Analysts at Truist Securities called the mid-stage data a “mixed bag,” also flagging gastrointestinal adverse events. However, the readout is unlikely to be “incremental” to Corcept’s overall stock narrative.
Corcept Therapeutics’ investigational cortisol modulator dazucorilant failed to boost functional performance in patients with amyotrophic lateral sclerosis—but the biotech dug into the data Thursday and came away with overall survival benefits.
Analysts at Truist Securities called the Phase II readout a “mixed bag” in an investor note on Thursday, adding that aside from the missed primary endpoint, dazucorilant also elicited “increased” gastrointestinal adverse events. “We would have liked to see some QoL [quality of life] assessments to better gauge commercial potential as discontinuation rates” seemed higher in the dazucorilant group versus placebo, they said.
Still, Truist considered Thursday’s readout to be only “incremental” to Corcept’s overall stock narrative. The analyst firm does not include dazucorilant in its valuation for the biotech.
Thursday’s data, presented at the 2025 annual meeting of the European Network to Cure ALS, showed no statistical separation between dazucorilant and placebo patients in terms of scores on the ALS Functional Rating Scale-Revised, a disease-specific severity score that evaluates patients’ disability and respiratory function, among other metrics.
However, an exploratory analysis found that dazucorilant treatment significantly improved overall survival. At 24 weeks, five of 82 patients on placebo died, as opposed none of the 83 patients in the dazucorilant arm. At one year, treatment with dazucorilant cut the risk of death by 84% versus placebo. The biotech called this effect “pronounced” in its Thursday release.
Given the mixed mid-stage findings, Corcept is currently “working with regulatory authorities” to determine the best path forward for dazucorilant, Bill Guyer, the company’s chief development officer, said in a prepared statement on Thursday.
The ALS readout comes after Corcept earlier this week unveiled Phase III data for its selective glucocorticoid receptor antagonist relacorilant, which it combined with nab-paclitaxel to treat patients with platinum-resistant ovarian cancer.
The findings, revealed in a late-breaking presentation at the recently concluded 2025 conference of the American Society of Clinical Oncology, showed that the relacorilant regimen cut the risk of disease progression by 30% versus nab-paclitaxel alone. Progression-free survival, the study’s primary endpoint, improved 29% in relacorilant-treated patients versus controls.
As in the case of dazucorilant in ALS however, Truist analysts flagged potential safety concerns with relacorilant. “Based on investor conversations, concerns may be around tolerability profile of relacorilant, which is numerically higher than nab-pac alone,” the analysts wrote in a June 2 note. “Nab-pac” is BMS’s formulation of the chemotherapy paclitaxel, sold as Abraxane.
However, Truist noted that these safety signals could be due to the “greater duration of exposure to nab-pac” in patients receiving the combo therapy. “When adjusted for duration of exposure, common AEs including neutropenia and anemia are comparable between study arms,” they said. Overall, the analysts found relacorilant’s profile “favorable,” adding that they “expect approval with commercial traction.”
Corcept plans to submit a regulatory application for relacorilant in the third quarter of this year.
