ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche (RHHBY) has received additional FDA 510(k) clearance for its VENTANA DP 600 slide scanner, expanding its Digital Pathology Dx system capabilities. This high-capacity scanner can process 240 slides and produces high-resolution digital images of stained tissue samples, representing a significant upgrade with 40 times the capacity of the previously cleared VENTANA DP 200 model.

The system, which received its initial FDA clearance on June 14, 2024, aids pathologists in reviewing and interpreting digital images from formalin-fixed paraffin-embedded (FFPE) tissue for patient diagnosis. The complete Roche Digital Pathology Dx system now includes both the DP 200 and DP 600 scanners, workflow software, and a display, enhancing diagnostic accuracy, consistency, and speed through advanced analysis tools.

Roche has successfully completed its tender offer for Poseida Therapeutics shares, with approximately 64,991,586 shares (66.11% of total outstanding) validly tendered at $9.00 per share in cash, plus a non-tradeable contingent value right (CVR) worth up to $4.00 per share in additional contingent payments.

Through its subsidiary Blue Giant Acquisition Corp., Roche will proceed with the merger, converting all remaining Poseida shares not owned by either company into the same consideration offered in the tender. Following the merger completion, Poseida will become a wholly owned Roche subsidiary, and its shares will be delisted from the Nasdaq Global Select Market.

Roche 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 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.

The ongoing Phase II PASADENA and Phase IIb PADOVA open-label extension studies will continue while Roche evaluates the data and consults with health authorities about next steps. Full results will be presented at an upcoming medical meeting.

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.