Immunoglobulin A

Vera Therapeutics to Present at Upcoming Conferences in September 2022

Retrieved on: 
Wednesday, September 7, 2022
B-cell activating factor, Immunoglobulin A, B cell, IgA nephropathy, Degenerative disease, Therapy, Lupus nephritis, Polyomaviridae, Standard of care, Calendar, Autoantibody, Conference, Virus, BK, BK virus, Vera, Patient, Vaccine

Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.

Key Points: 
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
  • Veras mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.
  • Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant.

Chinook Therapeutics to Present at Upcoming Investor Conferences

Retrieved on: 
Thursday, September 1, 2022
Kidney, RNA, Immunoglobulin A, IgA nephropathy, Therapy, Chronic kidney disease, EDT, LDHA, Primary hyperoxaluria, GLOBE, Conference, Nasdaq, Atrasentan, Investor, Pharmaceutical industry, Chinook

Morgan Stanley 20th Annual Global Healthcare Conference Fireside chat on Monday, September 12th at 4:50 pm EDT.

Key Points: 
  • Morgan Stanley 20th Annual Global Healthcare Conference Fireside chat on Monday, September 12th at 4:50 pm EDT.
  • To access the audio webcasts and subsequent archived recording of these and other company presentations, please visit the Investors section of Chinooks website.
  • Chinook Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing precision medicines for kidney diseases.
  • In addition, Chinook is advancing research programs for other rare, severe chronic kidney diseases.

Vaxart Announces Positive Top-line Phase II Clinical Study Data Demonstrating Safety and Immunogenicity of Its Wuhan S-Only COVID-19 Pill Vaccine Candidate

Retrieved on: 
Thursday, September 1, 2022
AES, COVID-19, Tablet, Immunoglobulin A, Vaccination, HPV, Glass, SAN, NASDAQ, RSV, Vaccine, Respiratory syncytial virus, Coronavirus, Risk, VXA, Degenerative disease, Infection, Volunteering, Vaxart, Water, Refrigeration, GLOBE, GMT, Immune system, Company, Report, Șaeș, Norovirus, Founder, Adult, Injury, Webcast, RNA transfection, Immunoglobulin G, TLR3, Day, Omicron, Silviculture

SOUTH SAN FRANCISCO, Calif., Sept. 01, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today reported positive top-line data from the first part of a planned two-part Phase II study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S. The data demonstrate that the trial met its primary safety and secondary immunogenicity endpoints and will inform ongoing development of new Omicron-based vaccine constructs.

Key Points: 
  • ET today
    SOUTH SAN FRANCISCO, Calif., Sept. 01, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today reported positive top-line data from the first part of a planned two-part Phase II study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S.
  • Vaxart is the first company to advance an oral pill COVID-19 vaccine to Phase II clinical development.
  • These Phase II data represent a very important milestone in the development of the worlds first COVID-19 pill vaccine, said Dr. James F. Cummings, Vaxarts Chief Medical Officer.
  • These data also demonstrate that a pill vaccine can induce strong serum antibody responses as well as mucosal and T cell responses.

Global IgA Nephropathy (IgAN) Drug Market Research Report 2022: Pipeline Analysis, Therapeutic Assessment, Unmet Needs, Impact of Drugs - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 25, 2022
Health, Pharmaceutical, NDA, Technology, II, Immunoglobulin A, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Administration, Route of administration, New Drug Application, Glomerulonephritis, Food, Kidney disease, Route, FDA, News, III, Clinical trial, Acquisition, Discovery, Patient, Medical device, Pharmaceutical industry, Atrasentan, IgA nephropathy

This "IgA Nephropathy - Pipeline Insight, 2022" report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in IgA Nephropathy pipeline landscape.

Key Points: 
  • This "IgA Nephropathy - Pipeline Insight, 2022" report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in IgA Nephropathy pipeline landscape.
  • A detailed picture of the IgA Nephropathy pipeline landscape is provided which includes the disease overview and IgA Nephropathy treatment guidelines.
  • The assessment part of the report embraces, in depth IgA Nephropathy commercial assessment and clinical assessment of the pipeline products under development.
  • IgA Nephropathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Oragenics Announces Favorable Preliminary Toxicology Data for Intranasal COVID-19 Vaccine Candidate

Retrieved on: 
Wednesday, August 24, 2022
Health, Infectious Diseases, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, NRC, National, GLP, COVID-19, Human, CEO, Immunoglobulin A, Immunization, NYSE, Research, Hand, Vaccine, Toxicity, National Research Council, Mouse, Infection, Scientific Reports, Blood, Good laboratory practice, NIH, Patent, U.S. Securities and Exchange Commission, Rabbit, Severe acute respiratory syndrome coronavirus 2, Antibody, Company, FDA, Communication, Toxicology, Immunoglobulin G, Private Securities Litigation Reform Act, Bacteria, Trial of the century, Viral load, Nature, Oragene

Oragenics, Inc. (NYSE American: OGEN) (Oragenics or the Company), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced favorable preliminary results from its ongoing Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits.

