Merck & Co Stock Price, News & Analysis

Moderna and Merck have received Breakthrough Therapy Designation from the FDA for their investigational personalized mRNA cancer vaccine mRNA-4157/V940. This designation is based on promising results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, showcasing efficacy in combination with Merck's KEYTRUDA for treating high-risk melanoma post-surgery. The designation expedites development for serious conditions with significant unmet needs. The companies plan to launch a Phase 3 study in adjuvant melanoma in 2023, with the potential to broaden to other cancers, including non-small cell lung cancer.

Merck (NYSE: MRK) announced the opening of enrollment for its new Phase 3 clinical program examining the investigational once-daily islatravir 0.25 mg combined with doravirine 100 mg for HIV-1 treatment. The studies aim to evaluate the efficacy and safety of this combination. Two studies, MK-8591A-051 and MK-8591A-052, have begun enrolling participants, while others are slated to start in March. Merck's commitment to HIV research continues as it develops antiviral options to combat the growing infection burden worldwide.

Merck (NYSE: MRK) has announced important clinical data to be presented at the American College of Cardiology's 72nd Annual Scientific Session and World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA from March 4-6, 2023. Notably, the pivotal Phase 3 STELLAR trial results for sotatercept, an investigational therapy for pulmonary arterial hypertension (PAH), will be showcased alongside data from a Phase 2b trial of MK-0616, an oral PCSK9 inhibitor for hypercholesterolemia. Dr. Eliav Barr expressed enthusiasm for these updates, emphasizing Merck's commitment to advancing cardiovascular treatment options and improving patient outcomes.

Merck (NYSE: MRK) announced that its COVID-19 treatment, LAGEVRIO™ (molnupiravir), did not achieve a statistically significant reduction in COVID-19 risk in the Phase 3 MOVe-AHEAD trial. The trial involved individuals exposed to COVID-19 and assessed the treatment's efficacy over 14 days. The LAGEVRIO group was only 23.6% less likely to develop COVID-19 compared to the placebo, falling short of the primary endpoint. Despite this, Merck plans to submit the full study results for publication or presentation. LAGEVRIO remains approved in several countries for treating COVID-19 in adults, though not for prevention.

Merck (NYSE: MRK) announced that the FDA accepted two supplemental new drug applications (sNDA) for PREVYMIS™ (letermovir). The first application is for CMV prophylaxis in kidney transplant recipients at high risk, with a PDUFA target date of June 5, 2023. The second extends prophylaxis from 100 to 200 days for patients receiving allogeneic HSCT, target date Sept. 7, 2023. PREVYMIS demonstrated non-inferior efficacy and a superior safety profile to the current standard of care, valganciclovir, in clinical trials. This acceptance could present a significant advance in treatment options for high-risk transplant patients.

Merck (NYSE: MRK) announced significant results from the Phase 3 KEYNOTE-859 trial, where KEYTRUDA combined with chemotherapy improved overall survival (OS) in patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma, reducing death risk by 22% (HR=0.78; p<0.0001). The median OS was 12.9 months for KEYTRUDA plus chemotherapy, compared to 11.5 months for chemotherapy alone. The trial also demonstrated improvements in progression-free survival (PFS) and objective response rate (ORR). Treatment-related adverse events occurred in 59.4% of patients receiving KEYTRUDA plus chemotherapy, indicating a manageable safety profile.

AstraZeneca and Merck (NYSE: MRK) have announced the final analysis results of the overall survival (OS) from the Phase 3 PROpel trial, evaluating LYNPARZA in combination with abiraterone and prednisone. The median OS was 42.1 months for the treatment group versus 34.7 months for the placebo, showing a 7.4-month difference; however, this did not reach statistical significance (p=0.0544). The trial also reported a significant reduction in disease progression or death (rPFS) by 34% for the treatment group. The most common adverse events included anemia (49.7%) and fatigue (38.7%), with 17% of patients discontinuing treatment due to these effects.

Merck announces significant advancements in gender diversity within its small molecule process research & development (SM PR&D) team, with the representation of women nearly doubling over the past seven years. Jamie McCabe Dunn, Director of Process Chemistry, emphasizes that diversity and inclusion drive innovation. Initiatives include active recruitment by women leaders and partnerships with academic institutions. Recognizing the contributions of female scientists, 12 women from the department have received prestigious awards in the last three years. The company asserts its commitment to fostering a more equitable environment for future generations.

Merck (NYSE: MRK) announced that its Phase 3 NRG-GY018 trial of KEYTRUDA, in combination with chemotherapy, significantly improved progression-free survival (PFS) in patients with stage III-IV or recurrent endometrial carcinoma. This trial met its primary endpoint, showing meaningful results for both mismatch repair proficient (pMMR) and deficient (dMMR) patients. The safety profile was consistent with previous studies, with no new safety signals. These findings will be presented at an upcoming medical meeting. KEYTRUDA's promising results highlight its potential as a treatment option for advanced endometrial cancer, which often has limited options.