Core Viewpoint - Corcept Therapeutics experienced a significant drop in share price, falling 50% on December 31, 2025, after receiving a complete response letter (CRL) from the FDA regarding its treatment relacorilant for hypercortisolism, indicating the need for additional evidence of effectiveness [1][2]. Company Summary - Corcept Therapeutics' relacorilant was previously promoted as having strong efficacy and commercial potential, with management expressing confidence in growing its hypercortisolism business to annual revenues between $3 billion and $5 billion within three to five years [2][3]. - The FDA's CRL indicated that the agency could not make a favorable benefit-risk assessment for relacorilant without further evidence, contrasting with Corcept's prior assurances about the drug's approval timeline [2][3]. - Following the announcement of the CRL, Corcept's market capitalization decreased by over $3.6 billion in a single day, reflecting the severe impact of the news on investor sentiment [1][2].

Company Overview - Corcept Therapeutics (CORT) shares increased by 9.8% to close at $38.2, following a significant volume of trading, despite a previous 58.9% loss over the past four weeks [1] - The stock experienced a decline after the FDA issued a complete response letter regarding its new drug application for relacorilant, aimed at treating hypercortisolism (Cushing's syndrome) [1] Earnings Expectations - Analysts project Corcept to report quarterly earnings of $0.27 per share, reflecting a year-over-year increase of 3.9% [2] - Revenue expectations stand at $254.39 million, which indicates a 39.9% increase compared to the same quarter last year [2] Stock Performance Insights - The consensus EPS estimate for Corcept has remained unchanged over the last 30 days, suggesting that stock price movements may not sustain without trends in earnings estimate revisions [4] - The stock currently holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [5] Industry Comparison - Corcept is part of the Zacks Medical - Drugs industry, where another company, Collegium Pharmaceutical (COLL), saw a 1.7% decrease in its stock price, closing at $45.53, with a -2.4% return over the past month [5] - Collegium's consensus EPS estimate for its upcoming report is $2.21, representing a 24.9% increase from the previous year, and it holds a Zacks Rank of 1 (Strong Buy) [6]

Company Overview - Corcept Therapeutics is a commercial-stage biotech company focused on treatments for cortisol modulation, particularly related to Cushing's Syndrome [1] Product Information - Since 2012, the company has marketed Korlym as a treatment for Cushing's Syndrome [1]

Market Overview - U.S. stocks opened 2026 with modest gains, with the Dow Jones Industrial Average and S&P 500 rising, while the Nasdaq Composite lagged behind, reflecting cautious optimism after a strong 2025 for equities [1] - Trading volumes were light, indicating a rebound from late-December weakness [1] Sector Performance - Chipmakers, particularly Nvidia and Micron, led early gains due to ongoing enthusiasm around AI demand, although weakness in several megacap technology and consumer discretionary stocks limited broader market gains [2] Economic Outlook - Investors are focusing on upcoming economic data and Federal Reserve signals to assess the outlook for rates and growth in 2026, with strategists cautioning that early January market movements may not dictate future trends [3] Bullish Stocks - Nike, Inc. shares rose nearly 3% following insider buying, which is seen as a vote of confidence in the company's turnaround strategy, with CEO Elliott Hill purchasing approximately $1 million in shares [4] - Energy Fuels Inc. exceeded its production guidance, mining over 1.6 million pounds of uranium and projecting Q4 sales around 360,000 pounds, generating approximately $27 million in revenue [6] - A potential SpaceX IPO in 2026 could significantly impact the market, potentially leading to capital rotation from Tesla as investors buy SpaceX shares, while ultimately benefiting Elon Musk-linked companies [5] Bearish Stocks - U.S.-listed Chinese tech stocks, including Alibaba, JD.com, and PDD Holdings, declined due to thin holiday trading volumes and disappointing economic data from China, reflecting broader market weakness [7] - Ultragenyx Pharmaceutical and Mereo BioPharma shares fell to 52-week lows after a late-stage clinical trial for a bone disease therapy failed to meet its primary endpoint [8] - Corcept Therapeutics shares dropped sharply following an FDA refuse-to-file letter for its investigational drug relacorilant, which surprised investors and led to reassessment of the company's regulatory pathway [9]

Company Overview - Intelligent Bio Solutions Inc. (NASDAQ:INBS) announced plans to raise $10 million through a private placement, leading to a significant drop in its share price [1] - Following the announcement, shares of Intelligent Bio fell 19.7% to $7.65 [1] Stock Movements - Lavoro Limited (NASDAQ:LVRO) saw a substantial increase of 181%, reaching $1.2900 [4] - Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) rose 57.7% to $5.32 after issuing FY26 guidance, expecting US net sales of Linzess to be between $1.125 billion and $1.175 billion [4] - Brand Engagement Network, Inc. (NASDAQ:BNAI) jumped 56% to $3.6290 after entering a Vendor Services Project Agreement with a global advertising agency [4] - ChowChow Cloud International Holdings Limited (NYSE:CHOW) increased by 39.7% to $0.8500 due to year-over-year revenue and net income growth in H1 2025 [4] - Sidus Space, Inc. (NASDAQ:SIDU) gained 29% to $4.0314, marking a 470% surge over the past month [4] - Baidu, Inc. (NASDAQ:BIDU) rose 12.1% to $146.57 after announcing a proposed spin-off and Hong Kong listing of its AI unit [4] Declines - Outlook Therapeutics, Inc. (NASDAQ:OTLK) experienced a significant decline of 58% to $0.6632 after receiving a complete response letter from the FDA regarding its biologics license application [4] - ESH Acquisition Corp. (NASDAQ:ESHA) fell 23.5% to $14.68 [4] - Nuvve Holding Corp. (NASDAQ:NVVE) declined 15.3% to $2.1500 after announcing the closing of a private placement [4]

