Shares of Corcept Therapeutics Incorporated (CORT) have rallied 56.4% in the past six months against the industry’s decline of 10.5%.The company’s sole-marketed drug, Korlym (mifepristone), which is approved for treating Cushing's syndrome or endogenous hypercortisolism, has been performing well. The drug has been witnessing strong demand in recent quarters and the trend is likely to continue in 2025.The company’s top line solely comprises product sales from Korlym. Sales of the drug increased almost 40% ye ...

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Corcept Therapeutics Incorporated regarding potential securities fraud or unlawful business practices [1] - A lawsuit has been filed against Corcept by a group of health insurers, alleging manipulation of the patent process to hinder Teva Pharmaceutical's generic product launch of Korlym [2] - Following the news of the lawsuit, Corcept's stock price experienced a significant decline of $8.44 per share, or 11.48%, closing at $65.09 per share [3] Company Overview - Corcept Therapeutics is known for its product Korlym, which has been a best-seller in its category [2] - The company is facing legal challenges that may impact its market position and stock performance [2][3] Legal Context - The lawsuit against Corcept highlights ongoing tensions in the pharmaceutical industry regarding patent enforcement and competition from generic drugs [2] - Pomerantz LLP, a prominent firm in corporate and securities litigation, is leading the investigation into Corcept's practices [1][4]

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For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Corcept Therapeutics (CORT) one of those stocks right now? Let's take a closer look at the stock's year-to-date performance to find out.Corcept Therapeutics is a member of our Medical group, which includes 1009 different companies and currently sits at #3 in the Zacks Sector Rank. The Zacks Sector Rank gauges the strength of our 16 individual sector groups by measuring t ...

Corcept Therapeutics Incorporated (CORT) reported fourth-quarter 2024 earnings of 26 cents per share, which missed the Zacks Consensus Estimate of 37 cents. The company had reported earnings of 28 cents per share in the year-ago quarter.See the Zacks Earnings Calendar to stay ahead of market-making news.Revenues in the fourth quarter increased 34.3% year over year to $181.9 million. However, the figure missed the Zacks Consensus Estimate of $196 million. The top line solely comprises product sales of the Cu ...

Corcept Therapeutics, Inc. (NASDAQ:CORT) Q4 2024 Earnings Conference Call February 26, 2025 5:00 PM ET Company Participants Atabak Mokari - CFO & Treasurer Gary Robb - Chief Business Officer & Secretary Joe Belanoff - Co-Founder, President, CEO & Director Bill Guyer - Chief Development Officer Sean Maduck - President, Endocrinology Conference Call Participants David Amsellem - Piper Sandler Swayampakula Ramakanth - H.C. Wainwright Asim Rana - Truist Operator Thank you for standing by, and welcome to Corcept ...

Corcept Therapeutics (CORT) Q4 2024 Earnings Call February 27, 2025 03:37 AM ET Company Participants Atabak Mokari - Chief Financial OfficerCharles Robbins - Chief Business OfficerJoseph Belanoff - Chief Executive Officer, President and DirectorWilliam Guyer - Chief Development OfficerSean Maduck - President of Endocrinology Conference Call Participants David Amsellem - Sr. Research AnalystRamakanth Swayampakula - Managing Director & Senior Research AnalystAsim Rana - Equity Analyst Operator Thank you for s ...

Core Insights - Corcept Therapeutics reported quarterly earnings of $0.26 per share, missing the Zacks Consensus Estimate of $0.37 per share, and showing a decrease from $0.28 per share a year ago, resulting in an earnings surprise of -29.73% [1] - The company posted revenues of $181.89 million for the quarter ended December 2024, which was 7.08% below the Zacks Consensus Estimate, but an increase from $135.41 million year-over-year [2] - Corcept has surpassed consensus EPS estimates three times over the last four quarters, indicating a mixed trend in estimate revisions ahead of the earnings release [2][6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.39 on revenues of $189.08 million, and for the current fiscal year, it is $1.85 on revenues of $811.91 million [7] - The stock has outperformed the S&P 500, gaining about 21.5% since the beginning of the year compared to the S&P 500's gain of 1.3% [3] - The Zacks Industry Rank for Medical - Drugs is in the top 50% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [8] Industry Context - Recursion Pharmaceuticals, another company in the same industry, is expected to report a quarterly loss of $0.36 per share, with revenues projected at $28.73 million, reflecting a year-over-year increase of 163.9% [9][10]

