US FDA Declines to Approve Corcept's Drug for Rare Hormonal Disorder

Reuters
2025/12/31

Dec 31 (Reuters) - The U.S. Food and Drug Administration has declined to approve Corcept Therapeutics' drug for the treatment of a rare hormonal disorder, the company said on Wednesday.

Shares of the drugmaker were down 50.2% in morning trading.

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.

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 shoulders, a rounded face, and pink or purple stretch marks on the skin. People with Cushing's also experience diabetes, high blood pressure, muscle weakness and immune suppression.

Relacorilant is a selective cortisol modulator designed to block the effects of cortisol, while avoiding certain off‑target hormonal effects.

Corcept is also studying the drug in a variety of serious disorders including ovarian and prostate cancer. Its other drug known as Korlym is approved to treat high blood sugar caused by hypercortisolism in adults with endogenous Cushing's syndrome.

Other approved treatments for Cushing's syndrome include Isturisa by Recordati and Xeris Biopharma's Recorlev.

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10