Autoimmune hepatitis

Xencor Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024

Both programs entered Phase 1 clinical development during the fourth quarter of 2023, and Xencor received $20 million in development milestones.

Key Points: 
  • Both programs entered Phase 1 clinical development during the fourth quarter of 2023, and Xencor received $20 million in development milestones.
  • In the fourth quarter of 2023, Xencor completed enrollment in subcutaneous dose-escalation cohorts of a Phase 1 study evaluating plamotamab.
  • Financial Results for the Fourth Quarter and Full Year Ended December 31, 2023
    Cash, cash equivalents, and marketable debt securities totaled $697.4 million as of December 31, 2023, compared to $584.5 million on December 31, 2022.
  • Total revenue for the fourth quarter ended December 31, 2023 was $44.7 million compared to $21.6 million for the same period in 2022.

Inventiva reports preliminary 2023 fiscal year financial Information¹ and provides an update on its clinical trial NATiV3

Retrieved on: 
Thursday, February 15, 2024

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.

Key Points: 
  • Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.
  • This allowed us to draw down the second tranche of €25 million of the €50 million EIB loan in January 2024.
  • We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor in NASH after the implementation of the revised study design in early 2023, with 913 patients randomized to date.
  • An adverse event of elevated aminotransferases has been reported in a patient enrolled in the trial following a scheduled visit.

Kezar Life Sciences Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 13, 2023

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.
  • In addition, Kezar recently announced a strategic restructuring to prioritize long-term growth and focus resources on its clinical-stage programs.
  • Actions to prioritize clinical programs and implement cost saving measures are expected to extend Kezar’s cash runway into late 2026.
  • Research and development expenses for the third quarter of 2023 increased by $9.8 million to $23.7 million compared to $13.9 million in the third quarter of 2022.

Kezar Life Sciences Announces Strategic Restructuring to Prioritize Clinical-Stage Assets and Extend Financial Runway and Appoints Christopher Kirk, Ph.D. as Chief Executive Officer

Retrieved on: 
Tuesday, October 3, 2023

The strategic realignment is expected to extend operating capital to fund PALIZADE, Kezar’s Phase 2b clinical trial in lupus nephritis.

Key Points: 
  • The strategic realignment is expected to extend operating capital to fund PALIZADE, Kezar’s Phase 2b clinical trial in lupus nephritis.
  • Actions to prioritize clinical programs and implement cost saving measures are expected to extend Kezar’s cash runway into late 2026.
  • All research and drug discovery activities have been paused, and Kezar will explore strategic partnering alternatives for its protein secretion platform and preclinical programs.
  • John Fowler will be resigning from his role as Chief Executive Officer effective November 7, 2023, and Christopher Kirk, Ph.D. has been appointed as Chief Executive Officer.

Biostax Corp Announces the FDAs Acceptance of Three Investigational New Drug Applications (IND) Transfers for JKB-122 for the Treatment of NASH, NAFLD and AIH

Retrieved on: 
Tuesday, August 15, 2023

Orlando, FL, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. d/b/a Biostax Corp. (OTC Pink: IMUN) ("Biostax"), a hub-and-spoke biotech development engine, announces that they have accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122 and the U.S. Food and Drug Administration (FDA) has finalized those transfers.

Key Points: 
  • Orlando, FL, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. d/b/a Biostax Corp. (OTC Pink: IMUN) ("Biostax"), a hub-and-spoke biotech development engine, announces that they have accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122 and the U.S. Food and Drug Administration (FDA) has finalized those transfers.
  • The INDs that were transferred to Biostax include IND 146955 for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis, IND 147347 for the treatment of Nonalcoholic Liver Disease (NAFLD) and IND 127303 for the treatment of Autoimmune Hepatitis along with the Orphan Designation for Autoimmune Hepatitis.
  • These INDs were transferred from TaiwanJ Pharmaceuticals, who licensed the development and commercialization of JKB-122 to Biostax Corp in 2022.
  • "This transaction is transformational for Biostax as it allows us to support a balanced pipeline and advance innovative therapeutic solutions that help people living with autoimmune diseases and chronic illness.”

