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Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT’ Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors
Globenewswire· 2025-06-04 12:00
Phase 1 First-In-Human study designed to assess safety, tolerability, right dose for Phase 2 and early signs of efficacy of 177Lu-RAD202 in individuals with advanced HER2-positive solid tumors Previous clinical proof-of concept data for targeting HER-2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans SYDNEY, June 04, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncol ...
Telix Investor Day in New York City on June 11, 2025: Presenting KOLs
Globenewswire· 2025-06-03 10:57
Core Insights - Telix Pharmaceuticals Limited is hosting an Investor Day on June 11, 2025, in New York City, focusing on growth opportunities in precision medicine and therapeutic radiopharmaceuticals [1][4] Company Overview - Telix is a biopharmaceutical company dedicated to developing and commercializing therapeutic and diagnostic radiopharmaceuticals, headquartered in Melbourne, Australia, with operations in the U.S., Brazil, Canada, Europe, and Japan [4] - The company is addressing significant unmet medical needs in oncology and rare diseases through its clinical and commercial stage products [4] Event Details - The Investor Day will feature key opinion leaders discussing the clinical utility and opportunities for Telix's theranostic candidates [2] - In-person attendance is available for institutional investors and analysts, with advance registration required [3] Key Opinion Leaders - Dr. Oliver Sartor, an expert in prostate cancer, will discuss TLX591, having published over 500 peer-reviewed articles and led pivotal Phase 3 studies [7] - Dr. John de Groot, a neuro-oncology expert, will present on TLX101, with over 200 peer-reviewed publications and significant involvement in clinical studies [7] - Dr. Joseph Osborne, specializing in renal cancer imaging, will cover TLX250-CDx, focusing on advancing molecular imaging [7]
Radiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour Uptake
Globenewswire· 2025-06-02 12:00
Supports plans to advance the RV01 program to first-in-human therapeutic basket study in solid tumour cancers Data completes preclinical package for Investigational New Drug submission in mid-2025 with Phase 1 therapeutic study initiation expected in 4Q25 SYDNEY, Australia, June 02, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of hig ...
Y-mAbs Therapeutics Inc (YMAB) Earnings Call Presentation
2025-05-28 14:30
Radiopharmaceutical R&D Update May 28, 2025 Mike Rossi President and Chief Executive Officer Natalie Tucker SVP, Radiopharmaceutical Business Unit Head Norman LaFrance, MD Chief Medical and Development Officer Additional Team Members Available During Q&A Disclaimer Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. The forward-looking statements involve substantial risks and uncertainties. All statem ...
SciSparc Announces Publication of Japanese Patent Application
Globenewswire· 2025-05-27 11:32
TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced today the publication of a Japanese divisional patent. The patent application introduces a novel pharmaceutical combination of paracetamol and palmitoylethanolamide (PEA) that may enhance pain relief and fever relief with lower doses an ...
Molecular Partners AG(MOLN) - 2025 FY - Earnings Call Transcript
2025-05-20 20:30
Molecular Partners (MOLN) FY 2025 Conference May 20, 2025 03:30 PM ET Speaker0 Good afternoon, and thanks for tuning into the HCW, BioConnect conference. I'm Robert Burns, the managing director and senior biotech analyst at HC Wainwright. And I'm joined by Seth Lewis, head of IR for MyPlay Partners. Seth, thank you for joining us today. Speaker1 Really appreciate the invite. Glad to be here. Awesome. So for Speaker0 those who might be unfamiliar with the company, its pipeline, as well as the Platts thing? S ...
