REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today announced that the U.S. Food and Drug Administration (FDA or the Agency) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment fo. ...

Core Insights - Corcept Therapeutics' Relacorilant is under FDA review with a PDUFA target date of December 30, 2025, which is crucial for the company's financial strategy to diversify revenue sources beyond Korlym [1] - The outcome of the PDUFA review is critical, as an unfavorable result could significantly impact Corcept's valuation due to the lack of other pre-registration drugs expected to reach approval in the next 3-5 years [1] Clinical & Regulatory Assessment - Relacorilant is a selective glucocorticoid receptor antagonist aimed at managing hypercortisolism in endogenous Cushing's syndrome, with its NDA supported by data from two Phase 3 trials: GRACE and GRADIENT [2] - In the GRACE trial, relacorilant met its primary endpoint, showing that patients switching to placebo had a higher risk of losing hypertension control, while in the GRADIENT trial, it failed to meet its primary endpoint of reducing mean systolic blood pressure [3] - The efficacy of relacorilant may be more pronounced in patients with non-adrenal etiology of endogenous Cushing's syndrome, which constitutes the majority of cases, but the failure in the GRADIENT trial raises concerns about the NDA's approval likelihood [3] Financial Position Outlook - Corcept Therapeutics has a market capitalization of $8.9 billion and maintains a strong liquidity position with no long-term debt, indicating financial stability [4] - The increase in R&D and SG&A expenses is consistent with the company's expanding clinical activities and preparations for the Relacorilant PDUFA event, and is not viewed as alarming [4] - The company's share outstanding remains stable with no imminent dilution expected, largely due to increased revenue from the commercialization of Korlym, which supports pipeline development [5]

Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the Stocks That Could Mint Millionaires in 2026. Corcept Therapeutics (CORT): Analyst Says Shares Pricing in Growth, New Launch On December 16, UBS analyst Ashwani Verma initiated coverage of Corcept Therapeutics Incorporated (NASDAQ:CORT) stock with a Neutral rating and $95 price target. In an investor note, the analyst cited valuation for the Neutral rating, with the shares up 64% year-to-date. Per the analyst, the stock was already pricing in b ...

Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) is recognized as a strong biotech investment by Wall Street analysts, with a Buy rating and a price target of $145 due to its growth potential despite facing commercial challenges [1] Financial Performance - Sales of Corcept's Korlym medication are projected to grow by 19% to 26% year over year, with a 40% increase in volume over the past two quarters, supporting the company's guidance of $800-$850 million [2] Product Pipeline - Corcept is preparing to launch relacorilant for Cushing's syndrome, with anticipated sales reaching $4.3 billion by 2034, indicating a robust product pipeline [3] Market Sentiment - Wolfe Research initiated coverage of Corcept with a Peer Perform rating, expecting the stock to trade between $70 and $75 until legal issues are resolved, while acknowledging the potential of relacorilant [4] Company Overview - Corcept Therapeutics develops drugs that modulate cortisol to treat severe metabolic, oncologic, and neuropsychiatric disorders, with its first approved drug, Korlym, targeting Cushing's Syndrome [5]

Core Insights - Corcept Therapeutics reported third-quarter 2025 earnings of 16 cents per share, missing the Zacks Consensus Estimate of 18 cents, and down from 41 cents per share in the same quarter last year [2] - Revenues for the third quarter increased approximately 14% year over year to $207.6 million, but fell short of the Zacks Consensus Estimate of $219 million, with the revenue solely coming from product sales of the Cushing's syndrome drug, Korlym [2] Financial Performance - Revenues from Korlym missed the model estimate of $222.6 million [3] - Research and development expenses rose 16% year over year to $68.8 million, while selling, general and administrative expenses surged around 68.2% year over year to $124 million [3] - Operating expenses increased 30.8% year over year to $197.4 million in the third quarter [3] - Cash and investments as of September 30, 2025, totaled $524.2 million, up from $515 million as of June 30, 2025 [3] 2025 Guidance - Corcept lowered its total revenue guidance for 2025, now expecting total revenues in the range of $800-$850 million, down from the previous projection of $850-$900 million [4] Estimate Trends - Fresh estimates have trended downward over the past month, with the consensus estimate shifting down by 36.91% [5] VGM Scores - Corcept has a Growth Score of B but lags in Momentum Score with an F, and has an aggregate VGM Score of D, placing it in the bottom 40% for the investment strategy [6] Industry Comparison - Corcept is part of the Zacks Medical - Drugs industry, where United Therapeutics reported revenues of $799.5 million for the last quarter, reflecting a year-over-year change of +6.8% [8] - United Therapeutics is expected to post earnings of $6.74 per share for the current quarter, representing a year-over-year change of +8.9% [9]

