Roche Hldg - RHHBY STOCK NEWS

Roche has received FDA approval for Xolair® (omalizumab) prefilled syringes for self-injection. This approval allows suitable patients to administer their treatment from home, enhancing flexibility and convenience, particularly for high-risk individuals during the COVID-19 pandemic. Xolair targets immunoglobulin E (IgE) and is used for moderate to severe allergic asthma, chronic idiopathic urticaria, and nasal polyps. Since its launch in 2003, around 460,000 patients have been treated with Xolair in the U.S.

Genentech has received FDA approval for the Xolair^® (omalizumab) prefilled syringe, allowing self-injection for all approved indications in the U.S. This biologic treats moderate to severe allergic asthma, chronic idiopathic urticaria, and nasal polyps. Patients will have the flexibility to administer the drug at home, provided they have no prior history of anaphylaxis. Approximately 460,000 patients have been treated with Xolair since its 2003 launch, supported by a strong clinical development program, including 10 Phase III studies.

Roche (OTCQX: RHHBY) announced positive results from the phase III REGN-COV 2069 trial for the investigational antibody cocktail casirivimab and imdevimab, demonstrating an 81% reduction in symptomatic COVID-19 infections among uninfected household contacts.

For recently infected asymptomatic patients, the treatment reduced the risk of progressing to symptomatic COVID-19 by 31%. The trial included 1,505 participants, with results indicating shorter symptom duration and no new safety concerns. Detailed findings will be presented to regulatory authorities like the FDA and EMA.

Roche (OTCQX: RHHBY) will present significant data at the 73rd American Academy of Neurology Annual Meeting, highlighting advancements in treatments for neurological disorders. Notable findings include:

• EVRYSDI shows improved motor function in infants with Type 1 spinal muscular atrophy (SMA).
• OCREVUS demonstrates consistent benefits in multiple sclerosis.
• ENSPRYNG reinforces efficacy for neuromyelitis optica spectrum disorder.
• Fenebrutinib shows a promising safety profile for multiple sclerosis.
• Additional presentations cover Alzheimer’s and Huntington’s disease research.

Roche has launched the Elecsys Anti-p53 immunoassay to aid in diagnosing throat, bowel, and breast cancers. This test helps detect anti-p53 antibodies, which can indicate cancer presence, and is now available in CE Mark markets. According to the company, early diagnosis may lead to improved patient outcomes. The Elecsys Anti-p53 assay, utilizing advanced ECLIA technology, aims to complement existing diagnostic methods. Roche remains committed to enhancing cancer diagnostics and treatment options.

Roche has launched the Elecsys® EBV panel in CE Mark-accepting countries, designed for accurate EBV infection staging from a single blood sample. This development aims to reduce confirmatory testing and facilitate quicker diagnoses for patients, particularly transplant recipients. The panel includes three immunoassays that detect specific antibodies and enhances laboratory efficiency while saving time and resources. Roche plans to file for FDA approval in the future, furthering its commitment to improving healthcare through targeted diagnostics.

On March 30, 2021, Roche announced the European Commission's approval of Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients aged two months and older. This decision, based on pivotal clinical trials FIREFISH and SUNFISH, marks a significant advancement in SMA treatment, enabling at-home administration. Over 3,000 patients have been treated with Evrysdi, and Roche is working with regulators in the EU to expedite patient access. The approval ensures availability across all 27 EU member states and is supported by favorable safety and efficacy data.

Roche has launched eight new configurations for its cobas pro integrated solutions, enhancing laboratory flexibility and efficiency. This new analyser can now process up to 4,400 tests per hour, effectively doubling previous capacities. The modifications allow labs to consolidate multiple analytical units on a single platform, ensuring faster turnaround times for patient samples. The cobas pro solutions cater to diverse testing needs in areas like cardiology and oncology, improving patient care through quicker diagnostics.

Roche announced positive results from the REGN-COV 2067 trial, demonstrating that the casirivimab and imdevimab antibody cocktail reduced the risk of hospitalization or death by 70% (1,200 mg) and 71% (2,400 mg) in non-hospitalized COVID-19 patients. The treatment also shortened symptom duration from 14 to 10 days. Ongoing studies include a phase II/III trial for hospitalized patients and another for prevention in household contacts. Over 25,000 individuals have participated in trials, and Roche aims for regulatory submissions soon.