Welcome to our dedicated page for Merck & Co news (Ticker: MRK), a resource for investors and traders seeking the latest updates and insights on Merck & Co stock.
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, generates frequent news across human health, animal health and corporate finance. As a research-intensive biopharmaceutical company with more than a century of history developing medicines and vaccines, Merck regularly announces clinical trial milestones, regulatory decisions, business development transactions and capital markets activity.
Recent news highlights include oncology updates from Merck’s extensive KEYTRUDA program, such as positive Phase 3 data in muscle-invasive bladder cancer and new trials in non-small cell lung cancer using combinations like calderasib (MK-1084) with KEYTRUDA QLEX. The company also reports on progress in other therapeutic areas, including pulmonary arterial hypertension with WINREVAIR, Alzheimer’s disease candidates MK-2214 and MK-1167, and cardiovascular research with the oral PCSK9 inhibitor candidate enlicitide.
Investors following MRK news will also see announcements related to Merck Animal Health, such as the conditional U.S. FDA approval of EXZOLT CATTLE-CA1 for the prevention and treatment of New World screwworm larvae and the treatment and control of cattle fever tick, as well as updates on acquisitions like the planned merger with Cidara Therapeutics to add the influenza candidate CD388 to Merck’s respiratory portfolio.
Corporate and financial communications include quarterly earnings calls, participation in major healthcare conferences and disclosures about note offerings under the company’s shelf registration statement. This news page aggregates these developments so readers can review clinical, regulatory, strategic and financial updates related to Merck & Co., Inc. and its MRK stock in one place.
Merck Animal Health, a division of Merck & Co., Inc. (NYSE:MRK), has announced the expansion of its NOBIVAC® NXT vaccine platform to include a new solution for protecting cats against feline leukemia virus (FeLV). The NOBIVAC NXT FeLV vaccine is the first and only FeLV vaccine using RNA-particle technology, designed to deliver optimized protection. It is expected to be available in veterinary clinics nationwide this fall.
Key features of the vaccine include:
- Nonadjuvanted, low volume 0.5 mL dose
- Labeled effective against persistent viremia
- Indicated for cats 8 weeks of age or older
- 2-year duration of immunity
- Administered in 2 doses, 3- to 4-weeks apart
FeLV affects nearly 4% of cats in North America and can lead to severe health issues. The new vaccine represents a significant advancement in feline healthcare.
Merck (NYSE: MRK) announced positive opinions from the European Medicines Agency's CHMP for KEYTRUDA® (pembrolizumab) in two gynecologic cancer indications:
1. In combination with chemotherapy for first-line treatment of primary advanced or recurrent endometrial carcinoma in adults eligible for systemic therapy.
2. Combined with chemoradiotherapy for FIGO 2014 Stage III-IVA locally advanced cervical cancer in adults without prior definitive therapy.
These recommendations are based on the Phase 3 NRG-GY018 (KEYNOTE-868) and KEYNOTE-A18 trials, respectively. Both studies showed significant improvements in progression-free survival. The European Commission's final decisions are expected in Q4 2024.
The FDA has approved Merck's KEYTRUDA (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This approval is based on the Phase 3 CCTG IND.227/KEYNOTE-483 trial results, which showed:
- 21% reduction in risk of death compared to chemotherapy alone
- Median overall survival of 17.3 months vs 16.1 months for chemotherapy alone
- Significant improvement in progression-free survival
- Higher overall response rate (52% vs 29%)
This marks the first indication for KEYTRUDA in MPM in the U.S., offering a new treatment option for patients with generally poor prognoses.
The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment has met its primary endpoint. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) compared to standard chemotherapy. This potential first-in-class HER3 directed antibody drug conjugate (ADC) is being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK). The results highlight the potential of patritumab deruxtecan to become an important treatment option for this patient population with high unmet need. Data will be presented at an upcoming medical meeting and shared with global regulatory authorities.
