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© Globe Newswire
11.12.2025
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Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu
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Basel, 11 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring. This establishes Roche's in-vitro diagnostics (IVD) menu as the broadest available for any automated mass spectrometry platform, including already 39 of the most fr...
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© Globe Newswire
09.12.2025
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Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE Mark
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Basel, 9 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE Mark for its cobas® BV/CV (Bacterial Vaginosis/Candida Vaginitis) assay to accurately identify specific bacteria and yeast responsible for BV and CV in vaginal samples from symptomatic patients collected using the cobas PCR Media proprietary tube....
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09.12.2025
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European Commission approves Roche’s Gazyva/Gazyvaro for adults with active lupus nephritis
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Basel, 9 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. These disease classifications de...
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Worth to know
20.10.2025
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© Globe Newswire
08.12.2025
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Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas
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Basel, 8 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new data highlighting the potential of Lunsumio® (mosunetuzumab) in earlier treatment lines for people living with different types of lymphoma, presented at the 67th American Society of Hematology Annual Meeting and Exposition, 6-9 December 2025 in Orlando, Florida, US....
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20.10.2025
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02.12.2025
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Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)
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Basel, 2 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to...
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© Globe Newswire
19.11.2025
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European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
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Basel, 19 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional marketing authorisation of Lunsumio® (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. Approval...
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© Globe Newswire
18.11.2025
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[Ad hoc announcement pursuant to Art. 53 LR] Roche’s giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer
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Basel, 18 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive phase III results from the lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer....
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© Globe Newswire
10.11.2025
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[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis
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Basel, 10 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the first Phase III (FENhance 2) of two pivotal, similarly-designed Phase III studies (FENhance 1 and 2) in patients with relapsing multiple sclerosis (RMS) met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, significan...
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© Globe Newswire
03.11.2025
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Positive phase III data for Roche’s Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus
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Basel, 3 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the phase III ALLEGORY study of Gazyva®/Gazyvaro® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy. The study met its primary endpoint showing a higher percentage of people...
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© Globe Newswire
30.10.2025
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Roche purchases shares in tender offer for 89bio, Inc
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Basel, 30 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Roche’s wholly owned subsidiary Bluefin Merger Subsidiary, Inc., has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of 89bio, Inc. (“89bio”, NASDAQ: ETNB) at a price of...
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© Globe Newswire
29.10.2025
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Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue
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Basel, 29 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE mark for its Elecsys® Dengue Ag test – a high-throughput, fully automated immunoassay to be used as an aid in the diagnosis of an acute dengue virus infection. This milestone promises to set a new standard for efficiency and reliability in tackling t...
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© Globe Newswire
28.10.2025
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Positive phase III results for Roche’s Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome
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Basel, 28 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the phase III INShore study of Gazyva®/Gazyvaro® (obinutuzumab) in children and young adults (aged >= 2-25 years) with idiopathic nephrotic syndrome (INS). The study met its primary endpoint, with more peop...
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20.10.2025
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23.10.2025
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Changes to the Roche Enlarged Corporate Executive Committee
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Basel, 23 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Nina Schwab-Hautzinger (1975) has been appointed Head of Group Communications and a member of the enlarged Corporate Executive Committee effective 1 February 2026....
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20.10.2025
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Roche’s Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatment
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Basel, 20 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for people with muscle-invasive bladder cancer (MIBC) who are at risk of recurrence after surgery (cystectomy) and have detectable circulating tumour DNA (ctDN...
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© Globe Newswire
20.10.2025
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FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
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Basel, 20 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Gazyva®/Gazyvaro®(obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for el...
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© Globe Newswire
18.10.2025
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Roche’s phase III evERA data showed giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer
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Basel, 18 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III evERA Breast Cancer study. Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) and ESR1-mut...
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© Globe Newswire
17.10.2025
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Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss
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Basel, 17 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from two phase III studies evaluating the efficacy and safety of two doses of investigational vamikibart (0.25 and 1 mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with uveitic macular edema (UME).1 UME is characterised by the...
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© Globe Newswire
17.10.2025
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CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis
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Basel, 17 October, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with...
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© Globe Newswire
16.10.2025
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Roche presents major advances for its sequencing by expansion technology(1), including a new GUINNESS WORLD RECORD™, at the ASHG conference 2025
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Basel, 16 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented major updates on its innovative sequencing by expansion (SBX) technology at the American Society of Human Genetics (ASHG) 2025 Annual Meeting in Boston, USA. Following its recent unveiling, SBX is already being recognized by early evaluators in the sequencing community for its co...
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© Globe Newswire
13.10.2025
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Roche data at ESMO 2025 showcase advances in science and cancer care across multiple tumour types
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Basel, 13 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) Congress 2025, held 17-21 October 2025 in Berlin, Germany. The data underscore Roche’s commitment to deliver transformative medicines for some of...
