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cept Therapeutics rporated(CORT) - 2025 Q3 - Quarterly Report
2025-11-04 21:12
Product Development and Trials - The company has marketed Korlym in the U.S. since 2012 for treating hypercortisolism, with an authorized generic version launched in June 2024[76]. - In the CATALYST study, 23.8% of 1,057 patients with difficult-to-control diabetes were found to have hypercortisolism, with Korlym showing a statistically significant HbA1c reduction of 1.47% compared to 0.15% for placebo (p-value: < 0.0001)[78]. - The MOMENTUM trial, initiated in March 2025, aims to enroll 1,000 patients to assess hypercortisolism prevalence in resistant hypertension[80]. - Relacorilant, a selective cortisol modulator, has been submitted for FDA approval with a PDUFA date of December 30, 2025, based on positive results from the GRACE and GRADIENT trials[84]. - In the GRACE trial, patients experienced a mean systolic blood pressure reduction of 7.9 mm Hg and a 63% response rate in hypertension[86]. - The GRADIENT study showed a placebo-adjusted reduction in fasting glucose of 22.2 mg/dL (p-value: 0.002) for patients receiving relacorilant[93]. - The company submitted an NDA for relacorilant in combination with nab-paclitaxel for platinum-resistant ovarian cancer, with a PDUFA date of July 11, 2026[98]. - The ROSELLA trial enrolled 381 women with recurrent ovarian cancer, assessing progression-free survival and overall survival as dual primary endpoints[99]. - The Phase 2 trial, BELLA, is enrolling 90 patients with platinum-resistant ovarian cancer to evaluate the efficacy and safety of relacorilant combined with nab-paclitaxel and bevacizumab[106]. - An interim analysis indicated a 31% reduction in risk of death for patients receiving relacorilant plus nab-paclitaxel, with a median overall survival of 16.0 months compared to 11.5 months for nab-paclitaxel alone[101]. - The Phase 2 trial DAZALS for ALS showed a statistically significant 84% reduction in risk of death for patients receiving 300 mg of dazucorilant compared to placebo[113]. - The Phase 2b trial MONARCH for miricorilant in patients with MASH has completed enrollment in two cohorts, with 82 patients in Cohort A and 93 patients in Cohort B[116]. - The FDA has granted dazucorilant Fast Track Designation and orphan drug status for the treatment of ALS in the United States[115]. Financial Performance - Net product revenue for Q3 2025 was $207.6 million, a 13.8% increase from $182.5 million in Q3 2024, driven by a 42.5% increase in sales volume[122]. - For the nine months ended September 30, 2025, net product revenue reached $559.3 million, up 13.4% from $493.2 million in the same period of 2024[122]. - Cost of sales for Q3 2025 was $4.6 million, representing 2.2% of revenue, compared to 1.6% in Q3 2024, primarily due to a $1.0 million write-off of scrapped inventory[124]. - Research and development expenses for Q3 2025 totaled $68.8 million, a 16.0% increase from $59.3 million in Q3 2024, attributed to advancing development programs and employee compensation[126]. - Selling, general and administrative expense increased to $124.0 million for Q3 2025 from $73.7 million in Q3 2024, and for the nine months ended September 30, 2025, it was $318.5 million compared to $196.9 million in 2024[129]. - Interest and other income decreased to $5.0 million for Q3 2025 from $6.3 million in Q3 2024, and for the nine months ended September 30, 2025, it was $16.2 million compared to $17.8 million in 2024[131]. - Income tax benefit for Q3 2025 was $4.4 million, compared to an expense of $5.7 million in Q3 2024, and for the nine months ended September 30, 2025, it was $18.8 million compared to $19.1 million in 2024[132]. - The company expects higher research and development and selling, general and administrative expenses in 2025 compared to 2024 due to advancing clinical programs and increased commercialization efforts[128][130]. Cash Flow and Assets - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $524.2 million, down from $603.2 million as of December 31, 2024[135]. - Net cash provided by operating activities was $103.5 million for the nine months ended September 30, 2025, compared to $138.2 million in the same period of 2024[137]. - Net cash provided by investing activities was $81.6 million for the nine months ended September 30, 2025, compared to net cash used of $113.2 million in 2024[138]. - Net cash used in financing activities was $189.2 million for the nine months ended September 30, 2025, compared to $23.8 million in 2024, with $209.3 million spent on share repurchases[139]. - Retained earnings as of September 30, 2025, were $619.1 million[140]. Regulatory and Legislative Impact - The FDA and European Commission have designated relacorilant as an orphan drug, providing benefits such as tax credits and exclusive marketing rights[96]. - The Inflation Reduction Act of 2022 may materially reduce profits starting in 2026 due to provisions limiting revenue from Medicare patients[118].
