Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced promising results from its Phase 3 STELLAR trial for sotatercept, an investigational biologic for treating pulmonary arterial hypertension (PAH). The study showed a significant improvement in exercise capacity with a 40.8 meters increase in six-minute walk distance (p<0.001) from baseline at week 24. Notably, sotatercept reduced the risk of clinical worsening or death by 84%. Eight out of nine secondary measures also showed significant improvements. The results were shared at the ACC.23/WCC and published in The New England Journal of Medicine. Merck plans to discuss these impactful findings with health authorities.

Merck (NYSE: MRK) announced positive results from its Phase 2b clinical trial for MK-0616, a novel oral PCSK9 inhibitor aimed at lowering LDL cholesterol in adults with hypercholesterolemia. The trial demonstrated significant reductions in LDL-C levels, ranging from 41.2% to 60.9% across various doses at 8 weeks compared to placebo. MK-0616 was well-tolerated, with no serious adverse events reported. Merck plans to initiate a Phase 3 pivotal study in the second half of 2023, potentially positioning MK-0616 as the first oral treatment of its kind, improving accessibility for patients at risk of cardiovascular disease.

Merck (NYSE: MRK) has received FDA approval for the intramuscular (IM) administration of its MMRV family of vaccines: M-M-R® II, VARIVAX®, and ProQuad®. This expansion allows healthcare professionals to administer these vaccines alongside other recommended pediatric vaccinations, enhancing vaccination options. Previously, these vaccines were only available via subcutaneous (SC) injection. The MMRV vaccines are crucial in preventing measles, mumps, rubella, and varicella, with historical approvals dating back to 1978 for M-M-R® II. The IM route is already licensed in the EU, marking a significant advancement in vaccination practices for children in the U.S.

AstraZeneca and Merck (NYSE: MRK) announced that the FDA will convene the Oncologic Drugs Advisory Committee (ODAC) on April 28, 2023, to discuss the supplemental new drug application (sNDA) for LYNPARZA, used in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). The sNDA is based on results from the Phase 3 PROpel trial, showing improved radiographic progression-free survival. LYNPARZA is already approved in the EU for this combination. The meeting provides expert guidance but is advisory only, as the FDA makes the final decision.

Merck (NYSE: MRK) announced positive results from the Phase 3 KEYNOTE-671 trial, showing KEYTRUDA® (pembrolizumab) combined with chemotherapy significantly improved event-free survival (EFS) in patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). The trial also reported statistically significant enhancements in secondary endpoints, including pathological complete response (pCR) and major pathological response (mPR). The FDA has accepted Merck's supplemental Biologics License Application (sBLA), with a PDUFA date set for October 16, 2023. No new safety signals were noted, and results will be shared at an upcoming medical meeting.

Merck (NYSE: MRK) announced the discontinuation of the Phase 3 KEYNOTE-641 trial for KEYTRUDA® (pembrolizumab) in combination with enzalutamide and androgen deprivation therapy for metastatic castration-resistant prostate cancer (mCRPC). The decision follows an independent committee's recommendation due to lack of improvement in radiographic progression-free survival (rPFS) and overall survival (OS). Additionally, the KEYNOTE-789 trial for KEYTRUDA with pemetrexed and platinum-based chemotherapy also failed to meet its OS primary endpoint for patients with metastatic nonsquamous non-small cell lung cancer. Safety profiles remained consistent with earlier studies.

Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced that the EMA's CHMP has recommended refusing marketing authorization for LAGEVRIO™ (molnupiravir) for certain COVID-19 patients in the EU. Merck plans to appeal this decision, believing it does not reflect data from the Phase 3 MOVe-OUT trial, which indicates LAGEVRIO can reduce hospitalization and death risks. Over 4 million patients have been treated globally, and LAGEVRIO is approved in over 25 countries. The EMA's scientific opinion supports availability based on the recommendations of 16 EU national authorities.

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.