Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced extensive research on cancer treatments to be presented at the ESMO Congress 2022 in Paris from September 9-13. Key highlights include:

• Long-term survival data for KEYTRUDA® in advanced lung cancer.
• Seven-year overall survival results for LYNPARZA® in ovarian cancer.
• First-time data combining KEYTRUDA with enfortumab vedotin for advanced urothelial cancer.

Dr. Eliav Barr emphasized the importance of these findings in enhancing treatment options across various cancer types.

Merck and AstraZeneca announced the approval of LYNPARZA by Japan's Pharmaceuticals and Medical Devices Agency for treating patients with high-risk, HER2-negative breast cancer with BRCA mutations.

This drug, a PARP inhibitor, shows a 42% reduced risk of invasive disease recurrence and a 32% lower risk of death, based on the OlympiA trial. Approximately 10% of patients experienced treatment discontinuation due to adverse reactions. The approval marks an important treatment advance for breast cancer patients in Japan.

Merck (NYSE: MRK) announced that the FDA has granted Fast Track designation for its investigational anticoagulant therapy, MK-2060, aimed at reducing major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). This designation allows more frequent FDA interactions and potential eligibility for Accelerated Approval. MK-2060 is a monoclonal antibody targeting Factor XI and is currently in a Phase 2 study for patients on hemodialysis. Merck emphasizes the urgent need for effective anticoagulation medicines for ESRD patients.

AstraZeneca and Merck (NYSE: MRK) announced that the FDA has accepted their supplemental New Drug Application for LYNPARZA in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). The FDA granted priority review status, with a decision expected in Q4 2022. In the PROpel trial, the combination showed a 34% reduction in disease progression risk, with median radiographic progression-free survival of 24.8 months compared to 16.6 months for placebo. Merck aims to address significant unmet needs in mCRPC treatment.

Merck (NYSE: MRK) and Orna Therapeutics have entered a strategic collaboration to develop vaccines and therapeutics targeting infectious diseases and oncology. Merck will pay Orna $150 million upfront and an additional $3.5 billion in potential milestones, plus royalties on approved products. Merck will also invest $100 million in Orna's Series B financing. Orna retains rights to its innovative oRNA technology platform, which has shown stability and effectiveness in therapeutic applications, promising advancements in RNA-based treatments.

The European Commission has approved LYNPARZA as the first PARP inhibitor for adjuvant treatment in adults with germline BRCA mutations and HER2-negative early breast cancer, based on the Phase 3 OlympiA trial results. LYNPARZA showed a 42% reduction in the risk of invasive disease recurrence and a 32% reduction in mortality compared to placebo. AstraZeneca will receive a $75 million payment from Merck due to this approval. This milestone indicates a shift in treatment options for high-risk patients, aiming to decrease recurrence rates.

Merck (NYSE: MRK) and Eisai announced that the Phase 3 LEAP-002 trial of KEYTRUDA combined with LENVIMA did not meet its primary endpoints for overall survival (OS) and progression-free survival (PFS) in unresectable hepatocellular carcinoma (uHCC). Although there were trends indicating potential benefits of the combination over LENVIMA monotherapy, results lacked statistical significance. The safety profile matched previous data. Merck and Eisai will showcase findings at a medical conference while continuing research on this combination across various cancers.

Merck (NYSE: MRK) announced that the Phase 3 KEYNOTE-921 trial for KEYTRUDA combined with chemotherapy (docetaxel) failed to meet its primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC). Despite modest trends favoring the combination, results lacked statistical significance. The safety profile of KEYTRUDA remained consistent with previous studies. Merck continues its commitment to developing new treatments for prostate cancer through various ongoing trials.

Merck reported robust financial performance for Q2 2022, with worldwide sales of $14.6 billion, a 28% increase from Q2 2021. Key drivers included KEYTRUDA sales rising 26% to $5.3 billion and GARDASIL growing 36% to $1.7 billion. Non-GAAP EPS improved to $1.87. The company received FDA approval for VAXNEUVANCE, and expanded indications for KEYTRUDA. Merck raised its full-year sales guidance to between $57.5 billion and $58.5 billion, reflecting a growth expectation of 18% to 20% despite foreign exchange impacts.