What Does Wall Street Think About Corcept Therapeutics (CORT)?
Yahoo Finance· 2025-11-04 14:36
Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) is identified as a strong investment opportunity with over 50% upside potential, supported by analysts maintaining a Buy rating and setting price targets of $140 and $145 respectively [1][2]. Company Overview - Corcept Therapeutics is a biopharmaceutical company focused on developing therapies that modulate cortisol effects, with its flagship product, Korlym, FDA-approved for treating Cushing's syndrome [5]. Clinical Developments - The company's relacorilant shows promise for treating ovarian cancer, particularly in patients with platinum-resistant ovarian cancer previously treated with PARP inhibitors, as indicated by recent ROSELLA trial data presented at a medical congress [3]. - Despite the typically poorer prognosis of this subgroup, significant progression-free survival benefits were observed with relacorilant in combination with nab-paclitaxel [4]. - Management is optimistic about the broader therapeutic potential of relacorilant, as evidenced by the expansion of the BELLA Phase 2 trial to include additional indications like endometrial cancer and platinum-sensitive ovarian cancer [4].
Corcept Presents ESMO 2025 Late-Breaker: Relacorilant Demonstrates Benefit in Patients with Platinum-Resistant Ovarian Cancer with Prior PARP Inhibitor Treatment
Businesswire· 2025-10-19 09:15
Core Insights - Corcept Therapeutics Incorporated presented new late-breaking data from its pivotal Phase 3 ROSELLA trial, focusing on the combination of relacorilant and nab-paclitaxel for treating platinum-resistant ovarian cancer [1] Company Overview - Corcept Therapeutics is a commercial-stage company that specializes in discovering and developing medications aimed at treating severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating cortisol hormone effects [1]
H.C. Wainwright Remains Bullish on Corcept Therapeutics Incorporated (CORT)
Insider Monkey· 2025-10-18 01:54
Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] - A specific company is highlighted as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI technologies [3][7] Investment Landscape - Wall Street is investing hundreds of billions into AI, but there is a pressing concern regarding the energy supply needed to sustain this growth [2] - AI data centers, such as those powering large language models, consume energy equivalent to that of small cities, indicating a looming energy crisis [2] Company Profile - The company in focus is not a chipmaker or cloud platform but is positioned as a vital player in the energy sector, particularly in nuclear energy infrastructure [7] - It is capable of executing large-scale engineering, procurement, and construction (EPC) projects across various energy sectors, including oil, gas, and renewables [7] Financial Position - The company is noted for being completely debt-free and holding a significant cash reserve, amounting to nearly one-third of its market capitalization [8] - It trades at less than 7 times earnings, suggesting it is undervalued compared to its potential in the AI and energy markets [10] Market Trends - The company is poised to benefit from the onshoring trend driven by tariffs, as well as the surge in U.S. LNG exports under the current administration's energy policies [5][14] - There is a growing recognition on Wall Street of this company's potential, as it quietly capitalizes on multiple favorable market trends without the high valuations typical of other energy firms [8][6] Future Outlook - The influx of talent into the AI sector is expected to drive continuous innovation and advancements, reinforcing the importance of investing in AI-related companies [12] - The company is positioned to capitalize on the anticipated energy demands of AI, making it a strategic investment opportunity for those looking to engage in the AI energy boom [3][11]
CORT Files MAA for Relacorilant in Platinum-Resistant Ovarian Cancer
