ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech announced results from its Phase IIb PADOVA study of prasinezumab in 586 early-stage Parkinson's disease patients. The study missed its primary endpoint of time to confirmed motor progression (HR=0.84, p=0.0657), though showing potential clinical efficacy. A pre-specified analysis revealed stronger effects in levodopa-treated patients (75% of participants, HR=0.79). The drug demonstrated consistent positive trends across multiple secondary and exploratory endpoints and maintained a favorable safety profile with no new concerns.

The company will continue the Phase II PASADENA and Phase IIb PADOVA open-label extension studies while working with health authorities to determine future steps. Full results will be presented at an upcoming medical meeting.

Roche has received CE mark approval for its cobas® Mass Spec solution, including the cobas® i 601 analyser and first Ionify® reagent pack for steroid hormone testing. This launch marks a significant advancement in clinical mass spectrometry diagnostics, making it accessible to routine laboratories worldwide.

The solution will expand to offer more than 60 analytes for testing steroid hormones, vitamin D metabolites, immunosuppressant drugs, therapeutic drug monitoring, and drugs of abuse testing. The technology provides enhanced sensitivity and specificity, considered the diagnostic 'gold standard' for various clinical situations.

The system integrates with Roche's cobas® pro solutions, offering full automation and standardization, addressing previous limitations of mass spectrometry testing that required specialist laboratories and highly skilled operators.

Roche has received European Medicines Agency approval for Vabysmo® prefilled syringe (PFS) to treat three retinal conditions: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). These conditions affect over 9 million people in the EU.

The Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody in the EU, featuring the only CE-marked needle specifically designed for intravitreal injection. Since its initial US approval in 2022, over 5 million doses of Vabysmo have been distributed globally. The PFS version was first approved in the US in July 2024.

Roche has received CE certification for its updated cobas 6800/8800 systems 2.0, marking a significant advancement in molecular diagnostic testing. The upgrade enhances laboratory efficiency through increased throughput, improved run flexibility, and sample prioritization capabilities. A key feature is the new Temperature-Activated Generation of Signal (TAGS) technology, enabling simultaneous detection of up to 15 targets in a single patient sample.

The systems are designed for mid-to-high volume molecular testing laboratories, offering intelligent workflows and enhanced testing capabilities. The majority of the cobas test menu is available with this update, which can be implemented as an upgrade to existing systems worldwide. FDA submission for U.S. 510(k) clearance is planned for 2025.

Roche presented new data for its CD20xCD3 bispecific antibodies Columvi and Lunsumio at ASH 2024, demonstrating durable remissions with fixed-duration treatment. Three-year follow-up showed Columvi achieved 40% complete response in large B-cell lymphoma, while Lunsumio showed 64% of follicular lymphoma patients remained progression-free at 45 months.

A new subcutaneous formulation of Lunsumio demonstrated non-inferiority to intravenous treatment, with 76.6% overall response rate and 61.7% complete response rate. Real-world data indicated reduced treatment-related travel burden due to less frequent dosing with these therapies.

The combination of Lunsumio with Polivy showed improved efficacy versus MabThera/Rituxan with Polivy in relapsed/refractory large B-cell lymphoma, achieving 77.5% overall response rate versus 50%.

Genentech presented new data at ASH 2024 for its CD20xCD3 bispecific antibodies Columvi and Lunsumio in lymphoma treatment. Long-term follow-up data showed durable remissions with fixed-duration treatment, with Columvi achieving 40% complete response in large B-cell lymphoma and Lunsumio showing 64% of follicular lymphoma patients remaining progression-free at 45 months.

A new subcutaneous formulation of Lunsumio demonstrated non-inferiority to intravenous treatment, with 76.6% overall response rate and 61.7% complete response rate. Real-world data indicated reduced treatment-related travel burden due to less frequent dosing schedules. The combination of Lunsumio with Polivy showed improved efficacy versus Rituxan-Polivy combination in relapsed/refractory large B-cell lymphoma.

Roche has initiated a tender offer to acquire all outstanding shares of Poseida Therapeutics for $9.00 per share in cash, plus a non-tradeable contingent value right (CVR) worth up to an additional $4.00 per share. The tender offer, announced on December 9, 2024, will expire on January 7, 2025, unless extended.

The acquisition follows a merger agreement dated November 25, 2024. The transaction requires regulatory approvals and the tender of a majority of Poseida's outstanding shares. After successful completion of the tender offer, remaining shares will be acquired through a second-step merger at the same terms. The deal is expected to close in Q1 2025.

Roche announced five-year follow-up data from the phase III POLARIX study evaluating Polivy combination therapy in untreated diffuse large B-cell lymphoma (DLBCL). The analysis showed a positive trend in overall survival with Polivy plus R-CHP compared to R-CHOP, with a reduction in death risk (HR 0.85). The study demonstrated that patients receiving Polivy combination needed nearly 25% fewer follow-up treatments compared to standard therapy.

The safety profile remained consistent with no new safety signals, and benefits in progression-free and disease-free survival were maintained. The treatment showed a numerical reduction in lymphoma-related deaths (9.0% vs 11.4%). More than 38,000 people worldwide have been treated with this combination, which is now approved in over 90 countries.

Genentech announced five-year follow-up data from the Phase III POLARIX study evaluating Polivy in combination with R-CHP for untreated diffuse large B-cell lymphoma (DLBCL). The analysis showed a positive trend in overall survival with a reduction in death risk (HR 0.85) compared to standard R-CHOP therapy.

Key findings include nearly 25% fewer follow-up treatments needed in the Polivy combination group, maintained benefits in progression-free and disease-free survival, and a numerical reduction in lymphoma-related deaths (9.0% vs 11.4%). The safety profile remained consistent with no new signals.

The treatment is currently approved in over 90 countries, with more than 38,000 patients treated worldwide. Genentech continues exploring Polivy combinations through additional Phase III trials SUNMO and SKYGLO.