cept Therapeutics rporated(CORT)
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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]
Corcept Primed For An Upside EPS Surprise
Seeking Alpha· 2025-09-26 16:06
Core Insights - Chuck Jones has extensive experience in equity analysis and investment management, with a career spanning over 28 years in various roles, including as a Wealth Strategist at Northern Trust [1] - He has a strong focus on technology, life sciences, and venture capital, leveraging his network to meet the financial goals of clients [1] - Jones has a proven track record of outperforming industry benchmarks for six consecutive years through financial modeling and direct engagement with company executives [1] Company and Industry Focus - At Northern Trust, Jones developed a go-to-market strategy for Investment Management and Trust Services targeting Technology Executives and Private Equity Partners [1] - His previous role at Atlantic Trust involved determining technology holdings, focusing on hardware, software, services, and Internet companies [1] - Jones authored significant industry reports, including one on Internet Security Software, showcasing his expertise in the technology sector [1] - His early career at IBM included various sales and manufacturing roles, where he was involved in demand projection and production scheduling for storage systems [1]
FDA Accepts New Drug Application for Corcept Therapeutics’s (CORT) Relacorilant
Yahoo Finance· 2025-09-24 08:06
Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) has received FDA acceptance for its new drug application for Relacorilant, aimed at treating platinum-resistant ovarian cancer [1][2] - The FDA has set a decision date of July 11, 2026, under the Prescription Drug User Fee Act [2] - Positive results from the Phase 3 ROSELLA trial and earlier Phase 2 studies supported the application acceptance [2] Clinical Trial Results - In the trials, Relacorilant was combined with nab-paclitaxel, showing improved progression-free survival and overall survival compared to nab-paclitaxel alone [3] - The combination therapy did not introduce additional safety risks, with side effect rates and severity being similar between the combination and monotherapy groups [3] Company Overview - Corcept Therapeutics is a pharmaceutical company focused on discovering, developing, and commercializing medications that target severe diseases by modulating cortisol, a hormone associated with various disorders [4]
Biotech Stocks Surge After Hours On Trial Updates And Strategic Moves
RTTNews· 2025-09-24 04:12
Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]
Corcept to Present New Late-Breaking Data From Pivotal ROSELLA Trial of Relacorilant in Platinum-Resistant Ovarian Cancer at ESMO 2025
Businesswire· 2025-09-22 18:30
Core Insights - Corcept Therapeutics Incorporated is a commercial-stage company focused on developing medications targeting severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating cortisol effects [1] Company Developments - The company will present new data from its pivotal Phase 3 ROSELLA trial, which investigates the combination of relacorilant and nab-paclitaxel for treating platinum-resistant ovarian cancer [1] - The presentation is scheduled for the 2025 European Society for Medical Oncology [1]
FDA Accepts Corcept's NDA for Relacorilant in Ovarian Cancer
ZACKS· 2025-09-11 17:01
Core Insights - Corcept Therapeutics (CORT) has received FDA acceptance for its new drug application (NDA) for relacorilant, aimed at treating platinum-resistant ovarian cancer, with a decision expected by July 11, 2026 [1][8] Group 1: NDA Submission and Study Results - The NDA submission was based on positive results from the pivotal phase III ROSELLA study and phase II studies, which assessed relacorilant in combination with nab-paclitaxel [2][8] - The ROSELLA study met its primary endpoint of improved progression-free survival, indicating the potential for relacorilant plus nab-paclitaxel to become a new standard of care for this patient population [3][8] Group 2: Financial Performance and Market Position - Year-to-date, Corcept's shares have increased by 42.1%, outperforming the industry average rise of 12.9% [4] - 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% [10] Group 3: Future Prospects and Additional Studies - Corcept is also pursuing an NDA for relacorilant to treat hypercortisolism (Cushing's syndrome), with a target action date set for December 30, 2025 [5][8] - 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 [9] - A successful approval for relacorilant could broaden Corcept's patient base and reduce reliance on Korlym for future growth [11]
Corcept’s (CORT) Multibagger Momentum Builds on Relacorilant and Expanding Commercial Footprint
Yahoo Finance· 2025-09-11 07:31
Core Insights - Corcept Therapeutics Inc. has revised its 2025 revenue guidance to $850-$900 million, down from $900-$950 million, but management remains confident in growth due to an expanded sales force, new pharmacy partnerships, and pipeline progress [1][2] - The potential of relacorilant is emphasized, with a projected annual revenue of $3-$5 billion in hypercortisolism alone, and a PDUFA date set for December 30, 2025 [2] - The company has established a dedicated oncology division to prepare for the commercialization of relacorilant, which is expected to launch quickly if approved [2][3] - Additional studies are being conducted in various cancer settings and other indications, with a second pharmacy expected to enhance revenue growth starting Q4 2023 [3] Financial Performance - Corcept's stock has doubled over the past year, with analysts projecting another 100% return over the next 12 months, all assigning a Buy or equivalent rating [4] - The company is focused on treating severe endocrinologic, oncologic, metabolic, and neurologic disorders through cortisol modulation [4]
Can Korlym Drive Corcept's Growth Through the Rest of 2025?
ZACKS· 2025-09-02 15:00
Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, has shown strong sales performance, with $351.6 million in sales for the first half of 2025, reflecting a year-over-year increase of approximately 13.2% [1][9] - The company anticipates full-year 2025 Korlym sales to reach $857.1 million, indicating a nearly 27% increase year-over-year [1][3] - Management expects a significant rise in Korlym prescriptions in the second half of 2025 as vendor issues are resolved [2][3] Sales and Revenue Expectations - Korlym sales were impacted by vendor capacity issues in Q1 2025 but improved in Q2, with expectations for continued growth in H2 2025 [2][3] - Corcept projects total revenues for 2025 to be between $850 million and $900 million [3] Pipeline Developments - Corcept is developing relacorilant for Cushing's syndrome, with a new drug application submitted to the FDA, and a decision expected by December 30, 2025 [4][9] - Approval of relacorilant is anticipated to broaden the patient base and reduce reliance on Korlym for future growth [5] Additional Indications and Studies - The company is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer and adrenal cancer [6][7] - The BELLA study is evaluating the efficacy of relacorilant combined with nab-paclitaxel and Avastin for ovarian cancer treatment [7] Market Performance and Valuation - Corcept's stock has increased by 38.3% year-to-date, outperforming the industry average of 8.3% [8] - The company's shares are trading at a premium, with a price-to-sales ratio of 11.73 compared to the industry average of 2.38 [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has decreased from $1.39 to $1.15, and for 2026, it has decreased from $2.08 to $1.71 [11]