Intel stock extends gains after report of possible U.S. government stake
NEW YORK - The U.S. Food and Drug Administration has accepted Merck’s (NYSE:MRK) New Drug Application for doravirine/islatravir, an investigational once-daily, oral, two-drug regimen for adults with HIV-1 infection who are virologically suppressed on antiretroviral therapy. Merck, a prominent player in the pharmaceuticals industry with annual revenue of $63.9 billion, continues to demonstrate its innovative capabilities. According to InvestingPro analysis, the company maintains excellent financial health with an impressive gross profit margin of 77% and appears undervalued at current market prices.
The FDA has set a target action date of April 28, 2026, under the Prescription Drug User Fee Act, according to a company press release.
If approved, doravirine/islatravir would be the first FDA-approved two-drug regimen without an integrase inhibitor that demonstrated non-inferior efficacy compared to three-drug regimens in clinical trials.
The application is based on Week 48 findings from two Phase 3 clinical trials where doravirine/islatravir showed non-inferiority to baseline antiretroviral therapy in one trial and to bictegravir/emtricitabine/tenofovir alafenamide in another. The safety profile was generally comparable to the comparator regimens in both trials. This development comes as Merck maintains its strong market position, with InvestingPro data showing the company has consistently paid dividends for 55 consecutive years and maintained dividend growth of 5.19% over the last twelve months.
"The health needs of people living with HIV often change over time - whether it’s managing comorbidities or navigating complex medication regimens," said Dr. Eliav Barr, senior vice president and chief medical officer at Merck Research Laboratories.
In the Phase 3 trials, 551 participants in one study and 513 in another were randomized to either switch to doravirine/islatravir or continue their current treatment. Both studies met their primary endpoint measuring the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
Merck has been involved in HIV research for more than 35 years. The company is also developing other HIV treatments, including potential once-weekly and once-monthly options.
In other recent news, Merck is nearing a significant acquisition of Verona Pharma, with a deal valued at approximately $10 billion. This acquisition will see Merck paying $107 per share, a 23% premium over Verona’s previous trading price. Jefferies has downgraded Verona Pharma stock from Buy to Hold in light of this acquisition, noting the transaction’s expected completion in the fourth quarter of 2025. Meanwhile, the U.S. Food and Drug Administration has granted priority review for Merck’s supplemental application to update the label for WINREVAIR, a drug for pulmonary arterial hypertension, with a target action date set for October 2025. Additionally, Merck is set to present new data from its HIV research pipeline at the upcoming International AIDS Society Conference, highlighting advancements in HIV prevention and treatment. UBS has reiterated its Buy rating on Merck stock, despite acknowledging some investor sentiment challenges. The firm remains optimistic about Merck’s key drivers, including the cancer drug Keytruda and the recently launched Winrevair. These developments reflect Merck’s ongoing efforts to expand its portfolio and address unmet medical needs in various therapeutic areas.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.