Scleroderma

aTyr Pharma Announces Fourth Quarter and Full Year 2022 Results and Provides Corporate Update

Retrieved on: 
Thursday, March 9, 2023

SAN DIEGO, March 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced fourth quarter and full year 2022 results and provided a corporate update.

Key Points: 
  • SAN DIEGO, March 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced fourth quarter and full year 2022 results and provided a corporate update.
  • This achievement triggered a $10.0 million milestone payment to aTyr in the fourth quarter.
  • Based on the Company’s current operational plans and existing cash, aTyr believes the Company’s cash runway will extend into 2026.
  • Links to a live audio webcast and replay may be accessed on the aTyr website Events page at: http://investors.atyrpharma.com/events-and-webcasts .

Quoin Pharmaceuticals Provides Corporate Update and Announces Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, March 8, 2023

Quoin CEO, Dr. Michael Myers, said, “2022 as a whole was a year of significant progress for Quoin and the fourth quarter continued that trend of operational execution across a number of important metrics.

Key Points: 
  • Quoin CEO, Dr. Michael Myers, said, “2022 as a whole was a year of significant progress for Quoin and the fourth quarter continued that trend of operational execution across a number of important metrics.
  • We were very pleased to announce the dosing of the first patient in our ongoing double blinded, placebo controlled study in Netherton Syndrome patients.
  • This study has continued to recruit and dose patients since then and overall interest in participation in the study remains very high.
  • We believe Quoin is the only pharmaceutical company currently conducting two clinical trials in Netherton Syndrome patients under an open IND application.

aTyr Pharma Announces Phase 2 Study of Efzofitimod in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Following FDA Clearance of IND Application

Retrieved on: 
Wednesday, March 1, 2023

SAN DIEGO, March 01, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today provided additional details regarding its plans to initiate a Phase 2 study of its lead therapeutic candidate, efzofitimod, in patients with systemic sclerosis (SSc, also known as scleroderma)-associated interstitial lung disease (ILD) following the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) announced earlier this year.

Key Points: 
  • Efzofitimod has been granted U.S. FDA orphan drug designation for SSc and Fast Track designation for SSc-ILD.
  • Efzofitimod is a potential first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2 (NRP2).
  • The company is currently investigating efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD, in a global Phase 3 study called EFZO-FIT™.
  • Current treatment options may help to slow lung function decline but do not impact underlying disease or improve quality of life.

Chemomab Announces FDA Clearance of Investigational New Drug Application for Phase 2 Clinical Trial of CM-101 in Patients with Systemic Sclerosis

Retrieved on: 
Tuesday, February 21, 2023

TEL AVIV, Israel, Feb. 21, 2023 /PRNewswire/ -- Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced U.S. Food and Drug Administration (FDA) clearance of the company's Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis (SSc).

Key Points: 
  • In preclinical studies, CM-101 reduced inflammatory and fibrotic injury to the lung, skin and vasculature—organ systems often affected in SSc patients.
  • CM-101 has been granted Orphan Drug designation by the FDA for SSc and for primary sclerosing cholangitis (PSC), a rare liver disease.
  • Matt Frankel, MD, Chief Medical Officer of Chemomab, said, "Achieving FDA clearance to initiate our Phase 2 systemic sclerosis trial is an important milestone for Chemomab.
  • I welcome the opportunity to help launch and coordinate this innovative clinical trial for patients with SSc in the U.S., Europe and Israel, scheduled to open later this year."

Talaris Therapeutics Announces Plans to Explore Strategic Alternatives and Implements Restructuring Plan

Retrieved on: 
Thursday, February 16, 2023

This decision was primarily attributable to the pace of enrollment and the associated timeline to critical milestones.

Key Points: 
  • This decision was primarily attributable to the pace of enrollment and the associated timeline to critical milestones.
  • The company will continue to enroll its FREEDOM-3 Phase 2 clinical trial evaluating FCR001’s ability to induce tolerance in scleroderma.
  • The Company has initiated a comprehensive review of strategic alternatives focused on maximizing shareholder value, including possible business combinations and/or a divestiture of the Company’s cell therapy CMC capabilities.
  • As of December 31, 2022, the Company’s cash, cash equivalents and short- and long-term marketable securities were approximately $181.3 million.

The Scleroderma Research Foundation Will Be Featured on "Behind The Mystery" Presented by The Balancing Act® Airing on Lifetime®

Retrieved on: 
Thursday, February 16, 2023

SAN FRANCISCO, Feb. 16, 2023 /PRNewswire/ -- The Scleroderma Research Foundation (SRF) will shine a light on scleroderma—a rare, often misdiagnosed disease—on "Behind The Mystery," a specialized series presented by The Balancing Act® and airing on Lifetime® on February 20 and on Rare Disease Day, February 28. Scleroderma Research Foundation Founding Board Member Susan Feniger, Dr. Lorinda Chung, Professor of Medicine and Dermatology, Division of Immunology and Rheumatology at Stanford University School of Medicine, and scleroderma patient Melissa will share insights about the disease and research developments supported by the Scleroderma Research Foundation—the country's first and leading nonprofit investor in medical research into scleroderma.

