Merck & Co Stock Price, News & Analysis

Merck announced significant findings for KEYTRUDA at the SMR 2021 Congress, showcasing its effectiveness in treating melanoma. The exploratory 7-year follow-up data from KEYNOTE-006 showed a median overall survival of 32.7 months for KEYTRUDA versus 15.9 months for ipilimumab. The 7-year survival rates were 37.8% vs. 25.3%, respectively. In the KEYNOTE-716 trial, KEYTRUDA demonstrated a 39% reduction in the risk of disease recurrence compared to placebo in patients with resected stage IIB/IIC melanoma. Safety profiles were consistent across studies, with no new safety signals identified.

Merck (NYSE: MRK) has withdrawn its Premerger Notification under the HSR Act concerning its acquisition of Acceleron Pharma Inc. (NASDAQ: XLRN), initially filed on October 14, 2021. This decision allows more time for FTC review, with a refiling expected around November 1, 2021. The tender offer for Acceleron shares at $180 per share is extended until November 18, 2021. As of October 28, 2021, approximately 8.4 million shares have been tendered, representing 13.7% of Acceleron's outstanding shares. The acquisition is anticipated to close in Q4 2021, pending regulatory approvals.

Avoro Capital Advisors, holding approximately 7% of Acceleron Pharma, opposes Merck's proposed acquisition of Acceleron at $180 per share, deeming it undervalued. Avoro believes Acceleron has significant potential as a standalone entity, especially with upcoming Phase 3 STELLAR trial results expected by end of 2022 that could enhance share price. The letter emphasizes monetizing existing royalties from Reblozyl and exploring better strategic alternatives to maximize shareholder value, criticizing the Board's decision-making process and urging fellow shareholders to reject the tender offer.

Organon (NYSE: OGN) will release its third quarter 2021 financial results on November 11, 2021, before a webcast and conference call at 8:30 a.m. ET. Interested parties can access the live call via the Organon website, with a replay available two hours post-event. Institutional investors must register in advance to participate. Formed from a spin-off of Merck (NYSE: MRK), Organon focuses on women's health with over 60 medicines and products, pursuing collaboration with biopharmaceutical innovators.

Merck (MRK) reported strong third-quarter 2021 sales of $13.2 billion, a 20% increase year-over-year. Key drivers included KEYTRUDA sales, up 22% to $4.5 billion, and GARDASIL, with sales surging 68% to $2 billion. The company achieved a GAAP EPS of $1.80 and non-GAAP EPS of $1.75. Merck raised its 2021 revenue outlook to $47.4-$47.9 billion, reflecting a 14-15% growth. The acquisition of Acceleron Pharma aims to enhance Merck's cardiovascular pipeline. Multiple regulatory approvals for cancer treatments and COVID-19 antiviral molnupiravir highlight ongoing innovation.

Merck (NYSE: MRK) announced Week 144 data from its Phase 2b study on islatravir combined with doravirine for HIV-1 treatment. The study found that this combination maintained viral suppression in treatment-naïve adults, showing 72.2% achieved HIV-1 RNA levels <50 copies/mL, comparable to 77.4% in the control group. The safety profile was similar across groups, with key adverse events reported at manageable rates. Merck is advancing its ILLUMINATE Phase 3 program, aiming for broader applications of islatravir, which is part of their commitment to addressing HIV globally.

Merck has announced a voluntary licensing agreement with the Medicines Patent Pool (MPP) for its investigational oral COVID-19 antiviral, molnupiravir. The agreement allows MPP to sublicense molnupiravir production in 105 low- and middle-income countries, ensuring affordable access without royalties for Merck, Ridgeback Biotherapeutics, and Emory University as long as COVID-19 is a public health emergency. Merck aims to enhance global healthcare access through this initiative, marking MPP's first voluntary license for a COVID-19 treatment.

The Phase 2 clinical study has commenced, evaluating a once-weekly oral combination of islatravir and lenacapavir for HIV treatment, led by Gilead Sciences (GILD) and Merck (MRK). This collaboration aims to provide long-acting HIV therapies to address diverse patient needs. The study will assess safety and antiviral effects, with a primary endpoint of HIV-1 RNA viral load at Week 24. Both investigational drugs have shown promise in earlier trials, with the goal of addressing adherence and stigma issues in HIV treatment.

Merck (NYSE: MRK) reported positive outcomes from two pivotal Phase 3 trials (ILLUMINATE SWITCH A and B) assessing the investigational combination pill doravirine/islatravir (DOR/ISL) in HIV-1 patients on antiretroviral therapy. Both trials met primary efficacy endpoints after 48 weeks, showcasing comparable antiviral efficacy with existing treatments. The safety profile remained consistent with previous studies. These findings will support global regulatory submissions and future presentations at scientific congresses, demonstrating Merck's commitment to advancing HIV treatments.