MRK HIV Regimen Meets Goal in New Study, Gains EU Nod for Keytruda SC

Merck MRK announced positive top-line results from a pivotal late-stage study evaluating its investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in treatment-naïve adults with HIV-1 infection.A regulatory filing seeking the approval of DOR/ISL for treating adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy (pre-treated) is already under review by the FDA. A decision from the regulatory body is expected on April 28, 2026.Merck’s phase III MK-8591A-053 study evaluated the antiretroviral activity, safety and tolerability of once-daily DOR/ISL in treatment-naïve adults with HIV-1 infection compared to Gilead’s GILD once-daily 3-drug combo therapy, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). The enrolled patient population was randomized equally into two groups to receive either DOR/ISL or GILD’s Biktarvy regimen for 48 weeks.Per the data readout, the late-stage study met its primary endpoint, demonstrating the non-inferiority of Merck’s DOR/ISL therapy to Gilead’s Biktarvy, as measured by the percentage of patients whose HIV-1 RNA fell below 50 copies/mL at week 48. Additionally, the phase III study also met its primary safety goal, as the safety profile of DOR/ISL was comparable to that of Biktarvy.Merck plans to present detailed results from the MK-8591A-053 study at a future medical conference. Based on the encouraging 48-week data, the company is also gearing up to submit applications to health authorities, seeking approval for DOR/ISL to treat treatment-naïve HIV patients.Year to date, shares of Merck have lost 4.4% against the industry’s growth of 14.5%.Image Source: Zacks Investment ResearchThe regulatory filing for the pre-treated patient population is supported by 48-week results from two pivotal phase III studies, MK-8591A-051 and MK-8591A-052, where DOR/ISL demonstrated non-inferiority to baseline antiretroviral therapy and Gilead’s Biktarvy, respectively. In both studies, DOR/ISL showed a generally similar safety profile to the respective comparator regimens.Please note that Merck currently markets doravirine for treating adults with HIV-1 in the United States, either as a monotherapy under the brand name Pifeltro, as well as part of the single-tablet combination under the brand name Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).MRK Gains EU Nod for Subcutaneous KeytrudaIn a separate press release, Merck announced that the European Commission (EC) has approved the subcutaneous (under the skin or SC) formulation of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab). This version, which will be marketed as Keytruda SC, is approved across all solid tumor indications for which the drug’s intravenous (into the vein or IV) version is already approved in the EU.The EC’s approval was expected, as the advisory committee to the European Medicines Agency issued a positive opinion recommending the approval of the new formulation in September 2025. The SC version of Keytruda is also currently approved in the United States and is marketed under the brand name Keytruda Qlex.A major advantage offered by Keytruda Qlex/SC over the IV formulation is improved patient convenience. Delivering a drug SC instead of IV can significantly reduce administration time. Per Merck, the SC version can be administered to patients in as little as one minute compared with the IV formulation, which takes at least 30 minutes. This also likely eases the burden on healthcare facilities, making treatment more accessible and potentially boosting adoption rates.The EU approval is supported by data from pivotal studies, which showed that treatment with Keytruda SC was at least as effective as the IV version.Cogent Biosciences, Inc. Price and Consensus Cogent Biosciences, Inc. price-consensus-chart | Cogent Biosciences, Inc. QuoteMRK's Zacks Rank & Stocks to ConsiderMerck currently has a Zacks Rank #3 (Hold).Some better-ranked stocks in the biotech sector include Arcutis Biotherapeutics ARQT and ADMA Biologics ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 100.2%.Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 57 cents to 58 cents for 2025. During the same time, earnings per share estimates for 2026 have improved from 88 cents to 90 cents. Year to date, shares of ADMA have lost 7%.ADMA Biologics’ earnings beat estimates in one of the trailing four quarters, matched once and missed the same on the remaining two occasions, with the average negative surprise being 3.01%.Zacks' Research Chief Names "Stock Most Likely to Double"Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%.Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Merck & Co., Inc. (MRK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report ADMA Biologics Inc (ADMA): Free Stock Analysis Report Arcutis Biotherapeutics, Inc. (ARQT): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks