What's Going On With Merck Stock On Friday?

On Thursday, the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend Merck & Co Inc’s MRK Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for adults 65 years of age and older. It is also commonly known as the pneumonia vaccine.

Specifically, the ACIP voted to recommend a single dose of Capvaxive for:

• Adults 65 years and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown.
• Adults 19-64 years of age with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown.
• Adults 19 years and older who have started their pneumococcal vaccine series with PCV13 (pneumococcal 13-valent conjugate vaccine) but have not received all recommended PPSV23 (pneumococcal 23-valent polysaccharide vaccine) doses.

Additionally, shared clinical decision-making is recommended regarding the use of a supplemental dose of Capvaxive for adults 65 years and older who have completed their vaccine series with both PCV13 and PPSV23.

Friday, Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of Winrevair (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies for adult PAH patients with World Health Organization Functional Class II to III, to improve exercise capacity.

The European Commission (EC) will now review the CHMP recommendation. The EC’s decision on Winrevair’s marketing authorization application is expected in the third quarter of 2024.

The CHMP recommendation is based on data from the Phase 3 STELLAR trial of Winrevair on top of background PAH therapy compared to background therapy alone.

Winrevair demonstrated a statistically significant and clinically meaningful improvement in the 6-minute walk distance, the study’s primary endpoint, and on multiple important secondary outcome measures, including reducing the risk of death from any cause or PAH clinical worsening events.

Also Read: FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug.

Price Action: MRK shares were trading higher by 0.13% at $129.99 premarket at the last check on Friday.

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