CORT Shares Plummet On FDA’s Drug Rejection Letter Reveal — Here’s What Retail Has To Say

by

As per the letter published by the FDA, the agency had alerted the company regarding its concerns for Relacorilant before.

  • FDA refused to approve Corcept’s Relacorilant for hypercortisolism in December, citing insufficient proof of effectiveness. 
  • The company CEO then said that the company is “surprised” by the FDA’s decision. 
  • The company also committed to meeting with the FDA to discuss a path forward.

Shares of Corcept Therapeutics Inc. (CORT) fell 11% on Friday after the U.S. Food and Drug Administration (FDA) published its amended letter to the company pertaining to refusal of approval for its drug Relacorilant.

Add Asianet Newsable as a Preferred Source

As per the letter, the results of the late-stage trials submitted by the company are insufficient to demonstrate effectiveness in treating patients with hypercortisolism. The agency also flagged risks of drug induced liver injury

“During the pre-submission meetings, we informed you on several occasions of our concerns about the adequacy of the clinical development program to assess the effect of Relacorilant on hypertension in the intended population including the design of CORT125134-455, and to expect significant review issues if you were to submit your application,” the letter said.

The agency further asked for new clinical data to address the concerns raised and also risk mitigation strategies for drug-induced liver injury in the letter.

FDA Rejects Drug

The FDA refused approval for the drug in December.

“We are surprised and disappointed by this outcome,” CEO Joseph K. Belanoff had then said.

The company also committed to meeting with the FDA to discuss a path forward.

Relacorilant Uses

Corcept is studying Relacorilant in both hypercortisolism and ovarian cancer. Hypercortisolism, or Cushing syndrome, is a disorder caused by prolonged, excessive exposure to cortisol, resulting in symptoms like weight gain, thin skin, purple stretch marks, and hypertension.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around CORT stock remained within the ‘bearish’ territory while retail chatter improved from ‘extremely low’ to ‘low’ levels over the past 24 hours.

A Stocktwits user said that the company might have to re-do a full late-stage trial for approval.

Another highlighted that FDA’s rejection of Relacorilant is old news and the market has already overreacted to it.

Yet another compared the experimental drug with approved Cushing’s syndrome treatment Recorlev. “Either Recorlev should be immediately pulled from market for being 10x more dangerous than Relacorilant, or Relacorilant should be approved,” they wrote.

CORT stock has dropped about 43% over the past 12 months. 

For updates and corrections, email newsroom[at]stocktwits[dot]com.<

Leave a Comment