oil and Treasury yields rose, and safe-haven assets gold and Bitcoin also moved higher, signaling a mixed risk backdrop as the broader market climbed despite the Nasdaq’s weakness.
Merck and Moderna reported positive phase 3 results for a personalized mRNA cancer vaccine used with Keytruda in melanoma patients who had surgery, significantly extending disease-free survival and reducing the risk of distant metastasis versus Keytruda alone; safety was comparable to vaccines, and the teams will pursue regulatory submissions while continuing to assess overall survival.
The FDA has approved Lipfendra (enlicitide), Merck’s oral PCSK9 inhibitor, to lower LDL-C in patients not adequately controlled on statins. As the first oral option in this class, enlicitide is a macrocyclic peptide designed to disrupt PCSK9-LDL receptor interactions and is produced via a biocatalytic process using 13 engineered enzymes. Because it’s a pill rather than an injectable antibody, it could be prescribed by general practitioners, expanding access, though cost and adherence remain concerns; patients must fast for 30 minutes after dosing for full absorption.
Merck posted 2Q26 sales of about $16.6B with KEYTRUDA/KEYTRUDA QLEX driving growth alongside WINREVAIR and Animal Health, while a $2.31 per-share charge tied to the Terns acquisition weighed on GAAP earnings and led to a narrowed full-year outlook of $66.3–$67.3B in sales and $2.66–$2.76 in non-GAAP EPS. The company highlighted FDA approvals for LIPFENDRA and several positive Phase 3 results across its oncology and HIV programs, plus continued progress across vaccines, immunology, and other pipeline milestones, including TroFuse-005 in endometrial cancer and ISL/LEN HIV regimens, as it advances its 2026 strategic plan.
The FDA approved Lipfendra, Merck's oral cholesterol-lowering drug that blocks the PCSK9 protein, offering a non-injectable option to reduce LDL cholesterol by up to about 60% after 24 weeks in trials. It targets hypercholesterolemia (including familial forms) for patients often already on statins, expanding treatment beyond injectable PCSK9 inhibitors. Lipfendra is priced at $10.50 per day (about $315 for a 30‑day supply), with Merck signaling lower out‑of‑pocket costs. The approval aligns with evolving guidelines urging aggressive LDL targets to cut heart-disease and stroke risk.
Merck’s cholesterol pill Lipfendra (enlicitide) was approved by the FDA, becoming the first oral PCSK9 inhibitor on the market and offering an alternative to injectable cholesterol drugs. The decision was based on two late‑stage trials showing significant LDL‑C reductions across a broad patient group, including those with familial hypercholesterolemia and statin users. The drug could help Merck diversify beyond Keytruda, with analysts forecasting potential tens of billions in peak sales amid competition from injectable PCSK9 drugs like Repatha and Praluent.
Merck and Gilead announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 trial evaluating Trodelvy in combination with Keytruda for previously untreated metastatic NSCLC with PD-L1 TPS ≥50% after the external Data Monitoring Committee reviewed the final PFS data and interim OS analysis. While progression-free survival improved numerically, it did not reach statistical significance, and the likelihood of a statistically significant overall survival result at the planned final analysis is low. Safety was consistent with the known profiles of both drugs. Regulators were informed, investigators and patients advised to discuss treatment with physicians, and there are no changes to ongoing Trodelvy or Merck studies. Data will be presented at a future medical meeting.
Regeneron disclosed a late-stage trial evaluating a Libtayo-based combination for melanoma failed to meet its endpoints when compared with Merck’s Keytruda, sparking investor scrutiny of Regeneron’s cancer-immunotherapy program.
FDA approved IDVYNSO, a once-daily two-drug regimen (doravirine/islatravir) for adults with virologically suppressed HIV-1, intended to replace their current antiretroviral therapy. It is the first non-INSTI, tenofovir-free two-drug therapy to demonstrate non-inferiority to a three-drug regimen in two Phase 3 trials (052 vs BIKTARVY and 051 vs baseline ART). The product will be available in pharmacies after May 11 and carries contraindications with strong CYP3A inducers and with lamivudine or emtricitabine, plus safety considerations including potential severe skin reactions and drug interactions. Trials enrolled 708 participants with diverse demographics, supporting another option in HIV treatment.
Merck reported first clinical data from its PD-1xVEGF bispecific MK-2010 in a Chinese phase 1/2 NSCLC trial, showing unconfirmed ORRs of 55% in treatment-naïve PD-L1-positive patients at 20 mg/kg every three weeks and 44% at 30 mg/kg, with lower responses in previously treated patients. Across backfill cohorts (n=72) the safety profile included dose-limiting toxicities like grade 3 proteinuria and hemoptysis, several bleeding events, and deaths in higher-dose arms, though the maximum tolerated dose has not been reached. Results are early, from small cohorts, and Merck has not disclosed phase 3 plans, as rivals advance multiple PD-(L)1xVEGF programs; more data are needed to define MK-2010's potential role.
An ICIJ investigation shows Merck’s Keytruda has become one of the world’s best-selling drugs not just because of therapeutic value but due to an expansive patent portfolio (more than 1,200 filings in 53 countries), lobbying, and pricing tactics that raise costs for patients worldwide while governments and insurers struggle to fund access; the report details price disparities, secrecy, accelerated approvals, and strategic moves like drug-dosing and product hopping that help Merck extend monopoly into the 2030s, with patients in India, Guatemala, the U.S. and elsewhere paying vast out-of-pocket or facing restricted access.