Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) is focused on developing medications that modulate cortisol effects to treat severe disorders, including oncologic conditions [1] - H.C. Wainwright upgraded CORT's stock to "Buy" and raised its price target from $90 to $105, with the stock priced at approximately $41.87 at the time of the announcement [1][5] Stock Performance - Following the upgrade, CORT's stock has seen a notable increase, currently priced at $41.30, reflecting a 13.74% increase with a change of $4.99 [3][5] - The stock has fluctuated between a low of $40.46 and a high of $52.84 during today's trading [3] - Over the past year, the stock reached a high of $117.33 and a low of $32.99 [3] Clinical Trial Results - The upgrade coincides with significant developments, particularly the successful results from the ROSELLA Phase 3 trial, which tested the combination of relacorilant and nab-paclitaxel for treating platinum-resistant ovarian cancer [2] - The trial demonstrated a 35% reduction in the risk of death for patients receiving the combination therapy [2][5] - The combination therapy was well-tolerated, with adverse events similar to those experienced with nab-paclitaxel monotherapy [4] Market Capitalization and Trading Volume - Corcept's market capitalization is approximately $4.34 billion, with a trading volume of 5,304,058 shares [4]

Core Insights - Corcept Therapeutics is focused on developing drugs for severe metabolic and oncologic disorders, particularly in cortisol modulation therapies [1] - The company faces competition from Teva Pharmaceuticals and Mylan in similar therapeutic areas [1] Stock Performance - Analyst Swayampakula Ramakanth from H.C. Wainwright set a new price target of $105 for CORT, indicating a potential increase of approximately 46.8% from the current price of $41.47 [2][6] - Corcept's stock has seen a significant increase, with trading volume reaching over 3 million shares following successful results from the ROSELLA Phase 3 trial [3][6] - The current stock price is $41.61, reflecting a 14.60% increase with a change of $5.30, and the stock has fluctuated between a low of $40.46 and a high of $43.50 during the day [5] Clinical Trial Results - The ROSELLA Phase 3 trial tested relacorilant and nab-paclitaxel in treating platinum-resistant ovarian cancer, showing a 35% reduction in the risk of death for patients receiving the combination therapy [3][6] - The median overall survival for patients treated with relacorilant was 16 months, compared to 11.9 months for those on nab-paclitaxel alone, marking an improvement of 4.1 months [4][6] - The combination therapy was well-tolerated, with adverse events similar to those experienced with nab-paclitaxel monotherapy [4] Market Capitalization - Corcept's market capitalization stands at approximately $4.38 billion, with today's trading volume at 4,189,821 shares on the NASDAQ exchange [5]

Core Insights - Corcept Medical (CORT.US) announced that its pivotal Phase 3 trial ROSELLA achieved the primary endpoint of overall survival (OS) [1] - The trial evaluated the efficacy of the selective cortisol modulator relacorilant in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer patients [1] - The FDA has accepted the New Drug Application (NDA) for relacorilant, with a PDUFA date set for July 11, 2026, and the EMA is also reviewing the marketing authorization application (MAA) for the same indication [1] Efficacy and Safety - Patients receiving relacorilant in combination with nab-paclitaxel experienced a 35% reduction in the risk of death compared to those receiving nab-paclitaxel alone (HR=0.65, p=0.0004) [1] - The median OS for patients treated with relacorilant was 16.0 months, compared to 11.9 months for those on nab-paclitaxel alone, representing a difference of 4.1 months [1] - The combination treatment demonstrated good tolerability, with adverse events being comparable in type, frequency, and severity to those in the nab-paclitaxel monotherapy group [2] Additional Findings - The ROSELLA trial also met the primary endpoint of progression-free survival (PFS) improvement, confirmed by blinded independent central review (BICR) [2] - Patients receiving the combination therapy had a 30% lower risk of disease progression compared to those receiving nab-paclitaxel alone (HR=0.70, p=0.008) [2] - Relacorilant is an oral selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity without binding to other hormone receptors [2] - Corcept is advancing the development of relacorilant for ovarian cancer and various other serious conditions, including endogenous Cushing's syndrome, endometrial cancer, cervical cancer, pancreatic cancer, and prostate cancer [2] - The drug has received orphan drug designation from the FDA and the European Commission for the treatment of Cushing's syndrome and ovarian cancer [2]