Key Points: 
  • Scleroderma Research Foundation Founding Board Member Susan Feniger, Dr. Lorinda Chung, Professor of Medicine and Dermatology, Division of Immunology and Rheumatology at Stanford University School of Medicine, and scleroderma patient Melissa will share insights about the disease and research developments supported by the Scleroderma Research Foundation—the country's first and leading nonprofit investor in medical research into scleroderma.
  • "The Scleroderma Research Foundation is laser-focused on funding and facilitating research in order to advance treatments and find a cure for scleroderma so that people don't need to suffer," says Joanne Gold, Executive Director of the Scleroderma Research Foundation.
  • "The Scleroderma Research Foundation works with top leaders across a variety of fields in order to expand our knowledge of the causes of scleroderma and improve treatments for patients.
  • The Scleroderma Research Foundation funds and facilitates the most promising, highest quality research aimed at improved therapies and, ultimately, a cure for scleroderma.

ROSALIND FRANKLIN UNIVERSITY COMPANY BLR BIO AWARDED $780,000 GRANT FROM THE CANADIAN INSTITUTES OF HEALTH RESEARCH

Retrieved on: 
Tuesday, February 14, 2023

Scleroderma is a chronic connective-tissue disorder primarily characterized by thickening and hardening of the skin and other tissues and organs.

Key Points: 
  • Scleroderma is a chronic connective-tissue disorder primarily characterized by thickening and hardening of the skin and other tissues and organs.
  • The condition can cause loss of mobility, pain and disfigurement, and it may lead to multiorgan disease that can result in death.
  • "International collaborative research is key to the discovery of new treatments for debilitating diseases like scleroderma," he said.
  • ROSALIND FRANKLIN UNIVERSITY encompasses six colleges and more than 10 research centers and institutes.

Systemic Sclerosis with Interstitial Lung Disease Fund Now Open at HealthWell Foundation

Retrieved on: 
Monday, January 30, 2023

GERMANTOWN, Md., Jan. 30, 2023 /PRNewswire/ -- The HealthWell Foundation®, an independent non-profit that provides a financial lifeline for inadequately insured Americans, is proud to announce that it has opened a new fund to provide financial assistance to individuals living with systemic sclerosis with interstitial lung disease (SSc-ILD). Through the new fund, HealthWell will provide up to $9,000 in medication copayment or insurance premium assistance to eligible patients with annual household incomes up to 500 percent of the federal poverty level for the management of their condition.

Key Points: 
  • GERMANTOWN, Md., Jan. 30, 2023 /PRNewswire/ -- The HealthWell Foundation®, an independent non-profit that provides a financial lifeline for inadequately insured Americans, is proud to announce that it has opened a new fund to provide financial assistance to individuals living with systemic sclerosis with interstitial lung disease (SSc-ILD).
  • Interstitial lung disease (ILD) is the development of inflammation and/or scarring around the air sacs of the lungs.
  • To determine eligibility and apply for financial assistance, visit HealthWell's Systemic Sclerosis with Interstitial Lung Disease page.
  • Note that all new fund openings and fund re-openings occur at 11:00 a.m. Eastern (8:00 a.m. Pacific) Monday – Friday.

aTyr Pharma Announces Pricing of Public Offering of Common Stock

Retrieved on: 
Thursday, February 9, 2023

SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the pricing of its previously announced underwritten public offering of 22,225,000 shares of its common stock at a public offering price of $2.25 per share.

Key Points: 
  • SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the pricing of its previously announced underwritten public offering of 22,225,000 shares of its common stock at a public offering price of $2.25 per share.
  • The gross proceeds to aTyr from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $50.0 million.
  • In addition, aTyr has granted the underwriters a 30-day option to purchase up to an additional 3,333,750 shares of its common stock at the public offering price per share, less underwriting discounts and commissions.
  • All of the shares being sold in the offering are being sold by aTyr.

aTyr Pharma Announces Commencement of Public Offering of Common Stock

Retrieved on: 
Wednesday, February 8, 2023

In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to an additional 15% of the shares sold in the public offering.

Key Points: 
  • In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to an additional 15% of the shares sold in the public offering.
  • All of the shares to be sold in the offering are to be sold by aTyr.
  • The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.
  • These forward-looking statements include statements regarding the timing, terms and completion of the proposed public offering and anticipated use of proceeds from the offering.