Merck & Co - MRK STOCK NEWS

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.

Moderna and Merck announced positive results from the Phase 2b KEYNOTE-942 trial of mRNA-4157/V940 combined with KEYTRUDA in stage III/IV melanoma patients. The study showed a 44% reduction in the risk of disease recurrence or death compared to KEYTRUDA alone. This marks the first efficacy demonstration of an mRNA cancer treatment in a randomized trial. The companies plan to initiate a Phase 3 study and expand to other tumor types in 2023. Adverse events associated with mRNA-4157/V940 were consistent with previous studies, indicating manageable safety.

Merck (NYSE: MRK) has initiated a cash tender offer for all outstanding shares of Imago BioSciences (NASDAQ: IMGO) at $36 per share. This follows a definitive agreement announced on November 21, 2022, to acquire Imago. The tender offer is set to expire on January 10, 2023. Upon successful completion, Imago will merge into a Merck subsidiary and become a wholly-owned entity. The tender offer is subject to conditions, including the tender of a majority of Imago's shares and necessary regulatory approvals. Closing is expected in Q1 2023.

Merck (NYSE: MRK) announced the presentation of new data on investigational drugs, including favezelimab, zilovertamab vedotin, and nemtabrutinib, at the 64th American Society of Hematology (ASH) Annual Meeting from Dec. 10-13, 2022, in New Orleans and virtually. Key findings will involve nearly 40 abstracts showcasing advancements in blood cancer treatments, including new insights on KEYTRUDA (pembrolizumab). Dr. Gregory Lubiniecki emphasized Merck's commitment to enhancing the treatment landscape for blood cancer patients and the importance of their growing pipeline of therapies.

Merck (NYSE: MRK) announced a quarterly dividend of $0.73 per share for Q1 2023, to be paid on Jan. 9, 2023. This payment is for shareholders of record as of Dec. 15, 2022. Merck aims to leverage leading-edge science to improve lives globally and remains committed to research and development in the biopharmaceutical sector. The company emphasizes its dedication to sustainability and a diverse workforce, striving for a healthy future for all communities.

Merck (NYSE: MRK) announced positive topline results from the pivotal Phase 3 KEYNOTE-859 trial, where KEYTRUDA® (pembrolizumab) combined with chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) for patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. The independent Data Monitoring Committee confirmed these statistically significant findings. No new safety concerns were identified. Results will be presented at future medical meetings and submitted for regulatory review.