Xeris Biopharma (NASDAQ:XERS) stock is rallying after the drug maker announced that its Recorlev drug had been approved by the U.S. Food and Drug Administration for certain patients with Cushing’s syndrome. The drug combats endogenous hypercortisolemia in adult patients.
The FDA approved Recorlev for “adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative,” the company stated.
So what does this mean? Endogenous hypercortisolemia is caused by the overproduction of an anti-inflammatory hormone, called cortisol, by the body. The condition is usually triggered by an overproduction of cortisol by “hormone-secreting tumors of the adrenal glands or the pituitary … gland.”
Individuals with who experience these hormone imbalances have weakened immune systems, making them more susceptible to Covid-19.
What to Know About Recorlev
The FDA approved Recorlev after the drug performed well in two Phase 3 studies. In one study, the drug meaningfully lowered “urinary free cortisol concentrations without a dose increase,” according to Xeris.
In the second trial, 95.5% of patients who were taken off the drug returned to the levels of urinary-free cortisol production that they had before beginning the treatment. Conversely, only 40.9% of patients who kept taking the drug returned to their prior levels of urinary-free cortisol production.
In a statement, John H. Johnson, the CEO of Xeris subsidiary Stonebridge Biopharma, called the results of the second trial “a major step forward in our mission to help address the needs of the estimated 8,000 Cushing’s syndrome patients in the U.S. who are treated with prescription therapy, many of whom are not well-controlled with current therapies.”
He added that, “We look forward to leveraging our rare disease expertise and infrastructure to bring this important new therapy to the Cushing’s community.”
The Bottom Line on Xeris and XERS Stock
The company is also developing treatments for hypoglycemia and epilepsy management. It has developed technology that solves problems caused by “water-based [drug] delivery systems.” Specifically, it has created a syringe and an injection pen for the treatment of hypoglycemia in diabetes patients.
As of the end of the third quarter, it had total cash of $93 million. In late morning trading, the market capitalization of XERS stock was $385 million.
On the date of publication, Larry Ramer did not have (either directly or indirectly) any positions in the securities mentioned in this article.