Week

Disc Presents Positive Initial Data from Phase 2 BEACON Trial of Bitopertin in Patients with Erythropoietic Protoporphyria (EPP) at European Hematology Association (EHA) 2023 Congress

Retrieved on: 
Friday, June 9, 2023
EPIQ, Sodium- and chloride-dependent glycine transporter 1, Protoporphyrin IX, European Hematology Association, Metallicity, Disc, Week, EPP, Bitopertin, Quality of life, First grade, Pain, Congress, Sunlight, IRON, Patient, Erythropoietic protoporphyria, EHA, XLP, Photosensitivity, Poster, Safety, Disease, Pharmaceutical industry, Medical device, Sewage treatment, PPIX

The initial trial data demonstrated consistent decreases in PPIX, significant increases in reported sunlight tolerance and improvements in measures of patient quality of life.

Key Points: 
  • The initial trial data demonstrated consistent decreases in PPIX, significant increases in reported sunlight tolerance and improvements in measures of patient quality of life.
  • “We’re delighted to share these initial, positive data from BEACON, which provide the first clinical evidence supporting our therapeutic hypothesis of bitopertin in EPP.
  • Due to batch processing of samples, the data cutoff for PPIX data was April 7, 2023.
  • Management will host a call to review the presented data on Friday, June 9th at 7:30 am ET.

Ventyx Biosciences Announces Completion of Enrollment of the Phase 2 Trial of VTX002 in Ulcerative Colitis and the Phase 2 Trial of VTX958 in Plaque Psoriasis

Retrieved on: 
Wednesday, June 7, 2023
Psoriasis Area and Severity Index, Week, Ulcerative colitis, Psoriasis, Patient, TYK2, PASI, Inflammation, Pharmaceutical industry

“I am very proud of our team’s execution as we mark another important milestone for Ventyx and for ulcerative colitis and plaque psoriasis patients,” said Dr. William Sandborn, President and Chief Medical Officer.

Key Points: 
  • “I am very proud of our team’s execution as we mark another important milestone for Ventyx and for ulcerative colitis and plaque psoriasis patients,” said Dr. William Sandborn, President and Chief Medical Officer.
  • “We believe the robust enrollment activity in these trials demonstrates tremendous interest from patients and investigators in novel oral therapies for autoimmune diseases.
  • The primary efficacy endpoint is the proportion of subjects achieving clinical remission at Week 13 as defined by the modified Mayo Score.
  • The Phase 2 SERENITY trial of VTX958, an oral, selective, allosteric TYK2 inhibitor, is a randomized, double-blind, placebo-controlled, dose-ranging trial in patients with moderate to severe plaque psoriasis.

Connect Biopharma Announces Positive Long-Term Data from the Maintenance Period Through Week 48 of CN002 Phase 2 Icanbelimod Trial in Patients with Moderate-to-Severe Ulcerative Colitis

Retrieved on: 
Thursday, June 1, 2023
Maintenance, University, University of Western Ontario, Week, Epidemiology, PO, CNTB, Inflammation, Ulcerative colitis, UC, Patient, SAN, Entrepreneurship, Lymphocyte, Safety, Biostatistics, Department of Medicine – University of Pamplona, Vaccine, Meat, Pharmaceutical industry, Birth control, Medicine, S1P1

Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period.

Key Points: 
  • Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period.
  • 80% (8/10) of patients who achieved clinical remission at the end of the induction period sustained it through Week 48.
  • Overall, 57% (12/21) of patients with clinical response at the end of the induction period achieved clinical remission at the end of the maintenance period.
  • Icanbelimod was well-tolerated and long-term safety data through Week 48 remained consistent with safety findings observed in the induction period.

