Autoimmune hepatitis

Revive Therapeutics Ltd. Announces Offering of Up to $5 Million

Retrieved on: 
Wednesday, November 30, 2022
Psilocybin, COVID-19, Autoimmune hepatitis, Regulation, RVV, Inflammation, Revive, Disorder, Part, Liver disease, Canadian Securities Exchange, Acquisition, Ischemia, NI, Legislation, Organ transplantation, Unit, Orphan drug, Drug development, SEDAR, News, Infection, Sale, Indian stock exchange, Research, Therapy, Risk, Offering, Person, CSE, FDA, Reperfusion injury, Pharmaceutical industry, Security (finance), CBD

There is an offering document (the Offering Document) related to the Offering that can be accessed under the Companys profile at www.sedar.com and on the Companys website at https://revivethera.com .

Key Points: 
  • There is an offering document (the Offering Document) related to the Offering that can be accessed under the Companys profile at www.sedar.com and on the Companys website at https://revivethera.com .
  • As disclosed in the Offering Document, the company intends to use the net proceeds for general working capital purposes and clinical development.
  • The Offering is anticipated to close on or about December 14, 2022, or such later date as the Company may determine.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Revive Therapeutics Announces Update for Type C Meeting to Discuss Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Thursday, November 24, 2022
Psilocybin, COVID-19, Autoimmune hepatitis, RVV, Inflammation, Disorder, Liver disease, Acquisition, Ischemia, Patient, Organ transplantation, Coronavirus, Orphan drug, FDA, Drug development, Infection, Research, Therapy, CSE, Type, Safety, Reperfusion injury, Pharmaceutical industry, CBD

Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

Key Points: 
  • Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Revive Therapeutics Announces FDA Recommendation for Type C Meeting to Discuss Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Tuesday, November 22, 2022
Psilocybin, COVID-19, Autoimmune hepatitis, RVV, Hospital, DSMB, Inflammation, Disorder, Liver disease, Safety, Acquisition, Ischemia, Patient, Organ transplantation, Coronavirus, Orphan drug, Drug development, Infection, Death, Research, Therapy, CSE, Data monitoring committee, Study, Type, FDA, Reperfusion injury, Pharmaceutical industry, Bucillamine, CBD

The FDA has now requested additional information, which would include clinical data, for them to agree on the Studys revised endpoints.

Key Points: 
  • The FDA has now requested additional information, which would include clinical data, for them to agree on the Studys revised endpoints.
  • The Company plans to go over with the FDA the overall development plan for Bucillamine in COVID-19 and further review the Pre-Dose selection data that would support the appropriate endpoints.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Kezar Life Sciences Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 10, 2022
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Other Health, EOS, IND, Lupus, Immunotherapy, Research, SLE, PD-1, EGFR, Company, UPCR, Quality of life, Forward-looking statement, Expressway Authority of Thailand, Tumor microenvironment, Annual general meeting, Food, Society, Total, Kezar Pavilion, Degenerative disease, U.S. Securities and Exchange Commission, Pharmacokinetics, Inflammation, Liver, Patient, Conditional sentence, American College, Private Securities Litigation Reform Act, Nasdaq, Week, AST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lupus nephritis, Clinical trial, ACR, ALT, Autoimmune hepatitis, CRR, American College of Rheumatology, Sec61, EOT, Safety, Association, Proteinuria, Biomarker, Disease, ASN, Immune system, AIH, ORR, SITC, LLC, Pharmaceutical industry

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.

Key Points: 
  • Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.
  • Kezar presented positive complete results for the 37-week Phase 2 MISSION clinical trial at the American Society of Nephrologys (ASN) Kidney Week 2022 Annual Meeting.
  • General and administrative expenses for the third quarter of 2022 increased by $1.0 million to $5.0 million compared to $4.0 million in the third quarter of 2021.
  • Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing novel treatments for immune-mediated and oncologic disorders.

The American Society for Clinical Pathology Expands List of Commonly Used Tests Physicians and Patients Should Question in Collaboration with ASCLS and ASM

Retrieved on: 
Tuesday, November 8, 2022
Plasma, Viral hepatitis, Human, Physician, Publication, Industry, Immunoglobulin G, Society, Patient, CMA Code of Ethics and Professionalism, Consumer, Professional, DLM, Decision-making, ASCP, Glycated hemoglobin, ENA, Certification, Disease, Connective tissue disease, EBV, Marie Cassidy, Neutropenia, Autoimmune hepatitis, INR, Student, Policy, Education, Urine, Partnership, Chlamydia trachomatis, American Society for Clinical Laboratory Science, ANA, Pathology, Neisseria gonorrhoeae, Medicine, DOAC, Choosing Wisely, ASM, Coeliac disease, Knowledge, MPH, AIH, Pharmaceutical industry, Medical imaging, Vaccine, Ethics, MD, Chlamydia

The lists of targeted, evidence-based recommendations are designed to support conversations between patients and physicians about what care is really necessary.

Key Points: 
  • The lists of targeted, evidence-based recommendations are designed to support conversations between patients and physicians about what care is really necessary.
  • The new Choosing Wisely recommendations, developed by ASCP in collaboration with ASCLS, include:
    1.Don't repeat HbA1c testing within 3 months of a previous result.
  • 2.Don't perform an extensive work-up in otherwise healthy neutropenic patients of African or Middle Eastern ancestry prior to Duffy-null phenotype testing.
  • The American Society for Microbiology (ASM) is the largest single life science society, composed of 30,000 scientists and health professionals.

