Both companies received agency requests for more evidence of the effectiveness of their therapies.
The FDA closed out 2025 with a pair of complete response letters, cratering the share prices of Corcept Therapeutics and Outlook Therapeutics.
Both companies reported that the agency had rejected a request for approval on Dec. 31. Corcept was seeking authorization of relacorilant in patients with high blood pressure secondary to hypercortisolism, a rare condition also called Cushing’s syndrome that is caused by too much cortisol. Outlook had applied for approval of a formulation of bevacizumab in wet age-related macular degeneration (AMD).
Corcept sought FDA approval despite finding relacorilant was statistically no better than placebo in one of two Phase III trials. The FDA acknowledged that one trial met its primary endpoint and that the failed study provided confirmatory evidence, according to Corcept.
Yet the FDA concluded Corcept needs more evidence of effectiveness to show that relacorilant, an oral selective glucocorticoid receptor antagonist, has a favorable benefit-risk profile in the patient population. Truist Securities analysts wrote in a note to investors that the request for additional data “may require additional trial(s), significantly dimming [Corcept’s] outlook in Cushing’s.”
Corcept CEO Joseph Belanoff said in a statement that he is “confident we will find a way to get relacorilant to the patients it could help,” adding that the biotech plans to meet with the FDA as soon as possible. Truist analysts said it is unclear if any dialogue can resolve the issues without one or more new trials, given that Corcept had chances to address the FDA’s concerns during the original review.
Shares in Corcept fell 50% to $34.80 at close on December 31 following the FDA rejection. The analysts cut their price target from $135 to $50. Corcept has a chance to regain momentum when the FDA rules on relacorilant in ovarian cancer. The analysts said the Cushing’s rejection has no bearing on the ongoing FDA review, which is to conclude by July 11.
Outlook shared details of its FDA rejection after the market closed on Dec. 31. The stock fell 61% to 62 cents in premarket trading on Jan. 2. The setback was the third time the FDA has rejected a request for approval of Outlook’s ophthalmic formulation of bevacizumab in wet AMD. Roche developed Avastin as a cancer drug, but physicians have used the anti-VEGF antibody off-label in eye diseases including wet AMD.
The FDA rejected Outlook’s second approval request in August over a lack of substantial evidence of effectiveness. Outlook included additional mechanistic and natural history data in its resubmission, but the FDA again rejected the application and asked for confirmatory evidence of efficacy. The biotech said its submission included data from a pivotal trial and confirmatory evidence from other studies.
Outlook CEO Bob Jahr said in a statement that the company remains “fully committed to taking all necessary steps to receive approval in the United States.” The company is now exploring all available pathways for potential approval. Outlook has already won approval in Europe, where it sells the drug as Lytenava.
The rejections came one week after the FDA issued a complete response letter for Sanofi’s multiple sclerosis drug candidate tolebrutinib. Houman Ashrafian, head of R&D at Sanofi, said in a statement that the FDA’s decision “is a significant and meaningful change in direction from the feedback the agency previously provided.”
