
Shares of Corcept Therapeutics, Inc. (CORT) slipped in extended trading on Tuesday after weaker-than-expected fourth-quarter (Q4) profit, as investors weighed the setback to its Cushing syndrome drug ahead of a key FDA meeting in April.
CORT stock jumped over 3% in Tuesday’s regular session.
Corcept reported Q4 revenue of $202.1 million, up from $181.9 million a year earlier but below expectations, while net income fell to $24.3 million, or $0.2 per diluted share, from $30.7 million, or $0.26 per share, also missing estimates.
For the full year, revenue rose to $761.4 million from $675.0 million in 2024, while net income declined to $99.7 million from $141.2 million. Corcept guided for full-year 2026 revenue of $900 million to $1 billion.
“In 2025, our Cushing’s syndrome business experienced a surge in demand due to growing recognition among physicians of hypercortisolism’s true prevalence and the necessity of appropriate treatment,” CEO Joseph K. Belanoff said, adding that there was a record number of new prescriptions and prescribers.
However, Belanoff noted that growth was partially constrained by capacity issues and operational disruptions tied to a specialty pharmacy transition in Q4. He said the transition is now complete, and February is on track to be a record month for new patient starts.
Investor attention remains centered on Relacorilant after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter in December, refusing approval of the drug for patients with hypercortisolism, also known as Cushing syndrome.
In an amended letter published last month, the FDA said the late-stage trial results were insufficient to demonstrate effectiveness and flagged concerns around drug-induced liver injury. The agency also said it had raised concerns during pre-submission meetings about the adequacy of Corcept’s clinical development program, particularly regarding the assessment of effects on hypertension, and requested new clinical data and risk mitigation strategies.
While the FDA acknowledged that Corcept’s pivotal Grace trial met its primary endpoint and that confirmatory evidence was provided, it said it could not reach a “favorable benefit-risk assessment” without additional evidence in December.
On Tuesday’s earnings call, Corcept pushed back on the FDA’s conclusions and said an April FDA meeting will be critical to understanding the decision.
Gary Robb, the company’s chief business officer, said Corcept believes the data “clearly met the hurdle for approval” and were consistent with those supporting previously approved treatments. “The confirmatory evidence we provided also met its endpoint until the agency mentioned sort of an analysis at the end that they performed that we had never seen and really can't replicate,” he added.
“There is daylight between our position and their position,” Robb said, adding that the April meeting is intended to clarify the FDA’s thinking and determine next steps.
Belanoff cited results from the company’s Catalyst study showing that treating hypercortisolism in certain patients led to symptom improvement. He said it is too early to say whether Corcept will pursue a new randomized trial.
Separately, Corcept said its New Drug Application for Relacorilant in platinum-resistant ovarian cancer remains under FDA review, with a July 11 deadline for the FDA to decide whether to approve the drug, and a European decision expected later this year.
The company also outlined multiple ongoing and planned studies across oncology, metabolic disease and (amyotrophic lateral sclerosis) ALS, including a planned Phase 3 trial of Dazucorilant in ALS by mid-year.
On Stocktwits, retail sentiment for CORT was ‘bullish’ amid a 1,200% surge in 24-hour message volume.
One user said, “CORT is a solid, growing company with multiple self-funded catalysts span across endocrinology and oncology. The current SP is an once-in-life-time bargain. GLTA! “
Another user said, “Beaten down and an absolute steal at these prices. This company is going nowhere, buy and hold.”
CORT stock has risen 5% year to date.
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