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Corcept (CORT) Rises as Cushing's Syndrome Study Meets Goal
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Corcept Therapeutics Incorporated (CORT - Free Report) announced that the pivotal phase III GRACE study, which evaluated its lead pipeline candidate, relacorilant, for treating patients with Cushing’s syndrome, met its primary endpoint. Shares of the company were up 14.9% on May 28 following the announcement of the news.
The GRACE study consisted of two parts — the open-label portion and the randomized withdrawal phase.
The study has now met the primary endpoint in the randomized withdrawal phase. Data from the same showed that patients who were treated with relacorilant experienced loss of blood pressure control, the study’s primary endpoint, versus placebo.
Last month, the company announced data from the open-label phase of the GRACE study, which showed that treatment with relacorilant led to clinically meaningful and statistically significant improvements in hypertension, hyperglycemia as well as other symptoms.
Notably, patients who experienced pre-specified improvements in hypertension, hyperglycemia or both symptoms were allowed to enter the GRACE study’s randomized withdrawal phase, in which half of the patients were treated with relacorilant while the other half was given a placebo for a period of 12 weeks.
Data from the open-label portion and the randomized withdrawal phase of the GRACE study will be presented at an upcoming medical conference next month.
Treatment with relacorilant was well-tolerated in both phases of the GRACE study.
Per the company, patients who were treated with relacorilant experienced rapid and sustained improvements in hypertension and were 5.9 times more likely to maintain their hypertension response versus patients who received placebo.
Shares of Corcept have decreased 2.6% year to date compared with the industry’s decline of 9.3%.
Image Source: Zacks Investment Research
The GRACE study meeting the primary endpoint is a significant step forward in the development path for relacorilant as a treatment for Cushing’s syndrome, also known as hypercortisolism.
The company plans to file a new drug application for relacorilant in Cushing’s syndrome in the third quarter of 2024.
Relacorilant enjoys orphan drug designation for the treatment of Cushing’s syndrome both in the United States and the European Union.
Corcept’s sole marketed drug, Korlym (mifepristone), is approved for the treatment of Cushing’s syndrome. The drug generated sales worth $146.8 million in the first quarter of 2024, increasing 39% on a year-over-year basis.
Hence a potential approval for relacorilant should help Corcept to address a broader patient population. It should also reduce the heavy dependence on Korlym for revenues.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 28.2%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.43 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 86.2%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 60.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.
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Corcept (CORT) Rises as Cushing's Syndrome Study Meets Goal
Corcept Therapeutics Incorporated (CORT - Free Report) announced that the pivotal phase III GRACE study, which evaluated its lead pipeline candidate, relacorilant, for treating patients with Cushing’s syndrome, met its primary endpoint. Shares of the company were up 14.9% on May 28 following the announcement of the news.
The GRACE study consisted of two parts — the open-label portion and the randomized withdrawal phase.
The study has now met the primary endpoint in the randomized withdrawal phase. Data from the same showed that patients who were treated with relacorilant experienced loss of blood pressure control, the study’s primary endpoint, versus placebo.
Last month, the company announced data from the open-label phase of the GRACE study, which showed that treatment with relacorilant led to clinically meaningful and statistically significant improvements in hypertension, hyperglycemia as well as other symptoms.
Notably, patients who experienced pre-specified improvements in hypertension, hyperglycemia or both symptoms were allowed to enter the GRACE study’s randomized withdrawal phase, in which half of the patients were treated with relacorilant while the other half was given a placebo for a period of 12 weeks.
Data from the open-label portion and the randomized withdrawal phase of the GRACE study will be presented at an upcoming medical conference next month.
Treatment with relacorilant was well-tolerated in both phases of the GRACE study.
Per the company, patients who were treated with relacorilant experienced rapid and sustained improvements in hypertension and were 5.9 times more likely to maintain their hypertension response versus patients who received placebo.
Shares of Corcept have decreased 2.6% year to date compared with the industry’s decline of 9.3%.
Image Source: Zacks Investment Research
The GRACE study meeting the primary endpoint is a significant step forward in the development path for relacorilant as a treatment for Cushing’s syndrome, also known as hypercortisolism.
The company plans to file a new drug application for relacorilant in Cushing’s syndrome in the third quarter of 2024.
Relacorilant enjoys orphan drug designation for the treatment of Cushing’s syndrome both in the United States and the European Union.
Corcept’s sole marketed drug, Korlym (mifepristone), is approved for the treatment of Cushing’s syndrome. The drug generated sales worth $146.8 million in the first quarter of 2024, increasing 39% on a year-over-year basis.
Hence a potential approval for relacorilant should help Corcept to address a broader patient population. It should also reduce the heavy dependence on Korlym for revenues.
Zacks Rank & Stocks to Consider
Corcept currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. (KRYS - Free Report) , Marinus Pharmaceuticals, Inc. (MRNS - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 28.2%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.43 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 86.2%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 60.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.