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Investing.com -- Bayer’s (ETR:BAYGN) experimental stroke drug could generate €3 billion in annual sales after successful trial results that Goldman Sachs analyst James Quigley called "transformational" for the German pharmaceutical company’s business.
Shares of the company were up 8.9% at 03:20 ET (08:20 GMT).
The drugmaker announced on Sunday that asundexian met its primary goals in the OCEANIC-STROKE trial, significantly reducing the risk of repeat strokes without increasing major bleeding rates compared to a placebo.
Both treatments were given alongside standard antiplatelet therapy in more than 12,300 patients who had previously experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
Quigley said removing the risk adjustment from his valuation model leads to a roughly 13% increase in his discounted cash flow analysis.
He noted this positive result is the first of two developments that could help narrow the gap between Bayer’s current share price and the value of its business units.
The second event, a potential recommendation from the solicitor general on a glyphosate legal case, is expected in the coming weeks.
The trial addresses a significant medical problem. Approximately 12 million people worldwide experience strokes each year, with 20% to 30% being recurrent strokes. One in five stroke survivors will have another stroke within five years.
Stroke ranks as the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry higher mortality risks than initial strokes.
"Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences," said Mike Sharma, the principal investigator from the Population Health Research Institute at McMaster University and director of the Stroke Program at Hamilton Health Sciences in a statement.
Asundexian works by blocking Factor XIa, a protein in the blood coagulation pathway. The Leverkusen-based company said Factor XIa plays a minor role in forming hemostatic plugs that seal vessel injuries but contributes to blood clot growth and vessel blockage.
The drugmaker theorizes asundexian reduces clot formation without significantly increasing major bleeding risk.
Patients in the multicenter, randomized, double-blind trial received either 50 mg of asundexian once daily or a placebo, both combined with antiplatelet therapy.
This marks the first time a drug in the Factor XIa inhibitor class has successfully completed a Phase III study.
The U.S. Food and Drug Administration granted asundexian Fast Track Designation as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. The compound has not been approved by any health authority for use in any country.