Merck & Co., Inc. - MRK STOCK NEWS

Merck (MRK) and Ridgeback Biotherapeutics have initiated the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIO™ (molnupiravir) for treating high-risk adults with COVID-19. The study targets adults who tested positive for SARS-CoV-2, have had symptoms for four days or less, and cannot receive nirmatrelvir/ritonavir due to various contraindications.

The trial will test a new formulation of LAGEVRIO using two 400-mg tablets per dose instead of four 200-mg capsules. The medication is currently approved or authorized in several countries, including Japan, Australia, and the US under emergency use authorization, and has been used by over 8.3 million patients worldwide.

Merck (MRK) announced that the FDA has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for treating advanced nonsquamous non-small cell lung cancer (NSCLC) with specific EGFR mutations. This designation is based on Phase 2 study data presented at the 2023 ASCO Annual Meeting. The company is advancing a global clinical development program with 10 ongoing Phase 3 studies across various solid tumors. Sac-TMT recently received its first marketing authorization in China for treating triple-negative breast cancer. The breakthrough designation may expedite development and review processes, with potential eligibility for Priority Review.

Merck (NYSE: MRK) has announced that its chairman and CEO Robert M. Davis, along with Dr. Eliav Barr, senior vice president and chief medical officer of Merck Research Laboratories, will participate in a fireside chat at the Citi 2024 Global Healthcare Conference. The event is scheduled for Thursday, December 5, 2024, at 8:00 a.m. EST. A live audio webcast of the presentation will be available to investors, analysts, media members, and the general public.

Merck (NYSE: MRK) announced positive topline results from the Phase 3 ZENITH study of WINREVAIR in adults with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality. The study met its primary endpoint, demonstrating a statistically significant reduction in the risk of morbidity or mortality events compared to placebo. Due to overwhelming efficacy, the independent monitoring committee recommended early study termination, with all participants being offered WINREVAIR through the SOTERIA open-label extension study. WINREVAIR is currently approved in the U.S. and 36 countries based on Phase 3 STELLAR trial results.

Merck (MRK) warns shareholders about TRC Capital's unsolicited mini-tender offer to purchase up to 1,000,000 shares at $96.38 per share. The offer price is approximately 4.32% below Merck's closing price of $100.73 on November 11, 2024, and 3.48% below the $99.86 closing price on November 21, 2024. Merck strongly recommends shareholders reject this offer, which seeks to acquire less than 5% of outstanding shares, thereby avoiding SEC disclosure requirements. The company emphasizes that mini-tender offers often catch shareholders off guard, potentially leading to below-market sales prices.

Merck (NYSE: MRK) has announced that Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer of Merck Research Laboratories, will participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference. The event is scheduled for Tuesday, December 3, 2024, at 1:20 p.m. EST. A live audio webcast of the presentation will be available to investors, analysts, media members, and the general public through a provided weblink.

Merck (MRK) has received approval from China's NMPA for WELIREG® (belzutifan), marking its first approval in China and 17th globally. The drug is approved for treating adult patients with certain von Hippel-Lindau (VHL) disease-associated tumors who require therapy but not immediate surgery. WELIREG is the first and only systemic therapy and HIF-2α inhibitor approved in China for this indication.

The approval is based on the Phase 2 LITESPARK-004 trial results, which showed significant response rates: 49% in VHL-associated RCC patients, 63% in CNS hemangioblastomas patients, and 83% in pNET patients. The median duration of response was not reached in any group, with responses lasting up to 22.3+ months.

Merck (MRK) announced that Surendralal L. 'Lal' Karsanbhai, president and CEO of Emerson Electric Co., will join its board of directors effective January 1, 2025. Karsanbhai will stand for election by shareholders in May 2025, bringing the total board membership to 13. With a career at Emerson since 1995, Karsanbhai became its CEO in 2021. He currently serves as deputy chair of the Federal Reserve Bank of St. Louis and on the US-China Business Council board.

Merck (MRK) announced the presentation of new data for its hematology pipeline at the ASH Annual Meeting in San Diego (Dec. 7-10). The company will showcase more than 20 abstracts, featuring research on investigational medicines including zilovertamab vedotin, an antibody-drug conjugate targeting ROR1, nemtabrutinib, a non-covalent BTK inhibitor, and bomedemstat, an oral LSD1 inhibitor. Key presentations include first-time results from Phase 2 studies evaluating zilovertamab vedotin in diffuse large B-cell lymphoma and mantle cell lymphoma, as well as nemtabrutinib in follicular lymphoma. Updated results for KEYTRUDA in Hodgkin lymphoma will also be presented.