Roche Hldg - RHHBY STOCK NEWS

Roche (RHHBY) announced positive two-year results from the EMBARK trial for Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD). The study demonstrated statistically significant and clinically meaningful improvements across three key motor function measures compared to an untreated control group.

Key findings after two years of treatment include improvements in North Star Ambulatory Assessment (+2.88 points), Time to Rise (-2.06 seconds), and 10-meter walk/run (-1.36 seconds). The functional differences between treated individuals and the control group increased between years one and two.

Patients who crossed over from placebo to Elevidys in part two showed similar improvements after one year. Muscle biopsies taken at 64 weeks showed sustained micro-dystrophin expression, with MRI data supporting functional benefits. No new safety concerns were identified.

Elevidys is currently approved in multiple countries, including the US, UAE, Brazil, and Israel, with pending applications in Europe, Japan, and other regions.

Roche (RHHBY) has received FDA 510(k) clearance and CLIA waiver for its cobas® liat STI multiplex assay panels, enabling rapid diagnosis of multiple sexually transmitted infections from a single sample. The tests, which will be available in the U.S. market in coming months, can detect chlamydia, gonorrhea, and Mycoplasma genitalium.

The point-of-care tests utilize PCR technology and deliver results in 20 minutes, allowing healthcare providers to diagnose and treat patients in a single visit. This development is particularly significant as over 1 million people acquire curable STIs daily worldwide, with most cases being asymptomatic.

The tests will be initially launched in the U.S. market, with CE mark commercialization expected to follow. These solutions aim to improve healthcare efficiency, reduce unnecessary antibiotic usage, and enhance patient outcomes through immediate diagnosis and treatment.

Roche (RHHBY) has received FDA 510(k) clearance for its VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail, a groundbreaking test for diagnosing B-cell lymphoma. This follows its CE Mark approval in June 2024. The test is the first clinically approved in-situ hybridisation (ISH) test capable of assessing all B-cell lymphoma subtypes.

The highly-sensitive test helps distinguish between B-cell cancer and normal immune responses, enabling faster diagnosis and treatment initiation. It can evaluate over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide, working with small biopsies and formalin-fixed tissue. This reduces the need for fresh tissue samples and additional biopsies.

B-cell lymphoma represents about 85% of non-Hodgkin lymphoma (NHL) cases, with NHL being one of the most common cancers in the US, accounting for 4% of all cancer cases and causing over 80,000 deaths annually.

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.