ZACKS· 2025-10-15 16:35
Core Insights - Corcept Therapeutics (CORT) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its lead candidate, relacorilant, aimed at treating platinum-resistant ovarian cancer [1] - The MAA is supported by positive results from the pivotal phase III ROSELLA study and phase II studies, which demonstrated improved progression-free and overall survival when relacorilant was combined with nab-paclitaxel compared to nab-paclitaxel alone [2] - The FDA has accepted a new drug application (NDA) for relacorilant, with a final decision expected on July 11, 2026 [2] Company Performance - Year-to-date, Corcept's shares have increased by 43.1%, significantly outperforming the industry average rise of 7.4% [3] - The company's sole marketed drug, Korlym (mifepristone), generated sales of $351.6 million in the first half of 2025, reflecting a year-over-year increase of 13.2% [7] Ongoing Development Activities - Corcept is also developing relacorilant for Cushing's syndrome, having submitted an NDA to the FDA in December 2024, with a target action date of December 30, 2025 [5][6] - The company is conducting the phase II BELLA study to evaluate the combination of relacorilant with nab-paclitaxel and Roche's Avastin for platinum-resistant ovarian cancer [6] Market Position - A potential approval of relacorilant could expand Corcept's market reach and reduce its dependence on Korlym for future growth [5][7] - Corcept currently holds a Zacks Rank of 5 (Strong Sell), while other biotech stocks like Chemomab Therapeutics and ANI Pharmaceuticals have better rankings [8]
Corcept Transition To New Specialty Pharmacy Well Underway
Seeking Alpha· 2025-10-15 13:13
Core Insights - The article expresses personal beliefs and opinions regarding the subject matter, specifically related to the company CORT and its stock performance [2][3] Company Analysis - The analyst holds a beneficial long position in CORT shares, indicating confidence in the company's future performance [1][2] - The report is based solely on publicly available information, which is believed to be reliable but not independently verified [2][3] Investment Considerations - The article emphasizes that past performance is not a guarantee of future results, highlighting the inherent uncertainties in investment decisions [3] - It is noted that the views expressed may not reflect those of the publication as a whole, suggesting a diversity of opinions among analysts [3]
Here’s What Makes Corcept Therapeutics (CORT) an Attractive Investment?
Yahoo Finance· 2025-10-03 12:21
Group 1: Market Overview - Global equity markets reported positive returns in Q2 2025, driven by U.S. trade deals and expected fiscal stimulus in Europe, which countered tariff challenges and geopolitical tensions [1] - The Clearbridge Global Value Improvers Strategy outperformed the benchmark MSCI World Value Index in the quarter, with strong contributions from industrials and IT holdings [1] Group 2: Corcept Therapeutics Incorporated - Corcept Therapeutics Incorporated (NASDAQ:CORT) is a biotechnology company focused on developing medications for severe endocrinologic, oncologic, metabolic, and neurologic disorders [2] - The stock of Corcept Therapeutics saw a one-month return of 23.24% and an impressive 88.16% increase over the last 52 weeks, closing at $85.48 per share with a market capitalization of $9.01 billion on October 2, 2025 [2] - Portfolio activity for the Clearbridge Global Value Improvers Strategy included exiting Uber Technologies and adding Corcept Therapeutics, which specializes in cortisol management with broader implications than previously understood [3] Group 3: Financial Performance - Corcept Therapeutics reported revenue of $194.4 million in Q2 2025, an increase from $163.8 million in Q2 2024 [4] - Despite the potential of Corcept as an investment, certain AI stocks are considered to offer greater upside potential and less downside risk [4]
Can Relacorilant Drive Corcept's Long-Term Growth Beyond Korlym?