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 Viewpoint - Corcept Therapeutics faced a significant setback after the FDA rejected its application for relacorilant, a treatment for Cushing's syndrome, due to insufficient data for a favorable benefit-risk assessment [1][3][4] Company Impact - The FDA's rejection has led to a 70% decline in CORT stock compared to its March high, indicating a drastic market reaction [2] - Relacorilant was expected to be a key product for Corcept's growth strategy, aimed at diversifying beyond its existing Korlym franchise [3][4] - The company now faces uncertainty as it must conduct additional trials, which will be costly and time-consuming [4] Market Competition - The rejection hampers Corcept's ability to compete with Xeris Biopharma's Recorlev in the Cushing's syndrome market, which is projected to triple from the current $1 billion by the end of the decade [5] - The extended timeline for relacorilant's development may allow Recorlev to capture a larger market share [5] Technical Analysis - CORT shares are trading below major moving averages, indicating ongoing weakness in the stock [6] - Insider selling has been prevalent over the past 12 months, reinforcing bearish sentiment for Corcept heading into 2026 [6] Wall Street Sentiment - Prior to the FDA decision, Wall Street had a consensus "Moderate Buy" rating on Corcept stock, with a mean target of approximately $127, suggesting an upside potential of about 80% from its previous close [7]

FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

Core Viewpoint - U.S. financial markets are experiencing a pause for the New Year's Day holiday, with trading set to resume on January 2nd, 2026. Despite a recent pullback, 2025 was a strong year for major stock indexes, which posted significant gains. Market Performance - On December 31st, 2025, major U.S. stock indexes closed lower, continuing a four-session losing streak. The Dow Jones Industrial Average fell 0.6% to 48,063.29, the S&P 500 declined 0.7% to 6,845.50, and the Nasdaq Composite dropped 0.8% to 23,241.99. Trading volume was light as many institutional investors had closed their books for the year [2][3]. - Sector performance was predominantly negative, with technology stocks being a major drag. The Energy Select Sector SPDR rose 0.8%, while the Information Technology Select Sector SPDR, Financials Select Sector SPDR, and Industrials Select Sector SPDR all declined by 0.3% [4]. Notable Stock Movements - Ares Management Corporation saw a share decline of 3.4%. Micron Technology and Western Digital experienced drops of 2.5% and 2.2%, respectively. Corcept Therapeutics shares plunged significantly after the FDA did not approve its treatment. Conversely, Nike shares rose 4.1% following the CEO's purchase of approximately $1 million in company stock [5]. Year-End Market Drivers - The strong performance in 2025 was largely driven by optimism surrounding artificial intelligence, with companies like Micron Technology, Palantir, Advanced Micro Devices, Alphabet, and Nvidia being significant contributors. The S&P 500 finished 2025 up approximately 16.4%, the Nasdaq Composite surged around 20.4%, and the Dow Jones Industrial Average added roughly 13% [6]. Upcoming Economic Data - Key economic data releases are scheduled for early January, including Initial Claims data and Construction PDF on January 2nd, ISM Manufacturing index on January 5th, and various employment reports on January 7th. Important inflation indicators like the Consumer Price Index and Producer Price Index will be released on January 13th and 14th, respectively [8]. Federal Reserve Meeting - The U.S. Federal Reserve's Federal Open Market Committee meeting is set for January 28th, where market participants will seek guidance on monetary policy for 2026, particularly regarding inflation and potential interest rate adjustments [9]. Upcoming Earnings Releases - The earnings season for Q4 2025 will begin to gain momentum later in January, with notable companies like BHP Group, JPMorgan Chase, and Bank of America expected to report. These earnings will provide critical insights into corporate performance and outlooks for the new year [10].

Group 1: Corcept Medical - Corcept Medical's stock plummeted by 50% after the FDA rejected its drug application for treating a rare hormonal disorder, resulting in a market value loss of $3.7 billion [1][3]. - The FDA's complete response letter indicated that while the company's GRACE clinical trial met its primary endpoint, additional evidence of efficacy is required for a favorable benefit-risk assessment [3][4]. - Corcept's CEO expressed disappointment but remains committed to finding a way to bring the drug Relacorilant to patients, planning to meet with the FDA to discuss next steps [3][4]. Group 2: Relacorilant Drug Details - Relacorilant is a selective cortisol modulator aimed at treating conditions like endogenous hypercortisolism and ovarian cancer, and it has orphan drug designation from both the FDA and the European Commission [5][6]. - The drug has shown improvements in various symptoms associated with hypercortisolism, which can lead to serious health issues such as diabetes and hypertension [4][5]. - The FDA has set a target date of July 11, 2026, for the drug's use in treating platinum-resistant ovarian cancer patients [6]. Group 3: Indian Tobacco Market - Indian tobacco stocks experienced significant declines, with ITC's stock dropping over 9% and Godfrey Phillips India falling more than 16% following the announcement of a substantial increase in cigarette consumption tax [1][7]. - The new tax, effective February 1, will impose a consumption tax based on cigarette length, potentially increasing overall costs by 22%-28% for certain products [7][8]. - Analysts predict that the increased tax burden may lead to higher retail prices and could negatively impact cigarette sales, with concerns about a shift to illegal tobacco markets [7][8].