Latest news with #Chimerix
Medscape
07-08-2025
- Business
- Medscape
FDA Approves Drug for Aggressive Glioma
The FDA has granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals) for H3 K27M-mutant diffuse glioma, marking the first time a systemic therapy has been approved for the aggressive glioma subtype. H3 K27M-mutant diffuse glioma is a grade 4 midline tumor that primarily affects children and young adults. Median survival is about a year. Historically, treatment has been limited to radiation, with few options available after recurrence besides palliative care. Dordaviprone is a first-in-class oral imipridone that disrupts tumor cell metabolism and increases tumor susceptibility to immune-mediated attack. Jazz Pharmaceuticals bought Chimerix in early 2025 for almost $1 billion based on dordaviprone's commercial prospects. 'Dordaviprone has the potential to rapidly become a standard of care for a rare oncology disease and also contribute durable revenue beginning in the near-term,' Jazz CEO Bruce Cozadd, said in a press release at the time. Approval was based on a pooled analysis of five single-arm studies enrolling 46 adults and four children with recurrent tumors previously treated with radiation, according to a statement from the FDA. Adults received 625 mg once weekly while pediatric patients received lower, weight-adjusted weekly doses. Mutation status was confirmed by immunohistochemistry or sequencing of archival tumor tissue. The overall response rate was 22%. The median time to response was 8.3 months, and the median duration of response (DOR) was 10.3 months. Among 11 patients with objective responses, 73% had a DOR of at least 6 months, and 27% had a DOR of at least 12 months. Seven of 15 evaluable patients (46.7%) were able to have corticosteroid dose reductions of at least 50%, and performance status improved in six of 34 (20.6%) patients. Sixty percent of subjects experienced treatment-related, treatment-emergent adverse events (TR-TEAEs), including fatigue (34%), nausea (18%), decreased lymphocyte levels (14%). The most common serious adverse events were hydrocephalus (8%) and nausea (8%). Grade 3 TR-TEAEs occurred in 20%, most commonly fatigue (10%). One case each of seizure and pulmonary embolism were seen. There were no treatment-related deaths. The drug's prescribing information includes warnings and precautions for hypersensitivity, QTc interval prolongation, and embryo-fetal toxicity, according to the FDA statement. A phase 3 trial is underway to confirm the benefit of dordaviprone for recurrent H3 K27M-mutant diffuse glioma. M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@
Reuters
06-08-2025
- Health
- Reuters
US FDA approves Jazz Pharma's drug for rare brain tumor
Aug 6 (Reuters) - The U.S. Food and Drug Administration said on Wednesday that it has approved Jazz Pharmaceuticals' (JAZZ.O), opens new tab drug to treat diffuse midline glioma, a rare and aggressive tumor, in adults and children aged one year and older. This marks the first FDA approval of a systemic therapy for diffuse midline glioma with a specific mutation that has progressed after previous treatments, the agency said. Diffuse midline glioma (DMG) is a rare and aggressive brain tumor that primarily affects children and young adults. It develops in the brain's and spinal cord's midline structures, such as the brainstem, thalamus, and spinal cord. Jazz Pharmaceuticals acquired the drug in March through its $935 million purchase of Chimerix.
Yahoo
14-07-2025
- Business
- Yahoo
Jazz Pharmaceuticals (JAZZ) Highlights Growth at Goldman Sachs Healthcare Conference
Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) is one of the 7 most undervalued pot stocks to buy according to analysts. On June 11, the company presented at the Goldman Sachs 46th Annual Global Healthcare Conference, where it outlined its strategic growth initiatives and acknowledged various challenges. A close up of cannabis plants growing in an outdoor facility, symbolizing the product of the cannabinoid company. According to the presentation, Jazz Pharmaceuticals reported robust growth in its neuroscience segment, particularly with Xywav (for sleep disorders like narcolepsy and idiopathic hypersomnia) and Epidiolex (for epilepsy). These products showed 'strong growth' in the first quarter of 2025. Xywav's low sodium content and flexible dosing were highlighted as key market advantages. The company detailed that it is expanding its oncology portfolio and pipeline, which now accounts for over half of its 2024 revenue, up from 26% in 2018. Key oncology initiatives include Zanidatamab (Ziihera), Zepzelca (lurbinectedin), Subzelca (formerly JZP-351), and Dordavapril (from Chimerix acquisition). The company stated that beyond marketed products, it is advancing its pipeline with upcoming product launches and regulatory decisions anticipated to drive future growth. This includes the orexin program (JZP-441 trials being monitored for cardiovascular effects) and prasinezumab in Europe. Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) expanded its footprint into the cannabis sector with the acquisition of GW Pharmaceuticals. Consequently, it develops and markets FDA-approved drugs that contain purified cannabis-based substances, specifically cannabidiol (CBD), to treat serious illnesses. While we acknowledge the potential of JAZZ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: Returns and 12 Best Consumer Goods Stocks Billionaires Are Quietly Buying. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Forbes
07-07-2025
- Business
- Forbes
Is JAZZ Stock Undervalued At $110?