Product Development and Clinical Trials - Korlym (mifepristone) has been marketed in the U.S. since 2012 for treating hypercortisolism, with an authorized generic version launched in June 2024[19]. - In the CATALYST study, 23.8% of 1,057 patients with difficult-to-control diabetes were found to have hypercortisolism, with Korlym showing a significant HbA1c reduction of 1.47% compared to 0.15% in the placebo group (p-value: < 0.0001)[25]. - Relacorilant, a proprietary cortisol modulator, was submitted for FDA approval in December 2024, based on positive results from multiple clinical trials[28]. - In the GRACE trial, patients receiving relacorilant showed a mean systolic blood pressure reduction of 7.9 mm Hg and diastolic blood pressure reduction of 5.4 mm Hg at 22 weeks (p-values: <0.0001)[30]. - GRADIENT study patients receiving relacorilant experienced a placebo-adjusted reduction in fasting glucose of 22.2 mg/dL (p-value: 0.002) and a reduction in body weight of 3.9 kg (p-value: 0.0001)[37][38]. - The pivotal Phase 3 trial "ROSELLA" for relacorilant combined with nab-paclitaxel has completed enrollment with 381 women randomized 1:1[43]. - In the Phase 2 trial, patients receiving 150 mg of relacorilant intermittently had a median progression-free survival (PFS) of 5.6 months compared to 3.8 months for nab-paclitaxel alone, with a hazard ratio of 0.66[46]. - The Phase 2 trial also showed that patients receiving relacorilant intermittently had a median overall survival (OS) of 13.9 months versus 12.2 months for nab-paclitaxel alone, with a hazard ratio of 0.67[46]. - The Phase 1b trial of relacorilant plus pembrolizumab in adrenal cancer patients showed significant symptom improvement but did not slow tumor progression[48]. - A Phase 2 trial of dazucorilant in ALS did not meet its primary endpoint, but the 300 mg dazucorilant arm had 0 deaths compared to 5 deaths in the placebo group[50]. - The Phase 2b trial "MONARCH" for miricorilant in patients with metabolic dysfunction-associated steatohepatitis (MASH) has a planned enrollment of 120 patients[51]. Regulatory and Compliance Issues - Regulatory approval from the FDA is required for all product candidates, involving significant time and expense for compliance with pre- and post-approval regulations[69][70]. - The FDA's review process for a New Drug Application (NDA) aims for a response within ten months for standard review and six months for priority review[74]. - The Orphan Drug Act provides exclusivity for seven years for drugs that receive FDA approval for rare diseases, along with tax credits and waivers for certain fees[75]. - The company is subject to various healthcare regulations, including anti-kickback and false claims laws, which could result in significant penalties for violations[82][84]. - The company is subject to the Physician Payments Sunshine Act, requiring reporting of payments and transfers of value to healthcare providers, with penalties for non-compliance[88]. - The company faces significant risks related to compliance with various healthcare regulations, which could lead to penalties and affect financial results[94]. - The company is under investigation by the United States Attorney's Office for the District of New Jersey regarding the sale and promotion of Korlym, with a focus on relationships and payments to healthcare professionals[139]. - Potential violations of federal healthcare laws could lead to civil and criminal penalties, including fines and exclusion from government healthcare programs, adversely affecting financial results[140]. - Regulatory compliance is critical, as failure to maintain approvals or comply with regulations could lead to significant penalties and loss of revenue[135]. - The company is subject to increased scrutiny regarding patient assistance programs, which may reduce the financial support available to patients needing treatment for hypercortisolism[123]. Financial Performance and Revenue - Research and development expenses were $246.9 million, $184.4 million, and $131.0 million for the years ended December 31, 2024, 2023, and 2022, respectively, accounting for 46%, 49%, and 45% of total operating expenses[57]. - The company’s ability to generate revenue is heavily dependent on the sales of its products for treating hypercortisolism[111]. - The commercial success of the company's products is highly dependent on acceptable pricing and adequate insurance coverage, with government and private payers increasingly limiting reimbursement for medicines[119]. - The Inflation Reduction Act (IRA) requires the Secretary of HHS to negotiate Medicare prices for selected drugs, which may significantly reduce revenue from sales of those drugs[120]. - Beginning in 2025, the IRA will shift a significant portion of Medicare beneficiary costs from the government to manufacturers, potentially limiting revenue and profits[122]. - The company faces potential revenue limitations due to government