Streetbeat News

RHHVF

Roche Holding AG

CEO

Severin Schwan

Industry

Medicinal and Botanical Manufacturing

Open

281.03

Mkt cap

227B

Volume

High

281.03

P/E Ratio

18.76

52-wk high

340.88

Low

281.03

Div yield

0.04

52-wk low

233.12

Roche's Genentech has been granted Priority Review by the FDA for Inavolisib, an investigational oral therapy, in combination with Palbociclib (Ibrance) and Fulvestrant. The FDA decision is expected by November 27, 2024. This regimen targets PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.

Portfolio Pulse from Benzinga Newsdesk

May 29, 2024 | 5:08 am

Roche and Hitachi High-Tech have extended their 46-year partnership to advance diagnostic testing. The renewed 10-year contract aims to accelerate the availability of new solutions, including the upcoming launches of cobas® c703 & ISE neo units and cobas® Mass Spec solution.

Portfolio Pulse from Benzinga Newsdesk

May 28, 2024 | 7:27 am

Roche announced that the FDA granted Breakthrough Therapy Designation to Genentech's Inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation. The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 5:32 am

Roche's Genentech reports positive Phase Ib results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity, showing significant weight loss and glycemia normalization with no new safety concerns.

Portfolio Pulse from Benzinga Newsdesk

May 16, 2024 | 6:13 am

Roche's Genentech announced that its drug Columvi, in combination with chemotherapy, met its primary endpoint of overall survival in a Phase III STARGLO study for patients with relapsed or refractory diffuse large B-cell lymphoma. The results, showing a statistically significant improvement in survival, will be submitted to health authorities and presented at an upcoming medical meeting.

Portfolio Pulse from Benzinga Newsdesk

April 15, 2024 | 5:34 am

Roche has launched navify Analytics and navify Monitoring as part of its navify operational excellence solutions aimed at laboratories and point of care services. These tools are designed to provide operational insights to lab managers and point of care coordinators, helping to manage workflows more efficiently, reduce costs, and improve productivity. The combination of navify Analytics and navify Monitoring allows laboratories to operate more efficiently, maintain quality, and improve test turnaround times.

Portfolio Pulse from Benzinga Newsdesk

March 12, 2024 | 7:11 am

Roche's Genentech announced positive results from the NIH-sponsored Phase III OUtMATCH study for Xolair, showing it increased tolerance to common food allergens in individuals as young as 1 year. Following this, the U.S. FDA approved Xolair as the first medicine for people with one or more food allergies. This approval is significant given the life-threatening nature of allergic reactions and the high number of food-related anaphylaxis cases treated in U.S. emergency rooms annually.

Portfolio Pulse from Benzinga Newsdesk

February 26, 2024 | 8:12 am

Genentech, a Roche subsidiary, announced new 72-week data from BALATON and COMINO studies evaluating Vabysmo for macular edema due to retinal vein occlusion (RVO). The data showed that Vabysmo sustained significant drying of retinal fluid and allowed up to 60% of patients to extend treatment intervals to three or four months. These results will be presented at the Angiogenesis, Exudation, and Degeneration 2024 conference. Vabysmo is approved in the U.S. for RVO and in over 90 countries for wet AMD and DME.

Portfolio Pulse from Benzinga Newsdesk

February 01, 2024 | 7:33 am

Roche's Genentech has announced new long-term data for Vabysmo, showing sustained improvements in retinal drying and vision for patients with Retinal Vein Occlusion (RVO). The data indicates that up to 60% of patients could extend treatment intervals to three or four months. Detailed results from two global Phase III RVO studies will be presented at the Angiogenesis, Exudation, and Degeneration 2024 conference. Vabysmo is approved in the U.S. for RVO and in over 90 countries for wet AMD and DME.

Portfolio Pulse from Benzinga Newsdesk

January 26, 2024 | 6:33 am

The European Commission has approved Roche's Tecentriq SC, a subcutaneous (SC) formulation of its cancer immunotherapy, which uses Halozyme's ENHANZE technology. This approval marks the EU's first subcutaneous PD-(L)1 cancer immunotherapy for multiple cancer types. The SC injection, which reduces treatment time by approximately 80% compared to standard IV infusion, is preferred by patients and healthcare practitioners due to its convenience and potential time savings for healthcare systems. The approval is based on the Phase IB/III IMscin001 study, demonstrating comparable blood levels of Tecentriq and a consistent safety and efficacy profile to the IV formulation.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 6:57 am

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