POLAND - 2025/02/22: In this photo illustration, the Jazz Pharmaceuticals company logo is seen ... More displayed on a smartphone screen. (Photo Illustration by Piotr Swat/SOPA Images/LightRocket via Getty Images) SOPA Images/LightRocket via Getty Images Jazz Pharmaceuticals (NASDAQ: JAZZ) is currently trading at approximately $110, having decreased by 11% year-to-date, even after a significant positive development with the conditional European Commission Marketing Authorization for Ziihera (zanidatamab) aimed at advanced HER2-Positive Biliary Tract Cancer. Ziihera is the first HER2-targeted therapy approved in the EU for this condition, with anticipated peak annual sales surpassing $2 billion. The stock's poor performance can primarily be linked to a revised earnings forecast for 2025, which has been adjusted downward from $22.50-$24 to $4-$5.60, due to a $1.1 billion impact from one-time IPR&D charges associated with the $935 million Chimerix acquisition along with some litigation costs. Despite this, we consider Jazz Pharmaceuticals to be undervalued at $110, offering an attractive buying opportunity for investors with a 3-5 year investment outlook. That being said, if you are looking for upside potential with less volatility compared to individual stocks, the Trefis High-Quality portfolio offers an alternative, having outperformed the S&P 500 and generated returns over 91% since its inception. Additionally, see – Should You Buy Oscar Health Stock At $17? Trailing Adjusted P/E: At $110, Jazz trades at only 5.5 times its trailing adjusted earnings of $20.19 per share, which is well below its four-year average P/E ratio of 8.1x. For further valuation metrics, examine – Jazz Pharmaceuticals Valuation Ratios. At $110, Jazz trades at only 5.5 times its trailing adjusted earnings of $20.19 per share, which is well below its four-year average P/E ratio of 8.1x. For further valuation metrics, examine – Jazz Pharmaceuticals Valuation Ratios. Future Earnings Potential: While 2025 earnings will be affected by one-off costs, 2026 earnings are anticipated to bounce back to $21.56. While 2025 earnings will be affected by one-off costs, 2026 earnings are anticipated to bounce back to $21.56. Pipeline Contribution: The Chimerix acquisition introduces dordaviprone to the oncology portfolio, with a peak annual sales potential over $500 million. The Chimerix acquisition introduces dordaviprone to the oncology portfolio, with a peak annual sales potential over $500 million. Analyst Consensus: The typical analyst price forecast of $188 suggests a substantial upside potential of 70%. High Debt Load: Jazz Pharmaceuticals has a considerable debt level of $5.4 billion with a market capitalization of $6.7 billion (as of July 3, 2025), leading to a Debt-to-Equity Ratio of 81.6%, which is significantly above the S&P 500 average of 19.4%. A lower debt-to-equity ratio is generally preferred. Jazz Pharmaceuticals has a considerable debt level of $5.4 billion with a market capitalization of $6.7 billion (as of July 3, 2025), leading to a Debt-to-Equity Ratio of 81.6%, which is significantly above the S&P 500 average of 19.4%. A lower debt-to-equity ratio is generally preferred. Historical Underperformance in Downturns: Historically, the stock has performed worse than the S&P 500 during market declines, such as the 2022 inflation shock (JAZZ down 38.7% versus S&P 500 down 25.4%) and the 2020 crisis (JAZZ down 42.6% versus S&P 500 down 33.9%). The stock has also yet to return to its pre-inflation crisis levels. Our dashboard on Buy or Sell JAZZ Stock has more details. Historically, the stock has performed worse than the S&P 500 during market declines, such as the 2022 inflation shock (JAZZ down 38.7% versus S&P 500 down 25.4%) and the 2020 crisis (JAZZ down 42.6% versus S&P 500 down 33.9%). The stock has also yet to return to its pre-inflation crisis levels. Our dashboard on Buy or Sell JAZZ Stock has more details. Slowing Oncology Portfolio Growth: There are specific concerns about a potential slowdown in the growth of the oncology portfolio. Despite the recent revisions to earnings and existing debt concerns, Jazz Pharmaceuticals offers a compelling value proposition. Its robust underlying fundamentals, appealing valuation metrics, and significant future sales potential from Ziihera and dordaviprone indicate that the current stock price does not adequately reflect its intrinsic value. While investors should remain aware of the substantial debt and historical sensitivity to market downturns, the long-term prospects for Jazz Pharmaceuticals seem positive for those with a 3-5 year investment horizon. However, there is always a significant risk associated with investing in a single stock or just a few stocks. Consider the Trefis High Quality (HQ) Portfolio which comprises 30 stocks and has a proven track record of consistently outperforming the S&P 500 over the past four years. Why is that? On the whole, HQ Portfolio stocks delivered superior returns with lower risk as compared to the benchmark index; experiencing less volatility, as evidenced by HQ Portfolio performance metrics .
