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Is DefenCath Sufficient to Support CorMedix's Long-Term Growth Path?
ZACKS· 2025-09-02 15:21
Key Takeaways CorMedix launched DefenCath in 2024 after FDA approval as the first antimicrobial catheter lock solution.DefenCath generated $78.8M in net revenues in H1 2025, showing early commercial traction.Patent protection through 2033 and U.S. reimbursement access support DefenCath's growth runway.CorMedix’s (CRMD) lead drug, DefenCath (Taurolidine + Heparin), is currently its only marketed product that generates revenues for the company.The FDA approved CorMedix’s DefenCath in late 2023 as the first an ...
Will Opdivo and Opdivo Qvantig Drive BMY's Top-Line Growth?
ZACKS· 2025-09-02 15:11
Key Takeaways Bristol Myers' Opdivo growth is fueled by new launches, label expansions, and solid global uptake.EC approved subcutaneous Opdivo and Opdivo Qvantig, boosting momentum across multiple tumor types.BMY trades at 7.60x forward earnings, below industry peers, as EPS estimates trend upward for 2025-2026.Bristol Myers ((BMY) has a strong oncology portfolio comprising blockbuster immune-oncology drug Opdivo, Opdivo Qvantig, and Yervoy, among others.Opdivo is a key drug in BMY’s Growth Portfolio that ...
Eli Lilly's New Drugs Beyond Mounjaro and Zepbound Boost Sales
ZACKS· 2025-09-02 15:06
Core Insights - Eli Lilly and Company (LLY) has significantly increased its market value over the past 2-3 years, primarily due to the success of its GLP-1 drugs, Mounjaro for type II diabetes and Zepbound for obesity [1] Drug Approvals and Revenue Contributions - Lilly has received approvals for several new drugs, including Omvoh for ulcerative colitis and Crohn's disease, Jaypirca for mantle cell lymphoma and chronic lymphocytic leukemia, Ebglyss for atopic dermatitis, and Kisunla for early symptomatic Alzheimer's disease, all contributing to revenue growth [2] - In the first half of 2025, Omvoh generated $111.9 million, while Ebglyss, Kisunla, and Jaypirca contributed $147.1 million, $70.1 million, and $215.3 million, respectively [3] Future Growth Potential - These drugs are being evaluated for additional indications and label expansions, with Ebglyss in phase III trials for perennial allergens and chronic rhinosinusitis, and Jaypirca being studied for earlier lines of therapy [4] - Lilly anticipates that Omvoh, Ebglyss, Kisunla, and Jaypirca will continue to drive revenue growth in the second half of 2025 [5] Upcoming Drug Approvals - A new drug, imlunestrant, is under review for treating ER+HER2-metastatic breast cancer in the US and EU [6] Competitive Landscape - Omvoh faces competition from AbbVie's Humira, Skyrizi, and Rinvoq, as well as J&J's Stelara, while Kisunla competes with Eisai/Biogen's Leqembi [7][8] - Jaypirca competes with older BTK inhibitors like Imbruvica and Calquence, and Ebglyss faces competition from Dupixent [9] Stock Performance and Valuation - Lilly's stock has declined by 4.6% this year, contrasting with a 1.3% increase in the industry [10] - The combined revenue from Omvoh, Ebglyss, Kisunla, and Jaypirca exceeded $540 million in H1 2025, with EPS estimates for 2025 and 2026 rising to $22.97 and $30.95, respectively [11] - Lilly's stock is currently trading at a price/earnings ratio of 25.87, higher than the industry average of 14.78, but below its 5-year mean of 34.54 [13] Consensus Estimates - The Zacks Consensus Estimate for 2025 EPS has increased from $22.04 to $22.97 over the past 30 days, while the estimate for 2026 has risen from $30.88 to $30.95 [14]
Can Korlym Drive Corcept's Growth Through the Rest of 2025?
ZACKS· 2025-09-02 15:00
Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, has shown strong sales performance, with $351.6 million in sales for the first half of 2025, reflecting a year-over-year increase of approximately 13.2% [1][9] - The company anticipates full-year 2025 Korlym sales to reach $857.1 million, indicating a nearly 27% increase year-over-year [1][3] - Management expects a significant rise in Korlym prescriptions in the second half of 2025 as vendor issues are resolved [2][3] Sales and Revenue Expectations - Korlym sales were impacted by vendor capacity issues in Q1 2025 but improved in Q2, with expectations for continued growth in H2 2025 [2][3] - Corcept projects total revenues for 2025 to be between $850 million and $900 million [3] Pipeline Developments - Corcept is developing relacorilant for Cushing's syndrome, with a new drug application submitted to the FDA, and a decision expected by December 30, 2025 [4][9] - Approval of relacorilant is anticipated to broaden the patient base and reduce reliance on Korlym for future growth [5] Additional Indications and Studies - The company is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer and adrenal cancer [6][7] - The BELLA study is evaluating the efficacy of relacorilant combined with nab-paclitaxel and Avastin for ovarian cancer treatment [7] Market Performance and Valuation - Corcept's stock has increased by 38.3% year-to-date, outperforming the industry average of 8.3% [8] - The company's shares are trading at a premium, with a price-to-sales ratio of 11.73 compared to the industry average of 2.38 [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has decreased from $1.39 to $1.15, and for 2026, it has decreased from $2.08 to $1.71 [11]
Praxis Precision Medicines (PRAX) Conference Transcript
2025-09-02 15:02
