Bayer's Pharmaceutical Setback: Asundexian Trial Halted, Shares Plummet
In a major blow for Bayer AG, the shares of the chemical and pharmaceutical giant took a nosedive following the sudden halt of a medical study for the anticoagulant Asundexian. The Frankfurt Stock Exchange witnessed a 19% plunge in Bayer's share price at its peak on Monday, settling just above the 33 euros mark.
The high hopes surrounding Asundexian, a drug intended for patients with atrial fibrillation and stroke risk, were dashed when Bayer announced on Sunday evening that the phase III trial would be prematurely terminated. The Independent Data Monitoring Committee (IDMC) had recommended this move due to the drug's "inferior efficacy" compared to the control arm of the trial. Bayer remains committed to analyzing the data further, hoping to gain a better understanding of the results and eventually publishing them.
Asundexian: A Beacon of Hope and Revenue
Asundexian was not just a glimmer of hope for patients, but also for Bayer's bottom line. The company had anticipated the drug to generate more than five billion euros in annual sales by 2026, making it Bayer's most profitable drug.
While the bad news returns, there remains a glimmer of hope with an ongoing study evaluating Asundexian's effectiveness against strokes. Analysts at Jefferies, a US investment bank, viewed the end of one trial as a significant blow yet acknowledged the ongoing study's potential impact.
Monsoon of Legal Woes
Just a week prior, Bayer endured another hurdle in the United States. A Missouri court ordered Bayer's subsidiary, Monsanto, to pay damages exceeding US$ 1.5 billion to three plaintiffs who attributed their cancer cases to long-term usage of glyphosate, the controversial weedkiller manufactured by Monsanto.
Bayer's acquisition of Monsanto for US$63 billion in 2018 has been mired in lawsuits ever since. Over 160,000 lawsuits have been filed by alleged victims, with around 113,000 cases already concluded. Bayer has set aside USD 16 billion in provisions, stating its intention to appeal the latest verdict.
Enrichment Insights:
- The underlying reason for the premature halt of the OCEANIC-AF trial was a higher incidence of thromboembolic events in the Asundexian group compared to the apixaban group, despite Asundexian demonstrating lower major bleeding rates (0.2% vs. 0.7%; HR, 0.32).
- The ongoing phase 3 trial, OCEANIC-Stroke, is still underway, with results anticipated in 2026, which could potentially provide further insights into the safety and efficacy of Asundexian.
While the halting of the OCEANIC-AF trial casts uncertainty over Asundexian's future, the impact on sales is yet to be clearly established. The results of the OCEANIC-Stroke trial, scheduled for 2026, will likely provide insights into the drug's future prospects.