health care programs and third-party payers increasingly restricting coverage and reimbursement[80]. - The launch of a generic version of Korlym by Teva in January 2024 could adversely affect the company's business and financial position[114]. - The court ruling on December 29, 2023, found that Teva's generic product would not infringe the company's patents, leading to an appeal by the company[114]. - The availability of generic versions of Korlym from other companies like Sun and Hikma could further harm the company's financial results, even if the appeal against Teva is successful[115]. - The company has made its own generic version of Korlym available, which may impact revenue[114]. - The company may need additional capital to fund operations, and if revenue declines significantly, it may have to curtail operations or raise funds under unfavorable terms[154]. - The company faces competition from other medications for hypercortisolism, including FDA-approved drugs like Isturisa® and Recorlev®, which could materially reduce revenue[125][126]. Intellectual Property and Patents - The company holds U.S. and foreign patents for selective cortisol modulators with expiration dates ranging from 2025 to 2041[61]. - The company holds U.S. and international patents for relacorilant, including its use in treating ovarian and pancreatic cancer, with orphan drug designation in both the U.S. and EU for pancreatic cancer treatment[67]. - The company owns patents for cortisol modulators applicable to various conditions, with expiration dates ranging from 2025 to 2039[68]. - Patent protection for the company's products may be challenged, and failure to secure adequate intellectual property rights could erode competitive advantage[156]. Employee and Operational Matters - The company employs 500 individuals as of December 31, 2024, and maintains good employee relations[96]. - The company offers competitive salaries, performance bonuses, and equity grants to attract and retain talent[97]. - The company is subject to significant political and regulatory uncertainties that may adversely affect its business operations and financial condition[184]. - The company faces significant challenges in managing growth due to limited administrative and operational resources, which could impact financial performance and competitiveness[165]. - The company is subject to complex and costly regulations related to drug development and commercialization, which may divert management's attention from revenue-generating activities[167]. Data Privacy and Cybersecurity - The company is subject to stringent data protection regulations, including HIPAA and GDPR, which could impose additional compliance costs[95]. - The company has experienced data breaches and cybersecurity threats, which could result in material costs and reputational damage[178]. - The company utilizes managed detection and response services and multi-factor authentication to protect sensitive information from cybersecurity threats[186]. - Compliance with evolving data privacy regulations, such as HIPAA and GDPR, is expected to increase operational costs and complexity for the company[173]. - The company may incur significant penalties and litigation risks due to non-compliance with privacy laws, including the California Consumer Privacy Act, which could adversely affect financial condition[172]. - The company must adapt to stringent data protection requirements in the EU, which could lead to increased costs and operational challenges[174]. Stock Performance and Market Conditions - The company’s stock price may decline if performance does not meet public guidance or analyst expectations[116]. - The average daily trading volume of the company's common stock was approximately 970,395 shares during the 52-week period ended February 18, 2025[160]. - The intra-day sales prices per share of the company's common stock ranged from $20.84 to $74.61 during the same period[160]. - Approximately 21 percent of the company's common stock is beneficially owned by officers, directors, and principal stockholders as of February 18, 2025[160]. - The company faces risks related to stock performance, which could be influenced by the outcomes of ongoing investigations and regulatory compliance[159]. - The Board of Directors authorized a stock repurchase program of up to $200 million in January 2024, which may reduce cash reserves and impact future capital requirements[181]. - As of February 18, 2025, officers and directors beneficially owned approximately 21% of the common stock, potentially influencing corporate actions significantly[183]. Legal Matters - The company faces ongoing litigation, including antitrust claims from Teva Pharmaceuticals, which could impact financial conditions and operations[194]. - The company has faced a securities class action lawsuit that resulted in a settlement requiring a one-time payment of $14 million, fully reimbursed by insurers[197].