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Corcept Therapeutics (CORT) Is Down 49.1% After FDA CRL On Relacorilant Effectiveness – Has The Bull Case Changed?

Simply Wall St · 5d ago
  • In late 2025, Corcept Therapeutics announced that the FDA issued a Complete Response Letter for its relacorilant NDA in hypertension secondary to hypercortisolism, citing the need for additional evidence of effectiveness despite positive GRACE and GRADIENT trial results.
  • This decision challenges Corcept’s plan to evolve beyond its existing Korlym franchise and raises fresh questions about the robustness of its regulatory pathway for relacorilant.
  • We’ll now examine how the FDA’s call for more effectiveness data on relacorilant may reshape Corcept’s previously optimistic investment narrative.

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Corcept Therapeutics Investment Narrative Recap

To own Corcept Therapeutics today, you need to believe the company can gradually reduce its dependence on Korlym while turning relacorilant into a meaningful, diversified revenue source. The FDA’s Complete Response Letter for relacorilant in Cushing’s related hypertension directly affects that transition and, in the near term, heightens the key risk that regulatory setbacks slow Corcept’s shift away from a maturing Korlym franchise.

The FDA’s request for additional effectiveness data on relacorilant is the most relevant recent development, because it strikes at what had been a central catalyst for the stock: potential approval in hypercortisolism related hypertension. With that path now delayed, investor attention is likely to focus more sharply on Corcept’s existing Korlym revenue base and on how quickly management can clarify relacorilant’s regulatory path with the Agency.

However, investors should be aware that if relacorilant faces prolonged regulatory delays while Korlym remains exposed to pricing pressure and generic challenges, then ...

Read the full narrative on Corcept Therapeutics (it's free!)

Corcept Therapeutics' narrative projects $2.0 billion revenue and $743.0 million earnings by 2028. This requires 40.7% yearly revenue growth and about a $611 million earnings increase from $132.0 million today.

Uncover how Corcept Therapeutics' forecasts yield a $127.20 fair value, a 256% upside to its current price.

Exploring Other Perspectives

CORT 1-Year Stock Price Chart
CORT 1-Year Stock Price Chart

Eleven members of the Simply Wall St Community currently see Corcept’s fair value anywhere from US$74.33 up to US$318.28 per share, underscoring how far apart individual views can be. You may want to compare those expectations with the heightened regulatory risk around relacorilant’s approval path and consider how different outcomes could affect Corcept’s longer term earnings power.

Explore 11 other fair value estimates on Corcept Therapeutics - why the stock might be worth over 8x more than the current price!

Build Your Own Corcept Therapeutics Narrative

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.