Jaki

Kiniksa Pharmaceuticals Announces Development Indication for Abiprubart

Retrieved on: 
Tuesday, April 2, 2024
Janus, Week, CD154, Rheumatoid arthritis, Jaki, Patient, Cohort, KNSA, Joint, Clinical trial, C-reactive protein, CD40, Least squares, Pharmacokinetics, Safety, FDA, Rheumatoid factor, Pharmaceutical industry

HAMILTON, Bermuda, April 02, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced plans to initiate a Phase 2b trial with abiprubart in Sjogren’s Disease. Additionally, the company announced data from Cohort 4 of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.

Key Points: 
  • HAMILTON, Bermuda, April 02, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced plans to initiate a Phase 2b trial with abiprubart in Sjogren’s Disease.
  • Additionally, the company announced data from Cohort 4 of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis.
  • Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.
  • “We believe abiprubart has the potential to provide meaningful benefit to patients suffering from Sjogren’s Disease, a debilitating disorder with no current FDA-approved therapies.

Topline Results from MYLOX-1 Trial Demonstrate Reduction in Fibrosis of the Bone Marrow in Patients with Myelofibrosis

Retrieved on: 
Thursday, December 21, 2023
Bone marrow, Plasma, Disease, TSS, Cancer, Ruxolitinib, Extrapyramidal system, Fibrosis, LOXL2, Patient, Safety, Nature, Jaki, Pharmaceutical industry

Six out of ten evaluable myelofibrosis patients who received GB2064 monotherapy for at least six months experienced a ≥ 1-grade reduction in collagen fibrosis of the bone marrow, an improvement suggesting that GB2064 could impact the progression of the disease and be disease-modifying.

Key Points: 
  • Six out of ten evaluable myelofibrosis patients who received GB2064 monotherapy for at least six months experienced a ≥ 1-grade reduction in collagen fibrosis of the bone marrow, an improvement suggesting that GB2064 could impact the progression of the disease and be disease-modifying.
  • Fibrosis is a key disease mechanism of myelofibrosis that destroys bone marrow function.
  • Bone marrow biopsies taken during the study showed that GB2064 penetrated the bone marrow and could exert its anti-fibrotic effect directly in the disease compartment.
  • All six patients who experienced a > 1-grade reduction in bone marrow fibrosis score also showed stable hematological parameters, including hemoglobin, white blood cell count and platelets.

Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis

Retrieved on: 
Wednesday, December 6, 2023
Health, Stem Cells, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Safety, JAK, BAT, Gold, Corporation, Patient, Pharmacokinetics, Jaki, Survival, Imetelstat, Geron Corporation, Ruxolitinib, MF, Bone marrow, Pharmaceutical industry, Medicine

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating the Company’s first-in-class telomerase inhibitor, imetelstat, versus best available therapy (BAT) in patients with relapsed/refractory myelofibrosis (MF).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating the Company’s first-in-class telomerase inhibitor, imetelstat, versus best available therapy (BAT) in patients with relapsed/refractory myelofibrosis (MF).
  • “This is the first Phase 3 trial to evaluate overall survival as a primary endpoint in relapsed/refractory MF and is also the first Phase 3 trial investigating a telomerase inhibitor in this patient population.
  • “There is therefore a very pressing need for treatments that can improve survival in relapsed/refractory MF.
  • A median OS of 29.9 months in imetelstat 9.4 mg/kg arm was observed in IMbark Phase 2, compared to 14-16 months median OS for historical controls for these JAKi relapsed/refractory MF patients.

