ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced FDA approval for the PATHWAY anti-HER2/neu (4B5) test, enhancing the identification of metastatic breast cancer patients with low HER2 levels. This test allows patients to explore treatment options with ENHERTU, a HER2-targeted therapy, potentially improving outcomes for a previously underserved group, comprising nearly half of mBC patients. The DESTINY-Breast04 trial showed a 50% reduction in disease recurrence or death among those treated with ENHERTU based on the new testing criteria. Roche's commitment to diagnostics innovation is evident in this advancement.

On October 3, 2022, Roche announced the appointment of Matt Sause as CEO of Roche Diagnostics, effective January 1, 2023. Sause has a 20-year career at Roche, showcasing expertise in both Diagnostics and Pharma sectors across various regions. Thomas Schinecker, new Roche CEO, and Severin Schwan, proposed as Chairman, emphasized Sause's leadership capabilities. Roche, recognized for its sustainability efforts, is a leader in biotechnology and in-vitro diagnostics, aiming to enhance healthcare delivery globally.

Roche (OTCQX: RHHBY) announced the resignation of Julie Brown from its Board of Directors, effective immediately, as she has accepted a new management role at another pharmaceutical company. Brown, who served on the Board since March 2016 and chaired the Audit Committee, will be succeeded temporarily by Dr. Patrick Frost until the Annual General Meeting in March 2023. Roche Chairman Christoph Franz acknowledged Brown's significant contributions to the company, emphasizing her impact on Roche's success.

Roche has received 510(k) clearance from the U.S. FDA for its cobas® pure integrated solutions, a modular system aimed at improving productivity in low- to mid-volume laboratories. This new system combines clinical chemistry, immunoassay, and Ion-Selective Electrode testing into a compact footprint of about 21 square feet.

It can perform up to 870 tests per hour and will offer over 186 tests across various disease areas within the first year. Furthermore, it reduces hands-on maintenance to just five minutes per day, enhancing lab efficiency and patient care.

On September 19, 2022, Roche announced the European Commission's approval of Vabysmo (faricimab) for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). This innovative treatment allows for administration every four months, reducing the injection burden by up to 33% compared to aflibercept. Phase III studies involving 3,220 patients demonstrated similar vision outcomes with less frequent dosing. Vabysmo targets two pathways, Ang-2 and VEGF-A, enhancing treatment efficacy and potentially benefiting over 60% of patients requiring fewer injections.

Roche has announced the CE IVDR approval of the VENTANA PD-L1 (SP263) Assay as a companion diagnostic for identifying non-small cell lung cancer (NSCLC) patients eligible for Libtayo treatment. This approval enhances access to Libtayo for patients with locally advanced and metastatic NSCLC, potentially improving their treatment outcomes. Over 60% of NSCLC patients are diagnosed at advanced stages. The assay is the only CE-marked product with indications for four immunotherapy drugs, providing oncologists with various treatment options.

Good Therapeutics has entered a definitive merger agreement to be acquired by Roche (SIX: RO, OTCQX: RHHBY) for $250 million in cash, plus additional milestone payments. This acquisition grants Roche access to Good Therapeutics’ innovative PD-1-regulated IL-2 program, which aims to enhance cancer treatment while minimizing systemic immune activation. The deal is subject to regulatory approval and is expected to close in Q3 2022. Post-acquisition, Good Therapeutics will focus on applying its technology to other immuno-oncology targets through a new entity, Bonum Therapeutics.

Roche announced the CE label expansion of the VENTANA PD-L1 (SP263) Assay, a significant development for non-small cell lung cancer (NSCLC). This assay helps identify patients who may benefit from Tecentriq immunotherapy post-surgery. The expansion is based on the Phase III IMpower010 study, which demonstrated a 57% reduction in disease recurrence for patients with high PD-L1 expression. With this advancement, Roche aims to enhance personalized healthcare and improve patient outcomes in NSCLC.

Roche has launched the Digital LightCycler System, its first digital PCR platform aimed at enhancing the detection of rare mutations in cancer and infectious diseases. This new system allows laboratories to segment clinical samples into 100,000 reactions, enabling precise DNA and RNA analysis. With CE marking and FDA 510(k) exempt status, it will be available in 15 countries by the end of 2022, expanding Roche's PCR solutions portfolio. CEO Thomas Schinecker emphasized its potential for improving patient diagnosis and treatment strategies.