Jazz Pharmaceuticals (JAZZ) 2025 Conference Transcript
2025-05-14 18:00
Summary of Jazz Pharmaceuticals (JAZZ) 2025 Conference Call Company Overview - **Company**: Jazz Pharmaceuticals (JAZZ) - **Event**: BofA Annual Healthcare Conference - **Date**: May 14, 2025 Key Points Financial Performance - **1Q Revenue**: Approximately $898 million, consistent with 1Q 2024 [3] - **Growth Drivers**: Strong performance in neuroscience products, particularly XiWave and Epidiolex [4] - **Oncology Performance**: Oncology revenue declined by 11% year-on-year, attributed to a calendar anomaly with only 12 shipping weeks in the quarter [5][6] Product Performance - **XiWave**: Experienced seasonality affecting patient insurance reauthorization, resulting in a net addition of 450 patients, with 325 in idiopathic hypersomnia and 125 in narcolepsy [4] - **Epidiolex**: Achieved double-digit growth, impacted by higher-than-usual inventory drawdown in 1Q [5] - **Oncology Products**: - Rylase faced competitive dynamics affecting sales [7] - Zepzelca's performance was impacted by competition and longer patient progression times due to new data from Imfinzi [7] - Upcoming ASCO presentation for Phase III IMFORT trial data for Zepzelca [7][8] Acquisitions and Pipeline - **Chimerix Acquisition**: Completed in April, bringing dordavaprone for H3K27M mutant diffuse glioma, a severe brain cancer with poor prognosis [11][12] - **Zanidatumab**: Positive CHMP recommendation for approval in Europe for second-line BTC, with data to be presented at ASCO [12][13] - **Phase II GEA Study**: Updated data to be presented at ASCO, with confidence in upcoming Phase III study results [13][14] Regulatory and Market Dynamics - **Tariffs**: Company positioned to mitigate potential impacts from tariffs on imported pharmaceuticals, with no expected impact on 2025 financials [14][15] - **FDA Interactions**: No disruptions noted in FDA review processes for upcoming PDUFA dates for Subselka and dordavaprone [21] Competitive Landscape - **Generics Impact**: Anticipation of true generics for Xyrem starting in 2026, with potential revenue impacts for Jazz [22][24] - **Xywav Positioning**: Positioned as the only low sodium oxybate, with expectations of maintaining market share despite generics [26][27] Future Outlook - **Revenue Guidance**: Confirmed top-line revenue guidance with modest adjustments, expecting mid-single-digit growth for the full year [17][18] - **Pipeline Investments**: Strong financial position allows for continued investment in marketed products and pipeline development [16] Additional Insights - **Orexin Therapies**: Seen as complementary to oxybate therapy rather than competitive, with current data not supporting claims of improved nighttime sleep quality [59][60] - **Chimerix Trial Adjustments**: Ongoing evaluation of the ACTION trial protocol to enhance chances of success [62][63] Conclusion - Jazz Pharmaceuticals is navigating a complex landscape with strong performance in neuroscience, challenges in oncology, and strategic acquisitions. The company is well-positioned to manage upcoming competitive pressures and regulatory challenges while maintaining a focus on growth and innovation in its product pipeline.
IBA launches CASSY®, a new compact radiochemistry module to enhance efficiency in radiopharmaceuticals production
Globenewswire· 2025-05-13 05:00
Core Insights - IBA has launched CASSY, a compact synthesizer aimed at revolutionizing radiopharmaceutical production processes, particularly for radiometals and radiotracers [1][5]. Group 1: Product Features - CASSY enhances efficiency in radiopharmaceutical production through seamless integration into laboratory workflows, user-friendly interfaces, and versatility for purification and radiolabelling [2]. - The compact design allows stacking of up to six units in a single standard hot cell, optimizing space and increasing production potential, making it suitable for laboratories with limited space [3]. - CASSY is adaptable for a wide range of radioisotopes, catering to diverse research and clinical needs, and is positioned for future innovations like radiotheranostics [3]. Group 2: Components and Technology - CASSY utilizes specific cassettes developed by Fluidomica, which include all necessary components for radioisotope and radiopharmaceutical manufacturing processes [4]. - The cassettes are designed for single use, ensuring efficiency and reliability in production [4]. Group 3: Company Commitment and Leadership - Charles Kumps, President of IBA RadioPharma Solutions, emphasized that CASSY represents a significant advancement in theranostic innovation, enhancing the quality and reliability of radiopharmaceutical manufacturing [5]. - IBA continues to lead the radiopharmaceutical industry through its commitment to innovation and improving healthcare outcomes globally [5]. Group 4: Company Overview - IBA is recognized as the world leader in particle accelerator technology and is a major supplier in proton therapy, industrial sterilization, and dosimetry, employing approximately 2,100 people worldwide [7]. - The company is listed on the EURONEXT stock exchange and is a certified B Corporation, meeting high standards of social and environmental performance [8].
Perspective Therapeutics Provides Recent Business Highlights and Reports 1Q 2025 Results
Globenewswire· 2025-05-12 20:36
First of several clinical updates through mid-2026 accepted for presentation at the 2025 American Society of Clinical Oncology Annual Meeting, with recruitment progressing for all three of our clinical stage potential new medicines based on our next generation targeted radiopharmaceutical technology platformEnrollment ongoing for VMT-α-NET, a next generation SSTR2-targeting potential new medicine, with 40 patients enrolled through end of April 2025 in Cohort 2 of the Phase 1/2a trial in neuroendocrine tumor ...
Radiopharm Theranostics to Participate in the D. Boral Capital Inaugural Global Conference
Globenewswire· 2025-05-07 12:00
For more information: Investors: Riccardo Canevari CEO & Managing Director P: +1 862 309 0293 E: rc@radiopharmtheranostics.com Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning pepti ...