Global Healthy Living Foundation to Present Pioneering Patient-Centered Research at ACR Convergence 2023

Retrieved on: 
Thursday, November 9, 2023
Biometrics, Telemedicine, Virtual Medicine, Pharmaceutical, General Health, Health, Wearables, Mobile Technology, Technology, Other Health, Online, Rheumatism, American College, Hospital, Treatment, Face, Doctor of Philosophy, Medicine, Disease, Efficacy, COVID-19, Overalls, Culture, PRO, Pain, Medical Affairs Bureau, Gold, MPH, Impact, Additive effect, RA, American College of Rheumatology, Data management, Exercise, Patient, ACR, Plant, Rehabilitation, MD, Motivation, Mindfulness, Quality of life, Longitudinal study, Research, Osteoporosis, DSM-IV codes, Guideline, Rheumatoid arthritis, Role, TNF inhibitor, Pros, Conjoint analysis, Jaki, Poster, Ageing, WEAR, Pharmaceutical industry, Medical device, Medical imaging, Nursing, Dietary supplement, Diet, Rheumatology, Fatigue, Flare, Epidemiology, Arthritis

The Global Healthy Living Foundation and its digital, arthritis patient centered research registry, formerly ArthritisPower, will collaboratively present eight scientific abstracts and five patient perspective posters at the American College of Rheumatology Convergence 2023 (Philadelphia, PA, November 10-15, 2023).

Key Points: 
  • The Global Healthy Living Foundation and its digital, arthritis patient centered research registry, formerly ArthritisPower, will collaboratively present eight scientific abstracts and five patient perspective posters at the American College of Rheumatology Convergence 2023 (Philadelphia, PA, November 10-15, 2023).
  • Collectively, GHLF researchers will focus on innovative approaches to remote therapeutic monitoring, patient engagement, and personalized care in rheumatic and musculoskeletal diseases.
  • This study offers key insights on innovative disease tracking methods, including those that can happen outside traditional clinical settings, particularly for diseases like rheumatoid arthritis (RA).
  • GHLF anticipates engaging with fellow organizations and professionals at ACR Convergence to share their year-long accomplishments in rheumatic disease research.

FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Thursday, October 26, 2023
Janus, Patient, FDA, Crohn's & Colitis Foundation, Eli Lilly and Company, Headache, Icahn School of Medicine at Mount Sinai, NYSE, Food, Lower respiratory tract infection, UC, UC-2, Hope, LLY, NRS, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Inflammation, Jaki, Ulcerative colitis, Rash, UC-1, Mount Sinai, Hepatotoxicity, Arthralgia, Immunology, Tuberculosis, European, Pharmaceutical industry, Lilly, Gastroenterology, Medicine

INDIANAPOLIS, Oct. 26, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Key Points: 
  • "Today's approval represents a novel scientific advancement, providing a treatment that may offer relief from three key symptoms—stool frequency, rectal bleeding and bowel urgency—regardless of past biologic use."
  • All patients in the LUCENT program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate.
  • Patients in steroid-free clinical remission were steroid-free for at least three months prior to the end of the 52-week assessment.
  • "Bowel urgency is one of the most disruptive symptoms for patients with ulcerative colitis," said Michael Osso, president and chief executive officer, Crohn's & Colitis Foundation.

Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at AACR 2023

Retrieved on: 
Tuesday, April 18, 2023
Neutropenia, Ruxolitinib, AACR, Primary myelofibrosis, Icahn School of Medicine at Mount Sinai, Week, JAK, XPO1, American Association for Cancer Research, Mount Sinai, February 24, Doctor of Philosophy, Bone marrow, Selinexor, KPTI, Incidence, City, Jaki, Spleen, MD, Patient, Anemia, Host, Peripheral neuropathy, Nausea, Therapy, Safety, Thrombocytopenia, Fatigue, Dietary supplement, Pharmaceutical industry, Medicine

NEWTON, Mass., April 18, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced updated results from the Phase 1 study evaluating the safety and efficacy of once-weekly selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389). The data, featured in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, show that rapid, deep and sustained spleen responses and robust symptom improvement were achieved at both weeks 12 and 24, in patients treated with  selinexor 60mg in combination with ruxolitinib.

Key Points: 
  • As of the February 24, 2023 data cut-off date, 24 patients had been assigned to either a 40mg or 60mg once weekly dose of selinexor, combined with ruxolitinib.
  • SVR35 responses were observed in 100% of evaluable patients at any time and rates were consistent regardless of subgroups, including males and patients treated with low dose ruxolitinib.
  • Dr. Mascarenhas will discuss the relevance of the updated data with selinexor in combination with ruxolitinib to the current treatment landscape and unmet medical need in treating patients with myelofibrosis.
  • He will also describe the design of the Company's selinexor and ruxolitinib Phase 3 study as the study's primary investigator.

