Roche Hldg Stock Price, News & Analysis

Roche's phase III SKYSCRAPER-01 study evaluating tiragolumab alongside Tecentriq for advanced non-small cell lung cancer (NSCLC) did not achieve its co-primary endpoint of progression-free survival. While overall survival data is still maturing, the study will proceed to further analysis. Despite these setbacks, tiragolumab continues to be explored in various cancer types, indicating Roche's commitment to developing this investigational therapy.

Roche has extended its commitment to the World Federation of Hemophilia's Humanitarian Aid Program until 2028, aiming to provide prophylactic treatment for up to 1,000 individuals with haemophilia A in underserved regions. This initiative, launched in February 2019, has already benefited over 940 people across 30 countries. The program addresses critical access issues for individuals with bleeding disorders, particularly in developing nations where standard care is limited. Roche has been recognized as a Visionary Contributor to the program, emphasizing its dedication to improving health outcomes for affected populations.

Roche (OTCQX: RHHBY) announced new three-year data from the FIREFISH study, showing that 91% of infants treated with Evrysdi (risdiplam) are alive after three years. The study indicates significant improvements in motor functions, including the ability to sitting without support and swallowing. The treatment demonstrated a reduction in serious adverse events and hospitalizations, with notable ongoing efficacy in over 5,000 patients. Evrysdi is now approved in 79 countries and under review in 29 more.

Roche reported a 11% increase in Group sales during Q1 2022, reaching CHF 16.4 billion. The Pharmaceuticals Division grew by 6%, driven by new medicines for severe diseases, while the Diagnostics Division surged 24%, largely due to high demand for COVID-19 tests. Significant developments included FDA approval of Vabysmo for eye diseases and EU recommendations for Polivy and Tecentriq for cancer treatments. Roche confirms its full-year outlook, projecting stable sales growth, although sales from COVID-19 products are expected to decline.

Roche announced that the EMA's CHMP has recommended the approval of Tecentriq (atezolizumab) as an adjuvant treatment for adults with non-small cell lung cancer (NSCLC) at high risk of recurrence. In the Phase III IMpower010 trial, Tecentriq showed a 57% reduction in disease recurrence or death compared to best supportive care. If approved, it will be the first cancer immunotherapy for early-stage NSCLC in Europe. Current treatment options are limited, and this approval could significantly enhance Roche's position in cancer immunotherapy.

Roche announced the European Medicines Agency's CHMP recommendation for conditional marketing authorization for mosunetuzumab, a bispecific antibody for treating relapsed or refractory follicular lymphoma (FL). If approved, it will be the first CD20xCD3 therapy available for this condition. The recommendation stems from the GO29781 study, which demonstrated a 60% complete response rate among heavily pretreated patients. More than 28,000 people are diagnosed with FL yearly in Europe, highlighting the need for effective treatment options. A final decision by the European Commission is anticipated soon.

Roche will showcase innovative diagnostics solutions at the 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine (EuroMedLab) in Munich from April 10-14, 2022. Key highlights include the cobas® 5800 System for expanded PCR testing and the handheld cobas® pulse glucose management device. Additionally, Roche will present the AVENIO Tumor Tissue Comprehensive Genomic Profiling Kit study results to aid oncology research. The company emphasizes its commitment to improving patient care and healthcare efficiency through digital solutions and integrated diagnostics.

Genentech announced promising interim results from the CONSONANCE study of Ocrevus (ocrelizumab) for treating secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS). Seventy-five percent of patients exhibited no evidence of progression (NEP) after one year. Moreover, 70% showed improvement in cognitive stability. The study revealed disparities in treatment initiation among minority populations, which the company aims to address through ongoing research. Ocrevus has been administered to over 225,000 patients globally, demonstrating significant long-term efficacy.

Roche announced the FDA's acceptance of the supplemental Biologics License Application for Actemra/RoActemra (tocilizumab) to treat COVID-19 in hospitalized adults. If approved, it would be the first FDA-approved immunomodulator for this indication. Over one million patients have been treated globally with Actemra/RoActemra. The submission is based on clinical studies involving over 5,500 patients and a decision on approval is expected in the second half of 2022. Roche is committed to improving access to this treatment worldwide, especially in low- and middle-income countries.