Merck & Co - MRK STOCK NEWS

Merck (MRK) reported its first-quarter 2023 financial results, highlighting a 9% year-over-year decline in total worldwide sales to $14.5 billion. However, excluding LAGEVRIO sales, the growth was 11% and 15% when factoring out foreign exchange impacts. KEYTRUDA sales surged 20% to $5.8 billion, while GARDASIL sales rose 35% to $2.0 billion. In contrast, LAGEVRIO's sales plummeted 88% to $392 million. The company reported a GAAP EPS of $1.11 and a non-GAAP EPS of $1.40, both reflecting a 35% decline from the previous year, largely due to acquisition charges. Merck also announced a proposed acquisition of Prometheus Biosciences, valued at approximately $10.8 billion, to bolster its immunology pipeline. The financial outlook for 2023 has been narrowed, with expected sales between $57.7 billion and $58.9 billion.

Merck (NYSE: MRK) announced the results from the Phase 3 KEYNOTE-966 trial, presented at the AACR 2023 Annual Meeting, showing that KEYTRUDA combined with standard chemotherapy significantly improved overall survival (OS) for patients with advanced biliary tract cancer (BTC). The trial reported a 17% reduction in the risk of death with KEYTRUDA therapy, yielding a median OS of 12.7 months versus 10.9 months for chemotherapy alone. One-year OS rates were 52% for the KEYTRUDA group compared to 44% in the control. These findings will be submitted to regulatory authorities worldwide. The safety profile was consistent with prior studies, with grade 3-4 treatment-related adverse events in 70% of patients receiving KEYTRUDA.

Moderna and Merck announced positive results from the Phase 2b KEYNOTE-942 trial involving mRNA-4157 (V940) in combination with KEYTRUDA for treating high-risk stage III/IV melanoma. The combination therapy reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone. The trial included 157 patients with a median follow-up of 23-24 months. In the combination group, 83.4% of patients were recurrence-free at 12 months, compared to 77.1% in the control group. The U.S. FDA granted Breakthrough Therapy Designation for this therapy. A Phase 3 study will start in 2023.

Merck (NYSE: MRK) has received acceptance from the FDA for a supplemental Biologics License Application (sBLA) for KEYTRUDA, its anti-PD-1 therapy, in combination with chemotherapy for patients with HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This decision is based on the Phase 3 KEYNOTE-859 trial, which demonstrated a significant overall survival benefit compared to chemotherapy alone, irrespective of PD-L1 expression. The FDA has a target action date of December 16, 2023. Merck is committed to expanding treatment options for gastric cancer patients, a group with a five-year survival rate of only six percent.

Merck and Eisai updated on two Phase 3 trials—LEAP-003 and LEAP-017—evaluating the anti-PD-1 therapy KEYTRUDA combined with LENVIMA. The LEAP-003 trial, which focused on adults with unresectable or metastatic melanoma, is being discontinued after an interim analysis indicated no improvement in overall survival (OS) compared to KEYTRUDA alone. However, a significant improvement in progression-free survival (PFS) was observed. The LEAP-017 trial, targeting metastatic colorectal cancer, also did not meet its OS primary endpoint, although a trend toward improvement was noted. Both trials maintained a consistent safety profile. The companies remain committed to further evaluations of KEYTRUDA plus LENVIMA in various cancers, with ongoing studies in the LEAP clinical program.

Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) announced that their investigational personalized mRNA cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, has received PRIME scheme designation from the European Medicines Agency (EMA). This designation follows positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial for treating high-risk stage III/IV melanoma after complete surgical resection. The first detailed results will be presented at the American Association for Cancer Research (AACR) from April 14-19. With a high unmet need for melanoma therapies, this designation aims to accelerate access to effective treatments for patients. Further, the FDA has granted Breakthrough Therapy Designation for the same combination, alongside plans for a Phase 3 study in 2023.

Merck's executive director of health equity, Josette Gbemudu, is prominently positioned to address health disparities and promote access to care for underserved populations. Drawing from her experiences in Nigeria, she emphasizes the importance of health equity within Merck's core strategies. Gbemudu is the first representative from Merck to join the Aspen Institute's First Movers Fellowship program, where she focuses on becoming a corporate social intrapreneur. This fellowship has enabled her to implement strategies to close care gaps while advocating for a health equity mindset. Gbemudu believes that addressing these significant challenges is essential for the company's long-term success and aligns with Merck's commitment to tackling pressing public health issues. Learn more about Merck's Environmental, Social & Governance (ESG) initiatives at merck.com/company-overview/esg.

Merck has been recognized for the third consecutive year as one of Barron's 100 Most Sustainable U.S. Companies, ranking No. 1 in the pharmaceutical sector and advancing from No. 67 to No. 29 overall. This accolade highlights Merck's commitment to social responsibility and sustainability, as expressed by Carmen Villar, vice president of Social Business Innovation. In addition to this, Merck has also received accolades from JUST Capital, CNBC, Newsweek, and Statista for its ethical operations. The evaluation was based on over 230 ESG performance indicators by Calvert Research and Management.

Merck (NYSE: MRK) announces FDA approval of KEYTRUDA in combination with Padcev for adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who cannot receive cisplatin-containing chemotherapy. This groundbreaking approval represents the first combination of an anti-PD-1 therapy and an antibody-drug conjugate for this patient group, based on the KEYNOTE-869 trial data. The objective response rate was 68%, with a median duration of response of 22.1 months. The approval is granted under accelerated terms, which may depend on further verification of clinical benefit. The ongoing Phase 3 trial, EV-302/KEYNOTE-A39, will serve as the confirmatory trial.