Xeris Biopharma Holdings, Inc. (XERS) stock surged 29.63% in the after-market trading session at the price of $3.15 following the approval of Recorlev by the Food and Drug Administration (FDA). XERS is a biopharmaceutical firm. It develops and commercializes novel therapies for neurology, endocrinology, and gastroenterology.  

FDA Granted Approval for Recorlev 

On 30th December 2021, XERS announced that FDA had approved Recorlev to treat endogenous hypercortisolemia. The drug had designed for patients with Cushing’s syndrome for whom there is no option for surgery. The approval was based upon the favorable results, safety, and efficacy data from two prior Phase-III studies. The studies evaluated 166 drug-treated U.S. adult patients with Cushing’s syndrome. 

Management Comments  

Chief executive officer of Xeris Biopharma, Paul R. Edick, remarked that they are excited after the FDA approved Recorlev to treat endogenous Cushing’s syndrome. With this approval, XERS’s endocrinology-focused unit has rapidly started working to address the unmet medical needs of U.S. adult populations with this syndrome. This notification also strengthens the value of Strongbridge Biopharma’s unique rare disease portfolio, which they believe will provide long-term value to the shareholders. They look ahead to commercialize Recorlev by the first quarter of 2022, Paul R. Edick added. 

President of the Cushing’s Support & Research Foundation, Leslie Edwin, stated that Cushing’s syndrome is a rare condition that can be emotionally and physically destructive to the patient. Most patients bear years of symptoms without getting diagnosed and later receive limited curative options. They are happy that the complicated journey of rare drug development has acquired FDA approval as a novel therapeutic option for Cushing’s patients.   

Leslie Edwin added that patients with such rare disorders know the significance of sharing their complex experiences. He thanked the researchers and contributors who worked with dedication to demonstrate the safety and efficacy of this effective treatment. Leslie Edwin also thanked Xeris Biopharma for being the first devotee of this vision. He especially thanked the patients who made this clinical trial progress possible.


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