Merck Stock Hits Record High as FDA Approves Its Cardiovascular Disease Drug

Sign outside Merck & Co. headquarters in Kenilworth, New Jersey

Christopher Occhicone / Bloomberg via Getty Images

Key Takeaways

  • Merck & Co. shares soared to a record high Wednesday, a day after the Food and Drug Administration (FDA) approved the drug maker's treatment for a rare cardiovascular disease.
  • The drug, named Winrevair, is for patients suffering from pulmonary arterial hypertension (PAH), a condition in which blood pressure is raised because of restrictions in lung arteries.
  • Merck called Winrevair a first-of-its-kind medicine for PAH.

Merck & Co. (MRK) shares hit an all-time high Wednesday, a day after the drug maker announced that the Food and Drug Administration (FDA) approved its treatment for a rare condition that causes high blood pressure in patients because of restrictions in their lung arteries.

The injectable drug, which goes by the brand name of Winrevair, is for adults suffering from pulmonary arterial hypertension (PAH). The company explained that Winrevair helps those taking it to increase exercise capacity and reduce their risk of worsening health events.

Merck said Winrevair is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy. The company noted the FDA had previously given it Breakthrough Therapy Designation.

Marc Humbert, who was an investigator in the Phase 3 study of Winrevair, called the approval “an important milestone, as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway.”

Winrevair reportedly is priced at $14,000 per dose, and patients take the injection once every three weeks to treat the disease, which affects nearly 40,000 people in the U.S. Merck, which paid $11.5 billion for the company developing the medicine in 2021, generates more than 40% of its revenue from cancer treatment Keytruda, the world’s top-selling drug.

Shares of Merck were up 3.9% to $130.46 as of 11:50 a.m. ET Wednesday after hitting a record-high $133.10 earlier in the session. They are up almost 20% so far this year.

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  1. FDA. "Drugs@FDA: FDA-Approved Drugs."

  2. Merck & Co. "FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)."

  3. The Wall Street Journal. “Merck’s $11.5 Billion Bet on Its Next Big Drug Finally Arrives.”

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