Core Insights - Corcept Therapeutics' stock is experiencing an increase, with a trading volume of 3.06 million shares on Thursday [1] - The ROSELLA Phase 3 trial for relacorilant combined with nab-paclitaxel in treating platinum-resistant ovarian cancer has met its primary endpoint for overall survival [1] Efficacy Data - Patients receiving relacorilant plus nab-paclitaxel showed a 35% reduction in the risk of death compared to those on nab-paclitaxel alone, with a hazard ratio of 0.65 and a p-value of 0.0004 [2] - The median overall survival for patients on the combination therapy was 16.0 months, compared to 11.9 months for those on nab-paclitaxel alone, indicating a 4.1-month improvement [2] - The combination therapy was well-tolerated, maintaining a safety profile consistent with previous data [2][3] Safety Profile - The type, frequency, and severity of adverse events in the combination therapy group were similar to those in the nab-paclitaxel monotherapy group, indicating that relacorilant did not increase the safety burden [3] - Corcept has also reported that the ROSELLA trial met its primary endpoint for improved progression-free survival [3][4] Regulatory Background - In December 2025, the FDA issued a Complete Response Letter regarding the New Drug Application for relacorilant for hypertension secondary to hypercortisolism, indicating the need for additional evidence of effectiveness [5][6] - Despite the FDA acknowledging the success of the pivotal GRACE trial, it concluded that a favorable benefit-risk assessment could not be made without further evidence from Corcept [6] Market Reaction - Following the positive trial results, Corcept Therapeutics shares rose by 19.14%, reaching a price of $43.26 [6]

Group 1 - Corcept Therapeutics announced that its experimental cancer drug successfully met the primary endpoint in a late-stage clinical trial [1]

Core Viewpoint - Corcept Therapeutics experienced a significant decline in share price, dropping 50% after receiving a complete response letter from the FDA regarding its treatment relacorilant for hypercortisolism, leading to a loss of over $3.6 billion in market capitalization [1][3]. Company Overview - Corcept Therapeutics has previously promoted relacorilant's efficacy and commercial potential, claiming that clinical trial patients showed meaningful improvements in hypercortisolism symptoms [3]. - The company expressed confidence in achieving annual revenues of $3 billion to $5 billion from its hypercortisolism business within three to five years [3]. FDA Response - The FDA's complete response letter indicated that additional evidence of effectiveness was required for relacorilant, contradicting Corcept's previous assurances about the drug's progress toward approval [3]. - A report noted that the likelihood of loss of blood pressure control was 83% lower in the relacorilant group compared to placebo, which may have influenced the FDA's decision [3]. Legal Investigation - Hagens Berman, a national shareholder rights law firm, has initiated an investigation into whether Corcept misled investors regarding relacorilant's efficacy and commercial prospects [2][4]. - The firm is encouraging investors who suffered losses to come forward and discuss their rights [2][4].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Corcept Therapeutics and its officers or directors following a significant stock price drop after the FDA's Complete Response Letter regarding relacorilant [1][3]. Group 1: Company Overview - Corcept Therapeutics Incorporated is a biopharmaceutical company focused on developing treatments for patients with conditions related to cortisol [3]. - The company’s stock price experienced a dramatic decline of $35.40 per share, or 50.42%, closing at $34.80 per share on December 31, 2025, after the FDA issued a Complete Response Letter for its New Drug Application for relacorilant [3]. Group 2: Regulatory Developments - On December 31, 2025, the FDA issued a Complete Response Letter regarding Corcept's New Drug Application for relacorilant, indicating that while the pivotal GRACE trial met its primary endpoint, additional evidence of effectiveness was required for a favorable benefit-risk assessment [3].

Core Insights - Corcept Therapeutics Incorporated is under investigation for potential violations of federal securities laws following a Complete Response Letter (CRL) from the FDA regarding its new drug application for relacorilant [1][2] - The FDA's decision was based on the need for additional evidence of effectiveness despite acknowledging previous trial results [2] - Following the announcement, Corcept's stock price experienced a significant drop of $31.42, or 44.76%, reaching a new 52-week low of $38.78 per share [2][3] Company Developments - The FDA's CRL was issued on December 31, 2025, denying approval for relacorilant as a treatment for hypertension secondary to hypercortisolism [1] - The stock price decline marks a significant downturn, with levels not seen since September 2024 [3] Legal Context - Levi & Korsinsky LLP has initiated an investigation into Corcept, indicating potential legal ramifications for the company and its investors [1][4] - The firm has a strong track record in securities litigation, having secured substantial recoveries for shareholders in the past [4]

Corcept Therapeutics Incorporated (NASDAQ:CORT) is among the most promising growth stocks according to analysts. According to an Investing.com report, William Guyer, Chief Development Officer at Corcept Therapeutics Incorporated (NASDAQ:CORT), sold 20,000 shares of common stock valued at $703,656 on January 6. Earlier on January 2, Swayampakula Ramakanth, an analyst at H.C. Wainwright, trimmed the price target on Corcept Therapeutics Incorporated (NASDAQ:CORT) to $90 from $145, while maintaining a ‘Buy’ ...

Core Insights - Corcept Therapeutics and Amicus Therapeutics reported Q3 2025 results, showcasing contrasting profitability levels within the rare disease biotech sector [1] Company Summaries Corcept Therapeutics - Corcept Therapeutics is positioned as a profitable entity within the rare disease biotech space, indicating strong financial performance [1] Amicus Therapeutics - Amicus Therapeutics, in contrast, is highlighted as being at the opposite end of the profitability spectrum, suggesting challenges in achieving financial stability [1]