RAHWAY, N.J. - Merck (NYSE:MRK) announced that its drug Winrevair met the primary endpoint in a Phase 2 study evaluating treatment for adults with combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction, according to a press release statement. The pharmaceutical giant's shares have surged 55% over the past six months, trading near its 52-week high of $125.14, as investors respond positively to the company's robust drug pipeline.
The CADENCE study showed Winrevair achieved a statistically significant reduction in pulmonary vascular resistance versus placebo at week 24. The 0.3 mg/kg dose reduced PVR by 1.02 Wood units (p=0.004) and the 0.7 mg/kg dose by 0.75 Wood units (p=0.024). The study enrolled 164 participants randomized to receive placebo, 0.3 mg/kg Winrevair, or 0.7 mg/kg Winrevair every three weeks.
Results were presented at the American College of Cardiology's Annual Scientific Session and published in Circulation. The median age of participants was 75 years, with 69.5% female. At baseline, 65.9% had NYHA functional class III diagnosis.
Secondary endpoints showed reductions in mean pulmonary arterial pressure of -9.19 for the 0.3 mg/kg dose and -9.22 for the 0.7 mg/kg dose. The 0.3 mg/kg dose showed a 20.3-meter increase in six-minute walk distance, while the 0.7 mg/kg dose showed a 5.8-meter increase that did not reach statistical significance.With a market capitalization of $295.8 billion and a P/E ratio of 16.47, Merck maintains a "GREAT" financial health score according to InvestingPro analysis. The platform's Fair Value calculation suggests the stock remains undervalued at current levels, placing it among opportunities on the Most Undervalued list. Investors can access detailed analysis through Merck's comprehensive Pro Research Report, one of 1,400+ available for US equities.
Serious adverse events occurred in 20% of participants receiving 0.3 mg/kg, 33% receiving 0.7 mg/kg, and 22% receiving placebo. The safety profile was generally consistent with Winrevair's known profile in pulmonary arterial hypertension.
Merck stated the results support advancing Winrevair into a Phase 3 registrational program for this condition, with the 0.3 mg/kg dose potentially optimizing the benefit-risk profile. The company is working with regulatory agencies to design the Phase 3 study.
There are currently no approved treatments specifically for CpcPH-HFpEF.
In other recent news, Merck & Co. has announced a definitive agreement to acquire Terns Pharmaceuticals for a transaction value of approximately $6.7 billion. This acquisition values Terns at $53 per share, marking a premium over recent stock prices. Following the announcement, analysts have adjusted their ratings for both companies. Mizuho downgraded Terns Pharmaceuticals to Neutral from Outperform, reflecting the expectation that the deal will proceed as planned. Similarly, TD Cowen downgraded Terns Pharmaceuticals to Hold from Buy, citing the pending acquisition as the reason for the change.
On the other hand, Guggenheim reiterated a Buy rating for Merck, maintaining a price target of $140, while BofA Securities also reiterated a Buy rating with a $132 price target. Morgan Stanley maintained an Equalweight rating on Merck with a $109 price target, noting the acquisition aligns with Merck's strategic focus on expanding its hematology-focused oncology pipeline. The deal includes TERN-701, an allosteric BCR-ABL inhibitor, which will be added to Merck's pipeline. As part of the transaction, Merck will incur a $5.8 billion in-process research and development charge in the second quarter.