Corcept Therapeutics Incorporated CORT announced data from the phase II DAZALS study evaluating its selective cortisol modulator, dazucorilant, for treating patients with amyotrophic lateral sclerosis (ALS), a degenerative neurologic disorder.
The double-blind, placebo-controlled DAZALS study evaluated two doses of dazucorilant (150 mg and 300 mg) for treating patients with ALS.
The study did not meet its primary endpoint, which was the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients treated with dazucorilant versus those treated with placebo.
Shares of Corcept were down in pre-market trading on Dec. 12 following the announcement of the news on Dec. 11.
Year to date, shares of Corcept have rallied 85% against the industry’s decline of 4.6%.
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More on CORT's DAZALS Study
Data from the study showed that patients who were treated with dazucorilant experienced substantially more gastrointestinal upset compared to those who received placebo at the onset of treatment.
Upon completing the study, patients were eligible to enter an open-label, long-term extension study that evaluated 300 mg of dazucorilant in the given patient population.
The open-label, long-term extension will continue and the overall survival will be assessed in March next year.
Corcept plans to present full data from the DAZALS study at an upcoming medical conference in 2025.
The FDA has granted a Fast Track Designation to dazucorilant for treating ALS.
CORT's Recent Pipeline Progress
Corcept’s lead pipeline candidate, relacorilant, is being evaluated in phase III of the GRACE study to treat Cushing’s syndrome.
Relacorilant is also being investigated in the phase III GRADIENT study for treating patients whose Cushing’s syndrome is caused by adrenal adenoma. While data from the GRACE study will form the basis of the new drug application (NDA) for relacorilant, data from the GRADIENT study will likely support the NDA.
An NDA for relacorilant in Cushing’s syndrome is likely to be submitted shortly.
Corcept is also studying relacorilant in combination with other drugs for treating different cancer indications.
The phase III ROSELLA study is evaluating relacorilant in combination with nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer, with data from the same expected by 2024 end. Another study is evaluating relacorilant in combination with pembrolizumab for treating patients with adrenal cancer along with cortisol excess.
CORT's Zacks Rank & Other Key Picks
Corcept currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 55%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Loss per share estimates for 2025 have narrowed from $1.54 to 79 cents during the same time. Year to date, shares of SPRO have declined 21.7%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 bottom line have moved from a loss of 58 cents per share to earnings of 34 cents per share. Loss per share estimates for 2025 have narrowed from $2.13 to $1.84 during the same time. Year to date, shares of CSTL have surged 36.6%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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