Baseball and Softball NIL Athletes Step Up to the Plate to Join Team Rapsodo

Retrieved on: 
Thursday, June 1, 2023
University of Miami, NCAA, Baseball, Partnership, No-hitter, University, College, USA Softball, Week, National championship, RBI, University of Oklahoma, Run batted in, NJCAA, Season, Herkimer County Community College, 1982 AIAW Women's College World Series, Tropical cyclone, Sooners, Wiegmann, Faronics, NIL, NJCAA Division I Women's Basketball Championship, Organization, Athlete, School, Division, Clemson, MLB, University of Louisville, College World Series, WCWS, Social media, Sport, Video game, Nightclub, Cassette tape

The list of stars joining team Rapsodo includes name, image, and likeness (NIL) athletes from top collegiate programs across the country.

Key Points: 
  • The list of stars joining team Rapsodo includes name, image, and likeness (NIL) athletes from top collegiate programs across the country.
  • They won their 48th consecutive game against Clemson on Saturday, the longest winning streak in NCAA D-I Softball History.
  • “Rapsodo technology has really helped me become a better pitcher, and I am glad the Rapsodo team has chosen me as an NIL partner,” May said.
  • I’m grateful the team trusts me to share with my audience how incredible Rapsodo technology is.”
    Wiegman’s Louisville teammate Greg Farone also joins team Rapsodo as an NIL partner.

Press Release: Positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab show significantly reduced disease activity in relapsing multiple sclerosis

Retrieved on: 
Wednesday, May 31, 2023
Railway Workers' Union (Austria), Macrophage, Barts and The London School of Medicine and Dentistry, Week, Disability, Research, Multiple sclerosis, CMSC, Queen Mary University of London, MS, St. Bartholomew's, Patient, Sanofi, Dentistry, Pivotal, CD40L, B cell, Blizard Building, Pharmaceutical industry, Vaccine, Neurology

Frexalimab met primary endpoint with 89% reduction in new gadolinium-enhancing T1 brain lesions achieved at Week 12 in the higher-dose treatment arm, compared with placebo

Key Points: 
  • Frexalimab met primary endpoint with 89% reduction in new gadolinium-enhancing T1 brain lesions achieved at Week 12 in the higher-dose treatment arm, compared with placebo
    Paris, May 31 2023.
  • New data, being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, demonstrate that frexalimab, Sanofi’s novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a Phase 2 trial of patients with relapsing multiple sclerosis (MS).
  • Following 12 weeks of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions was reduced by 89% and 79% in the higher- and lower-dose treatment arms, respectively, compared with placebo, meeting the study’s primary endpoint.
  • A substantial unmet need remains in MS for highly effective and well-tolerated treatment options that provide sustainable control of disease activity and disability progression, while minimizing risks.

Walmart Leadership to Participate in Upcoming Investor Events

Retrieved on: 
Tuesday, May 30, 2023
Home Goods, Cosmetics, Retail, Office Products, Footwear, Supply Chain Management, Online Retail, Other Retail, Department Stores, Supermarket, Specialty, Food, Beverage, Jewelry, Fashion, Toys, Shaun Ellis (wolf researcher), Inc., Club, TD, Oppenheimer, Week, Jefferies, E-commerce, Deutsche Bank, Evercore, WMT, Access, CDT, Investment, Conference, NYSE, Walmart, Cryptocurrency, Internet service provider

Walmart Inc. (NYSE: WMT) announced today that company leadership will participate in upcoming investor events, with several including live webcasts on Walmart’s investor relations website at stock.walmart.com.

Key Points: 
  • Walmart Inc. (NYSE: WMT) announced today that company leadership will participate in upcoming investor events, with several including live webcasts on Walmart’s investor relations website at stock.walmart.com.
  • Denise Incandela, executive vice president, apparel & private brands, will participate in a fireside chat at 11:10 a.m. CDT.
  • Walmart Investor Relations will participate in group meetings.
  • Walmart Investor Relations will participate in virtual group meetings.

Apellis Reports Top-Line Results from Phase 2 MERIDIAN Study in ALS

Retrieved on: 
Thursday, May 25, 2023
APLS, Week, Research, CAFS, Data, Function, ALS, Caregiver, Disease, Pharmaceutical industry, Survival

Systemic pegcetacoplan was well tolerated in the study, and the data were consistent with the established safety profile.

