Merck (MRK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending the approval of its pulmonary arterial hypertension (PAH) drug Winrevair (sotatercept) in Europe. The CHMP recommended Winrevair in combination with other PAH therapies for treating adult patients with PAH (WHO Functional Class II to III) to improve exercise capacity.The decision of the European Commission is expected in the third quarter of 2024. If ...

Merck (MRK) announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously voted to recommend MRK’s newly approved 21-valent pneumococcal conjugate vaccine (PCV) Capvaxive. The FDA approved Capvaxive earlier this month for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. Capvaxive became the first PCV specifically designed for adults to be approved by the FDA.Capvaxive targets serotypes that ...

Merck (MRK) and its partner Daiichi Sankyo announced that the FDA has issued a complete response letter (“CRL”) to the biologics license application (BLA) seeking accelerated approval for patritumab deruxtecan for previously-treated EGFR-mutated non-small cell lung cancer (NSCLC).The BLA seeks approval for patritumab deruxtecan, a specifically engineered potential first-in-class HER3-directed DXd antibody drug conjugate (ADC), to treat adult patients with locally advanced or metastatic EGFR-mutated NSCLC pr ...

Merck (MRK) closed the most recent trading day at $132.96, moving +1.71% from the previous trading session. The stock outperformed the S&P 500, which registered a daily loss of 0.31%. On the other hand, the Dow registered a gain of 0.67%, and the technology-centric Nasdaq decreased by 1.09%.The the stock of pharmaceutical company has risen by 0.95% in the past month, leading the Medical sector's gain of 0.61% and undershooting the S&P 500's gain of 2.73%.Market participants will be closely following the fin ...

Loading...Loading...Biotech stocks are high-risk, high-return opportunities that are under the mercy of several make-or-break catalysts, most of which are binary events. It pays to remain cognizant of the timing of these catalysts and which way they will likely pan out. Benzinga brings to investors a weekly feature focusing on five key catalysts that could impact the stock prices of the respective companies in an appreciable manner.1. Arrowhead Pharmaceuticals, Inc. ARWRDate: Tuesday, June 25Catalyst: Discu ...

In the latest trading session, Merck (MRK) closed at $127.99, marking a +0.38% move from the previous day. The stock outperformed the S&P 500, which registered a daily gain of 0.25%. Elsewhere, the Dow gained 0.15%, while the tech-heavy Nasdaq added 0.03%.Coming into today, shares of the pharmaceutical company had lost 2.66% in the past month. In that same time, the Medical sector gained 0.11%, while the S&P 500 gained 3.34%.The investment community will be closely monitoring the performance of Merck in its ...

The U.S. Food and Drug Administration (FDA) approved Merck & Co Inc's (NYSE:MRK) next-generation vaccine to protect adults against the pneumococcal disease. The company said the vaccine could become available later this summer, pending recommendation from the Centers for Disease Control and Prevention (CDC). In response, MRK is up 0.3% to trade at $127.90 at last check.Over the last few months, the security has repeatedly attempted to conquer its March 27, record high of $133.08, but the $130 level keeps ac ...

Merck (MRK) announced that the FDA had granted approval to V116, its 21-valent pneumococcal conjugate vaccine (PCV), for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. For the prevention of pneumonia indication, the FDA granted accelerated approval.The vaccine will be marketed by the trade name of Capvaxive. Capvaxive becomes the first PCV specifically designed for adults to be approved by the FDA. Capvaxive targets serotypes that account for approximately 84% of all i ...

The Food and Drug Administration on Monday approved Merck's new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, a spokesperson for the drugmaker said.Merck's shot, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It's the first pneumococcal conjugate vaccine designed speci ...

Merck & Co., Inc. (NYSE:MRK) Goldman Sachs 45th Annual Global Healthcare Conference Call June 11, 2024 10:00 AM ET Company Participants Robert Davis - Chairman, President and Chief Executive Officer Dean Li - Executive Vice President and President, Merck Research Laboratories Conference Call Participants Chris Shibutani - Goldman Sachs Chris Shibutani Okay, let's get underway. Good morning, everybody, and welcome to the Second Day of the conference. My name is Chris Shibutani. And on behalf of the entire Go ...