Cardinal Health’s (CAH) Presource kit plastic syringe makers Jiangsu Shenli Medical Production Co. Ltd and Jiangsu Caina have been facing FDA investigation. Recent inspections have unveiled multiple quality system violations, leading to warning letters and import alerts. CAH has recalled the affected products to ensure patient safety and compliance with FDA regulations.Following the recent warning, the import alert was expanded to preventJiangsu Shenli’s enteral syringes from entering the United States. The ...

DUBLIN, Ohio, July 23, 2024 /PRNewswire/ -- Cardinal Health (NYSE: CAH) plans to release fourth-quarter and year-end financial results for its fiscal year 2024 on August 14, prior to the opening of trading on the New York Stock Exchange. The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.To access the webcast and corresponding slide presentation, visit Cardinal Health's Investor Relations page. No access code is required. Presentation slides and a webcast replay will be av ...

Cardinal Health (CAH) ended the recent trading session at $95.97, demonstrating a +0.59% swing from the preceding day's closing price. The stock's performance was ahead of the S&P 500's daily loss of 1.39%. Elsewhere, the Dow saw an upswing of 0.6%, while the tech-heavy Nasdaq depreciated by 2.77%.Heading into today, shares of the prescription drug distributor had lost 8.34% over the past month, lagging the Medical sector's gain of 1.98% and the S&P 500's gain of 4.43% in that time.Market participants will ...

In the latest market close, Cardinal Health (CAH) reached $93.74, with a -0.38% movement compared to the previous day. The stock's performance was behind the S&P 500's daily gain of 0.28%. Elsewhere, the Dow saw an upswing of 0.53%, while the tech-heavy Nasdaq appreciated by 0.4%.The prescription drug distributor's shares have seen a decrease of 6.09% over the last month, not keeping up with the Medical sector's gain of 0.79% and the S&P 500's gain of 3.78%.Market participants will be closely following the ...

The latest trading session saw Cardinal Health (CAH) ending at $96.01, denoting a -0.9% adjustment from its last day's close. The stock trailed the S&P 500, which registered a daily gain of 0.07%. Elsewhere, the Dow saw a downswing of 0.13%, while the tech-heavy Nasdaq appreciated by 0.14%.Shares of the prescription drug distributor witnessed a loss of 1.98% over the previous month, beating the performance of the Medical sector with its loss of 1.99% and underperforming the S&P 500's gain of 4.34%.Analysts ...

Core Viewpoint - Neurocrine Biosciences has received FDA acceptance for two New Drug Applications (NDA) for crinecerfont, which could be the first new treatment for congenital adrenal hyperplasia (CAH) in 70 years, highlighting a significant advancement in addressing a serious endocrine disorder [1][2][3] Group 1: FDA Review and Designations - The FDA has set Prescription Drug User Fee Act (PDUFA) target action dates for the NDAs on December 29 and December 30, 2024, respectively [2] - Crinecerfont has been granted Priority Review designation, which accelerates the review timeline by four months, indicating the serious nature of CAH and the high unmet medical need [2][3] - The drug has also received Orphan Drug designation and Breakthrough Therapy designation, which provide various benefits including exemption from PDUFA fees and potential market exclusivity [3][4] Group 2: Clinical Data and Mechanism of Action - Crinecerfont is a selective corticotropin-releasing factor type 1 receptor (CRF1) antagonist aimed at reducing excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a glucocorticoid-independent mechanism [8] - The CAHtalyst Phase 3 studies demonstrated strong efficacy and safety results, supporting the NDAs submitted to the FDA [4][9] - The drug aims to enable lower, more physiologic dosing of glucocorticoids, potentially reducing complications associated with higher doses currently used in treatment [8] Group 3: Background on Congenital Adrenal Hyperplasia - Congenital adrenal hyperplasia (CAH) is a rare genetic condition primarily caused by a deficiency of the enzyme 21-hydroxylase, leading to severe health issues if untreated [5] - Current treatments involve glucocorticoids at supraphysiologic doses, which can result in significant complications, including metabolic and psychological issues [6][7]

Richard Drury Welcome back to another edition of upcoming dividend increases. We are starting July's increases. If you are trading, be aware of the modified market hours next week. The market will close at 1 p.m. EST on the 3rd and be closed on July 4th. We also have dividend king Sysco Corporation extending its 54-year streak with a 2% increase. The overall group of companies has an average increase of 4.1% and a median of 3.7%. My investment strategy involves buying, holding, and adding to companies t ...

