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Shares of Corcept Therapeutics Incorporated CORT were up a staggering 109.1% on March 31 after the company announced data from the phase III ROSELLA study, which evaluated its pipeline candidate, relacorilant, in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer.
The ROSELLA study met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR).
Per management, data from the ROSELLA study suggested that the combo of relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian cancer.
Year to date, shares of Corcept have skyrocketed 126.7% against the industry’s decline of 1.9%.
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The phase III ROSELLA study evaluated relacorilant in combination with nab-paclitaxel for treating patients with recurrent, platinum-resistant ovarian cancer.
Data from the same showed that treatment with relacorilant plus nab-paclitaxel reduced the risk of disease progression by 30% compared to patients treated with nab-paclitaxel alone. Patients who were treated with relacorilant plus nab-paclitaxel achieved a median PFS-BICR of 6.5 months compared to 5.5 months in patients who received nab-paclitaxel alone.
Patients treated with the combo of relacorilant plus nab-paclitaxel had a significant improvement in overall survival (OS), with the median OS being 16 months versus 11.5 months for patients receiving nab-paclitaxel alone, at an interim analysis of OS.
The combo of relacorilant plus nab-paclitaxel improved progression-free and overall survival without increasing the side effect burden.
The company plans to submit a new drug application in the United States in the third quarter of 2025, while a marketing authorization application in Europe is likely to be filed shortly thereafter.
Relacorilant is Corcept’s lead candidate, which is being developed for treating patients with Cushing’s syndrome. In December 2024, CORT submitted a new drug application (NDA) for relacorilant to the FDA for the same.
Last month, the FDA accepted the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 30, 2025.
The NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT, as well as long-term extension studies and a phase II study in hypercortisolism.
Another study is evaluating relacorilant in combination with Keytruda (pembrolizumab) for treating patients with adrenal cancer along with cortisol excess.
The successful development and commercialization of relacorilant for additional indications will be a big boost to the company.
Corcept currently carries a Zacks Rank #2 (Buy).
Some top-ranked stocks in the biotech sector are Amicus Therapeutics, Inc. FOLD, CytomX Therapeutics, Inc. CTMX and ANI Pharmaceuticals, Inc. ANIP, each carrying 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 Amicus’ earnings per share have increased from 43 cents to 52 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 72 cents to 78 cents. Year to date, shares of FOLD have declined 13.4%.
FOLD’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 45.42%
In the past 60 days, estimates for CytomX Therapeutics have improved from a loss of 31 cents per share to earnings of 25 cents per share. During the same time, loss per share estimates for 2026 have narrowed from 65 cents to 31 cents. Year to date, shares of CTMX have plunged 38.2%.
CTMX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 180.70%.
In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $5.54 to $6.35 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.75 to $7.21. Year to date, shares of ANIP have rallied 21.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.32%.
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This article originally published on Zacks Investment Research (zacks.com).
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