Corcept Therapeutics Resubmits NDA for Relacorilant
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Corcept Therapeutics announced it will resubmit its New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for relacorilant as a treatment for patients with Cushing's syndrome. "Following issuance of its complete response letter, the FDA asked us to conduct additional analyses of our NDA data," said Joseph Belanoff, M.D., Corcept's Chief Executive Officer. "Based on the positive outcome of those analyses and the productive tenor of our discussions, we plan to resubmit our NDA in the coming weeks. The agency has told us to expect a Prescription Drug User Fee Act date six months after the date of our submission. We appreciate the FDA's continued engagement with our efforts to bring relacorilant's benefits to patients with hypercortisolism."
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Analyst Views on CORT
Wall Street analysts forecast CORT stock price to rise
6 Analyst Rating
4 Buy
1 Hold
1 Sell
Moderate Buy
Current: 68.380
Low
50.00
Averages
91.00
High
121.00
Current: 68.380
Low
50.00
Averages
91.00
High
121.00
About CORT
Corcept Therapeutics Incorporated is a commercial-stage company. The Company is engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. The Company operates through the discovery, development and commercialization of the pharmaceutical products segment. The Company has marketed Korlym (mifepristone) in the United States for the treatment of patients suffering from Cushings syndrome. The Company’s portfolio of selective cortisol modulators consists of four series totaling approximately 1,000 compounds. Its portfolio of selective cortisol modulators consists of relacorilant, dazucorilant and miricorilant. Korlyms active ingredient, mifepristone, reduces the binding of excess cortisol to the GR, it can modulate the effects of abnormal levels and release patterns of cortisol without compromising cortisols healthy functions and rhythms.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Broad Applicability: The ROSELLA trial demonstrated significant survival benefits across all prespecified subgroups, including patients with poor prognostic features, indicating Lifyorli's consistent efficacy across diverse patient populations and its potential to reshape treatment paradigms for platinum-resistant ovarian cancer.
- Good Clinical Tolerability: The combination of Lifyorli with nab-paclitaxel was well-tolerated, with adverse events comparable to those in the nab-paclitaxel monotherapy group; although some patients experienced neutropenia, the overall safety profile supports its promotion in clinical practice.
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See More
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- New FDA Approval Standard: Lifyorli received FDA approval in March 2026 as the first selective glucocorticoid receptor antagonist for platinum-resistant ovarian cancer, with no biomarker selection required, marking a new standard in cancer treatment and expected to enhance patient treatment options.
- Broad Applicability: The ROSELLA trial demonstrated significant survival benefits across all prespecified subgroups, including patients with poor prognostic features, indicating Lifyorli's consistent efficacy across diverse patient populations and its potential to reshape treatment paradigms for platinum-resistant ovarian cancer.
- Good Clinical Tolerability: The combination of Lifyorli with nab-paclitaxel was well-tolerated, with adverse events comparable to those in the nab-paclitaxel monotherapy group; although some patients experienced neutropenia, the overall safety profile supports its promotion in clinical practice.
See More
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- FDA Review Progress: Corcept plans to resubmit its New Drug Application (NDA) for Relacorilant, aimed at treating Cushing's syndrome, in the coming weeks, with the FDA expected to provide a Prescription Drug User Fee Act (PDUFA) date six months post-submission, enhancing investor optimism.
- Stock Price Recovery: Following the announcement of the NDA resubmission, Corcept's shares (CORT) reached their highest levels in 2026, rising over 7% in Wednesday's morning session and extending a five-day winning streak, reflecting market confidence in the company's future prospects.
- Patient Impact: Patients with Cushing's syndrome often experience symptoms such as high blood pressure and obesity, and untreated hypercortisolism can be life-threatening, with cardiovascular complications being the leading cause of death, highlighting the potential market demand for Relacorilant.
- Market Sentiment Analysis: Despite the recent stock price increase, retail sentiment for CORT on Stocktwits remains bearish, indicating cautious market views on the company's future FDA review outcomes, particularly with the anticipated Class 2 review.
See More
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- Price Target Increase: UBS raised its price target from $44 to $72, implying nearly a 41% upside from Tuesday's close of $51.16, reflecting analysts' confidence in the company's growth potential.
- Revenue Expectations: Analysts anticipate that the approval of Lifyoril for ovarian cancer will generate $936 million in peak PROC revenue, while Korlym sales are projected to reach $897 million by 2030, 17% above consensus, showcasing the company's competitive position in the market.
- Market Performance: Corcept Therapeutics' stock has gained over 58% year-to-date, significantly outperforming the S&P 500's 8% increase, indicating strong performance in the biopharmaceutical sector and investor confidence.
See More
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- Nvidia's Positive Outlook: Oppenheimer reiterates Nvidia as an outperform, projecting CY26 free cash flow to approach $200 billion, and if half is allocated for dividends, the yield could reach nearly 2.5%, which would bolster investor confidence and drive stock price appreciation.
- Apple's Strong Ecosystem: Daiwa raises Apple's price target from $310 to $325, emphasizing its vast ecosystem as a core strength, while acknowledging potential memory management challenges in 2H CY26, the long-term outlook remains favorable for this core holding.
- Positive Outlook for Housing Platform: UBS upgrades KE Holdings to buy from neutral, citing significant upside due to its agency business in tier 1 cities, particularly as the market recovery is led by the secondary market, positioning the company for strong performance.
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See More
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- New Stock Additions: John Hussman added a total of 97 stocks in Q1 2026, with Ulta Beauty Inc being the largest addition at 7,350 shares valued at $3.84 million, representing 0.83% of the portfolio, indicating confidence in the beauty sector.
- Key Position Increases: Hussman increased his stake in Corcept Therapeutics Inc by 94,500 shares, a significant 300% increase, bringing total holdings to 126,000 shares valued at $5.08 million, reflecting strong bullish sentiment towards the biopharmaceutical company.
- Complete Exits: Hussman exited 81 holdings in Q1, including Qualcomm Inc and Charter Communications Inc, which impacted the portfolio by -1.13% and -0.95% respectively, demonstrating a cautious approach towards these tech stocks.
- Portfolio Overview: As of Q1 2026, Hussman's portfolio comprised 268 stocks, primarily concentrated across 11 industries including healthcare, technology, and consumer goods, showcasing a diversified investment strategy to mitigate market fluctuations.
See More
Corcept Therapeutics Reports Q1 2026 Earnings and Raises Revenue Guidance
- Revenue Growth: Corcept Therapeutics reported Q1 2026 revenue of $164.9 million, up from $157.2 million in the prior year, indicating sustained market demand that is expected to enhance future profitability.
- Guidance Upgrade: Management raised the 2026 revenue guidance to $950 million to $1.05 billion, primarily driven by strong performance in the endocrinology business and the new oncology drug Lifyorli, reflecting confidence in future growth.
- FDA Approval Impact: Lifyorli was included in the National Comprehensive Cancer Network (NCCN) guidelines just 15 days post-FDA approval, which is expected to accelerate market adoption and enhance the company's competitiveness in oncology.
- Long-term Growth Outlook: Management anticipates that the Cushing's Syndrome business will reach at least $2 billion in annual revenue by 2030, while Lifyorli is expected to exceed $1 billion in annual revenue in the U.S., demonstrating strong confidence in future market potential.
See More