Core Insights - Corcept Therapeutics (CORT) is making significant progress with its sole-marketed drug, Korlym (mifepristone), which is approved for treating Cushing's syndrome or endogenous hypercortisolism. The company's revenue is currently derived entirely from Korlym sales [1] Sales Performance - In the first nine months of 2025, Korlym generated sales of $559.3 million, reflecting a year-over-year increase of approximately 13.4%. The sales momentum is expected to continue, with a projected compound annual growth rate (CAGR) of around 26.4% over the next three years [2][10] - Despite earlier sales disruptions due to insufficient capacity from a specialty pharmacy vendor, sales have improved, and further enhancements are anticipated with new pharmacy vendors in 2026. For the full year of 2025, Corcept expects total revenues to be between $800 million and $850 million [3][10] Pipeline Development - Corcept is developing relacorilant, its lead pipeline candidate, for treating Cushing's syndrome and certain cancer indications. A new drug application (NDA) for relacorilant was submitted to the FDA in December 2024, with a target action date of December 30, 2025 [4][5] - Approval of relacorilant for Cushing's syndrome is expected to diversify Corcept's revenue streams and reduce reliance on Korlym. Management anticipates that all current Korlym patients will transition to relacorilant upon its approval [6] - The FDA accepted an NDA for relacorilant in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer, with a decision expected on July 11, 2026. Additionally, a marketing authorization application (MAA) has been submitted to the European Medicines Agency for the same indication, with potential approval by the end of 2026 [7] - Corcept is also conducting studies evaluating relacorilant in combination with nab-paclitaxel and Avastin for platinum-resistant ovarian cancer, as well as with Xtandi for early-stage prostate cancer [8][9] Financial Performance and Valuation - Year-to-date, Corcept's shares have increased by 57.6%, outperforming the industry, which rose by 9.4%. The stock has also surpassed the performance of the sector and the S&P 500 [11] - From a valuation perspective, Corcept is trading at a premium, with a price-to-sales (P/S) ratio of 12.80, significantly higher than the industry average of 2.38 and above its five-year mean of 7.66 [12] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has decreased from $1.15 to $0.89 over the past 60 days, with 2026 EPS estimates also declining from $1.71 to $1.25 [13]

Core Insights - Several small-cap biotech and therapeutics companies experienced significant gains in after-hours trading, driven by earnings updates, financial guidance, and regulatory developments [1] Company Summaries - Inotiv, Inc. (NOTV) saw a 36.61% increase in after-hours trading to $0.94, recovering from a 33.20% decline at the close, following preliminary Q4 revenue expectations of $137.5 million to $138.5 million and full-year revenue projections of $512.5 million to $513.5 million [2] - Applied Therapeutics, Inc. (APLT) rose 16.89% to $0.33 after a 30.19% gain at the close, with investors reacting positively to a narrower Q3 net loss of $19.0 million, or $0.13 per share, compared to a $68.6 million loss, or $0.48 per share, in the same quarter last year [3] - Alumis Inc. (ALMS) advanced 7.09% to $5.97, despite reporting a Q3 net loss of $110.8 million, wider than the $93.1 million loss in the prior year, with $2.1 million in collaboration income potentially boosting investor confidence [4] - TELA Bio, Inc. (TELA) increased 7.89% to $1.23 after a 14.08% gain at the close, reporting a reduced Q3 net loss of $8.6 million compared to $10.4 million a year earlier, with revenue growth of 9% to $20.7 million and revised 2025 guidance projecting at least 16% revenue growth over 2024 [5] - Corcept Therapeutics Inc. (CORT) gained 4.90% to $78.80, reflecting continued investor interest despite no specific news released [6] - BioRestorative Therapies, Inc. (BRTX) jumped 8.06% to $1.34, rebounding from a 6.77% decline at the close, following the announcement of a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application pathway for its BRTX-100 program [7]

