Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) and Orion announced the mutual exercise of an option, converting their co-development agreement for opevesostat, an investigational CYP11A1 inhibitor for metastatic castration-resistant prostate cancer, into an exclusive global license for Merck.

With this agreement, Merck gains exclusive rights to develop and commercialize opevesostat and other CYP11A1-targeting candidates. Orion is eligible for up to $1.63 billion in milestone payments and tiered royalties from net sales.

Merck will assume all development and commercialization costs, while Orion will manufacture the clinical and commercial supply. The license agreement is anticipated to take effect in Q3 2024, pending regulatory approval.

Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, will host its second-quarter 2024 sales and earnings conference call on July 30 at 9:00 a.m. ET. The call will include a detailed overview of the company's quarterly performance, presented by company executives. Institutional investors, analysts, journalists, and the public can access the live audio webcast through Merck's website. A replay, along with additional financial materials such as the earnings news release, supplemental disclosures, and slides, will also be available online. Participants in the U.S. and Canada can join the call by dialing (800) 779-0641, while international participants can dial (517) 308-9147 using access code 4761229.

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of WINREVAIR™ (sotatercept) for treating pulmonary arterial hypertension (PAH) in adults. If approved by the European Commission, WINREVAIR will be the first activin signaling inhibitor therapy for PAH in Europe, potentially expanding treatment options for WHO Functional Class II to III PAH patients. This recommendation is based on the Phase 3 STELLAR trial, which showed significant improvements in exercise capacity and reduced risks of death and clinical worsening events. The European Commission's decision is expected in Q3 2024.

The CDC's Advisory Committee on Immunization Practices (ACIP) has unanimously recommended Merck's CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for adults 65 years and older, as well as adults 19-64 with certain risk conditions.

This recommendation targets individuals who have not previously received a pneumococcal conjugate vaccine or whose vaccination status is unknown. Additionally, those over 65 who have completed their vaccine series with PCV13 and PPSV23 are advised to consider a supplemental dose of CAPVAXIVE.

CAPVAXIVE covers 24 Streptococcus pneumoniae serotypes, addressing invasive disease and pneumonia. It has accelerated approval based on immune response metrics, though continued approval is contingent on further clinical trial results. Final recommendations are pending review by the CDC and the Department of Health and Human Services.

CAPVAXIVE should not be administered to individuals with severe allergic reactions to its components or diphtheria toxoid. Side effects include injection-site pain, fatigue, and headache.

The FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of patritumab deruxtecan, developed by Daiichi Sankyo and Merck (MRK). This drug aims to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have been treated with at least two systemic therapies.

The CRL arose from inspection findings at a third-party manufacturing facility, not from issues with the drug's efficacy or safety data.

Patritumab deruxtecan showed promising results in the HERTHENA-Lung01 phase 2 trial with an objective response rate of 29.8% and a median duration of response of 6.4 months. The safety profile was consistent with previous trials, although there were some significant treatment-emergent adverse events (TEAEs).

Daiichi Sankyo and Merck are committed to resolving the manufacturing issues and bringing this first-in-class HER3-directed medicine to patients with treatment options.

Merck Animal Health announced the USDA approval of NOBIVAC® NXT Canine Flu H3N2, the first and only canine influenza vaccine utilizing RNA-particle technology. This innovative vaccine is designed to offer a precise immune response, improving protection against the prevalent canine flu virus in the United States. The nonadjuvanted, low volume vaccine is indicated for dogs eight weeks and older and will be available nationwide by late summer. NOBIVAC NXT marks a significant milestone in Merck's commitment to veterinary innovation and preventive care.

Merck has partnered with North Carolina Agricultural and Technical State University (N.C. A&T), the largest historically Black college and university in the U.S., to launch the Merck Biotechnology Learning Center. The 4,025 square-foot facility, located near Merck's Durham and Wilson manufacturing sites, will enhance academic programming and training for biotechnology careers. This collaboration aims to diversify talent, expand local bioeconomy initiatives, and provide advanced discovery opportunities. It also includes training in vaccine manufacturing processes for new and existing employees.

The U.S. FDA has approved Merck's CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for preventing invasive pneumococcal disease and pneumonia in adults 18 and older. CAPVAXIVE covers 84% of invasive pneumococcal disease (IPD) serotypes in adults 50+ and 85% in adults 65+. The approval is backed by robust Phase 3 trials demonstrating strong immune responses in both vaccine-naïve and experienced adults. The CDC's Advisory Committee on Immunization Practices is set to meet and discuss recommendations for CAPVAXIVE's use in adults. This approval, under the FDA's Priority Review, aims to address serotypes not covered by other vaccines. Continued approval may require verification of clinical benefits in a confirmatory trial.

The FDA has approved Merck's (NYSE: MRK) KEYTRUDA® (pembrolizumab) in combination with carboplatin and paclitaxel for treating adult patients with primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status. This marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and its 40th overall in the U.S.

The approval is based on results from the Phase 3 NRG-GY018 trial, which showed significant reductions in disease progression or death by 40% for mismatch repair proficient cancers and 70% for deficient cancers.

However, KEYTRUDA may cause severe or fatal immune-mediated adverse reactions and should be discontinued as necessary. The median progression-free survival for patients with mismatch repair proficient cancers was 11.1 months compared to 8.5 months for the placebo group, while the median was not reached for deficient cancers (30.7 months vs 6.5 months).