Fibrosis

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

Retrieved on: 
Tuesday, April 2, 2024

"Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.

Key Points: 
  • "Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.
  • In January 2023, Cardiol announced the first patient had been enrolled in the Company's Phase II open-label pilot study ("MAvERIC-Pilot") investigating the tolerance, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis.
  • In November 2023, Cardiol announced that it had exceeded 50% of the patient enrollment target for the MAvERIC-Pilot study.
  • In January 2024, Cardiol announced that ARCHER had exceeded 50% patient enrollment and was progressing ahead of the original study timeline.

Madrigal Pharmaceuticals Announces U.S. Availability of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic NASH with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Tuesday, April 9, 2024

I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.

Key Points: 
  • I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.
  • This program is designed to help patients navigate insurance and affordability challenges and provide co-pay support for eligible patients.
  • Madrigal has also established a patient assistance program (PAP) to help patients with no insurance access Rezdiffra.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Akero Therapeutics, Inc. - AKRO

Retrieved on: 
Monday, April 8, 2024

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Akero Therapeutics, Inc. (“Akero” or the “Company”) (NASDAQ: AKRO).

Key Points: 
  • NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Akero Therapeutics, Inc. (“Akero” or the “Company”) (NASDAQ: AKRO).
  • The investigation concerns whether Akero and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • In addition, Akero added that 12 patients, including 11 in EFX groups, discontinued the trial due to drug-related adverse events.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

US Gastroenterologists Project Swift Uptake of Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Retrieved on: 
Friday, April 5, 2024

As anticipation builds for the launch of Rezdiffra, Spherix Global Insights recently conducted a pulse survey among gastroenterologists (n=81) to assess prescriber feedback and projected uptake of the brand post-launch.

Key Points: 
  • As anticipation builds for the launch of Rezdiffra, Spherix Global Insights recently conducted a pulse survey among gastroenterologists (n=81) to assess prescriber feedback and projected uptake of the brand post-launch.
  • Furthermore, 70% of gastroenterologists in the March 2024 pulse now report they are at least moderately familiar with Rezdiffra, a significant increase compared to April 2023.
  • When discussing the primary benefits of Rezdiffra, gastroenterologists highlight its distinction as the first indicated product for MASH, alongside its prospective efficacy in improving fibrosis.
  • Furthermore, gastroenterologists indicate that over one-third of MASH patients under their care would be suitable candidates for Rezdiffra, further bolstering the likelihood of swift uptake and utilization.

Protara Therapeutics Announces Alignment with FDA on Registrational Path Forward for IV Choline Chloride in Patients Dependent on Parenteral Nutrition

Retrieved on: 
Friday, April 5, 2024

IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.

Key Points: 
  • IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.
  • The Company plans to advance the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PN.
  • The FDA has granted IV Choline Chloride Orphan Drug Designation for the prevention of choline deficiency in PN patients.
  • “We look forward to advancing the clinical development of IV Choline Chloride, which we believe has the potential to become the first FDA approved IV choline therapy for patients dependent on PN.

Surrozen Publishes Study in 'Respiratory Research' Demonstrating the Promise of a Wnt Mimetic Antibody in Treating Pulmonary Fibrosis

Retrieved on: 
Wednesday, April 3, 2024

SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, announced today publication of data in Respiratory Research highlighting the potential for Surrozen’s Wnt mimetic technologies to treat serious lung diseases like idiopathic pulmonary fibrosis (IPF) https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-0.... The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.

Key Points: 
  • The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.
  • Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by areas of myofibroblast accumulation and extracellular matrix (ECM) deposition, disruption of alveolar architecture, and restricted lung physiology.
  • In pulmonary fibrosis, multiple cell types may need to be targeted to provide a regenerative environment facilitating repair.
  • “This work published in Respiratory Research represents a breakthrough in understanding the role of the Wnt pathway in lung fibrosis and the potential for Wnt mimetics to reduce fibrosis and improve lung function.”

GRI Bio Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024

LA JOLLA, CA, April 01, 2024 (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 reported its financial results for the fiscal year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream.
  • GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells.
  • Research and development expenses were $3.2 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively.
  • General and administrative expenses were $8.2 million and $2.0 million for the years ended December 31, 2023 and 2022, respectively.

aTyr Pharma to Participate in April Investor Conferences

Retrieved on: 
Monday, April 1, 2024

SAN DIEGO, April 01, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the company will participate in two upcoming investor conferences scheduled to take place in April 2024.

Key Points: 
  • SAN DIEGO, April 01, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the company will participate in two upcoming investor conferences scheduled to take place in April 2024.
  • Details of the conferences appear below:
    For more information on how to register, please contact your Evercore ISI or Piper Sandler representative.
  • aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation.
  • tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans.

Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 29, 2024

NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.

Key Points: 
  • NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.
  • Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We have been focused on advancing our Metabolic Dysfunction-Associated Steatohepatitis (MASH, formerly known as NASH) cirrhosis program.
  • Dr. Jamil’s extensive experience in advanced liver disease, specifically for late-stage cirrhotic patients, is a tremendous asset to our program.
  • These results are included in the Company's Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov .

Omega Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Strategic Update

Retrieved on: 
Thursday, March 28, 2024

Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.

Key Points: 
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $6.2 million, compared to $5.7 million for the fourth quarter of 2022.
  • Net loss for the fourth quarter of 2023 was $20.2 million, compared to $30.8 million for the fourth quarter of 2022.
  • The decrease in net loss for 2023 compared to 2022 was primarily due to decreases in R&D expenses.