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Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies
GlobeNewswire News Room· 2024-11-26 06:10
Acquisition supports Roche’s Pharma Strategy and allows for a range of potentially first and best-in-class therapies across oncology, immunology, and neurology, uniquely positioning Roche in the new field of donor-derived off-the-shelf cell therapiesRoche to acquire Poseida Therapeutics for US $9.00 per share in cash at closing, representing a total equity value of approximately US $1.0 billion Stockholders would also receive a non-tradeable contingent value right (CVR) for up to an aggregate of US $4.00 pe ...
Roche reports update on Phase III SKYSCRAPER-01 study results
GlobeNewswire News Room· 2024-11-26 06:00
Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) reports an update on the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).  SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced u ...
Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA
Prnewswire· 2024-11-25 06:00
The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA. There are currently very few options for BTC patients as most cases are at an advanced stage at the time of diagnosis. This approval represents a new indication for Roche's existing PATHWAY HER2 (4B5) test and expands its clinical utility by broadening the scope of patients who are eligible for HER2-targeted thera ...
Roche receives CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE
Prnewswire· 2024-11-18 06:00
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers. The test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE. This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year.TUCSON, Ariz., Nov. 18, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received C ...
Flare Therapeutics Announces Strategic Discovery Collaboration with Roche to Address Previously Undrugged Transcription Factor Targets in Oncology
Prnewswire· 2024-11-12 12:00
Collaboration will leverage Flare Therapeutics' proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecules aimed at transcription factor targets in oncologyFlare Therapeutics to receive US$70 million upfront, and potential milestone payments exceeding US$1.8 billion, as well as royaltiesCAMBRIDGE, Mass., Nov. 12, 2024 /PRNewswire/ -- Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcri ...
Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024
GlobeNewswire News Room· 2024-11-05 14:15
Basel, 05 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 in San Diego, US. The data underscore Roche’s commitment to advance patient outcomes in lymphoma with long-term follow-up of its approved medicines Polivy® (polatuzumab vedotin), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab) as well as new investigation ...
PredicineCARE™ Liquid Biopsy Assay Featured in NEJM as Pivotal Tool in Roche's Phase III Itovebi Breast Cancer Trial
GlobeNewswire News Room· 2024-11-04 17:28
PredicineCARE™ was utilized to identify and enroll patients with PIK3CA-mutated metastatic breast cancer in China, a key component contributing to the FDA's approval of Inavolisib in the U.S. on October 10, 2024. HAYWARD, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a pioneer in the field of liquid biopsy, is pleased to announce the publication of a landmark study in The New England Journal of Medicine (NEJM). This study highlights the clinical utility of the PredicineCARE™ liquid biopsy assay ...
Virtual Neurology Investor Event
2024-11-02 07:10
Roche This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others ...
Roche Holding AG (RHHBY) Virtual Neurology Investor Event Conference Transcript
Seeking Alpha· 2024-11-02 06:53
Roche Holding AG (OTCQX:RHHBY) Virtual Neurology Investor Event Conference October 31, 2024 11:00 AM ET Company Participants Bruno Eschli – Investor Relations Azad Bonni – Senior Vice President and Global Head-Neuroscience and Rare Diseases-pRED Luka Kulic – Therapeutic Area Leader-Dementia and Expert Medical Director-Neuroscience and Rare Diseases-pRED Margherita Carboni – Indication Lead, Neurology and Clinical Development Lead-Neurology, Endocrinology and OBGYN-Roche Diagnostics Hanno Svoboda – Head-Port ...
Roche Holding AG (RHHBY) Virtual Neurology Investor Event Conference Transcript
2024-11-02 06:53
Summary of Roche Holding AG Neurology Investor Event Conference Company Overview - **Company**: Roche Holding AG (OTCQX:RHHBY) - **Event Date**: October 31, 2024 - **Focus**: Neurology pipeline updates, particularly in Alzheimer's disease and related therapies Key Points Industry and Company Focus - Roche is focusing on neurology as a significant growth area, with existing products like Ocrevus and Evrysdi, and upcoming opportunities such as Elevidys and fenebrutinib [3][4] - The company has a robust pipeline for Alzheimer's disease, including trontinemab and gamma-secretase modulators [10][11] Alzheimer's Disease Pipeline - **Trontinemab**: A novel Brainshuttle A-beta antibody designed to cross the blood-brain barrier effectively, showing promise in early studies [37][38] - **Gamma-secretase modulator (GSM)**: Aims to prevent amyloid accumulation rather than just clear existing amyloid plaques, with early positive results in human trials [26][29] Clinical Trials and Data - **Trontinemab Phase 1b/2a Study**: Ongoing with 160 participants, showing safety and biomarker data. The study includes dose escalation and expansion phases [39][43] - **Safety Profile**: No new safety concerns reported; however, a serious adverse event (cerebral macrohemorrhage) occurred in a participant with pre-existing conditions, leading to protocol amendments [46][48] - **Amyloid PET Results**: Significant reductions in amyloid plaque levels observed, with a decrease of approximately 90 centiloids at the highest dose after 12 weeks [54][61] Diagnostic Innovations - Roche Diagnostics is advancing blood-based biomarkers for Alzheimer's, including the Elecsys Amyloid Plasma Panel, which has shown high clinical performance in ruling out amyloid pathology [68][70] - Breakthrough device designations received for pTau-181 and pTau-217, enhancing diagnostic capabilities [68][69] Market Outlook - The prevalence of Alzheimer's disease is projected to reach 150 million by 2050, highlighting the urgent need for effective treatments [19] - Roche's dual approach in diagnostics and therapeutics aims to improve patient outcomes and streamline treatment pathways [23][66] Additional Insights - The company emphasizes the importance of patient journey mapping, integrating diagnostics with therapeutic interventions to enhance treatment efficacy [23][25] - The potential for oral small molecule approaches in the future is noted, aiming for more convenient administration of therapies [22] Future Developments - Roche plans to continue expanding its neurology pipeline, with pivotal Phase 3 trials for trontinemab expected to start in the second half of 2025 [7][62] - The company is committed to addressing safety concerns and optimizing treatment protocols based on ongoing trial data [48][60] Conclusion Roche Holding AG is strategically positioned in the neurology sector, with a strong focus on Alzheimer's disease through innovative therapies and diagnostics. The ongoing clinical trials and advancements in biomarker development are expected to enhance the company's market presence and address the growing public health challenge posed by neurodegenerative diseases.