Roche Hldg Stock Price, News & Analysis

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.

Roche has introduced a new COVID-19 test aimed at researchers, capable of detecting the BA.2.75 subvariant and distinguishing it from BA.4 and BA.5. The test targets unique mutations within BA.2.75, enhancing epidemiological tracking and understanding of public health implications. Since its emergence in May 2022, BA.2.75 has been observed in multiple countries, although it is not yet classified as a Variant of Concern. Roche aims to support healthcare efforts globally by developing over 20 COVID-19 diagnostic solutions and distributing more than 1.5 billion tests since March 2020.

Roche announced that the FDA has accepted the supplemental Biologics License Application for Polivy (polatuzumab vedotin-piiq) in combination with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). The decision is expected by April 2, 2023. The POLARIX study showed that Polivy plus R-CHP reduced the risk of disease progression by 27% compared to R-CHOP, with a safety profile comparable to that treatment. Roche aims to establish this regimen as the new standard of care for DLBCL.

Roche announces the launch of the Elecsys IGRA SARS-CoV-2 test on August 15, 2022, in CE Mark-accepting countries. This new diagnostic tool enhances understanding of the immune response to SARS-CoV-2 infections and vaccinations, particularly for immunocompromised and high-risk patients. By detecting T-cell responses, the test supports informed clinical decisions. Roche continues to expand its COVID-19 portfolio, affirming its commitment to improving patient outcomes amid the ongoing pandemic.

Xofluza has received FDA approval as the first single-dose oral treatment for influenza in children aged five to less than 12 years. The approval includes the use of Xofluza for post-exposure prophylaxis in children following contact with infected individuals. This significant advancement underscores the importance of effective influenza antivirals, especially amid ongoing public health challenges. Clinical studies demonstrated comparable efficacy to existing treatments, with Xofluza achieving a 90% reduction in influenza risk among household contacts.

Xofluza, the first single-dose oral medicine for influenza, has been approved by the FDA for children aged five to under twelve. This includes treatment for acute uncomplicated influenza and post-exposure prophylaxis for those in contact with infected persons. The approval is based on Phase III studies demonstrating its effectiveness against influenza. Adverse events in children included vomiting and diarrhea, reported in 5% of cases. Xofluza's mechanism targets viral replication, providing an innovative solution to influenza management amidst ongoing public health challenges.