Nuvectis Pharma's NXP900 is emerging as a promising candidate in the fight against Non-Small Cell Lung Cancer (NSCLC), particularly for patients resistant to EGFR and ALK targeted therapies. Like Summit Therapeutics' Ivonescimab, which recently outperformed Merck's Keytruda in a Phase 3 trial, NXP900 targets treatment resistance but through a different mechanism.
NXP900 inhibits SRC/YES1 kinases, key drivers of cancer survival. Preclinical studies show its potential to reverse resistance to existing therapies and enhance their effectiveness when used in combination. While still in early clinical development, NXP900's targeted approach and potential applications beyond NSCLC make it a noteworthy contender in the evolving landscape of cancer treatment.
Merck's KEYTRUDA (pembrolizumab) plus chemotherapy has shown significant promise in treating high-risk early-stage triple-negative breast cancer (TNBC). In the Phase 3 KEYNOTE-522 trial, this regimen reduced the risk of death by 34% compared to chemotherapy alone. After a median follow-up of 75.1 months, the five-year overall survival rate was 86.6% for the KEYTRUDA regimen versus 81.7% for the chemotherapy-placebo regimen.
Key points:
- First immunotherapy-based regimen to show significant improvement in overall survival for high-risk early-stage TNBC
- Consistent benefit across subgroups, including PD-L1 expression, tumor size, and nodal status
- Safety profile consistent with previous studies
- KEYTRUDA is approved in the U.S. for this indication based on earlier trial results
Merck's KEYTRUDA demonstrates sustained overall survival benefit in advanced melanoma patients after 10 years. Key findings from the KEYNOTE-006 trial include:
- 34.0% of KEYTRUDA-treated patients were alive at 10 years vs. 23.6% for ipilimumab
- KEYTRUDA reduced death risk by 29% (HR=0.71)
- Median overall survival: 32.7 months for KEYTRUDA vs. 15.9 months for ipilimumab
- Median modified progression-free survival: 9.4 months for KEYTRUDA vs. 3.8 months for ipilimumab
These results highlight KEYTRUDA's long-term efficacy in advanced melanoma treatment, showcasing its potential to improve patient outcomes significantly.
Merck (NYSE: MRK) and Eisai announced positive results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) in combination with transarterial chemoembolization (TACE) for treating unresectable, non-metastatic hepatocellular carcinoma (HCC). The study showed:
1. 34% reduction in the risk of disease progression or death compared to TACE alone
2. Median progression-free survival (PFS) of 14.6 months vs 10.0 months for TACE alone
3. Trend toward improved overall survival, though data not yet mature
4. Safety profile consistent with previous studies
The results, presented at ESMO Congress 2024, highlight the potential of this combination therapy to extend PFS in patients with unresectable, non-metastatic HCC.
Merck's KEYTRUDA (pembrolizumab) plus chemoradiotherapy (CRT) showed significant benefits in treating high-risk locally advanced cervical cancer. The Phase 3 KEYNOTE-A18 trial demonstrated:
- 33% reduction in death risk compared to CRT alone
- 36-month overall survival rate of 82.6% vs 74.8% for CRT alone
- First positive overall survival results for an immunotherapy-based regimen in this patient group
The study, presented at the ESMO Congress 2024, could potentially change the treatment paradigm for these patients. KEYTRUDA's safety profile was consistent with previous studies, with no new safety signals identified.
Merck (NYSE: MRK) announced significant overall survival (OS) results from the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy for first-line treatment of HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The KEYTRUDA regimen demonstrated:
- 20% reduction in risk of death (HR=0.80) compared to trastuzumab and chemotherapy alone
- Median OS of 20.0 months vs 16.8 months
- 21% reduction in risk of disease progression or death in patients with PD-L1 expressing tumors (CPS ≥1)
- Consistent safety profile with previous studies
These results support the existing accelerated approval in the U.S. and recent approval in the EU for this indication.