Kezar Life Sciences Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 10, 2023

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 second quarter ended June 30, 2023 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 second quarter ended June 30, 2023 and provided a business update.
  • The complete MISSION Phase 1b/2 results were presented as an oral presentation at the LUPUS & KCR 2023 meeting, which took place May 17-20, 2023 in Seoul, Korea.
  • Research and development expenses for the second quarter of 2023 increased by $9.7 million to $21.0 million compared to $11.3 million in the second quarter of 2022.
  • General and administrative (G&A) expenses for the second quarter of 2023 increased by $0.8 million to $5.8 million compared to $5.0 million in the second quarter of 2022.

Enanta Pharmaceuticals Announces Data Presentation at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2023

Retrieved on: 
Wednesday, June 7, 2023

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that preclinical data from Enanta’s out-licensing portfolio has been accepted for a poster presentation at the European Association for the Study of the Liver (EASL) International Liver Congress 2023 being held June 21 – 24, 2023 in Vienna, Austria at the Messe Wien Exhibition Congress Centre.

Key Points: 
  • Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that preclinical data from Enanta’s out-licensing portfolio has been accepted for a poster presentation at the European Association for the Study of the Liver (EASL) International Liver Congress 2023 being held June 21 – 24, 2023 in Vienna, Austria at the Messe Wien Exhibition Congress Centre.
  • In the poster, Enanta’s HSD17B13 inhibitors, which have previously been shown to be anti-inflammatory in vivo with modulation of sphingolipids, were evaluated in a mouse model of autoimmune hepatitis for anti-inflammatory and hepatoprotective effects.
  • The full scientific program for The International Liver Congress 2022, as well as the abstracts, can be found at https://www.easlcongress.eu/ .

Kezar Life Sciences Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, May 11, 2023

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 first quarter ended March 31, 2023 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 first quarter ended March 31, 2023 and provided a business update.
  • Kezar plans to initiate the dose expansion study in the second half of 2023, with topline data expected starting mid-2024.
  • Kezar plans to report safety and dose escalation data from this trial in the second half of 2023.
  • Research and development expenses for the first quarter of 2023 increased by $7.4 million to $18.3 million compared to $10.9 million in the first quarter of 2022.

Boston Marathon Runners Hit the Pavement to Fight Liver Disease

Retrieved on: 
Tuesday, April 11, 2023

NEW YORK, April 11, 2023 /PRNewswire/ -- The American Liver Foundation (ALF) is proud to once again be a member of the Boston Marathon Official Charity Program for the 2023 Boston Marathon®, which takes place on Monday, April 17, 2023.

Key Points: 
  • Since 1988, the American Liver Foundation Marathon Team has made a dramatic impact on the American Liver Foundation's mission to promote education, advocacy, support services and research for the prevention, treatment, and cure of liver disease .
  • Liver disease affects their family members, friends or loved ones and the funds they raise through the Boston Marathon® are critical in our fight against liver disease."
  • The American Liver Foundation team is comprised of novice to experienced runners, most of whom have a connection to liver disease.
  • To support individual runners in the 2023 Boston Marathon, view the team list and donate with the Boston Marathon® official giving platform, GivenGain .

Kezar Life Sciences Reports Fourth Quarter and Year End 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 14, 2023

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 fourth quarter and year ended December 31, 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 fourth quarter and year ended December 31, 2022 and provided a business update.
  • “We made tremendous progress in both of our first-in-class programs during 2022,” said John Fowler, Kezar’s Co-founder and Chief Executive Officer.
  • Research and development expenses for the fourth quarter of 2022 increased by $5.1 million to $14.9 million compared to $9.8 million in the fourth quarter of 2021.
  • General and administrative (G&A) expenses for the fourth quarter of 2022 increased by $0.9 million to $5.2 million compared to $4.3 million in the fourth quarter of 2021.