ROG

Roche Enters Into a Definitive Agreement to Acquire Telavant Including Rights to Novel TL1A Directed Antibody (RVT-3101) for the Treatment of Inflammatory Bowel Disease From Roivant

Retrieved on: 
Monday, October 23, 2023

The agreement includes the development, manufacturing and commercialization rights in the US and Japan for RVT-3101, a novel TL1A directed antibody.

Key Points: 
  • The agreement includes the development, manufacturing and commercialization rights in the US and Japan for RVT-3101, a novel TL1A directed antibody.
  • RVT-3101 is a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.
  • The global, randomized, double-blinded, placebo controlled trial delivered the first long-term, dose finding data in a large number of patients (n=245).
  • Telavant was jointly formed by Roivant and Pfizer in 2022 to develop and commercialize RVT-3101 in the US and Japan.

Genentech’s Alecensa Reduces the Risk of Disease Recurrence or Death by an Unprecedented 76% in People With ALK-Positive Early-Stage Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, October 18, 2023

A clinically meaningful improvement of central nervous system (CNS)-DFS was also observed (HR=0.22; 95% CI: 0.08-0.58).

Key Points: 
  • A clinically meaningful improvement of central nervous system (CNS)-DFS was also observed (HR=0.22; 95% CI: 0.08-0.58).
  • The safety and tolerability of Alecensa in this trial were consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.
  • “We urgently need to do more to help people with lung cancer, as about half of patients with early-stage NSCLC experience disease recurrence.
  • For those receiving Alecensa, 5.5% of patients discontinued treatment due to AEs versus 12.5% in the chemotherapy arm.

Micron Delivers High-Speed 7,200MT/s DDR5 Memory Using 1β Technology

Retrieved on: 
Tuesday, October 10, 2023

BOISE, Idaho, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Micron Technology, Inc. (Nasdaq: MU), today announced it has extended its industry-leading 1β (1-beta) process node technology with the introduction of 16Gb DDR5 memory.

Key Points: 
  • BOISE, Idaho, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Micron Technology, Inc. (Nasdaq: MU), today announced it has extended its industry-leading 1β (1-beta) process node technology with the introduction of 16Gb DDR5 memory.
  • With demonstrated in-system functionality at speeds up to 7,200 MT/s, Micron’s 1β DDR5 DRAM is now shipping to all data center and PC customers.
  • Micron’s 1β technology enables Micron to deliver a broad portfolio of memory-based solutions, including DDR5 RDIMMs and MCRDIMMs using 16Gb, 24Gb and 32Gb DRAM die, LPDDR5X using 16Gb and 24Gb DRAM die , HBM3E and GDDR7.
  • “By leveraging Micron’s advanced 1β DDR5 memory, we’re able to evaluate and qualify our high-performance DDR5 IP with speeds up to 7,200MT/s.”

Late-Breaking Data for Genentech’s BTK Inhibitor Fenebrutinib Show Brain Penetration and Significant Reduction in Lesions in Patients With Relapsing Multiple Sclerosis

Retrieved on: 
Friday, October 13, 2023

The late-breaking data were featured in an oral presentation at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis).

Key Points: 
  • The late-breaking data were featured in an oral presentation at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis).
  • After 12 weeks of continuous treatment, the mean fenebrutinib concentration was 43.1 ng/mL.
  • Thus, the level of fenebrutinib in the brain and central nervous system may conceivably become high enough to reduce MS disease activity and progression.
  • The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib clinical trials across more than 2,500 people to date.

Rogers Schedules Third Quarter 2023 Earnings Call for October 26

Retrieved on: 
Thursday, October 12, 2023

Rogers Corporation (NYSE:ROG) (“Rogers”) plans to announce third quarter results on October 26 after market close, which will be followed by a conference call at 5:00 pm ET.

Key Points: 
  • Rogers Corporation (NYSE:ROG) (“Rogers”) plans to announce third quarter results on October 26 after market close, which will be followed by a conference call at 5:00 pm ET.
  • The call will be hosted by Colin Gouveia, President and Chief Executive Officer, who will be joined by Ram Mayampurath, Senior Vice President and Chief Financial Officer.
  • A live webcast of the event and related slide presentation can be accessed on Rogers’ Investor Relations website at https://rogerscorp.com/investors .
  • A replay of the event will also be available on the Investor Relations’ website.