Kezar Life Sciences Presents Positive Complete Results from the MISSION Phase 2 Trial Evaluating Zetomipzomib in Lupus Nephritis at ASN’s Kidney Week 2022 Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, EOS, Patient, ORR, EOT, Immunosuppression, Private Securities Litigation Reform Act, DNA, Dialysis, Week, Lupus nephritis, Society, Association, Glomerular filtration rate, Death, Safety, Biomarker, CRR, SLE, Disease, Phase 1, EGFR, Nasdaq, Sec61, UPCR, Chronic kidney disease, Annual general meeting, ASN, CD163, U.S. Securities and Exchange Commission, Clinical trial, Autoimmune hepatitis, Forward-looking statement, Risk, Expressway Authority of Thailand, Inflammation, Degenerative disease, Proteinuria, Kidney, Plasma protein binding, Diagnosis, Treatment, Lupus, Pharmaceutical industry, Medical imaging, Synthetic oil, Dentistry, LN

The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.

Key Points: 
  • The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.
  • Patients in the MISSION Phase 2 clinical trial received zetomipzomib without induction therapy, which represents a significant difference from other recently published clinical trials in LN.
  • In the MISSION Phase 2 clinical trial, 17 of 21 enrolled patients reached end-of-treatment at Week 25 and end-of-study at Week 37.
  • Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor has completed a Phase 2 clinical trial in lupus nephritis.

Revive Therapeutics Announces Finalization of Amended Phase 3 COVID-19 Study Protocol to FDA

Retrieved on: 
Friday, October 14, 2022
Psilocybin, Autoimmune hepatitis, Organ transplantation, Therapy, Hospital, Liver disease, Ischemia, RVV, Patient, Drug development, Data monitoring committee, DSMB, Coronavirus, Research, Orphan drug, Study, Infection, Company, Acquisition, Disorder, CSE, Safety, Reperfusion injury, GLOBE, Inflammation, Death, FDA, COVID-19, Pharmaceutical industry, CBD

Additional secondary endpoints may include the time to the polymerase chain reaction resolution, clinical outcome (death or hospitalization), disease severity, supplemental oxygen use, and progression of COVID-19.

Key Points: 
  • Additional secondary endpoints may include the time to the polymerase chain reaction resolution, clinical outcome (death or hospitalization), disease severity, supplemental oxygen use, and progression of COVID-19.
  • Should the FDA agree with the revised protocol, the Data Safety Monitoring Board (DSMB) will review the completed Post-Dose selection data of approximately 500 subjects in the context of the new primary endpoint.
  • Regardless of the outcome, the Company would proceed to seek a meeting with the FDA to agree on a proposed plan for potential regulatory approval.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Kezar Announces Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, October 6, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Autoimmune hepatitis, Lupus nephritis, Disease, Kezar Stadium, Financial compensation, Board, Sec61, List of life sciences, Safety, Employment, Pharmaceutical industry

The stock options were granted as an inducement award material to the individuals entering employment with Kezar, in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The stock options were granted as an inducement award material to the individuals entering employment with Kezar, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The options are subject to the terms and conditions of Kezars 2022 Inducement Plan and the stock option agreement covering the grants.
  • Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders.
  • KZR-261 is the first anti-cancer clinical candidate from the companys platform targeting the Sec61 translocon and the protein secretion pathway.

Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19

Retrieved on: 
Thursday, October 6, 2022
Psilocybin, Autoimmune hepatitis, Organ transplantation, Communication, Therapy, Hospital, Liver disease, Ischemia, RVV, Patient, Drug development, Data monitoring committee, DSMB, Coronavirus, Research, Orphan drug, Study, Infection, Company, Acquisition, Disorder, CSE, Safety, Reperfusion injury, GLOBE, Inflammation, Death, FDA, COVID-19, Pharmaceutical industry, CBD

Additional secondary endpoints may include clinical outcome (death or hospitalization), the time to the polymerase chain reaction resolution, disease severity, supplemental oxygen use, and progression of COVID-19.

Key Points: 
  • Additional secondary endpoints may include clinical outcome (death or hospitalization), the time to the polymerase chain reaction resolution, disease severity, supplemental oxygen use, and progression of COVID-19.
  • Regardless of the outcome, the Company would proceed to seek a meeting with the FDA to agree on a proposed plan for potential regulatory approval.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Kezar Life Sciences Receives FDA Clearance of IND for Zetomipzomib for the Treatment of Autoimmune Hepatitis

Retrieved on: 
Monday, October 3, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Inflammation, Association, Disease, Lupus nephritis, Conditional sentence, Indiana University, U.S. Securities and Exchange Commission, Mortality, ALT, Assistant, Physician, Nasdaq, IND, Private Securities Litigation Reform Act, Food, AST, Liver, Cataract, Prednisone, Autoimmune hepatitis, Polymyositis, Immune system, Lupus, List of life sciences, Week, Hepatocellular carcinoma, Safety, Immunosuppression, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, Program, Cirrhosis, Liver failure, Dermatomyositis, Patient, AIH, Forward-looking statement, Sec61, Degenerative disease, Diabetes, Pharmaceutical industry, Vaccine, Medicine

Standard of care treatment for AIH is immunosuppressive treatment with chronic corticosteroids that can lead to additional morbidity and mortality.

Key Points: 
  • Standard of care treatment for AIH is immunosuppressive treatment with chronic corticosteroids that can lead to additional morbidity and mortality.
  • There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression using corticosteroids.
  • Zetomipzomib is a unique small molecule with the potential to be a non-immunosuppressive, anti-inflammatory treatment for multiple autoimmune diseases.
  • Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders.