Bayer is holding back from raising its sales forecast for its promising new drug Asundexian, despite a pivotal success in clinical trials. On Friday, the company reaffirmed the blood thinner's blockbuster potential—meaning possible annual sales of more than one billion euros. However, Bayer said it was still too early for a more specific estimate, as it must first await the exact conditions of regulatory approval as well as price negotiations. On Thursday, Bayer released final study data showing that Asundexian reduces the risk of recurrent ischemic stroke by 26 percent without increasing the risk of bleeding.

The study's success provided a boost on the stock market. Bayer shares rose as much as 3.2 percent at their peak, making them one of the strongest performers in the DAX index. "You can almost feel the sigh of relief under the Bayer cross," said analyst Frank Sohlleder of ActivTrades. One trader estimated the drug's peak sales potential at up to three billion euros, highlighting the strategic importance of the compound as several of Bayer's current revenue drivers face increasing pressure from generic competitors.

"We continue to firmly believe in the blockbuster potential of Asundexian. I am very confident that we will deliver on this promise," said Jan Voss, who is responsible for Asundexian at Bayer, during a conference call with analysts on Friday. However, how much more remains to be seen. For concrete figures on peak sales, it is currently "still a little too early." This will partly depend on the final approval label Bayer receives from the U.S. Food and Drug Administration (FDA) and other health authorities. "That will largely define the commercial potential."

Voss also pointed to a currently "quite volatile" global pricing environment. Bayer must ensure that payers worldwide understand the full economic impact of a stroke. This is not just about preventing strokes, but also about cost factors such as bleeding. "The data show there is no increase in bleeding rates compared to placebo. That alone is an important value driver," said Voss. This will ultimately determine pricing levels and thus peak sales.

On Thursday, Bayer presented the results of the pivotal Oceanic-Stroke study at a medical conference. Among participants who had already suffered a stroke, Asundexian reduced the risk of another ischemic stroke by 26 percent compared to placebo. Study co-leader Ashkan Shoamanesh of Canada's McMaster University described the results as "truly revolutionary," as the effect was achieved without an increased risk of major or minor bleeding. He expects this to become a new global standard of care.

The success is strategically crucial for Bayer. The company's pharmaceutical division must contend with the loss of patent protection for its high-revenue blood thinner Xarelto. After Asundexian failed in a 2023 study for treating patients with atrial fibrillation and stroke risk, the originally hoped-for peak sales potential of more than five billion euros also became obsolete. Bayer is now exploring further possible uses for the compound. The company is actively considering new studies, including gathering more data in the current indication and exploring its potential in other indications.

(Reporting by Patricia Weiß. Edited by Olaf Brenner. For any inquiries, please contact our editorial team at berlin.newsroom@thomsonreuters.com (for politics and economy) or frankfurt.newsroom@thomsonreuters.com (for companies and markets).