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© Globe Newswire
06.10.2025
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Roche receives CE Mark for AI-based Kidney Klinrisk Algorithm(1) and launches new comprehensive chronic kidney disease (CKD) algorithm panel
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Basel, 6 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), in collaboration with KlinRisk, Inc., has received the CE-mark for the first AI-based risk stratification tool to assess progressive decline in kidney function. This milestone allows Roche to introduce the Chronic Kidney Disease (CKD) algorithm panel on its navify® Algorithm Suite to suppo...
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© Globe Newswire
03.10.2025
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FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer
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Basel, 3 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell...
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© Globe Newswire
03.10.2025
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Change in the Roche Board of Directors
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Basel, 3 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Dr. Claudia Süssmuth Dyckerhoff has decided not to stand for re-election as a member of the Roche Board of Directors at the Annual General Meeting in 2026. Instead she will be nominated for election to the board of another company which is serving the healthcare industr...
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© Globe Newswire
01.10.2025
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Roche commences tender offer for all shares of 89bio, Inc. for $14.50 per share in cash, plus a non-tradeable contingent value right for up to $6.00 per share in cash
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Basel, 1 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has commenced a tender offer for all of the outstanding shares of common stock of 89bio, Inc. (89bio) (NASDAQ: ETNB) at a price of $14.50 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain milestone payments of up to an aggregate...
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30.09.2025
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Data show Roche’s sixth-generation Troponin T test offers a new level of accuracy critical for diagnosing heart attacks
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Basel, 30 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the primary results from the TSIX Study Program, which evaluated the performance of its new sixth-generation high-sensitivity Troponin T test for diagnosing heart attacks. Presented at the European Society for Emergency Medicine (EUSEM) 20252 and the European Society of Cardiol...
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© Globe Newswire
24.09.2025
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Roche presents new data for OCREVUS and fenebrutinib across broad patient populations at ECTRIMS 2025
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Basel, 24 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presents new data for OCREVUS® (ocrelizumab) and the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain (24-26 September)....
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22.09.2025
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Positive phase III results show Roche’s giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer
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Basel, 22 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer p...
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© Globe Newswire
19.09.2025
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CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma
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Basel, 19 September - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a subcutaneous (SC) formulation of Lunsumio® (mosunetuzumab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL...
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18.09.2025
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Roche enters into a definitive merger agreement to acquire 89bio, and its phase 3 FGF21 analog for the therapy of moderate to severe MASH
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Basel, 18 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a definitive merger agreement to acquire 89bio, Inc. (Nasdaq: ETNB), a publicly listed clinical-stage biopharmaceutical company pioneering the development of innovative therapies for the treatment of liver and cardiometabolic diseases. 89bio’s peg...
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16.09.2025
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Roche receives CE Mark for Accu-Chek SmartGuide Continuous Glucose Monitoring and mySugr App integration, offering an enhanced diabetes management experience
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The integration of Accu-Chek SmartGuide's AI-enabled predictive CGM with the popular mySugr app delivers a simple, intuitive solution for people to manage their diabetes with greater ease.Accu-Chek SmartGuide is now available in 13 countries, with plans to accelerate access to over 30 countries across Europe, Latin America and Asia-Pacific by yea...
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© PR Newswire
16.09.2025
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Roche receives CE Mark for Accu-Chek SmartGuide Continuous Glucose Monitoring and mySugr App integration, offering an enhanced diabetes management experience
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The integration of Accu-Chek SmartGuide's AI-enabled predictive CGM with the popular mySugr app delivers a simple, intuitive solution for people to manage their diabetes with greater ease.Accu-Chek SmartGuide is now available in 13 countries, with plans to accelerate access to over 30 countries across Europe, Latin America and Asia-Pacific by yea...
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© Globe Newswire
05.09.2025
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New data for Roche's Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD)
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Basel, 05 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new data from the AVONELLE-X and SALWEEN studies of Vabysmo® (faricimab),1,2 presented at the 25th Euretina Congress in Paris, France. Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in neovascular or “wet...
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04.09.2025
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Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD)
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Basel, 04 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the EU CE mark for its Port Delivery Platform containing Susvimo, which will now be known as Contivue® in the EU.6 The device comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill, a...
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30.08.2025
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Roche and Alnylam advance zilebesiran into global phase III cardiovascular outcomes trial for people with uncontrolled hypertension
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Basel, 30 August 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam (Nasdaq: ALNY) today announced the decision to initiate a Phase III cardiovascular outcomes trial (CVOT) to evaluate the ability of zilebesiran, a RNAi therapeutic, to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension. This decisio...
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25.08.2025
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Roche’s US subsidiary Genentech breaks ground on state-of-the-art manufacturing facility in North Carolina, USA
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Basel, 25 August 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today broke ground on its newest US manufacturing site in Holly Springs, North Carolina. This significant development marks the establishment of Genentech’s first manufacturing facility on the East Coast. The 65,000 m² facility is strategically designed to...
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01.08.2025
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Roche’s Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD)
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Basel, 01 August 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo® (ranibizumab injection) for the treatment of people with nAMD.1 Results show that Susvimo’s immediate and predictable durabi...
