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Corcept (CORT) Completes Enrollment in Phase II ALS Study
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Corcept Therapeutics Incorporated (CORT - Free Report) announced that it has completed enrollment in the phase II DAZALS study, which is evaluating its selective cortisol modulator, dazucorilant, for treating patients with amyotrophic lateral sclerosis (ALS), a degenerative neurologic disorder.
The primary endpoint of this double-blind, placebo-controlled phase II study is to see the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R), a measure of motor impairment and functional deterioration in ALS patients. Meanwhile, overall survival and quality of life remain key secondary endpoints of DAZALS.
Patients in the study received either dazucorilant (150 mg), dazucorilant (300 mg) or placebo every day for 24 weeks. Data from the DAZALS study is expected by the end of 2024.
The study has been conducted at various sites across the United States, Europe and Canada.
Shares of Corcept have plunged 28.7% so far this year compared with the industry’s decrease of 10%.
Image Source: Zacks Investment Research
We remind investors that Corcept is evaluating its lead pipeline candidate, relacorilant, in the phase III GRACE study to treat Cushing’s syndrome. A new drug application is expected to be submitted later in the second quarter of 2024.
Also, the phase III GRADIENT study is evaluating relacorilant for patients whose Cushing’s syndrome is caused by adrenal adenoma. Earlier this month, the company completed enrollment in the GRADIENT study. Data from the same is expected in the fourth quarter of 2024.
Last week, CORT completed enrollment in the phase III ROSELLA study, which is investigating relacorilant in combination with Abraxane (nab-paclitaxel) for treating patients with recurrent, platinum-resistant ovarian cancer.
The primary endpoint of this phase III study is progression-free survival, while overall survival is a key secondary endpoint. Progression-free survival data from the ROSELLA study is expected by 2024-end.
A phase Ib study is evaluating relacorilant in combination with Merck’s blockbuster PD-1 checkpoint inhibitor, Keytruda (pembrolizumab), for treating patients with adrenal cancer with cortisol excess completed enrolment. Data from the study is expected in mid-2024.
Corcept’s top line solely comprises product sales from Cushing’s syndrome drug, Korlym. Therefore, the successful development and commercialization of relacorilant for additional indications will be an added boost for the company.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 32.3%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have gained 11.7%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 20.2%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.
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Corcept (CORT) Completes Enrollment in Phase II ALS Study
Corcept Therapeutics Incorporated (CORT - Free Report) announced that it has completed enrollment in the phase II DAZALS study, which is evaluating its selective cortisol modulator, dazucorilant, for treating patients with amyotrophic lateral sclerosis (ALS), a degenerative neurologic disorder.
The primary endpoint of this double-blind, placebo-controlled phase II study is to see the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R), a measure of motor impairment and functional deterioration in ALS patients. Meanwhile, overall survival and quality of life remain key secondary endpoints of DAZALS.
Patients in the study received either dazucorilant (150 mg), dazucorilant (300 mg) or placebo every day for 24 weeks. Data from the DAZALS study is expected by the end of 2024.
The study has been conducted at various sites across the United States, Europe and Canada.
Shares of Corcept have plunged 28.7% so far this year compared with the industry’s decrease of 10%.
Image Source: Zacks Investment Research
We remind investors that Corcept is evaluating its lead pipeline candidate, relacorilant, in the phase III GRACE study to treat Cushing’s syndrome. A new drug application is expected to be submitted later in the second quarter of 2024.
Also, the phase III GRADIENT study is evaluating relacorilant for patients whose Cushing’s syndrome is caused by adrenal adenoma. Earlier this month, the company completed enrollment in the GRADIENT study. Data from the same is expected in the fourth quarter of 2024.
Last week, CORT completed enrollment in the phase III ROSELLA study, which is investigating relacorilant in combination with Abraxane (nab-paclitaxel) for treating patients with recurrent, platinum-resistant ovarian cancer.
The primary endpoint of this phase III study is progression-free survival, while overall survival is a key secondary endpoint. Progression-free survival data from the ROSELLA study is expected by 2024-end.
A phase Ib study is evaluating relacorilant in combination with Merck’s blockbuster PD-1 checkpoint inhibitor, Keytruda (pembrolizumab), for treating patients with adrenal cancer with cortisol excess completed enrolment. Data from the study is expected in mid-2024.
Corcept’s top line solely comprises product sales from Cushing’s syndrome drug, Korlym. Therefore, the successful development and commercialization of relacorilant for additional indications will be an added boost for the company.
Zacks Rank & Other Stocks to Consider
Corcept currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , 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 ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 32.3%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have gained 11.7%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 20.2%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.