Globe and Mail
21-05-2025
- Business
- Globe and Mail
Glioblastoma Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, NICE Approvals, Therapies and Companies by DelveInsight
Glioblastoma Companies are Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai, Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, and others. (Albany, USA) DelveInsight's " Glioblastoma Market Insights, Epidemiology and Market Forecast– 2034" report delivers an in-depth understanding of the Glioblastoma, historical and forecasted epidemiology as well as the Glioblastoma market trends in the United States, the EU-4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan. The Glioblastoma market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Glioblastoma market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Glioblastoma treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Glioblastoma market. The pipeline review for the glioblastoma treatment market highlights a dynamic landscape of ongoing clinical trials and emerging therapies aimed at addressing this aggressive brain cancer. Several biopharmaceutical companies are actively developing novel approaches, including targeted therapies, immunotherapies, and gene-based treatments. The glioblastoma treatment pipeline also features advancements in personalized medicine and biomarker-driven strategies. This evolving pipeline holds promise for improving patient outcomes and expanding therapeutic options in the coming years. Key Takeaways from the Glioblastoma Market Report The increase in Glioblastoma Market Size is a direct consequence of the increasing patient population and anticipated launch of emerging therapies in the 7MM. As per DelveInsight analysis, the Glioblastoma Market is anticipated to witness growth at a considerable CAGR. The leading Glioblastoma Companies working in the market include Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai, Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, Forma Therapeutics, VBI Vaccines, and TME Pharma, and others. Promising Glioblastoma Pipeline Therapies in the various stages of development include ITI-1000 (pp65 DC Vaccine), VBI-1901, Selinexor (KPT-330), Trans Sodium Crocetinate, Ofranergene obadenovec (VB-111), Temodar/Temodal, Avastin, Azeliragon, PLX3397, Temozolomide, VXM01, Avelumab, and others. In May 2025, CNS Pharmaceuticals Inc. announced a study that is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria. In May 2025, In8bio Inc . Conducted a Phase 1b/2 study is being conducted to determine if the experimental cell therapy is safe, tolerable and can delay the return of cancer in patients with a newly diagnosed or recurrent glioblastoma multiforme (GBM) in combination with standard chemotherapy treatment temozolomide (TMZ). If there is a 25% or greater improvement in survival in this study then the therapy should be studied further. In April 2025, Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology. In December 2024, Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today provided a regulatory update on paxalisib for the treatment of glioblastoma (GBM) following its Type C clinical meeting with the United States Food and Drug Administration (FDA). On October 15, 2024, the FDA granted Fast Track designation to LP-184, a small-molecule alkylating agent developed by Lantern Pharma for the treatment of glioblastoma (GBM). LP-184 induces tumor cell death through DNA damage and is currently in a Phase 1a trial assessing its safety and tolerability in patients with various solid tumors, including GBM. The Fast Track status aims to accelerate the development and review of LP-184, particularly given the limited treatment options for aggressive brain cancers like GBM. April 2024:- Boston Scientific Corporation- FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM. Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in <7% of patients surviving to five years post-diagnosis. External beam radiotherapy (EBRT) is currently a mainstay treatment for GBM; however, the dose delivered is limited by side effects. The targeted radiotherapy of the TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) has promising potential to provide GBM patients with reduced side effects compared to external beam radiotherapy as well as a more effective treatment for this catastrophic disease. April 2024:- TJ Biopharma Co., Ltd. - A Phase 2, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT). A Phase 2, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients with Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT). Stay ahead in oncology R&D with our latest pipeline review glioblastoma treatment market overview, covering immunotherapies and targeted agents, visit @ Glioblastoma Treatment Market Landscape Glioblastoma Overview Glioblastoma (GBM) is an aggressive and the most common primary malignant brain tumor in adults. Classified as a grade IV astrocytoma by the World Health Organization, it originates from astrocytes, the supportive glial cells in the brain. GBM is characterized by rapid growth, extensive infiltration into surrounding brain tissue, and significant heterogeneity at the cellular and molecular levels. Patients often present with neurological symptoms such as headaches, seizures, cognitive decline, or focal deficits, depending on the tumor's location. Diagnosis typically involves magnetic resonance imaging (MRI) and confirmation via biopsy or surgical resection, which also serves as an initial treatment step. Standard treatment includes maximal safe surgical