Core Insights - Corcept Therapeutics (CORT) reported Q3 2025 earnings of $0.16 per share, missing the Zacks Consensus Estimate of $0.18, and down from $0.41 in the same quarter last year [1][8] - Revenues for Q3 increased approximately 14% year over year to $207.6 million, but fell short of the Zacks Consensus Estimate of $219 million, with the revenue solely coming from product sales of Korlym [1][8] - The company lowered its total revenue guidance for 2025 to a range of $800-$850 million, down from the previous estimate of $850-$900 million, which contributed to a 4.6% drop in shares during after-hours trading [2][9] Financial Performance - Revenues from Korlym missed the model estimate of $222.6 million [5] - Research and development expenses rose 16% year over year to $68.8 million [5] - Selling, general and administrative expenses increased approximately 68.2% year over year to $124 million, leading to total operating expenses rising 30.8% year over year to $197.4 million in Q3 [5] Cash Position - As of September 30, 2025, cash and investments totaled $524.2 million, an increase from $515 million as of June 30, 2025 [6] Pipeline Developments - Corcept is developing relacorilant for Cushing's syndrome and certain cancer indications, with a new drug application submitted to the FDA in December 2024 [10] - The FDA accepted a new NDA for relacorilant in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer, with a decision expected on July 11, 2026 [11] - Corcept is also conducting a phase II study evaluating relacorilant plus nab-paclitaxel for cervical cancer and plans to start another phase II study for pancreatic cancer soon [13][14] Market Performance - Year to date, shares of Corcept have increased by 41.1%, significantly outperforming the industry average rise of 6.7% [4]

Core Insights - Corcept Therapeutics reported quarterly earnings of $0.16 per share, missing the Zacks Consensus Estimate of $0.18 per share, and down from $0.41 per share a year ago, representing an earnings surprise of -11.11% [1] - The company posted revenues of $207.64 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 5.27%, compared to $182.55 million in the same quarter last year [2] - Corcept shares have increased by approximately 47.2% since the beginning of the year, outperforming the S&P 500's gain of 16.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.42 on revenues of $281.34 million, and for the current fiscal year, it is $1.07 on revenues of $852.16 million [7] - The estimate revisions trend for Corcept was unfavorable prior to the earnings release, resulting in a Zacks Rank 5 (Strong Sell) for the stock, indicating expected underperformance in the near future [6] Industry Context - The Medical - Drugs industry, to which Corcept belongs, is currently in the top 36% of over 250 Zacks industries, suggesting that stocks in the top 50% of Zacks-ranked industries tend to outperform those in the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $207.6 million, up from $182.5 million in the same period last year, reflecting a year-over-year increase of approximately 13% [3] - Net income decreased to $19.7 million from $47.2 million in Q3 2024 [3] - Cash and investments as of September 30, 2025, totaled $524 million, which includes a $50 million stock repurchase [3] Business Line Data and Key Metrics Changes - The hypercortisolism business experienced a 42.5% increase in tablet shipments compared to Q3 2024, driven by record prescriptions for Korlym [7] - The company is transitioning to a new pharmacy vendor due to capacity constraints with the previous vendor, which may affect growth in the short term [7][8] Market Data and Key Metrics Changes - The company reported around 3,250 paying patients at the end of Q3 2025, with expectations for significant market capacity growth as relacorilant is launched [34][35] - The authorized generic accounted for approximately 70% of the business in Q3 2025, with expectations to reach around 75% by year-end [42] Company Strategy and Development Direction - The company is preparing for the launch of relacorilant, with PDUFA dates set for December 30, 2025, for hypercortisolism and July 11, 2026, for ovarian cancer [12] - The oncology program is expanding significantly, with plans for new studies in various solid tumors and a focus on combining treatments with existing therapies [20][21] - The company aims to triple the potential patient base for gynecological cancers from 20,000 to 60,000 annually in the U.S. [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of relacorilant, anticipating it could generate $3-$5 billion in annual revenue in hypercortisolism alone within three to five years [11] - The company is optimistic about the upcoming FDA approvals and the potential impact of its clinical studies on treatment paradigms [28][29] Other Important Information - The company is finalizing a phase 3 trial design for dazcorilant in ALS, expected to start by mid-2026 [14][27] - The CATALYST study revealed that one in four patients with resistant diabetes has hypercortisolism, indicating a significant opportunity for treatment [24] Q&A Session Summary Question: How many patients were on drug at the end of the quarter? - Approximately 3,250 paying patients were reported at the end of Q3 2025 [34] Question: What is the capacity of the new pharmacy compared to the old one? - The new pharmacy has the ability to continually expand and has multiple locations, which is expected to support the business effectively [34] Question: Are there any downward pressures on margins? - No downward pressure on margins has been observed, and the company does not expect any [36] Question: What is the net pricing relative to brand pricing? - The net pricing is about a 30% discount to Korlym's list price, with the authorized generic making up a significant portion of the business [42] Question: Was the lack of priority review for the ovarian cancer NDA surprising? - Management was not surprised by the lack of priority review, acknowledging the FDA's many priorities [44] Question: What are the expectations for R&D and SG&A in 2026? - R&D expenditures are expected to remain stable, while SG&A expenses are anticipated to increase due to preparations for product launches [46]