logo
CORT Shares Rise as Relacorilant Combo Meets Ovarian Cancer Study Goal

CORT Shares Rise as Relacorilant Combo Meets Ovarian Cancer Study Goal

Yahoo02-04-2025

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%.
Image Source: Zacks Investment Research
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%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Amicus Therapeutics, Inc. (FOLD) : Free Stock Analysis Report
Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report
ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report
CytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval

Yahoo

time14 hours ago

  • Yahoo

Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval

Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval

Yahoo

time14 hours ago

  • Yahoo

Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval

Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio

URGN INVESTOR NEWS: UroGen Pharma Ltd. has been Sued for Securities Fraud – Contact BFA Law before July 28 Deadline (NASDAQ:URGN)
URGN INVESTOR NEWS: UroGen Pharma Ltd. has been Sued for Securities Fraud – Contact BFA Law before July 28 Deadline (NASDAQ:URGN)

Business Upturn

time17 hours ago

  • Business Upturn

URGN INVESTOR NEWS: UroGen Pharma Ltd. has been Sued for Securities Fraud – Contact BFA Law before July 28 Deadline (NASDAQ:URGN)

NEW YORK, June 08, 2025 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against UroGen Pharma Ltd. (NASDAQ: URGN) and certain of the Company's senior executives for potential violations of the federal securities laws. If you invested in UroGen you are encouraged to obtain additional information by visiting Investors have until July 28, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased UroGen securities. The case is pending in the U.S. District Court for the District of New Jersey and is captioned: Cockrell v. UroGen Pharma Ltd., et al. , No. 3:25-cv-06088. Why was UroGen Sued for Securities Fraud? UroGen develops treatments for specialty cancers. The Company's lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. One of the Phase 3 trials for UGN-102 is named ENVISION. As alleged, UroGen stated that the ENVISION trial met its primary endpoint and that UroGen had reached 'agreement with the FDA' that the ENVISION trial would support an NDA submission. In truth, the FDA had previously expressed significant concerns to UroGen regarding the ENVISION trial, which lacked a concurrent control arm. The Stock Declines as the Truth is Revealed On May 16, 2025, the FDA published a briefing document stating that it doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. FDA stated that because 'ENVISION lacked a concurrent control arm,' the primary endpoints were 'difficult to interpret' and that UroGen 'chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.' On this news, the price of UroGen stock declined $2.54 per share, or nearly 26%, from a closing price of $9.85 per share on May 15, 2025, to $7.31 per share on May 16, 2025. Then, on May 21, 2025, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA, finding that the overall benefit-risk profile of UGN-102 was not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock declined $3.37 per share, or nearly 45%, from a closing price of $7.54 per share on May 20, 2025, to $4.17 per share on May 21, 2025. Click here if you suffered losses: What Can You Do? If you invested in UroGen you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact:Ross Shikowitz [email protected] 212-789-3619

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store