Core Insights - Merck (MRK) has received FDA acceptance for the new drug application (NDA) for its investigational two-drug regimen doravirine/islatravir (DOR/ISL) aimed at treating virologically suppressed adults with HIV-1 infection, with a decision expected by April 28, 2026 [1][7] Drug Efficacy and Studies - If approved, DOR/ISL would be the first non-integrase inhibitor-based two-drug regimen demonstrating comparable efficacy and safety to the current three-drug standard, BIC/FTC/TAF, in phase III studies [2] - The NDA is supported by data from two pivotal phase III studies (MK-8591A-051 and MK-8591A-052), which showed that DOR/ISL (100 mg/0.25 mg) was non-inferior to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 [3] Ongoing Research and Collaborations - Merck is continuing its HIV research with additional trials, including MK-8591A-053 and MK-8591A-054, which evaluate DOR/ISL in treatment-naïve individuals and those from earlier studies, respectively [9][10] - The company is collaborating with Gilead Sciences (GILD) to evaluate islatravir in combination with GILD's lenacapavir in a phase II study for HIV treatment [10] Stock Performance - Year to date, Merck's shares have decreased by 15.5%, contrasting with a 0.2% rise in the industry [4]

SAN DIEGO, July 10, 2025 (GLOBE NEWSWIRE) -- The law firm of Robbins Geller Rudman & Dowd LLP announces that it has filed a class action lawsuit seeking to represent purchasers of Organon & Co. (NYSE: OGN) publicly traded securities between November 3, 2022 and April 30, 2025, both dates inclusive (the “Class Period”). Captioned Lerner v. Organon & Co., No. 25-cv-12983 (D.N.J.), the Organon class action lawsuit charges Organon and certain of Organon’s top executives with violations of the Securities Exchang ...

JUPITER, Fla., July 10, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner Pelthos Therapeutics Inc. (NYSE American: PTHS) has commercially launched ZELSUVMI™ (berdazimer) topical gel 10.3%, the first and only FDA-approved at-home treatment for molluscum contagiosum. The Company has earned a $5 million milestone payment from Pelthos following the commercial launch of ZELSUVMI. “Molluscum impacts millions of people in the U.S., particularly children. ...

Key Takeaways MRK faces major headwinds as Keytruda, its top seller, nears the loss of exclusivity in 2028. Gardasil sales dropped 40% in Q1 2025 due to weak China demand, despite strength in other regions. MRK expects IRA's Medicare drug pricing to impact Januvia in 2026 and Keytruda starting in 2028.Merck (MRK) is expected to face several hurdles over the next few years that could affect its long-term growth trajectory, starting with the anticipated loss of exclusivity of its blockbuster PD-L1 inhibitor ...

Merck & Co (MRK) M&A Announcement July 09, 2025 08:00 AM ET Speaker0 Thank you for standing by. Welcome to the Merck and Company Incorporated Rahway, New Jersey USA Investor Event announcing the acquisition of Verona Pharma Public Limited Company. This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations. Sir, you may begin. Speaker1 Thank you, Ivy. Good morning, everyone ...

Acquisition Overview - Merck将以每ADS 107美元的价格收购Verona Pharma的所有已发行股份[14,47]，总交易价值约为100亿美元[14,47]（约98亿美元扣除约2亿美元的现金、投资和债务[47]），预计将于2025年第四季度完成[14,47] - 这项以科学为驱动的业务发展[14]，加强并补充了心肺产品组合[14] - Ohtuvayre®是20多年来的首个新型吸入性COPD维持治疗药物[14]，这是一个巨大的疾病领域，存在着显著未被满足的医疗需求[14] Ohtuvayre® Clinical Data - Ohtuvayre®是一种磷酸二酯酶3（PDE3）和磷酸二酯酶4（PDE4）的双重抑制剂[24]，是20多年来首个用于COPD维持治疗的新型吸入机制[24] - 在两项3期试验中，Ohtuvayre®在肺功能方面表现出具有临床意义的改善，平均FEV1 AUC0-12h从基线相比安慰剂显著改善+87 mL和+94 mL[25,27] - 汇总数据显示，在ENHANCE-1和ENHANCE-2研究中，Ohtuvayre®降低了24周内的年度中度或重度加重率[28,29]，ENHANCE-2研究中，Ensifentrine 3 mg组的年度事件率为0.24，安慰剂组为0.42[29]，风险比为0.57[29]，降低了43%[29] Commercial Opportunity - 美国约有860万接受维持治疗的COPD患者[35,40]，其中约50%仍然持续有症状[36,40]，针对持续有症状的患者是启动重点[40]，人数约为430万[40] - 2025年第一季度，处方量约为25000张[42]，约60%的处方是续方[42]，自上市以来约有5300名处方医生[42]，相比2024年第四季度，处方医生增加了约50%[42] - Ohtuvayre®代表着到2030年代中期的一个数十亿美元的商业机会[14,43] Financial Impact - 预计该交易将在最初的12个月内对非GAAP每股收益产生约0.16美元的负面影响[47]，这代表着与为交易融资相关的成本，部分被Ohtuvayre®的业绩所抵消[47]，预计将在2027年实现非GAAP每股收益的增厚[47]，并在2028年全年实现增厚[47]

默克公司同意以每股107美元的价格收购 维罗纳制药公司。据悉，此次收购对维罗纳的估值约为100亿 美元。 ...

默克公司同意以每股107美元的价格收购维罗纳制药（Verona ）。 ...

智通财经7月9日电，默克公司同意以每股107美元的价格收购维罗纳制药（Verona ），总交易价值约为 100亿美元。 ...

RADNOR, Pa., July 08, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced a new collaboration with Merck, known as MSD outside of the United States and Canada, that expands Merck's use of the Certara Pinnacle 21 software platform to include a metadata repository and data standards workflow management. This agreement builds upon Merck's existing technology collaboration with Certara to aid in regulatory submissions. Certara accelerates me ...