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RAHWAY, N.J. - Merck (NYSE:MRK), a prominent pharmaceutical company currently trading near its 52-week low and identified as undervalued by InvestingPro analysts, announced Tuesday that its pulmonary arterial hypertension (PAH) drug WINREVAIR significantly reduced the risk of clinical worsening events by 76% in recently diagnosed patients when added to background therapy.
The Phase 3 HYPERION trial results, presented at the European Respiratory Society Congress and published simultaneously in the New England Journal of Medicine, showed benefits when the drug was initiated within the first year of PAH diagnosis. The company, which maintains an impressive 77.4% gross profit margin and has consistently paid dividends for 55 consecutive years, continues to demonstrate its strength in drug development.
The study enrolled 320 adults with PAH who were diagnosed within 12 months of screening. Most participants (78.8%) were classified as functional class III, with 72.2% on double background therapy.
Results showed that 10.6% of patients treated with WINREVAIR experienced at least one clinical worsening event compared to 36.9% in the placebo group. The treatment benefit was observed within six weeks of randomization and was consistent across all prespecified subgroups.
"The patients with PAH enrolled in HYPERION were early in their treatment journey, had co-morbidities and were older, which reflects the type of patients we are diagnosing in a contemporary real-world setting," said Dr. Vallerie McLaughlin, Director of the Pulmonary Hypertension Program at the University of Michigan.
WINREVAIR also demonstrated statistically significant improvements in two secondary endpoints: multicomponent improvement (29.4% vs 14.6% for placebo) and maintenance or achievement of a low REVEAL Lite 2 score (60.1% vs 47.9%).
The safety profile was generally consistent with previous trials, with adverse events occurring in 89.4% of WINREVAIR patients versus 90.0% in the placebo group. Serious adverse events were reported in 24.4% versus 28.1%, respectively.
WINREVAIR is currently approved in more than 54 countries based on results from the earlier STELLAR study. The HYPERION trial was stopped early based on the totality of data from the WINREVAIR clinical program, with all patients offered the opportunity to receive the drug through an open-label extension study.
According to the company’s press release statement, Merck plans to submit these results to regulatory authorities worldwide. With a healthy dividend yield of 4.12% and a "GREAT" financial health score from InvestingPro, which offers 12 additional exclusive insights about Merck’s investment potential, the company appears well-positioned to maintain its market leadership in pharmaceuticals. Investors seeking detailed analysis can access Merck’s comprehensive Pro Research Report, available among 1,400+ top stocks on InvestingPro.
In other recent news, Evaxion Biotech announced that MSD, known as Merck & Co. in the United States, has exercised its option to license Evaxion’s vaccine candidate EVX-B3. Under this agreement, Evaxion will receive $7.5 million upfront and could earn up to $592 million in future milestone payments, along with royalties on net sales. Meanwhile, Merck is actively involved in several developments, including the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval of its RSV antibody, ENFLONSIA, for newborns and infants. Additionally, Merck’s KEYTRUDA received positive opinions for a new subcutaneous administration route and indication from the same committee. In a strategic financial move, Merck is tapping into the bond market to fund its $10 billion acquisition of Verona Pharma. This involves offering investment-grade corporate bonds, including a 30-year option. However, Berenberg has downgraded Merck’s stock rating from Buy to Hold, citing concerns about Keytruda’s patent despite acknowledging the success of Merck’s pipeline developments and deal-making activities in 2025. These recent developments highlight Merck’s ongoing efforts in expanding its pharmaceutical portfolio and securing financial backing for its strategic acquisitions.
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