Key Points: 
  • Systemic pegcetacoplan was well tolerated in the study, and the data were consistent with the established safety profile.
  • Based on the lack of efficacy, Apellis and Sobi plan to discontinue development of systemic pegcetacoplan for ALS.
  • In April, Apellis and Sobi discontinued treatment in the open-label portion of the study, following a recommendation from an independent data monitoring committee.
  • “We are disappointed in the outcome of the MERIDIAN study, especially on behalf of the ALS community who has been waiting for new treatments for this complex and unrelenting disease.

89bio Initiates Phase 3 ENTRUST Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG)

Retrieved on: 
Tuesday, May 23, 2023
Hypertriglyceridemia, NASH, Week, Triglyceride, FGF21, Magnetic resonance imaging, Patient, SAN, Fatty liver disease, Liver, Fasting, TC, Safety, Glycated hemoglobin, Medical imaging

SAN FRANCISCO, May 23, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with severe hypertriglyceridemia (SHTG).

Key Points: 
  • SAN FRANCISCO, May 23, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with severe hypertriglyceridemia (SHTG).
  • "We are pleased to initiate the ENTRUST trial of pegozafermin in SHTG, an important milestone for the company that demonstrates the rapid progress we have made since inception, and also signifies entry of the first FGF21 analog into Phase 3 development,” said Hank Mansbach, Chief Medical Officer of 89bio.
  • We remain encouraged by pegozafermin’s unique and differentiated profile relative to existing therapies and those in development to treat SHTG.
  • The primary endpoint is the percent change from baseline in fasting triglycerides at Week 26 compared to placebo.

Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with dermatomyositis

Retrieved on: 
Tuesday, May 23, 2023
Galapagos NV, ACR, CET, DM, Week, American College of Rheumatology, Doctor of Philosophy, Muscle weakness, European Alliance of Associations for Rheumatology, Euronext, MD, Patient, TYK2, EULAR, American College, Safety, Disease, Pharmaceutical industry, Dermatomyositis, Galápagos Islands, Immunology

The GALARISSO Phase 2 trial ( NCT05695950 ) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of GLPG3667.

Key Points: 
  • The GALARISSO Phase 2 trial ( NCT05695950 ) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of GLPG3667.
  • A daily oral administration of GLPG3667 150mg or placebo will be investigated in approximately 62 adult patients with DM over 24 weeks.
  • “Dermatomyositis is a debilitating inflammatory disease marked by muscle weakness and a distinctive skin rash that can severely impact patients’ daily lives.
  • Its efficacy and safety have not been established or fully evaluated by any regulatory authority.

GRI Bio (NASDAQ: GRI) Provides Business Outlook and Highlights Upcoming Milestones for Innovative Pipeline of NKT Cell Modulators

Retrieved on: 
Monday, May 22, 2023
Injury, Week, Serum, Oxygen, Overalls, Aes, NKT, Pharmacokinetics, IL-6, Bronchoalveolar lavage, SLE, Inflammation, Biomarker, Lupus, Multiple sclerosis, Doctor of Philosophy, Movement, Rheumatoid arthritis, Inflammatory bowel disease, Fibrosis, BAL, Type 2, GRI, HIV disease progression rates, Patient, Blood, Autoimmune disease, Immune system, Lupus nephritis, LA, Cytokine, IPF, Liver function tests, Natural killer T cell, ALS, Autoimmunity, Safety, Autoantibody, Pharmaceutical industry, Vaccine

LA JOLLA, CA, May 22, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today provided a business outlook and highlighted upcoming milestones for its innovative pipeline of NKT cell modulators in development.

Key Points: 
  • Rapidly advancing clinical pipeline in potential high-value inflammatory, fibrotic and autoimmune diseases
    LA JOLLA, CA, May 22, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today provided a business outlook and highlighted upcoming milestones for its innovative pipeline of NKT cell modulators in development.
  • “We believe our leading NKT platform technology represents a compelling opportunity with the potential for significant value creation.
  • GRI Bio’s lead program, GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human Type I, iNKT cells.
  • GRI Bio’s second asset in development, GRI-0803, is a novel activator of human Type 2 NKT cells.