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Stock impact report

US FDA declines to approve Corcept's drug for rare hormonal disorder [Yahoo! Finance]

Xeris Biopharma Holdings, Inc. (XERS) 
Last xeris biopharma holdings, inc. earnings: 3/11 06:00 am Check Earnings Report
Company Research Source: Yahoo! Finance
Shares ?of the drugmaker were down 48% at $36.41. The company said the FDA could not arrive at a ?favorable benefit-risk assessment for the hormone-blocking oral treatment, known as relacorilant, without Corcept providing additional evidence of effectiveness. The company was seeking approval for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism. "FDA's request for additional data may require ?additional trials, significantly dimming Corcept's ?outlook in Cushings," said Truist analyst Joon Lee. Hypercortisolism, also known as Cushing's syndrome, occurs when the body is exposed to ?high cortisol activity. Corcept had submitted trial data that showed that relacorilant made improvements in a wide array of hypercortisolism's signs and symptoms. "We will meet with the FDA as soon ?as possible to discuss the best path forward," said Joseph Belanoff, Corcept's ?CEO. Main symptoms of hypercortisolism include a fatty hump between the should Show less Read more
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