ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech, part of Roche Group (SIX: RO, ROG; OTCQX: RHHBY), released promising 2-year results from the SUNFISH study on Evrysdi™ (risdiplam) for Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA) in patients aged 2-25. Improvements in motor function achieved at 12 months were maintained or enhanced at 24 months across primary and secondary endpoints. The study, presented at the 2021 MDA Conference, showed no new safety signals. The findings reinforce Evrysdi's potential long-term benefits and favorable risk profile for SMA patients.

Roche announced new long-term data from the SUNFISH Part 2 study on Evrysdi (risdiplam) for Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA). The study shows that motor function improvements seen at 12 months were maintained or improved at 24 months, indicating sustained efficacy. The study, involving patients aged 2-25, demonstrated a favorable safety profile with no new safety signals. Evrysdi, the first at-home SMA treatment approved by the FDA, has treated over 2,500 patients in clinical and real-world settings.

Roche is set to acquire GenMark Diagnostics for US$ 24.05 per share, totaling approximately US$ 1.8 billion. This all-cash transaction represents a 43% premium over GenMark's stock price before acquisition rumors. The merger will enhance Roche's molecular diagnostics portfolio, particularly for infectious diseases, by incorporating GenMark’s ePlex platform. The acquisition is expected to close in the 2nd quarter of 2021, subject to regulatory approvals and shareholder tender.

Roche has announced that its cobas® HIV-1 and cobas® HCV Tests for the cobas® 6800/8800 Systems received WHO prequalification. This recognition aims to enhance access to reliable diagnostics in regions with limited healthcare resources, improving disease management for patients, particularly in the context of HIV and HCV. The Global Access Program, launched in 2014, aims to provide affordable diagnostic solutions and support WHO's 2030 goals for disease elimination. Roche's innovative cobas Plasma Separation Card further facilitates testing in remote settings.

Genentech announced that the global Phase III REMDACTA study of Actemra (tocilizumab) plus Veklury (remdesivir) for treating severe COVID-19 pneumonia did not meet its primary endpoint of improved hospital discharge time. No new safety signals were reported for Actemra. The study, conducted with Gilead Sciences, failed to meet key secondary endpoints as well. Previous studies COVACTA did not meet its primary endpoint, while EMPACTA did. Genentech remains committed to evaluating the overall data for potential application of Actemra in COVID-19 treatments.

Roche's REMDACTA clinical trial evaluating Actemra/RoActemra and Veklury for severe COVID-19 pneumonia failed to meet its primary endpoint of improved hospital discharge time. Neither did it meet key secondary endpoints, including mortality rates. No new safety concerns were raised during the trial. Roche plans to submit the results for peer-reviewed publication and continues to explore data from this and other COVID-19 studies involving Actemra. Currently, Actemra is not approved for treating COVID-19 pneumonia, despite ongoing evaluation of its potential role in certain patient scenarios.

Roche has received FDA approval for the VENTANA ALK (D5F3) CDx Assay, a companion diagnostic that identifies ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with LORBRENA® (lorlatinib). This assay is unique as the only FDA-approved immunohistochemistry test for LORBRENA. Previous studies showed ALK-positive patients treated with ALK inhibitors can achieve nearly three years of progression-free survival, compared to seven to eight months with chemotherapy. The assay also identifies more patients suitable for anti-ALK therapy than traditional FISH testing.

Genentech has announced the voluntary withdrawal of Tecentriq® (atezolizumab) from the U.S. market for prior-platinum treated metastatic urothelial carcinoma (mUC), following FDA consultation. This decision follows the failure of the IMvigor211 study to meet its primary overall survival endpoint. Genentech emphasizes that other approved indications for Tecentriq remain unaffected. The withdrawal reflects the evolving treatment landscape and aims to uphold the integrity of the FDA's Accelerated Approval Program.

Roche (OTCQX: RHHBY) announced the voluntary withdrawal of Tecentriq® for prior-platinum treated metastatic urothelial carcinoma in the US, following FDA review. This decision stems from the IMvigor211 study's failure to meet primary endpoints, promoting Roche's adherence to the Accelerated Approval Program principles. Although disappointing, Tecentriq remains approved for other indications and continues to provide benefits across multiple cancer types. Roche assures that this action will not impact patients currently receiving treatment.