On Tuesday, Roche Holdings AG RHHBY agreed to acquire Poseida Therapeutics, Inc. PSTX for an equity value of approximately $1.5 billion on a fully diluted basis.The deal consideration includes $9.00 per share in cash plus a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $4.00 per share in cash upon achievement of specific milestones.Also Read: Roche’s Q3 Sales Surge Led By Ocrevus, Vabysmo, Urges Regulators To Block Novo Holdings’ $16.5B Catalent AcquisitionThe proposed ac ...

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 ...

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 ...

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 ...

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 ...

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.

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 ...

ItovebiTM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study1 The U.S. FDA recently approved the Itovebi-based regimen as a first-line treatment for people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease2 Basel, 31 October 2024 - Roche (SIX: RO, ROG; ...

Financial Data and Key Metrics - Year-to-date group sales grew by 6% at constant exchange rates, driven by strong base business growth of 8% [3] - COVID-19 sales decreased by approximately CHF 800 million, and the loss of exclusivity (LOE) impact was also around CHF 800 million, both in line with guidance [3] - Full-year COVID-19 sales decline is expected to be CHF 1.1 billion, with a CHF 300 million impact in Q4 due to a rapid antigen order from the previous year [7][12] - Core EPS growth guidance was raised, with group sales expected to grow in the mid-single-digit range [12] Business Line Performance - Pharma division grew by 9%, while Diagnostics grew by 8% in the base business [3] - Oncology sales increased by 2% to CHF 11.9 billion, driven by strong performance in HER2 franchise and Tecentriq [22][23] - Hematology sales grew by 12% to CHF 5.8 billion, with Hemlibra achieving a 42% market share [28] - Neurology franchise grew by 14%, reaching CHF 7 billion in sales, driven by Ocrevus and Elevidys [31][33] - Immunology sales increased by 1% to CHF 4.6 billion, with Xolair growing by 12% [36][37] - Ophthalmology franchise grew by 47%, reaching CHF 3 billion in sales, led by Vabysmo [38] Market Performance - North America base business grew by 10%, EMEA by 6%, and APAC by 5%, excluding COVID-19 sales [50] - China experienced a slowdown due to macroeconomic conditions, but the company remains the market leader [50] - The US market saw strong growth in Vabysmo, with market shares increasing in AMD, DME, and RVO [38] Strategic Direction and Industry Competition - The company expects to launch two new NMEs (PiaSky and Itovebi) in 2024, with the new and young portfolio now making up 56% of Pharma sales [9][10] - Key growth opportunities include Itovebi EU approval, Evrysdi GYM329 readout, and anti-TL1A Phase 3 trials in UC and Crohn's disease [10][11] - The company completed the acquisition of LumiraDx, which is expected to contribute significantly to Diagnostics sales in the coming years [55] Management Commentary on Operating Environment and Future Outlook - The company expects strong base business growth to continue into Q4 and next year, with no significant COVID-19 impact expected in 2025 [7][12] - Management highlighted cost discipline and confidence in achieving core EPS growth, with plans to increase dividends in Swiss francs [12] - The company remains optimistic about its pipeline, with several key readouts and regulatory events expected in 2025 [45][46] Other Important Information - The company received five regulatory approvals in Q3, including Itovebi in the US and Vabysmo in the EU [4][5] - Key launches in Diagnostics include the cobas pro serology solution and the Respiratory flex test, which leverages TAGS technology [5][53] - The company expects to deliver 12 key launches in Diagnostics by the end of 2024, with nine already achieved by Q3 [55][56] Q&A Session Summary Question: Impact of Amgen's EYLEA biosimilar on Vabysmo - The company does not expect material impact on Vabysmo's growth trajectory, as the ophthalmology market has been about 50% generic biosimilar [58] Question: Tecentriq sales outlook - Tecentriq is expected to grow low single digits for the next year, with competitive pressure in adjuvant lung in the US [59] Question: Xolair biosimilar entry in 2025 - The company confirmed no biosimilar entry for Xolair in 2025, but did not provide specific reasons [63] Question: Elevidys sales and market traction - Elevidys sales reached CHF 137 million, with strong adoption in Gulf states and health tourism observed [65] Question: Fenebrutinib in MS - The company is pleased with the results so far and does not plan to change the primary endpoint [66] Question: TL1A opportunity in IBD - The TL1A pathway is well-validated in IBD, with a potential $10 billion market opportunity and significant unmet need [84][85] Question: Ocrevus subcutaneous formulation - The company expects the subcut formulation to expand Ocrevus use in settings where IV is not available, with an incremental CHF 2 billion sales opportunity [77] Question: Inavolisib physician feedback - Physicians are excited about inavolisib, and the company is working to generate additional data with other CDK4/6 backbones [90] Question: Prasinezumab and Lunsumio outlook - Prasinezumab is a high-risk, high-reward trial, and Lunsumio's real opportunity lies in moving beyond third-line follicular lymphoma [93][94]

Swiss pharma giant Roche Holding AG (RHHBY) posted strong growth in the third quarter. Sales increased 6% year over year to CHF 15.1 billion and were up 9% at constant exchange rates (CER).Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.The company reports under two divisions — Pharmaceuticals and Diagnostics. All growth rates mentioned below are on a year-over-year basis and at CER.Total sales increased 6% in the first nine months of 2024 to CHF 45 billion. Excluding COVID-19-relat ...