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Roche Holding AG (OTCQX:RHHBY) Virtual Hematology Investor Conference Call June 23, 2025 1:00 PM ET Company Participants Bruno Eschli - Head of Investor Relations Charles S. Fuchs - Global Head of Oncology & Hematology Drug Development—Genentech & Roche Daud Chaudry - Corporate Participant Conference Call Participants Colin Peter White - UBS Investment Bank, Research Division David Paul Evans - Kepler Cheuvreux, Research Division Justin Steven Barrie Smith - Sanford C.
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 progression-free survival (PFS) and objective response rate (ORR) compared to MabThera®/Rituxan® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for transplant.1 Primary analysis data were featured at the 18th International Conference on Malignant Lymphoma as a late-breaking oral presentation.
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today results from the Phase III SUNMO [NCT05171647] study showing Lunsumio® (mosunetuzumab-axgb) administered subcutaneously in combination with Polivy® (polatuzumab vedotin-piiq) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to Rituxan®.
Genentech and AbbVie noted that Venclexta failed to help treat patients with newly diagnosed higher-risk MDS; However, this drug has already been approved for several other hematological indications. The 2% increase in revenue growth of the oncology portfolio was thanks to HER2 franchise; Primarily driven by 47% conversion rate in 58 launch countries by Phesgo. The decision was made to advance anti-alpha-synuclein monoclonal antibody prasinezumab into phase 3 development; Time to confirmed motor progression endpoint more pronounced in patients who took the drug alongside levodopa therapy.
Roche is set to advance prasinezumab into phase III for early Parkinson's, eyeing potential first-in-class disease-modifying therapy.
The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (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 Phase II PASADENA studies. "We are encouraged by the efficacy signals observed across the two.
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 Phase II PASADENA studies.
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 no longer receive Elevidys. In the clinical trial setting, enrolment and dosing of non-ambulatory patients will be immediately paused until additional risk mitigation measures (e.g. immune modulatory treatment) are implemented in the study protocol. Health authorities, investigators and physicians are being informed so that patient care can be quickly adjusted.
JUPITER, Fla., June 10, 2025 (GLOBE NEWSWIRE) -- In a milestone rarely achieved in the clinical laboratory industry, Access Medical Labs — the largest private diagnostic lab in Florida — has completed a full transition from Siemens to Roche Diagnostics systems in under 6 months.