BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSE: MRK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic ther ...

Merck & Co., Inc. (NYSE:MRK) 6th Annual Evercore ISI HealthCONx Conference Transcript November 30, 2023 1:20 PM ET Executives Dr. Eliav Barr - Senior Vice President, Head, Global Clinical Development and CMO Peter Dannenbaum - Vice President, Investor Relations Analysts Umer Raffat - Evercore Umer Raffat Thank you. Listen, thank you guys for being here. Apologies. I’m a couple minutes behind. Pleasure to have Merck management join us. This is our last fireside of this conference, at least on my end. Dr. Eli ...

Merck & Co., Inc. (NYSE:MRK) Jefferies London Healthcare Conference November 16, 2023 5:00 AM ET Company Participants Caroline Litchfield - Chief Financial Officer Peter Dannenbaum - Head of Investor Relations Conference Call Participants Akash Tewari - Jefferies Akash Tewari All right, good morning, day three of our London Healthcare Conference. It has been a blast to see everyone here, really do appreciate it. Joining us -- and my name is Akash Tewari. I'm a pharma and biotech analyst, here at Jefferies. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File No. 1-6571 Merck & Co., Inc. (Exact name of registrant as specified in its charter) New Jersey 22-1918501 (State or other jurisdicti ...

Merck & Co., Inc. (NYSE:MRK) Q3 2023 Earnings Conference Call October 26, 2023 9:00 AM ET Company Participants Peter Dannenbaum - Vice President, Investor Relations Rob Davis - Chairman and CEO Caroline Litchfield - Chief Financial Officer Dr. Dean Li - President, Merck Research Labs Conference Call Participants Chris Shibutani - Goldman Sachs Mara Goldstein - Mizuho Carter Gould - Barclays Seamus Fernandez - Guggenheim Terence Flynn - Morgan Stanley Andrew Baum - Citi Louise Chen - Cantor Chris Schott - JP ...

Merck Q3 2023 Earnings Agenda ...

Merck & Co. Inc. (NYSE:MRK) October 22, 2023 1:00 PM ET Company Participants Peter Dannenbaum - VP, IR Dr. Dean Li - President, Merck Research Labs Eliav Barr - CMO & Head of Global Clinical Development, Merck Research Laboratories Marjorie Green - Senior VP & Head of Late-Stage Oncology, Global Clinical Development Jannie Oosthuizen - President, Human Health U.S. Conference Call Participants Umer Raffat - Evercore Luisa Hector - Berenberg Trung Huynh - UBS Conor MacKay - BMO Capital Markets Louise Chen - C ...

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Summary of Merck & Co., Inc. Conference Call Company Overview - **Company**: Merck & Co., Inc. (NYSE:MRK) - **Event**: Citi 18th Annual BioPharma Conference - **Date**: September 6, 2023 - **Participants**: Marjorie Green (SVP and Head of Late Stage Oncology, Global Clinical Development), Andrew Baum (Citi) Key Points Industry Focus - **Oncology Development**: Discussion centered around Merck's oncology pipeline, particularly the development of anti-TIGIT therapies and their combination with KEYTRUDA. Core Insights 1. **TIGIT Development**: Merck emphasizes overall survival (OS) as the key endpoint for TIGIT studies, rather than progression-free survival (PFS), due to the modest efficacy improvements in PFS not always translating to OS [3][14] 2. **G5003 Study**: The G5003 study is designed to test the efficacy of anti-TIGIT co-formulation compared to KEYTRUDA, with an increased sample size to focus on patients with high PD-L1 expression [5][6] 3. **Chemotherapy Combination Trials**: Merck is conducting trials combining chemotherapy with PD-1 inhibitors, with ongoing debates about the role of immunogenic cell death in enhancing efficacy [10][11] 4. **Antigen Presentation**: The company believes that increased antigen presentation can occur without immunogenic cell death, suggesting that efficacy can still be achieved across a range of PD-L1 expressions [11][12] 5. **ADC Development**: Merck is exploring antibody-drug conjugates (ADCs) and their potential in various cancers, acknowledging the challenges in biomarker-dependent efficacy [19][21] 6. **HER2 Targeting**: Discussion on the potential of targeting HER2 low expression in solid tumors, with a focus on the challenges of demonstrating efficacy in this area [28][29] 7. **Nemtibrutinib and IRA Impact**: The Inflation Reduction Act (IRA) is influencing drug development strategies, but Merck remains committed to developing nemtibrutinib, which may help prevent resistance to BTK inhibitors [46] 8. **Early Stage Cancer Focus**: Merck is committed to improving cure rates in early-stage cancers, with ongoing studies and a focus on innovative therapies [59][60] Additional Insights - **Regulatory Relationships**: Merck has established good relationships with regulators, which may facilitate the advancement of their mRNA technology and other therapies [36][38] - **Clinical Trial Design**: The company is cautious about trial designs and outcomes, particularly in the context of competitive landscapes and emerging data [52][56] - **Investment in Discovery**: Merck is investing in its internal discovery capabilities while also pursuing external partnerships and acquisitions to enhance its oncology portfolio [48] Potential Risks - **Market Competition**: The crowded field of KRAS inhibitors and ADCs presents challenges for differentiation and market positioning [52][56] - **Regulatory Challenges**: Ongoing changes in healthcare policy, such as the IRA, may impact the development timelines and financial viability of new therapies [46] Conclusion Merck is actively advancing its oncology pipeline with a focus on innovative therapies, particularly in the areas of anti-TIGIT and ADCs. The company is navigating a complex regulatory environment while maintaining a commitment to improving patient outcomes in cancer treatment.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File No. 1-6571 Merck & Co., Inc. (Exact name of registrant as specified in its charter) New Jersey 22-1918501 (State or other jurisdiction of ...