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
Artemis II's moonbound toilet is working again to astronauts' relief after overnight fix - 2Students were skipping my astrophysics class to play video games – so I turned the class itself into a video game
- 3Heading to Florida for NASA's Artemis 2 moon launch? Here's what to know before you go
- 4Treason trial of South Sudan's suspended VP is further eroding peace deal, UN experts say
- 5Charli xcx teases new film ‘The Moment’: What to know about the A24 movie
- The Best 10 Innovation Developments of the Year
- Three killed as unfinished building collapses on church service in Ghana
- From Iran to Israel: An Iranian volunteer’s unlikely stand in wartime
- 5 Critical Rules For Business Regulation Chiefs
- Flu is rising rapidly, driven by a new variant. Here's what to know
- The cheap health insurance promoted by Trump officials has this catch
- Vote In favor of Your Favored Web based Dating Application
- The Ascent of the Kona SUV: How Hyundai's Reduced Hybrid Is Vanquishing the Streets
- Don't fall for it: These common tourist scams in Rome are easy to avoid if you know what you're looking for
