ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has launched the Digital Pathology Open Environment, enhancing collaboration among software developers to improve personalized healthcare through advanced image analysis. This platform enables secure data exchange, allowing pathologists to access algorithms from third-party developers alongside Roche’s AI tools for improved diagnostic precision. By leveraging this open environment, Roche aims to foster partnerships and expedite the development of next-generation diagnostic tests, ultimately benefiting cancer patients with more targeted treatments.

Roche has announced its definitive agreement to acquire the TIB Molbiol Group, with the transaction expected to close in the fourth quarter of 2021. This acquisition aims to enhance Roche's molecular diagnostics portfolio, particularly in assays for infectious diseases, including SARS-CoV-2 variants. TIB Molbiol, recognized for its rapid assay development, has over 45 CE-IVD assays and more than 100 research use assays available on Roche’s LightCycler PCR systems. The two companies have collaborated for over 20 years, responding swiftly to biological threats.

Genentech, part of Roche Group, will present new oncology data at the ESMO Congress from September 16-21, 2021. Highlights include Phase II results from the coopERA study on giredestrant for ER-positive, HER2-negative breast cancer, and Phase III data from the IMpower010 study showing Tecentriq improves outcomes in early-stage non-small cell lung cancer (NSCLC). Genomic insights from the CUPISCO study may enhance personalized treatment for Cancer of Unknown Primary. This underscores Genentech’s commitment to advancements in oncology.

NeuExcell Therapeutics and Spark Therapeutics, part of Roche Group (OTCQX: RHHBY), announced a collaboration to develop a gene therapy for Huntington’s Disease (HD) on September 7, 2021. The agreement grants Spark access to NeuExcell's neuro-regenerative gene therapy platform and potential milestone payments up to $190 million plus royalties. The partnership aims to leverage Spark's expertise in gene therapy to accelerate the HD program, addressing the challenges of neurodegenerative conditions.

Roche (OTCQX: RHHBY) has voluntarily withdrawn its US accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy for treating adults with metastatic triple-negative breast cancer (mTNBC). This decision follows consultations with the US FDA, who deemed it inappropriate to maintain this approval due to changes in the treatment landscape. The withdrawal does not affect other approved uses of Tecentriq and is not linked to efficacy or safety issues. Roche remains committed to exploring treatments for mTNBC and will work with the FDA to finalize the withdrawal process.

Roche has received FDA approval for the VENTANA MMR RxDx Panel, a first-of-its-kind diagnostic test that identifies solid tumor patients with deficient DNA mismatch repair (dMMR) who may benefit from GSK's JEMPERLI treatment. This test is crucial for personalizing cancer therapy, particularly in cancers like endometrial, gastric, and colorectal cancers, where approximately 14% of patients show dMMR. The approval aligns with Roche's commitment to advancing personalized healthcare and expanding its diagnostic capabilities.

Roche announced that the pivotal phase III POLARIX trial for Polivy in combination with chemotherapy regimen R-CHP has met its primary endpoint, showing significantly improved progression-free survival in previously untreated diffuse large B-cell lymphoma (DLBCL) patients compared to standard treatment R-CHOP. Given that 40% of DLBCL patients relapse, this outcome could transform first-line treatment. Roche plans to submit these results to health authorities globally and will present them at an upcoming medical meeting.

Roche has received FDA acceptance for its supplemental Biologics License Application for Tecentriq (atezolizumab) as an adjuvant treatment for non-small cell lung cancer (NSCLC). The application is based on Phase III IMpower010 study results, demonstrating a 34% reduction in disease recurrence or death in patients with PD-L1-positive NSCLC compared to best supportive care. The FDA's review falls under the Real-Time Oncology Review program, aiming for expedited availability of effective treatments. A decision is expected by December 1, 2021.

Roche announced that the FDA has accepted its Biologics License Application for faricimab, targeting neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) under Priority Review. Faricimab could be the first bispecific antibody for eye treatments, addressing two pathways implicated in retinal diseases. Phase III trials showed that nearly half of patients could extend treatment intervals to four months, maintaining vision gains comparable to the standard care, aflibercept. The European Medicines Agency has also validated the marketing application for faricimab.