Roche Hldg - RHHBY STOCK NEWS

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Roche (OTCQX: RHHBY) has voluntarily withdrawn its US accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy for treating adults with metastatic triple-negative breast cancer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.

Roche announced positive results from the FIREFISH Part 2 study, demonstrating that Evrysdi significantly benefits infants aged 1-7 months with Type 1 spinal muscular atrophy (SMA). By month 12, 29% of infants could sit unsupported, while 93% remained alive, and 85% were free from permanent ventilation. The study showed promising motor milestone improvements with Evrysdi, and safety was consistent with established profiles. RHHBY has treated over 4,000 patients globally, revealing Evrysdi’s potential in addressing SMA, a leading genetic cause of infant mortality.

Genentech announced the publication of pivotal study results for Evrysdi (risdiplam) in Type 1 spinal muscular atrophy (SMA) in the New England Journal of Medicine. In the FIREFISH Part 2 study, 29% of infants (12/41) achieved the significant motor milestone of sitting unsupported for at least 5 seconds by month 12. The treatment demonstrated consistent safety with 93% of infants alive and 85% free from permanent ventilation at the same time point. The drug is part of the collaboration with the SMA Foundation and is being evaluated in multiple trials worldwide.

Roche reported an 8% increase in Group sales at constant exchange rates for H1 2021, totaling CHF 30.7 billion. The Pharmaceuticals Division experienced a 3% sales decline, offset by a 51% surge in Diagnostics, driven by COVID-19 tests. Key highlights include positive study results for Tecentriq in lung cancer and new EU approvals for Venclyxto and Enspryng. Despite continued biosimilar challenges, new medicines recorded 30% growth. Roche maintains its 2021 outlook, expecting low to mid-single-digit sales growth. Core EPS rose by 6%, affirming the company's strong market position amid recovery signs in the Pharma Division.