Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) has announced that Robert M. Davis, CEO, and Dr. Dean Y. Li, President of Merck Research Laboratories, will participate in a fireside chat at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 5:15 PM PT / 8:15 PM ET. A live audio webcast of the presentation will be available for investors and the public.

Merck is committed to advancing healthcare through research and innovation, focusing on developing medicines and vaccines to improve lives globally.

Merck (NYSE: MRK) announced that CEO Robert M. Davis will participate in a fireside chat at the Goldman Sachs Healthcare CEOs Unscripted Conference on Thursday, Jan. 5, 2023, at 8:55 a.m. ET. Investors, analysts, and the public can access the live video webcast here.

Merck (NYSE: MRK) and Kelun-Biotech have entered an exclusive collaboration to develop seven investigational preclinical antibody-drug conjugates (ADCs) for cancer treatment. The agreement includes an upfront payment of $175 million to Kelun-Biotech, with potential future milestone payments totaling $9.3 billion if all candidates achieve regulatory approval. Merck gains global licenses for these ADC therapies while Kelun retains rights in China, Hong Kong, and Macau. This partnership builds on earlier collaborations for two ADC candidates, aiming to enhance Merck's oncology pipeline.

Merck (NYSE: MRK) and AstraZeneca announce the approval of LYNPARZA in the European Union for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC). This groundbreaking approval follows positive results from the Phase 3 PROpel trial, demonstrating a 34% reduction in disease progression risk. LYNPARZA's combination with abiraterone and prednisone leads to a median radiographic progression-free survival of 24.8 months. The approval addresses an unmet need in mCRPC treatment, with over 473,000 prostate cancer cases diagnosed in Europe in 2020.

Seagen, Astellas Pharma, and Merck announced the FDA's acceptance of supplemental Biologics License Applications for their combination therapy of PADCEV and KEYTRUDA, targeting locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-based chemotherapy. The FDA granted the applications Priority Review, setting a PDUFA date of April 21, 2023. The combination therapy, previously designated as Breakthrough Therapy, is supported by clinical trial data. Continued research includes a phase 3 study to assess the treatment's efficacy and facilitate potential accelerated approval.

Astellas Pharma, Seagen, and Merck announced that the FDA has accepted their applications for Priority Review of PADCEV® and KEYTRUDA® in combination for treating locally advanced or metastatic urothelial cancer. This therapy aims to provide a new treatment option for patients who cannot receive cisplatin-based chemotherapy. The FDA set a PDUFA date of April 21, 2023, for potential accelerated approval. Supported by data from the EV-103 trial, the combination has shown promise, with additional studies ongoing to further evaluate its effectiveness.

AstraZeneca and Merck (NYSE: MRK) announced an extension to the FDA's Prescription Drug User Fee Act (PDUFA) date by three months for the supplemental new drug application (sNDA) regarding LYNPARZA in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). The extension aims to allow further review of the application, which is supported by the Phase 3 PROpel trial data. LYNPARZA is already approved for certain indications in the U.S. and EU, with ongoing regulatory reviews in additional countries.