By Sneha S K and Sahil Pandey
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 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 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.
"Given the company had opportunities to address FDA's concerns during mid and late-stage reviews, it's unclear if any further dialogue can resolve the review issues without additional trials," Lee added.
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.
(Reporting by Sahil Pandey and Sneha S K in Bengaluru; Editing by Shailesh Kuber)
LATEST POSTS
- 1
What’s your chronotype? Knowing whether you’re a night owl or an early bird could help you do better on tests and avoid scams - 2I took my shoes off and went for a barefoot hike. I couldn’t believe what happened next
- 3New funding transforms lives by expanding electricity access across Africa
- 4Winona Ryder didn't take the 'Stranger Things' plot lightly. How 'otherworldly' grief and a kidnapping in her hometown informed her character.
- 5Ferrari Cavalcade Suspended After High-Speed Crash in Argentina Involving a Purosangue
- Best Amusement Park in Europe: Where Do You Very much want to Visit?
- Pilot captures jaw-dropping northern lights show from 36,000 feet (photos)
- Artemis 2 astronauts are now headed to the moon. Why has it taken humanity so long to go back?
- IDF strikes terror infrastructure across Iran, attack reported on Kashan airport
- FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access
- ‘This year nearly broke me as a scientist’ – US researchers reflect on how 2025’s science cuts have changed their lives
- Launch pad damaged as Russian rocket blasts off for space station, agency says
- Health officials report 14 Legionnaires' disease cases in Florida, gym connection suspected
- National health ranking puts Georgia near bottom of list. Here's why