ZACKS· 2025-10-01 15:41
Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, is approved for treating Cushing's syndrome, and the company's revenue is entirely dependent on Korlym sales [1][2] Sales Performance - In the first half of 2025, Korlym generated sales of $351.6 million, reflecting a year-over-year increase of approximately 13.2% [1][9] - Full-year 2025 sales for Korlym are estimated to reach $857.1 million, indicating a nearly 26% year-over-year growth [1] Revenue Guidance - Management has revised its total revenue guidance for 2025, now expecting revenues between $850 million and $900 million, down from the previous estimate of $900 million to $950 million [3] Pipeline Development - Corcept is developing relacorilant as a potential alternative to reduce dependence on Korlym, with a new drug application submitted to the FDA for Cushing's syndrome [4][5] - The FDA has set a target action date of December 30, 2025, for the relacorilant application for Cushing's syndrome [4][9] Additional Indications - Corcept is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer, with an FDA decision expected on July 11, 2026 [6][9] - The BELLA study is evaluating relacorilant in combination with nab-paclitaxel and Avastin for ovarian cancer treatment [7] - Other studies are assessing relacorilant with Keytruda for adrenal cancer and with Xtandi for early-stage prostate cancer [8]
Corcept Therapeutics Beats Q2 Estimates, Cuts Guidance and Advances NDA for New Cancer Drug
Yahoo Finance· 2025-09-29 23:20
Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) is recognized as one of the 12 stocks with consistent growth potential for investment [1] - The company reported a strong Q2 performance but subsequently lowered its full-year revenue guidance [2] Financial Performance - In Q2 2025, Corcept achieved an EPS of $0.29, surpassing estimates by 45% compared to the expected $0.20 [2] - Revenue for the quarter was $194.4 million, reflecting an 18.7% year-over-year increase [2] - The company has revised its full-year revenue guidance to a range of $850 million to $900 million [2] Drug Development and Regulatory Updates - The FDA has accepted the New Drug Application (NDA) for Corcept's drug candidate, Relacorilant, aimed at treating platinum-resistant ovarian cancer [3] - A decision date for the NDA has been set for July 11, 2026, which is expected to de-risk a significant portion of the company's pipeline [3] - Corcept plans to present new data from the pivotal Phase 3 ROSELLA trial at the European Society for Medical Oncology (ESMO) annual meeting on October 19, 2025 [3] Company Overview - Corcept Therapeutics has demonstrated a remarkable 10-year performance increase of 1534.68%, indicating a strong market position [4] - Founded in 1998, the company focuses on developing drugs for severe metabolic, psychiatric, and oncologic disorders by modulating cortisol effects [4]
4 Biotechnology Stocks That Outshine In Momentum Amid Strong Technicals - Arrowhead Pharma (NASDAQ:ARWR), Assembly Biosciences (NASDAQ:ASMB)
Benzinga· 2025-09-29 11:11
Core Insights - Four biotechnology stocks have surged into the top 10th percentile for momentum ranking, indicating strong technical strength and price action [1][2] Group 1: Momentum Ranking - Arrowhead Pharmaceuticals Inc. (ARWR), Assembly Biosciences Inc. (ASMB), Atara Biotherapeutics Inc. (ATRA), and Corcept Therapeutics Inc. (CORT) have shown significant momentum percentile increases, making them stand out in the competitive biotech sector [2][5] - Joining the top decile for momentum ranking means these stocks are outperforming 90% of all tracked stocks in terms of price appreciation and volatility-adjusted returns [5] Group 2: Individual Stock Performance - ARWR's momentum percentile increased from 89.87 to 93.79, with a week-on-week gain of 3.92 percentage points; the stock has risen by 66.92% year-to-date and 69.33% over the year [7] - ASMB moved from 87.58 to 93.13, posting a 5.55 percentage point increase; it is up 43.85% YTD and 62.95% over the year [7] - ATRA climbed from 88.24 to 92.76, translating to a weekly gain of 4.52 percentage points; the stock has declined 2.97% YTD but advanced 69.00% over the year [8] - CORT advanced from 88.05 to 90.50, achieving a week-on-week improvement of 2.45 percentage points; it has risen by 67.84% YTD and 81.22% over the year [8]