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28.07.2025
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Roche presents new insights in Alzheimer’s disease research across its diagnostics and pharmaceutical portfolios at AAIC
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Basel, 28 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its Alzheimer’s development portfolio is being presented at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada (July 27-30). These data exemplify the comprehensive approach Roche is taking in addressing Alzheimer’s across the enti...
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25.07.2025
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Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU
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Basel, 25 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys™ (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years wi...
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24.07.2025
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[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong momentum with 7% growth (CER) in the first half of 2025
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Basel, 24 July 2025...
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23.07.2025
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Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer’s disease
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Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by...
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23.07.2025
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European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation
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Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, loc...
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22.07.2025
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Roche’s Board of Directors proposes exchange of Genussscheine for participation certificates (Partizipationsscheine)
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Basel, 22 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today its Board of Directors' decision to propose to shareholders a modernisation of Roche Holding Ltd’s capital structure for approval at the Annual General Meeting to be held on 10 March 2026 ("2026 AGM"). The proposal includes the exchange of the existing non-voting equity securi...
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21.07.2025
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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on astegolimab in chronic obstructive pulmonary disease
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Basel, 21 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today topline results from the pivotal phase IIb ALIENTO (n=1,301) and the phase III ARNASA (n=1,375) trials investigating astegolimab compared to placebo, on top of standard of care maintenance therapy in people with moderate to very severe chronic obstructive pulmonary disease (CO...
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30.06.2025
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Changes to the Roche Enlarged Corporate Executive Committee
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Basel, 30 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Johannes (Hans) Clevers (1957), M.D., Ph.D., Head of Roche Pharma Research and Early Development (pRED) and member of the enlarged Corporate Executive Committee will be retiring from Roche. Hans Clevers joined the Roche Board of Directors in 2019 and then was appointed He...
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23.06.2025
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Early data suggest Roche’s NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A
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Basel, 23 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive phase I/II data on NXT007 in people with haemophilia A, supporting its progression into phase III clinical development. NXT007 is a next-generation investigational bispecific antibody, engineered by Chugai, a member of the Roche Group. Early data from the NXTAGE study...
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20.06.2025
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Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma
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Basel, 20 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today results from the phase III SUNMO [NCT05171647] study showing Lunsumio® (mosunetuzumab) administered subcutaneously in combination with Polivy® (polatuzumab vedotin) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progr...
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16.06.2025
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Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease
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Basel, 16 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today its decision to proceed with Phase III development of prasinezumab, an investigational anti-alpha-synuclein antibody, in early-stage Parkinson’s disease. This decision is informed by data from the Phase IIb PADOVA study and ongoing open-label extensions (OLEs) of PADOVA and Ph...
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15.06.2025
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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides safety update on Elevidys™ gene therapy for Duchenne muscular dystrophy in non-ambulatory patients
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Basel, 15 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new dosing restrictions, effective immediately, for ELEVIDYS™ (delandistrogene moxeparvovec), for non-ambulatory Duchenne muscular dystrophy (DMD) patients, irrespective of age, in both clinical and commercial settings. In the commercial setting, non-ambulatory patients should...
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04.06.2025
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Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy (SMA)
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Basel, 04 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved a label extension for Evrysdi® (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA). The 5mg tablet (approx. 6.5mm), which can either be swallowed whole or dispersed in...
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03.06.2025
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Roche’s Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer
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Basel, 3 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III IMforte study of Tecentriq® (atezolizumab) in combination with lurbinectedin (Zepzelca®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, eto...
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31.05.2025
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New data show Roche’s Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer
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Basel, 31 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive final results from the overall survival (OS) analysis of the phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvest...
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30.05.2025
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Roche’s fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis
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Basel, 30 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. The latest results for this investigational Bruton’s tyrosine kinase (BTK) inhibit...
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23.05.2025
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CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer
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Basel, 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen re...
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23.05.2025
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Roche announces new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technology
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Basel, 23 May 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today a strategic collaboration with Broad Clinical Labs to develop and pilot groundbreaking applications using Roche’s recently unveiled next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology. This collaboration will focus on harnessing the power of the SBX techno...
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23.05.2025
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New two-year follow-up of Roche’s Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients
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Basel, 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today two-year follow-up data from the phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) and OS was not reach...
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© Globe Newswire
22.05.2025
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FDA approves Roche’s Susvimo for diabetic retinopathy
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Basel, 22 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the US and more than 100 million people globally.1,2...
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© Globe Newswire
20.05.2025
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Roche provides update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
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Basel, 20 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or...
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© Globe Newswire
13.05.2025
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Ten-year APHINITY data show Roche’s Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer
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Basel, 13 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HE...
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© Globe Newswire
06.05.2025
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Roche introduces innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity
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Basel, 06 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its Elecsys® PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients showing signs of metabolic dysfunction–associated steatotic liver disease (MASLD). The test, developed in partnership with Nordic Bioscience, offers c...
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© Globe Newswire
30.04.2025
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CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
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Basel, 30 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo®, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (tr...
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