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]

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]

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]

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]

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]

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]

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]

Core Insights - Corcept Therapeutics (CORT) has shown a strong performance in 2025, with shares increasing by 39.6%, significantly outperforming the industry average of 10.2% [1][7] - The company's lead pipeline candidate, relacorilant, is progressing towards potential FDA approval for Cushing's syndrome by December 2025, which is expected to enhance growth prospects [2][3] Pipeline Developments - Corcept submitted a new drug application (NDA) for relacorilant to the FDA for treating hypercortisolism in December 2024, which was accepted in March 2025 [3][7] - The NDA is supported by positive data from the GRACE study and phase III GRADIENT study, indicating strong efficacy for relacorilant [4] - A second NDA was submitted for relacorilant in combination with nab-paclitaxel for platinum-resistant ovarian cancer, based on positive phase III ROSELLA study results [5][8] Financial Performance - Korlym, the only marketed product, generated sales of $351.6 million in the first half of 2025, reflecting a year-over-year increase of approximately 13.2% [12] - Full-year 2025 sales for Korlym are estimated at $857.1 million, indicating a nearly 27% increase year-over-year [12] - The company has lowered its total revenue guidance for 2025 to a range of $850-$900 million, down from the previous estimate of $900-$950 million [13] Valuation Metrics - Corcept's shares are trading at a price-to-sales (P/S) ratio of 11.83, which is significantly higher than the industry average of 2.42 and above its five-year mean of 7.52 [14] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has decreased from $1.39 to $1.21, with 2026 EPS estimates also declining from $2.08 to $1.84 [16] Future Outlook - The potential approval of relacorilant is anticipated to broaden the patient base and positively impact stock performance in future quarters [17] - However, the reliance on Korlym for revenue remains a concern, and any regulatory or developmental setbacks could adversely affect the company's growth prospects [17][18]

Core Insights - Corcept Therapeutics (CORT) reported Q2 2025 earnings of $0.29 per share, exceeding the Zacks Consensus Estimate of $0.23, but down from $0.32 in the same quarter last year [1][7] - Revenues for the second quarter increased by 18.7% year over year to $194.4 million, although this figure fell short of the Zacks Consensus Estimate of $204 million [1][4] - The revenue was solely derived from product sales of the Cushing's syndrome drug, Korlym [1] Financial Performance - Revenue from Korlym missed the model estimate of $211.7 million [4] - Research and development expenses rose by 3.1% year over year to $60.5 million [4] - Selling, general, and administrative expenses surged by approximately 55.1% year over year to $103.8 million [4] - Total operating expenses increased by 30.8% year over year to $167.8 million in Q2 [4] - Cash and investments as of June 30, 2025, totaled $515 million, down from $570.8 million as of March 31, 2025 [5] Guidance and Market Reaction - Corcept lowered its total revenue guidance for 2025 to a range of $850-$900 million from the previous $900-$950 million [6][8] - This revision may have negatively impacted investor sentiment, leading to a 4.7% decline in stock price during pre-market trading on August 1 [8] Pipeline Developments - Corcept submitted a new drug application (NDA) to the FDA for its lead pipeline candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [9] - The NDA submission was based on data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [10] - The company is also evaluating relacorilant in combination with nab-paclitaxel and Avastin in the phase II BELLA study for the same indication [11][12] - Additional studies are ongoing for relacorilant in early-stage prostate cancer and for other pipeline candidates targeting various conditions [13] Market Performance - Year-to-date, Corcept's shares have increased by 33.3%, significantly outperforming the industry average rise of 4.5% [2]

Core Insights - Corcept Therapeutics (CORT) reported quarterly earnings of $0.29 per share, exceeding the Zacks Consensus Estimate of $0.23 per share, but down from $0.32 per share a year ago, resulting in an earnings surprise of +26.09% [1] - The company posted revenues of $194.43 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 4.73%, compared to $163.8 million in the same quarter last year [2] - Corcept shares have increased approximately 38.7% year-to-date, significantly outperforming the S&P 500's gain of 8.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.38 on revenues of $242.34 million, and for the current fiscal year, it is $1.39 on revenues of $899.03 million [7] - The estimate revisions trend for Corcept was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which Corcept belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - ARS Pharmaceuticals, Inc. is another company in the same industry, expected to report a quarterly loss of $0.41 per share, with revenues projected to be $15.12 million, reflecting a significant year-over-year increase [9]