New Data for Genentech’s Ocrevus Show That After 10 Years of Treatment 77% of People With Relapsing Multiple Sclerosis Were Free From Disability Progression and 92% Continue to Walk Unaided

Retrieved on: 
Thursday, October 12, 2023

In patients with PPMS, 36% were free from disability progression based on 48-week CDP events and 80% of those patients treated continuously with Ocrevus over 10 years were still able to walk.

Key Points: 
  • In patients with PPMS, 36% were free from disability progression based on 48-week CDP events and 80% of those patients treated continuously with Ocrevus over 10 years were still able to walk.
  • The risk characteristics of Ocrevus in the all-exposure population (RMS and PPMS) remained consistent with the characteristics observed during the controlled treatment periods.
  • Outcomes were known for 1,145 prospectively reported pregnancies and 512 of these had in utero exposure to Ocrevus.
  • There are more than 30 ongoing Ocrevus clinical trials designed to help us better understand MS and its progression.

Genentech’s Ocrevus Twice-Yearly, 10-Minute Subcutaneous Injection Was Non-Inferior to Intravenous Infusion and Provided Near-Complete Suppression of Brain Lesions

Retrieved on: 
Wednesday, October 11, 2023

Study results demonstrate the effect of Ocrevus® (ocrelizumab) as an investigational twice-yearly, 10-minute subcutaneous injection on pharmacokinetic, biomarker, and MRI measures in patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS).

Key Points: 
  • Study results demonstrate the effect of Ocrevus® (ocrelizumab) as an investigational twice-yearly, 10-minute subcutaneous injection on pharmacokinetic, biomarker, and MRI measures in patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS).
  • “We are pleased to share that Ocrevus 10-minute subcutaneous injection suppressed brain lesions as effectively as the intravenous infusion,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development.
  • Peak Ocrevus blood (serum) concentrations were similar for subcutaneous injection (132 µg/mL) and IV infusion (137 µg/mL).
  • Ocrevus subcutaneous injection provided rapid, sustained and near-complete B-cell depletion that was similar to Ocrevus IV infusion (97% and 98% of patients respectively had B cell levels of 5 cells/µL or less when first measured at 14 days), which was sustained over 24 weeks.

First-Ever Clinical Trial Exclusively in Black and Hispanic / Latinx People Living With Multiple Sclerosis Shows Genentech’s Ocrevus Effectively Manages Disease Activity

Retrieved on: 
Wednesday, October 11, 2023

One-year data from the trial show that Ocrevus effectively manages MS disease activity in these populations.

Key Points: 
  • One-year data from the trial show that Ocrevus effectively manages MS disease activity in these populations.
  • The safety and efficacy profile demonstrated in the trial was consistent with the large body of clinical evidence from other Ocrevus studies.
  • “We know that Black and Hispanic / Latinx people with MS often experience more severe disease and greater disability compared with their white counterparts.
  • Despite making up almost 20% of the MS population,1 Black and Hispanic / Latinx people living with the disease are vastly underrepresented in clinical research.

Genentech’s Vabysmo Maintained Vision Improvements With Extended Treatment Intervals Up to Four Months for People With Retinal Vein Occlusion (RVO) in Phase III Trials

Retrieved on: 
Tuesday, October 10, 2023

Data showed people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials.

Key Points: 
  • Data showed people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials.
  • Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by reduction in central subfield thickness.
  • This is the first time that vision and anatomical improvements have been maintained for more than a year using a personalized treat-and-extend dosing regimen in both global Phase III BRVO and CRVO trials.
  • In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous trials.

Majority of Newborn Babies With Spinal Muscular Atrophy (SMA) Treated With Genentech’s Evrysdi Able to Sit Independently After 1 Year of Treatment

Retrieved on: 
Wednesday, October 4, 2023

“Evrysdi is the only non-invasive SMA treatment and can be used within hours of birth, potentially allowing these babies to sit, stand and walk, similar to healthy individuals,” said Levi Garraway, M.D., Ph.

Key Points: 
  • “Evrysdi is the only non-invasive SMA treatment and can be used within hours of birth, potentially allowing these babies to sit, stand and walk, similar to healthy individuals,” said Levi Garraway, M.D., Ph.
  • The primary efficacy population included babies with 2 SMN2 copies and a CMAP amplitude of ≥1.5 mV at baseline.
  • The majority of AEs were not considered treatment-related, and there were no deaths or AEs leading to withdrawal or treatment discontinuation.
  • The AEs observed in the RAINBOWFISH primary analysis are generally consistent with those AEs seen in other Evrysdi trials in SMA.