Merck & Co Stock Price, News & Analysis

Merck has launched a new podcast series called 'Career On Purpose', with the first episode focusing on their 'Skills-First' program. This initiative aims to attract, develop, advance, and retain talented individuals without four-year degrees. The episode features insights from Ngozi Motilewa, enterprise HR lead for the Skills-First Diversity Talent Initiative, who discusses the program's origins and impact. Robert Roberson, an enterprise shared service manager at Merck, shares his personal journey and highlights the importance of mentoring in his career progression within the program.

Merck, known as MSD outside the US and Canada, is a research-intensive biopharmaceutical company with a 130-year history of developing medicines and vaccines. The company emphasizes its commitment to diversity, inclusion, and responsible operations to create a sustainable and healthy future for communities worldwide.

Merck (NYSE: MRK) has completed the acquisition of CN201, a novel investigational clinical-stage bispecific antibody, from Curon Biopharmaceutical. CN201 is designed for B-cell depletion therapy with potential applications in B-cell malignancies and autoimmune diseases.

CN201 is currently in Phase 1 and Phase 1b/2 clinical trials for treating relapsed or refractory non-Hodgkin's lymphoma (NHL) and B-cell acute lymphocytic leukemia (ALL). Preliminary data suggest it has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well-tolerated.

Merck has acquired full global rights to CN201. The transaction is being accounted for as an asset acquisition, with Merck recording a pre-tax charge of approximately $750 million, or about $0.28 per share, to be included in third-quarter non-GAAP results.

Merck (NYSE: MRK) has announced its upcoming third-quarter 2024 sales and earnings conference call, scheduled for Thursday, October 31 at 9:00 a.m. ET. The call will provide institutional investors and analysts with an overview of the company's performance for the quarter. A live audio webcast will be accessible to investors, journalists, and the general public through a provided weblink. Following the call, a replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and result highlights, will be available on www.merck.com. Participants can also join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 using the access code 9818590.

Merck (NYSE: MRK) announced new long-term data for tulisokibart (MK-7240), an investigational anti-TL1A monoclonal antibody, in inflammatory bowel disease to be presented at UEG Week 2024. The data from Phase 2 ARTEMIS-UC and APOLLO-CD studies show maintenance of treatment efficacy at week 50 in 12-week induction responders for both ulcerative colitis and Crohn's disease.

Merck has initiated two Phase 3 studies (ATLAS-UC and ARES-CD) to evaluate tulisokibart's efficacy and safety. Recent results from the ARTEMIS-UC study, published in the New England Journal of Medicine, demonstrated tulisokibart's superiority over placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis after 12 weeks.

Merck (NYSE: MRK) announced that the Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab and pembrolizumab (KEYTRUDA®) did not meet its primary endpoint of overall survival (OS) for treating patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The combination did not demonstrate an improvement in OS compared to standard of care. The safety profile was consistent with previous studies, with no new safety signals observed.

Dr. M. Catherine Pietanza, VP of global clinical development at Merck Research Laboratories, acknowledged the challenges in treating MSS metastatic colorectal cancer. Merck will continue to advance its clinical development program for KEYTRUDA-based combinations and novel candidates for colorectal cancer patients. The favezelimab and pembrolizumab combination is also being evaluated in other malignancies, including the ongoing KEYFORM-008 Phase 3 study for relapsed or refractory classical Hodgkin lymphoma.

Merck (NYSE: MRK) announced new approvals for KEYTRUDA (pembrolizumab) in Japan for certain lung and urothelial cancers. The approvals include:

1. KEYTRUDA with chemotherapy as neoadjuvant treatment, then as monotherapy for adjuvant treatment in non-small cell lung carcinoma (NSCLC) patients.

2. KEYTRUDA with Padcev for first-line treatment of radically unresectable urothelial carcinoma.

3. KEYTRUDA monotherapy for radically unresectable urothelial carcinoma patients ineligible for platinum-containing chemotherapy.

These approvals are based on positive results from clinical trials KEYNOTE-671, KEYNOTE-A39, and KEYNOTE-052, respectively, showing significant improvements in overall survival and progression-free survival compared to standard treatments.

Merck Animal Health, a division of Merck & Co., Inc. (NYSE:MRK), has announced the expansion of its NOBIVAC® NXT vaccine platform to include a new solution for protecting cats against feline leukemia virus (FeLV). The NOBIVAC NXT FeLV vaccine is the first and only FeLV vaccine using RNA-particle technology, designed to deliver optimized protection. It is expected to be available in veterinary clinics nationwide this fall.

Key features of the vaccine include:

• Nonadjuvanted, low volume 0.5 mL dose
• Labeled effective against persistent viremia
• Indicated for cats 8 weeks of age or older
• 2-year duration of immunity
• Administered in 2 doses, 3- to 4-weeks apart

FeLV affects nearly 4% of cats in North America and can lead to severe health issues. The new vaccine represents a significant advancement in feline healthcare.

Merck (NYSE: MRK) announced positive opinions from the European Medicines Agency's CHMP for KEYTRUDA® (pembrolizumab) in two gynecologic cancer indications:

1. In combination with chemotherapy for first-line treatment of primary advanced or recurrent endometrial carcinoma in adults eligible for systemic therapy.

2. Combined with chemoradiotherapy for FIGO 2014 Stage III-IVA locally advanced cervical cancer in adults without prior definitive therapy.

These recommendations are based on the Phase 3 NRG-GY018 (KEYNOTE-868) and KEYNOTE-A18 trials, respectively. Both studies showed significant improvements in progression-free survival. The European Commission's final decisions are expected in Q4 2024.

The FDA has approved Merck's KEYTRUDA (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This approval is based on the Phase 3 CCTG IND.227/KEYNOTE-483 trial results, which showed:

- 21% reduction in risk of death compared to chemotherapy alone
- Median overall survival of 17.3 months vs 16.1 months for chemotherapy alone
- Significant improvement in progression-free survival
- Higher overall response rate (52% vs 29%)

This marks the first indication for KEYTRUDA in MPM in the U.S., offering a new treatment option for patients with generally poor prognoses.