23 Results Found

Merck to Hold Investor Event to Highlight Oncology Portfolio and Pipeline

More than 80 potential oncology approvals expected through 2028 from Merck’s leading oncology portfolio and diverse pipeline Merck (NYSE: MRK), known as MSD outside the United States and Canada, will provide a detailed overview of the company’s oncology portfolio and pipeline at an investor event today at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago at 7 a.m. CT/8 a.m. ET. At this year’s ASCO, data for Merck’s oncology portfolio and pipeline will be presented from nearly 120 abstracts in more than 25 cancer types. At the investor event, the company will highlight key data presented at ASCO and provide updates from its late-stage development programs and diverse earlier-stage oncology pipeline. Merck leaders will also share the company’s progress in oncology since last year’s ASCO, including 12 U.S. Food and Drug Administration approvals—five in earlier stages of cancer—and three pivotal study readouts. “Ten years ago, at ASCO 2012, interim data from

https://www.merck.com/news/merck-to-hold-investor-event-to-highlight-oncology-portfolio-and-pipeline/

Merck Announces Retirement of Dr. Roy D. Baynes; Dr. Eliav Barr Appointed Head of Global Clinical Development and Chief Medical Officer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Dr. Roy D. Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July. Dr. Baynes will be succeeded by Dr. Eliav Barr, effective April 1, 2022. Dr. Baynes will continue to report to Dr. Dean Y. Li, president, Merck Research Laboratories, until his retirement. “Roy is one of the world’s pre-eminent oncologists and clinical development experts, and his masterful spearheading of the development of KEYTRUDA leaves an indelible mark on Merck, on oncology and on the lives of patients and their families. As textbooks are updated to reflect the era of immuno-oncology, Roy’s contributions cannot be overstated, and will persist far beyond his eight years with Merck,” said Dr. Li. “I know there are many who join me in thanking Roy for his efforts and wishing him well in his next chapter.” Dr. Baynes joined Merck in

https://www.merck.com/news/merck-announces-retirement-of-dr-roy-d-baynes-dr-eliav-barr-appointed-head-of-global-clinical-development-and-chief-medical-officer/

Merck Announces Third-Quarter 2023 Financial Results

Sales Reflect Sustained Growth, Particularly in Oncology and Vaccines Total Worldwide Sales Were $16.0 Billion, an Increase of 7% From Third Quarter 2022; Excluding LAGEVRIO, Growth Was 6%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 8% KEYTRUDA Sales Grew 17% to $6.3 Billion; Excluding the Impact of Foreign Exchange, Sales Also Grew 17% GARDASIL/GARDASIL 9 Sales Grew 13% to $2.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 16% LAGEVRIO Sales Grew 47% to $640 Million; Excluding the Impact of Foreign Exchange, Sales Grew 51% GAAP EPS Was $1.86; Non-GAAP EPS Was $2.13 Announced Collaboration Agreement With Daiichi Sankyo for Three Clinical-Stage ADC Candidates Received FDA Approval of KEYTRUDA for Perioperative Treatment of Certain Patients With NSCLC in Combination With Chemotherapy, Based on KEYNOTE-671 Trial Obtained FDA Priority Review of Biologics License Application for Sotatercept Presented Compelling Data at ESMO 2023 Congress, Including:

https://www.merck.com/news/merck-announces-third-quarter-2023-financial-results/

FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

WELIREG Approved for Adult Patients With VHL Disease Who Require Therapy for Associated Renal Cell Carcinoma, Central Nervous System Hemangioblastomas, or Pancreatic Neuroendocrine Tumors, Not Requiring Immediate Surgery WELIREG Expands Merck’s Oncology Portfolio as the First and Only Systemic Therapy Approved for These Patients With VHL Disease Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptable toxicity. The approval is based on results from the

https://www.merck.com/news/fda-approves-mercks-hypoxia-inducible-factor-2-alpha-hif-2%ce%b1-inhibitor-welireg-belzutifan-for-the-treatment-of-patients-with-certain-types-of-von-hippel-lindau-vhl-disease/

Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)

Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), not requiring immediate surgery. This NDA is based on data from the Phase 2 Study-004 trial, in which belzutifan showed a confirmed overall response rate of 36.1% (n=22/61) (95% CI: 24.2-49.4) in patients with VHL disease-associated RCC. The FDA has set a Prescription

https://www.merck.com/news/merck-receives-priority-review-from-fda-for-new-drug-application-for-hif-2%ce%b1-inhibitor-belzutifan-mk-6482/

Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results

Fourth-Quarter and Full-Year Sales Reflect Sustained Growth Across Oncology and Vaccines Fourth-Quarter Worldwide Sales Were $14.6 Billion, an Increase of 6% From Fourth Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 13% Fourth-Quarter GAAP Loss per Share Was $0.48; Non-GAAP EPS Was $0.03; GAAP Loss per Share and Non-GAAP EPS Include a Charge of $1.69 per Share for a Collaboration With Daiichi Sankyo Full-Year Worldwide Sales Were $60.1 Billion, an Increase of 1% From Full-Year 2022; Excluding LAGEVRIO, Growth Was 9%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 12% KEYTRUDA Sales Grew 19% to $25.0 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 21% GARDASIL/GARDASIL 9 Sales Grew 29% to $8.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 33% LAGEVRIO Sales Declined 75% to $1.4 Billion; Excluding the Impact of Foreign Exchange, Sales Declined 74% Full-Year 2023 GAAP

https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/

Merck To Present New Data From Its Broad Oncology Portfolio and Pipeline at ESMO 2021, Including in Earlier Stages of Cancer

Pivotal Phase 3 Data for KEYTRUDA® (pembrolizumab) in Stage II Melanoma (KEYNOTE-716) and Recurrent, Persistent or Metastatic Cervical Cancer (KEYNOTE-826) Selected for ESMO Presidential Symposium Sessions and Official Press Program New Data for KEYTRUDA Demonstrate Significant Progress in Breast and Gynecological Cancer Clinical Programs Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that data spanning 20 types of cancer from its leading oncology research program will be presented at the European Society for Medical Oncology (ESMO) Congress 2021 from Sept. 16–21. Key data include new Phase 3 results for the company’s oncology medicines, specifically: KEYTRUDA, Merck’s anti-PD-1 therapy in melanoma (KEYNOTE-716) and recurrent, persistent or metastatic cervical cancer (KEYNOTE-826), which were selected for inclusion in the ESMO Presidential Symposium sessions and the ESMO Press Program, and in metastatic triple-negative breast cancer (TNBC)

https://www.merck.com/news/merck-to-present-new-data-from-its-broad-oncology-portfolio-and-pipeline-at-esmo-2021-including-in-earlier-stages-of-cancer/

Merck Announces Fourth-Quarter and Full-Year 2022 Financial Results

Fourth-Quarter and Full-Year 2022 Results Reflect Sustained Strong Revenue Growth Fourth-Quarter 2022 Worldwide Sales Were $13.8 Billion, an Increase of 2% From Fourth Quarter 2021; Growth Excluding the Impact of Foreign Exchange Was 8% Fourth-Quarter 2022 GAAP EPS From Continuing Operations Was $1.18; Fourth-Quarter 2022 Non-GAAP EPS Was $1.62 Full-Year 2022 Worldwide Sales Were $59.3 Billion, an Increase of 22% From Full Year 2021; Growth Excluding LAGEVRIO Was 12%; Growth Excluding LAGEVRIO and the Impact of Foreign Exchange Was 15% KEYTRUDA Sales Grew 22% to $20.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 27% GARDASIL/GARDASIL 9 Sales Grew 22% to $6.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 27% Full-Year 2022 GAAP EPS From Continuing Operations Was $5.71; Full-Year 2022 Non-GAAP EPS Was $7.48 In 2022, Augmented Pipeline Through Strategic Business Development, Including Acquisition of Imago and Key Agreements With Moderna, Orna, Orion and

https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2022-financial-results/

Merck Highlights Scientific Data at 2021 ASCO Annual Meeting Across More Than 20 Cancer Types From Broad Oncology Research Program

First-Time Data for KEYTRUDA® (pembrolizumab) in Early-Stage Kidney Cancer and for LYNPARZA® (olaparib) in Early-Stage Breast Cancer To Be Featured in ASCO Plenary Session New Data To Be Presented for KEYTRUDA in Advanced Gastric Cancer Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that data spanning more than 20 cancer types from its oncology research program will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8. These data include new or updated findings from Merck’s broad oncology portfolio and diverse pipeline including KEYTRUDA, Merck’s anti-PD-1 therapy; LYNPARZA (in collaboration with AstraZeneca); LENVIMA ® (lenvatinib, in collaboration with Eisai); and belzutifan, an investigational hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. “Our expansive oncology clinical development program is designed to help us understand the full potential of our established and pipeline medicines and

https://www.merck.com/news/merck-highlights-scientific-data-at-2021-asco-annual-meeting-across-more-than-20-cancer-types-from-broad-oncology-research-program/

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