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.

應版權方要求,你需要登入查看該內容

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

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