Summary of Praxis Precision Medicines (PRAX) Conference Call Company Overview - **Company**: Praxis Precision Medicines (PRAX) - **Event**: Conference Call on September 02, 2025 - **Key Speaker**: Marcio Souza, CEO Core Industry Insights - **Industry Focus**: Epilepsy drug development - **Market Size**: Estimated at approximately 3 million patients in the US [62] - **Unmet Need**: Significant unmet medical need in epilepsy treatment, indicating a larger market opportunity than previously anticipated [11] Key Points Discussed RADIANCE Study Highlights - **Study Objective**: To evaluate the efficacy of vormatrogene in reducing seizures, focusing on the reduction in seizure frequency and understanding pharmacokinetics (PK) and pharmacodynamics (PD) in patients with focal onset seizures [17][18] - **Results**: - Achieved a **56% sustained overall seizure reduction rate** [20] - **22% of patients** experienced a **100% seizure reduction** in the last 28 days, with **14% being seizure-free** over the entire 8-week treatment period [45] - **Rapid Response**: Seizure reduction was observed as early as one week into treatment, indicating a rapid therapeutic effect [20][22] Comparative Efficacy - **Placebo Effect**: Expected placebo seizure reduction rate estimated at **10-15%**, making the observed efficacy of 56% particularly robust [44] - **Comparison with Other Drugs**: Vormatrogene's efficacy is positioned as superior to many existing treatments, with the potential to replace less effective drugs like levetiracetam [106][110] Safety and Tolerability - **Adverse Events**: Treatment-emergent adverse events (TEAEs) were reported to be lower than those of other drugs, although dropout rates were higher than expected [86][101] - **Patient Experience**: The experience of principal investigators (PIs) and patient counseling were identified as critical factors influencing dropout rates [90][91] Future Development Plans - **Upcoming Studies**: - **Power One**: Expected to provide further data on efficacy and safety, with recruitment ongoing and anticipated completion in late 2026 [119][122] - **Power Two**: Set to begin shortly, with expectations of higher response rates due to increased dosing [116][121] - **Regulatory Submission**: Anticipated NDA submission within the next 18 months based on the outcomes of ongoing studies [122] Market Positioning - **Differentiation**: Vormatrogene is positioned as a highly effective and convenient treatment option for refractory epilepsy, with a compelling profile that could dominate the market [105][110] - **Physician Feedback**: Positive reception from physicians regarding the potential to replace existing treatments, highlighting the drug's efficacy and tolerability [106][107] Additional Insights - **Patient Compliance**: High compliance rates observed with electronic diaries for tracking seizures, enhancing data accuracy for ongoing studies [128][129] - **Long-term Expectations**: Anticipation of a significant number of patients achieving seizure freedom as treatment progresses and background medications are optimized [54][55] This summary encapsulates the key discussions and insights from the Praxis Precision Medicines conference call, focusing on the RADIANCE study results, market positioning, and future development plans.
Why Is United Therapeutics Stock Rallying On Tuesday?
Benzinga· 2025-09-02 14:59
United Therapeutics Corporation UTHR released data on Tuesday from its TETON-2 study evaluating the use of nebulized Tyvaso (treprostinil) Inhalation Solution for idiopathic pulmonary fibrosis (IPF).The study met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo. FVC is a standard pulmonary function test.Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL from baseline to week 52 in patients with IPF.Bene ...
GSK Adds Around $5B in a Month: Here's How to Play the Stock
ZACKS· 2025-09-02 14:51
Key Takeaways GSK gained 6.4% in a month, adding nearly $5B in market value despite slowing vaccine sales.Specialty Medicines rose 16% in H1 2025, with oncology and long-acting HIV drugs driving growth.GSK's R&D, pipeline approvals and upcoming launches bolster its long-term sales outlook.GSK (GSK) stock has risen 6.4% over the past month, adding nearly $5 billion to its market value.The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an optimistic outl ...
片仔癀-业绩回顾 -2025 年上半年因原材料成本上升业绩不及,8 月起价格下降;买入
2025-09-02 14:24
Revenue miss - 1H25 revenue decreased by 4.8% (-7.5% vs. GSe), and net profits also missed at Rmb1,442mn (-16.2% yoy, -16.2% vs. GSe). Its core revenue (hepatic disease medication) still grew by 9.7% yoy despite weak consumption power, while total revenue missed mainly due to revenue decrease from distribution (-13% yoy) and cosmetics & personal goods (-17% yoy). Earnings miss - 1H25 net profits also missed, attributed to higher raw material cost in 1H25, resulting in GPM of hepatic disease medication decre ...
Court Ruling & Tariff Uncertainty: Time to Bet on POST, TME & KNSA?
ZACKS· 2025-09-02 14:06
Market Overview - The U.S. stock market is expected to remain volatile due to uncertainty following a federal appeals court ruling that a significant portion of President Trump's worldwide tariffs is unlawful [1][7] Investment Strategy - To mitigate risks in the uncertain market, investors are advised to consider low-beta stocks such as Post Holdings, Inc. (POST), Tencent Music Entertainment Group (TME), and Kiniksa Pharmaceuticals International, plc (KNSA) [1][7] Company Insights Post Holdings - Post Holdings is restructuring its portfolio, recently announcing the divestment of its 8th Avenue pasta business for $375 million in cash, while retaining its nut butter, granola, and fruit & nut businesses for better alignment with operations and potential cost synergies [6][7] Tencent Music Entertainment - Tencent Music is poised for growth through its expanding music subscription service, boasting over 124 million paying subscribers and 15 million Super VIP members, alongside a booming advertising business supported by new ad formats and key shopping events [7][8] Kiniksa Pharmaceuticals - Kiniksa Pharmaceuticals is a leading player in treating recurrent pericarditis with its drug ARCALYST, which is currently the only treatment option available for this condition [9][7]
X @Bloomberg
Bloomberg· 2025-09-02 13:43
Merck is selling investment-grade corporate bonds Tuesday to help fund its acquisition of fellow drugmaker Verona https://t.co/hkHo8oKF6z ...