resection, followed by concurrent radiotherapy and temozolomide chemotherapy. Despite aggressive multimodal therapy, GBM remains highly resistant to treatment, with a median survival of 15–18 months. Recurrence is almost inevitable, and treatment options for recurrent disease are limited. Molecular profiling of GBM, including markers like MGMT promoter methylation and IDH mutation status, guides prognosis and treatment decisions. Emerging therapies, such as tumor-treating fields (TTFs), immunotherapy, and targeted molecular inhibitors, are under investigation. While these advances offer hope, GBM remains a formidable challenge, highlighting the urgent need for innovative therapies. Glioblastoma Epidemiology Insights The epidemiology section of Glioblastoma offers insights into both historical and current patient populations, as well as forecasted trends across seven major countries. This section aids in understanding the factors behind present and projected trends through analysis of various studies and input from key opinion leaders. Additionally, this portion of the market report provides information on the diagnosed patient pool, trends, and underlying assumptions. Download the report to understand which factors are driving Glioblastoma Epidemiology trends @ Glioblastoma Epidemiological Insights Glioblastoma Drugs Market The Glioblastoma Drugs Market is expected to witness substantial growth in the coming years as more targeted therapies receive regulatory approval and enter clinical practice. Additionally, ongoing research efforts aimed at better understanding the molecular mechanisms underlying Glioblastoma signaling in Glioblastoma are likely to uncover new therapeutic targets and further expand treatment options for patients. Glioblastoma Treatment Market Landscape The Glioblastoma treatment market landscape has witnessed significant advancements over the past years, with targeted therapies playing a crucial role in improving outcomes for patients. Among these targeted therapies, the emergence of Glioblastoma has garnered attention in the medical community, presenting both challenges and opportunities in treatment strategies. Glioblastoma Market Outlook The report's outlook on the Glioblastoma market aids in developing a comprehensive understanding of historical, current, and projected trends. This is achieved by examining the influence of existing Glioblastoma therapies, unmet needs, as well as drivers, barriers, and the demand for advanced technology. This section provides detailed insights into the trends of each marketed Glioblastoma drug and late-stage pipeline therapy. It assesses their impact based on various factors such as annual therapy costs, inclusion/exclusion criteria, mechanism of action, compliance rates, market demand, patient population growth, covered patient segments, anticipated launch year, competition with other therapies, brand value, and input from key opinion leaders. The analyzed Glioblastoma market data are presented concisely through relevant tables and graphs to offer a clear overview of the market dynamics. Glioblastoma Drugs Uptake The drug chapter of the Glioblastoma report provides a comprehensive analysis of both marketed drugs and late-stage pipeline drugs for this condition. It delves into the details of clinical trials, pharmacological actions, agreements, collaborations, approvals, patents, and advantages, and disadvantages of each drug, as well as the latest news and press releases related to Glioblastoma. A comprehensive pipeline review glioblastoma treatment market analysis reveals promising investigational drugs and upcoming clinical trial milestones. Major Glioblastoma Companies Several Glioblastoma Companies working in the market include Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai, Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, Forma Therapeutics, VBI Vaccines, and TME Pharma, and others. Scope of the Glioblastoma Market Research Report Coverage- 7MM Glioblastoma Companies- Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai, Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, Forma Therapeutics, VBI Vaccines, and TME Pharma, and others. Glioblastoma Pipeline Therapies- ITI-1000 (pp65 DC Vaccine), VBI-1901, Selinexor (KPT-330), Trans Sodium Crocetinate, Ofranergene obadenovec (VB-111), Temodar/Temodal, Avastin, Azeliragon, PLX3397, Temozolomide, VXM01, Avelumab, and others. Glioblastoma Market Dynamics: Glioblastoma Market Drivers and Barriers Glioblastoma Market Access and Reimbursement, Unmet Needs and Future Perspectives Discover more about Glioblastoma Drugs in development @ Glioblastoma Clinical Trials and FDA Approvals Table of Content 1. Key Insights 2. Report Introduction 3. Glioblastoma Multiforme Market Overview at a Glance 4. Epidemiology and Market Forecast Methodology 5. Executive Summary of Glioblastoma Multiforme (GBM) 6. Key Events 7. Glioblastoma SWOT Analysis 8. Disease Background and Overview: Glioblastoma Multiforme 9. Glioblastoma Treatment 10. Guidelines and Recommendations from Different Organizations 11. Glioblastoma Epidemiology and Patient Population 12. Glioblastoma Patient Journey 13. Key Endpoints in Glioblastoma Multiforme 14. Glioblastoma Marketed Products 15. Emerging Glioblastoma Drugs 16. Glioblastoma Market: Seven Major Market Analysis 17. Glioblastoma KOL Views 18. Glioblastoma Unmet Needs 19. Glioblastoma Market Access and Reimbursement 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer 23. About DelveInsight About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