Key Points: 
  • Oragenics, Inc. (NYSE American: OGEN) (Oragenics or the Company), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced favorable preliminary results from its ongoing Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits.
  • We believe our intranasal vaccine candidate will have the potential to reduce transmission and offers a needle-free COVID-19 vaccine option.
  • Our intranasal vaccine candidate has previously shown strong immune responses in preclinical studies against multiple SARS-CoV-2 variants of interest.
  • Its lead product is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus.

CSL Vifor and Travere Therapeutics announce EMA has accepted for review the Conditional Marketing Authorization application for sparsentan for the treatment of IgA Nephropathy

Retrieved on: 
Monday, August 22, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, COVID-19, Jay Traver, Safety, Swelling, Heart Protection Study, Dialysis, CSL, U.S. Securities and Exchange Commission, Medicine, Company, ESKD, Risk, Patient, EMA, Fresenius Medical Care, Chronic kidney disease, Caregiver, Immunoglobulin A, Kidney, EGFR, Private Securities Litigation Reform Act, Proteinuria, Nephrology, Hematuria, Security (finance), NDA, Form 10-K, Therapy, NASDAQ, DUET, Irbesartan, Disease, Blood, Multimedia, Patent, ASX, Review, Marketing, ARB, File, Focal segmental glomerulosclerosis, CMA, Union, Edema, Urine, Life, Conditional, Pharmaceutical industry, EU, FSGS, IgA nephropathy

The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.

Key Points: 
  • The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.
  • We look forward to continuing to collaborate with our partners at CSL Vifor and with the EMA throughout the review process.
  • Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
  • There is no guarantee that the EMA will grant conditional marketing authorization of sparsentan for IgAN or that sparsentan will be approved at all.

Travere Therapeutics and CSL Vifor Announce EMA has Accepted for Review the Conditional Marketing Authorization Application for Sparsentan for the Treatment of IgA Nephropathy

Retrieved on: 
Monday, August 22, 2022
COVID-19, Jay Traver, Safety, Swelling, SAN, Heart Protection Study, Dialysis, CSL, U.S. Securities and Exchange Commission, GLOBE, Medicine, Company, ESKD, Risk, Patient, EMA, Fresenius Medical Care, Chronic kidney disease, Caregiver, Immunoglobulin A, Kidney, EGFR, Private Securities Litigation Reform Act, Proteinuria, Nephrology, Hematuria, Security (finance), NDA, Form 10-K, Therapy, NASDAQ, DUET, Irbesartan, Disease, Blood, Patent, ASX, Review, Marketing, ARB, File, Focal segmental glomerulosclerosis, CMA, Union, Edema, Urine, Life, Conditional, Pharmaceutical industry, EU, FSGS, IgA nephropathy

SAN DIEGO and ST. GALLEN, Switzerland, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and CSL Vifor today announced that the EMA has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and leading cause of end-stage kidney disease (ESKD). The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.

Key Points: 
  • The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.
  • We look forward to continuing to collaborate with our partners at CSL Vifor and with the EMA throughout the review process.
  • If approved, sparsentan would receive CMA in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • There is no guarantee that the EMA will grant conditional marketing authorization of sparsentan for IgAN or that sparsentan will be approved at all.

Omeros Corporation Receives Interim Response from FDA on Formal Dispute Resolution Request for Narsoplimab

Retrieved on: 
Wednesday, August 17, 2022
FDA, Health, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, FDA, PNH, U.S. Securities and Exchange Commission, Drug Quality and Security Act, OND, Forward-looking statement, Securities Exchange Act of 1934, Breakthrough therapy, Security (finance), Atypical hemolytic uremic syndrome, Immunoglobulin A, Cancer, Calendar, COVID-19, Corporation, Securities Act of 1933, BLA, IgA nephropathy, Pharmaceutical industry, Glomerulopathy, Agency

Omeros Corporation (Nasdaq: OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the companys formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the companys formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
  • Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the Agency, in this case the Office of New Drugs (OND).
  • As part of FDAs standard procedures for dispute resolution, Omeros and OND met last month to discuss the appeal.
  • Per FDA guidelines for formal dispute resolution, a final decision from OND was to be rendered within 30 calendar days of the meeting unless the deciding official in OND required additional information.