Galapagos presents roadmap for pipeline and commercial growth at its R&D Day 2022

Retrieved on: 
Friday, November 4, 2022
UC, CPK, Kidney disease, Lipid, Investigational New Drug, Investment, Saitama (city), Board, BCMA, FDA, D, CD, Safety, IND, Interferon, Fibrosis, SLE, Quality of life, CD19, RA, Intention, Rheumatoid arthritis, EULAR, Inflammatory bowel disease, CET, CEO, Filgotinib, JAK1, Gilead Sciences, Ulcerative colitis, NASDAQ, Jaki, Galapagos NV, Rheumatism, Union, Euronext, Psoriasis, Axial spondyloarthritis, Kidney, TYK2, JAK2, Patient, Renewable energy, Fine chemical, Pharmaceutical industry, Medical imaging, Vaccine, Dermatomyositis

Our renewed focus on two strategic therapeutic areas goes hand in hand with redirecting our resources.

Key Points: 
  • Our renewed focus on two strategic therapeutic areas goes hand in hand with redirecting our resources.
  • Aligned with our Vision 2028, we presented our financial outlook and capital allocation strategy at our R&D Day 2022.
  • We also presented our Vision 2028 roadmap for oncology at our R&D Day 2022.
  • Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the European Union, Norway, Great Britain, and Japan.

Geron Corporation Reports Third Quarter 2022 Financial Results and Upcoming Expected Milestones

Retrieved on: 
Thursday, November 3, 2022
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, MDS, LR, MF, Company, Lymphatic system, Private Securities Litigation Reform Act, Xi, Exercise, Research, Prejudice, Corporation, Imetelstat, XV, GAAP, RBC, Microdeletion syndrome, Apoptosis, FDA, Intellectual property, Safety, 100,000, Webcast, Pharmacokinetics, U.S. Securities and Exchange Commission, IMPRESS, Geron Corporation, Nasdaq, COVID-19, Agreement, Income, TI, Review, ESA, Clinical trial, Fast Track, New Drug Application, Risk, Jaki, Disease, Security (finance), Insurance, JAK, Depreciation, Fault, Nobel Prize, Pharmaceutical industry, Life insurance, Video game, EU

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results for the third quarter of 2022 and upcoming expected milestones.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results for the third quarter of 2022 and upcoming expected milestones.
  • ET on Thursday, November 3, 2022 to review recent events and third quarter 2022 financial results.
  • This projected non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance projected in accordance with GAAP.
  • Geron encourages investors to carefully consider the Companys results under GAAP, as well as the supplemental non-GAAP financial information, to more fully understand Gerons business.

Galapagos 2021 results set stage for future growth

Retrieved on: 
Thursday, February 24, 2022
Pharmacology, D, TYK2, Income, Annual report, Saitama (city), IPF, Inflammation, European Commission, Atopic dermatitis, Jaki, JAK1, Osteoarthritis, Sale, Safety, OA, Exercise, Observational study, PRAC, Leadership, EMA, Drug discovery, Pharmacovigilance, Patient, UC, Pharmaceutical industry, Medical device, Aquaculture, Renewable energy, Cryptocurrency, Filgotinib, Galápagos Islands

The results of Fidelta, including the impact of the 2021 sale, are presented as Net profit from discontinued operations in our consolidated income statements for the years 2021 and 2020.

Key Points: 
  • The results of Fidelta, including the impact of the 2021 sale, are presented as Net profit from discontinued operations in our consolidated income statements for the years 2021 and 2020.
  • We reported net sales of Jyseleca in 2021 amounting to 14.8 million, which reflects the sales booked by Galapagos after the country-by-country transition from Gilead.
  • We realized a net loss from continuing operations of 125.4million in 2021, compared to a net loss of 311.0million in 2020.
  • Galapagos expects to be able to publish its fully audited annual report for the full year 2021 on or around 24 March 2022.