Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) has received approval from the European Commission for VAXNEUVANCE™, a Pneumococcal 15-valent Conjugate Vaccine, which will be marketed in all 27 EU Member States, as well as Iceland, Norway, and Lichtenstein. This vaccine targets invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 and older. The approval is based on positive results from seven clinical studies involving 7,438 participants, showing that VAXNEUVANCE achieved immune responses superior to the previously available 13-valent vaccine.

Merck has received approval from the European Commission for its pneumococcal vaccine, VAXNEUVANCE, aimed at preventing invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 and older. This approval follows a positive opinion from the European Medicines Agency based on data from clinical studies involving 7,438 participants. VAXNEUVANCE is now authorized for marketing in all 27 EU member states, as well as in Iceland, Norway, and Lichtenstein, offering a new immunization option for patients in these regions.

Merck (NYSE: MRK) announced that the FDA has placed clinical holds on several investigational new drug applications for islatravir (MK-8591) due to decreases in lymphocyte and CD4+ T-cell counts observed during clinical studies. The holds affect oral and injectable formulations for HIV-1 treatment and prevention, halting further dosing and enrollment in several trials. Affected studies include Phase 3 trials for oral islatravir as pre-exposure prophylaxis (PrEP) in high-risk populations. Merck remains committed to addressing unmet needs in HIV care.

Organon (NYSE: OGN) has completed its acquisition of Forendo Pharma, enhancing its women's health pipeline with novel treatments for endometriosis and polycystic ovarian syndrome (PCOS). The transaction includes a $75 million upfront payment and potential total consideration of up to $954 million based on development and commercial milestones. Forendo's lead candidate, FOR-6219, is entering Phase 2 clinical trials and aims to offer a long-term treatment option for endometriosis, addressing significant unmet needs in women's health.

Merck (NYSE: MRK) has announced an additional $150 million commitment to its Merck for Mothers initiative, aiming to enhance maternal health globally. This investment builds upon a previous $500 million commitment made in 2011, targeting to support programs that will reach 25 million women by 2025, up from 13.1 million to date. The funding is crucial as the COVID-19 pandemic has hindered maternal care, particularly in high-need regions like India, Nigeria, and Kenya. A minimum of $15 million will also support initiatives addressing maternal health disparities in the U.S.

Merck (NYSE: MRK) has announced a pause in enrollment for the Phase 3 clinical studies IMPOWER 22 and IMPOWER 24, which evaluate the investigational drug islatravir for pre-exposure prophylaxis against HIV-1. This decision follows recommendations from an external data monitoring committee. However, participants already enrolled will continue receiving the study medication. Merck will enhance monitoring measures for participants during this period. The company remains committed to addressing unmet needs in HIV treatment and prevention.

Merck (NYSE: MRK) has received FDA approval for KEYTRUDA as an adjuvant treatment for pediatric and adult patients with completely resected stage IIB and IIC melanoma. This decision is based on KEYTRUDA's performance in the Phase 3 KEYNOTE-716 trial, demonstrating a 35% reduction in the risk of disease recurrence or death compared to placebo. After 14.4 months, 11% of patients treated with KEYTRUDA experienced recurrence, compared to 17% for the placebo group. This approval expands treatment options for patients at high risk of recurrence following surgery.