FDA approval marks first and only subcutaneous anti-PD-(L)1 cancer immunotherapy SAN DIEGO, Sept. 12, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) inf ...

Roche (RHHBY) presented results of an early-stage study on its experimental obesity drug, CT-996, at the European Association for the Study of Diabetes annual meeting. CT-996 is an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity. However, shares of the company were down 6% on Sept. 11, post the presentation on concerns of side-effects from the investigational obesity drug. Image Source: Zacks Investment Research Ye ...

The company had a dispiriting update to offer about an investigational drug. For the second trading session in less than a week, Roche Holding (RHHBY -6.02%) stock really took it on the chin Wednesday. Dispiriting news about its investigational obesity drug was the culprit; disseminating this, investors sold out of the pharmaceutical veteran. At the end of the day's action, Roche had lost almost 6% of its value. Obesity drug disappoints In a meeting of the European Association for the Study of Diabetes that ...

10'000 Hours/DigitalVision via Getty Images Investment Overview I last covered the Swiss pharma giant Roche (OTCQX:RHHBY) in a note for Seeking Alpha in mid-May, giving the company's stock a "Buy" recommendation. Shares have risen in value by ~22% since, trading at ~$40 at the time of writing, which translates to a market cap valuation of $254bn. In that note I wrote: Roche has been struggling for top and bottom line growth over the past several years, and this may have affected its share price and valuatio ...

Lunit's AI-powered biomarker, Lunit SCOPE PD-L1 TPS, integrates into Roche's navify® Digital Pathology platform to enhance precision medicine and improve cancer biomarker testing SEOUL, South Korea, Sept. 9, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AIpowered solutions for cancer diagnostics and therapeutics, today announced its collaboration with Roche to integrate Lunit SCOPE PD-L1 22C3 TPS into Roche's navify® Digital Pathology platform. This marks the first deployment of Lunit's ...

For Immediate Releases Chicago, IL – September 9, 2024 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Amazon.com, Inc. (AMZN) , Roche Holding AG (RHHBY) , GE Aerospace (GE) , Canterbury Park Holding Corp. (CPHC) and NVE Corp. (NVEC) . Here are highlights from Monday's Analyst Blog: Top Analyst Reports for Amazon.com, ...

Stratipath, a global leader in artificial intelligence (AI)-based precision diagnostic solutions, is thrilled to announce a collaboration with Roche, the world's largest biotechnology company and the global leader in invitro diagnostics. In this non-exclusive collaboration, Roche will have the distribution rights to the integrated Stratipath solution, Stratipath Breast. The integration between Stratipath Breast and Roche's navify® Digital Pathology enterprise software enables Roche customers to seamlessly p ...

Core Insights - Roche's investigational BTK inhibitor fenebrutinib shows promising results in treating relapsing multiple sclerosis (RMS), with 96% of patients free from relapses after one year and an annualized relapse rate (ARR) of 0.04 [2][3] - The Phase II FENopta study data indicates that fenebrutinib effectively suppresses disease activity, with 99% of patients free from T1 gadolinium-enhancing lesions after 48 weeks [3][4] - The ongoing Phase III trials aim to further validate fenebrutinib's efficacy and safety across multiple sclerosis types, with results expected by the end of 2025 [5][7] Company Overview - Roche is focused on developing fenebrutinib as a dual inhibitor targeting both B-cell and microglia activation, addressing unmet medical needs in multiple sclerosis [6][7] - The company has treated over 2,700 patients and healthy volunteers with fenebrutinib across various clinical programs, emphasizing its commitment to neuroscience research [7][15] - Roche's ongoing research includes multiple sclerosis and other neurological disorders, aiming to improve treatment outcomes and patient quality of life [14][15] Clinical Study Details - The FENopta study was a global Phase II trial involving 109 adults with RMS, assessing the efficacy, safety, and pharmacokinetics of fenebrutinib [8][9] - Patients who completed the FENopta study were given the option to participate in an open-label extension study, with 96 patients remaining after one year [10] - The study demonstrated that fenebrutinib crosses the blood-brain barrier and significantly reduces new lesions compared to placebo [9][10]

With the option to self-administer, PiaSky® (crovalimab) has the potential to reduce treatment burden for people with paroxysmal nocturnal haemoglobinuria (PNH) in Europe and their caregivers Approval is based on COMMODORE 2, where subcutaneous (SC) PiaSky once a month was equivalent to intravenous eculizumab every two weeks1,2 PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration3 Basel, 27 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announc ...

PASADENA, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) ("LIXTE" or the "Company"), today announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. ("Roche") for treatment of unresponsive (MSI Low) metastatic colorectal cancer. As part of the clinical trial (NCT06012734, clinicaltrials.gov), LIXTE is providing its lead compound, LB-100, and R ...