100% of Participants (n=6) With CAH Maintained Androstenedione (A4) Below the Upper Limit of Normal at all Time Points on Atumelnant (80 mg) CAH Participants Achieved More Than a 90% Reduction of A4 and 97% Reduction of 17-OHP on Atumelnant (80 mg), Beginning at Two Weeks and Sustained Through 12 Weeks In the ADCS Trial, Atumelnant (80 mg) Normalized 24-hr Urinary Free Cortisol Levels for 100% of Participants (n=5) During Treatment Management to Host Investor Conference Call Today at 4:30 PM ET and Onsite ...

Core Insights - Neurocrine Biosciences and Diurnal Ltd. presented data from their neuroendocrinology pipeline at the Endocrine Society Annual Meeting, focusing on the CAHtalyst Phase 3 studies of crinecerfont for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency [1][2][15] - The CAHtalyst Phase 3 studies demonstrated significant efficacy in reducing glucocorticoid (GC) dosing while maintaining androgen control in both pediatric and adult patients [3][4][15] CAHtalyst Phase 3 Data - In adult patients, 63% of those treated with crinecerfont achieved a reduction in GC dosing to physiologic range (≤ 11 mg/m²/day) at Week 24, compared to 18% in the placebo group [3] - In pediatric patients, 29.9% of crinecerfont participants achieved a similar reduction in GC dosing at Week 28, while 0% of placebo participants did [4] CAHtalog Registry Findings - A real-world study from the CAHtalog registry highlighted the negative impacts of high GC doses, including premature adiposity rebound and early growth acceleration in pediatric patients [5][6] - The study found that 27.3% of pediatric patients received high GC doses (>15 mg/m²/day), which were associated with significant comorbidities such as hypertension and metabolic complications [5][6] Natural History of CAH - Longitudinal data from the CAHtalog registry indicated abnormal growth patterns in pediatric patients, with early growth acceleration followed by blunted pubertal growth, particularly in females [7] - The study also reported high rates of obesity and comorbidities among adult patients, with 83% of females and 100% of males having a BMI ≥ 25 kg/m² [7] Comorbidity Analysis - A claims-based cohort analysis revealed that CAH patients had significantly higher rates of comorbidities compared to the general population, including anxiety disorders (34% vs. 26%) and obesity (23% vs. 13%) [10][11] - The data underscored the chronic clinical burden of CAH, emphasizing the need for optimized disease management strategies [11] Crinecerfont Overview - Crinecerfont is an investigational oral CRF1 antagonist aimed at reducing ACTH and adrenal androgens through a glucocorticoid-independent mechanism [14][15] - The ongoing CAHtalyst studies are designed to evaluate the safety, efficacy, and tolerability of crinecerfont in patients with CAH due to 21-hydroxylase deficiency [15]

Core Insights - The CAHtalyst Pediatric Phase 3 study demonstrated that crinecerfont effectively reduced androstenedione levels and allowed for glucocorticoid dose reduction while maintaining androgen control in pediatric patients with congenital adrenal hyperplasia (CAH) [1][3][4] Group 1: Study Results - The study met its primary endpoint, showing a significant reduction in androstenedione levels with crinecerfont compared to placebo, with a least squares mean change of -196.8 ng/dL versus +71.0 ng/dL at Week 4 [4][5] - At Week 28, crinecerfont treatment resulted in a significant glucocorticoid dose reduction of -18% compared to a +5.6% increase in the placebo group, with 30% of crinecerfont participants achieving a physiologic glucocorticoid dose [5][6] - Favorable trends were observed in secondary endpoints, including reductions in body weight, improved insulin resistance, and decreased hirsutism in female participants [2][5] Group 2: Treatment Mechanism - Crinecerfont is an investigational oral selective corticotropin-releasing factor type 1 receptor (CRF1) antagonist designed to reduce excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a glucocorticoid-independent mechanism [2][10] - The mechanism of action allows for lower glucocorticoid dosing, potentially reducing complications associated with long-term supraphysiologic glucocorticoid use [11] Group 3: Safety and Tolerability - Crinecerfont was generally well tolerated, with common adverse events including headache, fever, and vomiting, and no adrenal crises reported during the study [6][9] - The incidence of adverse events leading to glucocorticoid stress dosing was similar between crinecerfont and placebo groups, indicating a favorable safety profile [6][9]