Todos Medical Completes Trial Design for Tollovid™ Long COVID Clinical Study in Adults

Retrieved on: 
Thursday, August 11, 2022
U.S. Securities and Exchange Commission, Vital signs, Trial of the century, GLOBE, Clinical trial, Brain, Knowledge, Research, Method, Immunoglobulin M, Patient, Monocyte, Contract, TBIA, Immune system, Entrepreneurship, Part, Neuron, Technology, Cell cycle, Immunoglobulin A, Lymphocyte, Șaeș, Biotechnology, Neurodegeneration, Safety, IRB, Pressure, OTCQB, Amazon, Apoptosis, COVID, Cancer, Synthase, MERS, COVID-19, CRP, Capsule, Virus, Solution, Severe acute respiratory syndrome coronavirus 2, PCR, Legislation, Immunoglobulin G, Biomarker, Plasma, Company, TMB-2, Alzheimer's disease, Intention, VEGF, Cancer immunotherapy, Pharmaceutical industry, Medical imaging, Pharma, Long COVID

New York, NY, and Tel Aviv, ISRAEL, Aug. 11, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned subsidiary 3CL Pharma, Ltd has finalized plans for a proposed safety and efficacy clinical trial for its 3CL protease inhibitor immune support dietary supplement Tollovid™ in patients with Long COVID. The 45-patient Part A of the study will be conducted as a 3-arm, randomized, controlled, observer-blinded clinical study evaluating Tollovid’s effects on the structure/function of the immune system as measured by the presence of neutralizing antibodies, total anti SARS-CoV-2 antibodies (IgG, IgA, IgM) and VEGF cytokine levels.  Participating subjects will be randomized into three cohorts: 1) a 15-patient cohort to receive 30-day treatment regimen of 12 capsules per day; 2) a 15-patient cohort to receive a 15-day treatment regimen of 12 capsules per day, followed by 15-day treatment regimen of 6 capsules per day; and 3) an untreated control group who will be eligible to receive Tollovid at the conclusion study. All three groups will be allowed to continue taking their standard of care medications while on study, with the exception of other 3CL protease inhibitors.  3CL Pharma intends to initiate this clinical study in early fourth quarter of 2022. Two Long COVID clinics are in the process of finalizing contracts to participate in the study. It is the intention that study participants can enroll and be evaluated both virtually via remote monitoring, as well as in person.

Key Points: 
  • Two Long COVID clinics are in the process of finalizing contracts to participate in the study.
  • It is the intention that study participants can enroll and be evaluated both virtually via remote monitoring, as well as in person.
  • The secondary structure/function endpoints of Part A of the study are changes in the Amerimmune/Provista Long Covid Panel, CRP and VEGF after administration of Tollovid at day 30 following enrollment.
  • Preliminary data from an ongoing IRB-waived study of customers who used the products to assist with their COVID and Long COVID were recently announced.

Vera Therapeutics Provides Business Update and Reports Second Quarter 2022 Financial Results

Retrieved on: 
Wednesday, August 10, 2022
Lupus nephritis, U.S. Securities and Exchange Commission, BKV, Association, Autoantibody, ATC, Mortality, IgA nephropathy, Kidney disease, CEO, GLOBE, Standard of care, Private Securities Litigation Reform Act, B cell, Congress, Security (finance), Research, Immunoglobulin A, Patient, Virus, Therapy, COVID-19, Program, BK, Chronic kidney disease, B-cell activating factor, Polyomaviridae, Disease, Â, European Renal Association – European Dialysis and Transplant Association, BK virus, Vera, Nasdaq, Degenerative disease, Pharmaceutical industry, Cryptocurrency, Viremia

In the first half of 2022, we continued to successfully execute our development strategy and are on track to realize several significant milestones.

Key Points: 
  • In the first half of 2022, we continued to successfully execute our development strategy and are on track to realize several significant milestones.
  • Topline results from the study are expected to be presented early in the first quarter of 2023.
  • During the past quarter, we presented at multiple congresses highlighting our clinical data for each program.
  • Vera reported $131.9 million in cash, cash equivalents, and marketable securities as of June 30, 2022.