Core Insights - Corcept Therapeutics (CORT) received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for relacorilant, a selective cortisol modulator intended for treating hypercortisolism (Cushing's syndrome) [1][5] - Following the announcement, Corcept's shares fell by 50.4% on December 31, 2025 [1][5] - The FDA's decision was based on the need for additional evidence of relacorilant's effectiveness, despite positive results from the GRACE and GRADIENT studies [3][5] Regulatory Developments - The NDA for relacorilant was submitted in December 2024, with an expected decision date of December 30, 2025 [2] - The FDA indicated that further studies are required to establish the drug's effectiveness for patients with hypertension secondary to hypercortisolism, which may delay approval [4] Financial Impact - Over the past six months, Corcept's shares have decreased by 51.8%, contrasting with a 3.4% increase in the industry [4] - Korlym, Corcept's currently marketed drug for Cushing's syndrome, generated sales of $559.3 million in the first nine months of 2025, reflecting a year-over-year increase of approximately 13.4% [9] Future Prospects - Corcept is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer, with regulatory decisions expected in 2026 [6][7] - The outcome of the FDA's CRL for relacorilant in Cushing's syndrome may influence the upcoming decision regarding its use in ovarian cancer [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 - 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 Viewpoint - Roche is actively engaging with the US government regarding drug pricing reforms, aligning with President Trump's initiatives to lower drug prices for patients [1][2]. Group 1: Government Engagement and Pricing Reforms - Roche's CEO, Thomas Schinecker, indicated ongoing discussions with the US government throughout the year concerning drug pricing reforms [2]. - The Trump administration's Most Favored Nation (MFN) executive order aims to link US drug prices to those in other developed countries, part of a broader strategy to provide cheaper options for patients [1]. - Pfizer and AstraZeneca have already signed deals with the Trump administration to offer medications at significant discounts through the upcoming direct-to-consumer platform, TrumpRx.gov, launching in January 2026 [3]. Group 2: Financial Performance - Roche reported total sales of Sfr45.9 billion ($57.6 billion) for the first nine months of 2025, reflecting a growth of 7% [4]. - The pharmaceuticals division saw a 9% increase in sales, contributing Sfr35.6 billion in revenue [4]. - However, total sales growth in Swiss francs was only 2%, and pharmaceutical growth was 4%, primarily due to the appreciation of the Swiss franc against the US dollar [5]. Group 3: Currency Impact and Earnings Outlook - The strengthening of the Swiss franc against the US dollar has negatively impacted sales values, although Roche has raised its earnings outlook for 2025 [6]. - The company now anticipates a high-single to low-double-digit percentage increase in earnings per share, an upgrade from the previous high-single-digit target [6]. Group 4: Product Exclusivity Challenges - Roche is facing challenges due to the loss of exclusivity for several blockbuster drugs, including Avastin (bevacizumab), which previously generated peak sales of around $7 billion before losing exclusivity in 2019 [7].

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 - Shares of Outlook Therapeutics (OTLK) fell by 54.1% following the FDA's issuance of a second complete response letter (CRL) rejecting the biologics license application (BLA) resubmission for ONS-5010 in the treatment of wet age-related macular degeneration (wet AMD) [1][7]. Regulatory Developments - The CRL highlighted a single deficiency: insufficient evidence of efficacy, as ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT study, necessitating additional confirmatory data for approval [2][7]. - The FDA's first CRL in 2023 raised concerns regarding chemistry, manufacturing, and controls, which were later addressed by the company [3]. - The NORSE EIGHT study, which was a follow-up to the initial BLA based on the NORSE TWO study, failed to meet the pre-specified non-inferiority endpoint at week 8 [9]. Company Performance - Year-to-date, OTLK shares have decreased by 42.3%, contrasting with a 3.3% growth in the industry [4]. - Following the second regulatory setback, the company plans to meet with the FDA to clarify the requirements for potential approval of ONS-5010 as the first on-label bevacizumab product for intravitreal use in the U.S. [10]. Market Expansion - ONS-5010 received regulatory approval in the EU and the UK in 2024, marketed under the brand name Lytenava for treating wet AMD [12]. - The company launched Lytenava in the UK and Germany in June 2025, positioning it as the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment in these regions [13]. - Outlook Therapeutics aims to provide a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use [11][13].

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) has submitted a new drug application (NDA) to the FDA for its lead candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [1][7] - The NDA submission is based on positive data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [3][2] - The company aims to diversify its product offerings beyond its sole marketed drug, Korlym, to reduce reliance on it for growth [9][7] NDA Submissions and Studies - In December 2024, CORT submitted an NDA for relacorilant to treat hypercortisolism (Cushing's syndrome), which was accepted by the FDA in March 2025 with a target action date of December 30, 2025 [5][2] - The NDA for platinum-resistant ovarian cancer is supported by data from the ROSELLA study and other phase II studies [2][3] - CORT is also conducting additional studies, including the BELLA study, which evaluates relacorilant in combination with nab-paclitaxel and Roche's Avastin for the same indication [10] Financial Performance - Year to date, CORT shares have increased by 44.4%, significantly outperforming the industry average rise of 4.1% [4] - Korlym generated sales of $157.2 million in Q1 2025, reflecting a year-over-year increase of 7.1% due to strong demand [8] Pipeline and Future Prospects - CORT is exploring relacorilant in combination with Xtandi for early-stage prostate cancer and evaluating its selective cortisol modulator dazucorilant for amyotrophic lateral sclerosis (ALS) [11] - Another candidate, miricorilant, is being studied for metabolic dysfunction-associated steatohepatitis [12] - A potential approval for relacorilant could expand CORT's patient base and reduce dependence on Korlym for long-term growth [9]

Core Viewpoint - Tempest Therapeutics, Inc. is exploring strategic options to enhance stockholder value, which may include mergers, acquisitions, partnerships, or licensing arrangements [1] Company Development Plans - Tempest is developing amezalpat (TPST-1120), a PPAR-alpha antagonist, for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [2] - The company is also working on TPST-1495, a selective EP2-EP4 dual antagonist, for treating familial adenomatous polyposis (FAP) [2] - Tempest has partnered with Roche to evaluate amezalpat in combination with Roche's Tecentriq and Avastin for HCC treatment [5] - The FDA has cleared Tempest to begin a pivotal phase III study for amezalpat in combination with Roche's therapy for HCC [6] - Ongoing studies have shown that amezalpat combined with Roche's therapy resulted in a six-month improvement in median overall survival compared to the standard therapy alone [7] - The FDA has granted Fast Track and Orphan Drug designations to amezalpat for HCC treatment [7] - Tempest has received a "Study May Proceed" letter from the FDA for a phase II study on TPST-1495, expected to start in 2025 [9] - The FDA has also granted Orphan Drug designation to TPST-1495 for FAP treatment [9] - Management believes that amezalpat has blockbuster potential in HCC, while TPST-1495 also shows promise [10] Stock Performance - Following the announcement of strategic options, Tempest's shares rose by 6.3% in after-hours trading on April 9 [2] - Year-to-date, Tempest's shares have decreased by 34.1%, compared to a 14.6% decline in the industry [3]