Corcept Therapeutics (NASDAQ: CORT) crashed about 50% on Dec. 31 after the FDA requested additional data to support the efficacy of relacorilant, its candidate treatment for Cushing’s syndrome.
The setback cast doubt on CORT’s pipeline strength and triggered a sharp re-evaluation by analysts. It underscores the market’s sensitivity to regulatory developments in small-cap drug makers.
Following today’s plunge, Corcept stock is down 70% versus its year-to-date high in late March.
What FDA setback means for Corcept stock
FDA’s request for more evidence on relacorilant’s effectiveness has materially weakened investor confidence in Corcept’s near-term growth.
The drug was expected to be a key revenue driver in the Cushing’s syndrome market, where CORT already sells Korlym.
With relacorilant now facing delays or potential rejection, analysts have removed it from their financial models for this indication.
Korlym itself is under pressure from generic competition, particularly from Teva Pharmaceuticals. This leaves CORT stock with limited upside in its core therapeutic area.
The regulatory hurdle not only impacts future sales but also raises questions about the robustness of Corcept Therapeutics’ clinical data and trial strategy.
CORT shares’ price action may still be overdone
Despite the major FDA setback, some analysts believe the market reaction may have overshot the fundamentals.
Truist Securities, for example, slashed its price objective on Corcept shares to $50, acknowledging the recent news is significantly bearish for the biotech firm.
However, the investment firm maintained a “buy” rating, with the downwardly revised price target still indicating potential upside of more than 40% from here.
“We see value in Korlym in Cushing’s with upside from relacorilant in PROC,” its analysts noted, referring to platinum-resistant ovarian cancer.
After today’s crash, Corcept Therapeutics is going for a price-to-sales (P/S) ratio of about 10 only, which isn’t particularly expensive for a fast-growing biotech company.
In short, while the FDA news is undeniably negative, the removal of relacorilant for Cushing’s altogether from valuation models may be premature, especially if the management can address the agency’s concerns.
Should you buy Corcept on the pullback?
CORT shares may be worth owning heading into 2026, as it isn’t one of those unprofitable biotech names.
In the latest reported quarter, the company had nearly $20 million in net income and $208 million in revenue – up some 14% on a year-over-year basis.
Moreover, Corcept’s balance sheet remains strong, and its ongoing research in ovarian cancer could unlock new revenue streams.
Korlym, despite generic headwinds, continues to generate cash flow, and relacorilant’s potential in oncology remains intact.
For long-term investors, the current valuation may offer an attractive entry point, especially if management can navigate regulatory challenges and diversify its pipeline.
The selloff has reset expectations, but the fundamentals suggest Corcept is far from broken. With execution and clarity, the stock could rebound meaningfully in the months ahead.
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