US approval is crucial for the pharmaceutical division: its bestseller Xarelto is losing sales. Asundexian is intended to close the gap - especially in the USA, where Bayer is growing fastest.
The US Food and Drug Administration (FDA) has approved Bayer's new stroke treatment Asundexian, which will be the first drug in its class to be available in the USA.
Bayer plans to use Asundexian to offset lost sales of generics for the bestseller Xarelto and sees the drug as an important part of its growth strategy in the USA.
The Chinese Medicines Agency has already approved Asundexian, and Bayer expects EU approval next year.
Bayer is investing $2.2 billion in a new pharmaceutical plant in Ohio in order to also produce active ingredients and medicines in the USA in the future.
Dusseldorf, New York. The US Food and Drug Administration (FDA) has approved Bayer's new stroke treatment Asundexian, thereby securing one of the pharmaceutical company's most important growth drivers. The Leverkusen team announced this on Tuesday night. The drug is said to significantly reduce the risk of a second stroke. It is the first product in a new class of active ingredients to be available in the important US market. On the stock exchange, Bayer shares temporarily rose by two percent to an annual high of 57.78 euros on Tuesday.
With Asundexian, Bayer wants to replace the sales that generics are currently taking away from the previous bestseller Xarelto. "We are far from reaching the end of our growth in the USA. Asundexian is an essential building block in this strategy," says US boss Sebastian Guth, who is also responsible for the pharmaceutical business in all markets as Chief Operating Officer.
The USA is the group's largest and fastest-growing pharmaceutical market. According to Guth, Bayer now generates 35 percent of its pharmaceutical sales there. When he came to the US in 2018, it was around 20 percent.
At the end of October, the Chinese Medicines Agency had already approved the drug after an accelerated testing procedure, making it the first representative of the new class of active ingredients in the world. This means that Bayer received approval “in the two largest pharmaceutical markets in the world” almost at the same time, says Guth. “This is a novelty.”
The group is also “in constructive dialogue” with the European approval authorities. “I assume that we will receive approval in Europe over the next year.”
The approval marks a turning point. Investors had already written off the drug three years ago. In November 2023, Bayer had to stop a large study in patients with atrial fibrillation because the drug initially performed worse than a competing product. The stock then experienced its biggest fall in prices in decades.
However, a second study with stroke patients turned things around: Asundexian reduced the risk of another ischemic stroke by 26 percent without increasing the frequency of severe bleeding. This is exactly where the promise of the new class of active ingredients lies. Asundexian inhibits clotting factor XIa. This protein is considered a driving force in the growth of dangerous blood clots.
Asundexian is one of the most important new products with which Bayer wants to compensate for the losses caused by patent expiry of previous revenue generators. The anticoagulant Xarelto was Bayer's top-selling drug for a long time. In 2023 the funds brought in almost 4.1 billion euros, in 2025 it was only a good 2.3 billion euros. This year, analysts only expect sales of 1.4 billion euros.
Copycat products are also putting the company under pressure when it comes to the eye drug Eylea. For 2026, Bayer expects a decline in sales of 20 to 25 percent.
The declines have so far been offset by the prostate cancer drug Nubeqa and the heart and kidney drug Kerendia, which together had sales of a good 3.2 billion euros in 2025. Nubeqa could be the best-selling drug that Bayer has ever released. Analysts estimate the potential at almost five billion euros.
In the third quarter alone, Bayer generated around one billion euros in sales with Nubeqa. CEO Bill Anderson now sees the turning point in the pharmaceutical business and speaks of the beginning of a new growth cycle.
Bayer has not yet estimated how much Asundexian will bring in. “When we look at the medical need, we are talking about a drug with blockbuster potential,” says Guth. In the industry, that means at least a billion per year.
According to Christoph Koenen, Bayer's head of medicine, the value is also measured by the economic benefit. “The risk of a second stroke is significant.” One in ten patients suffers another stroke within a year, one in five within five years. “Stroke is the second most common cause of death in Europe today,” says Koenen.
Bayer estimates the economic costs of all strokes worldwide to be around $900 billion per year. “Preventing the second stroke is much more important because the consequences are much more serious and therefore the economic consequences are much greater,” says Koenen.
Commercially, Bayer has more control over Asundexian than over Xarelto, which the group still markets together with Johnson & Johnson. Bayer wants to sell the new product in all important markets without a partner. According to the company, patent protection extends well into the next decade.
Bayer also has a lead: Bristol-Myers Squibb and Johnson & Johnson are still waiting for the results of the crucial stroke study for their competitor drug Milvexian. “Then it will be decided whether Bayer has to share the market or not,” says Markus Manns, portfolio manager at Union Investment, the cooperative banks’ fund management company. He estimates the total market volume to potentially be $3 billion.
The group is also expanding its US presence in production. At the beginning of October, Bayer announced that it would invest $2.2 billion over several years in a modular pharmaceutical plant in New Albany, Ohio.
Cancer, cardiovascular and kidney drugs will initially be produced there, the active ingredients from 2031 and the finished drugs from 2034. In the previous five years, the company said it had already invested more than seven billion dollars in research, development and production in its US pharmaceutical business.
"Asundexian comes from our research and development unit in Germany. With our investment decision in Ohio, we will also be able to provide substantial production capacity in the United States in the future," says Guth. So far, Asundexian is manufactured in Europe. Bayer is still leaving it open which products will be manufactured in Ohio.
It is also unclear what price the Leverkusen company can charge in the USA. The government of US President Donald Trump is urging pharmaceutical companies not to offer new medicines in the USA at a higher price than in comparable industrialized nations.
A total of 26 manufacturers have already concluded agreements with the White House, and Bayer is not among them so far. The agreements also protect against tariffs: patent-protected medicines from the EU have been subject to 15 percent in the USA since this summer; manufacturers with price agreements are exempt from this.
Guth also sees other countries as having a duty: “We expect that other countries, especially economically strong countries, will also pay an adequate price for this innovation.” When asked by Handelsblatt, he left it open whether Bayer itself was seeking an agreement with Washington: “We are in continuous exchange with the American government on various topics, just as we are in continuous exchange with many other governments.”
