NESS

Government of Canada: Updated 2024 wildfire season projections and preparedness measures

Retrieved on: 
Jeudi, mai 9, 2024

Environment and Climate Change Canada's (ECCC) meteorologists continue to predict weather conditions for spring and summer 2024 that could lead to greater wildfire risks.

Key Points: 
  • Environment and Climate Change Canada's (ECCC) meteorologists continue to predict weather conditions for spring and summer 2024 that could lead to greater wildfire risks.
  • To counter the growing threat of wildfires in Canada, the federal government will continue to support provinces and territories in wildfire mitigation, response, and monitoring.
  • We are making sure we have the capacity to support provinces and territories and mobilize resources when they are needed for the 2024 wildfire season.
  • With the 2024 wildfire season approaching, our government is ensuring that people in Canada have the tools and information they need to understand and manage the health risks associated with wildfires."

BiomX to Present at the 2024 RBC Capital Markets Global Healthcare Conference

Retrieved on: 
Lundi, mai 6, 2024

CAMBRIDGE, Mass.

Key Points: 
  • CAMBRIDGE, Mass.
  • and NESS ZIONA, Israel, May 06, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the company will participate in the RBC Capital Markets Global Healthcare Conference in New York City on Wednesday, May 15, 2024.
  • The live webcast of the presentation will be accessible through the Investors section of the Company’s website at https://ir.biomx.com/news-events/ir-calendar .
  • The webcast also will be archived on the BiomX website for a period of 3 months.

BiomX to Present Data from Phase 1b/2a Study of BX004 for the Treatment of Cystic Fibrosis Patients with Chronic Pulmonary Infections at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024)

Retrieved on: 
Mardi, avril 23, 2024

CAMBRIDGE, Mass.

Key Points: 
  • CAMBRIDGE, Mass.
  • and NESS ZIONA, Israel, April 23, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the Company will present data from the Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections at ECCMID 2024, which is being held from 27-30 April 2024, in Barcelona, Spain.
  • The abstract submitted by the Company was selected as a “Top Poster”, ranking it among the 1-2% of top-rated abstracts in the category submitted and accepted at ECCMID 2024.
  • Chronic Pseudomonas aeruginosa pulmonary infection treated with a nebulised phage cocktail in patients with cystic fibrosis: a phase 1b/2a randomised, double-blind, placebo-controlled, multicentre study

BiomX Announces the Appointment of Susan Blum to its Board of Directors

Retrieved on: 
Jeudi, avril 18, 2024

and NESS ZIONA, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the appointment of Susan Blum to its Board of Directors.

Key Points: 
  • and NESS ZIONA, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the appointment of Susan Blum to its Board of Directors.
  • Ms. Blum was also appointed to serve as a member and chair of the audit committee of the Board.
  • Prior to joining Melinta, Ms. Blum served as Corporate Controller at Textura Corporation from 2013 to 2016, supporting the company’s IPO and transformation into a publicly-traded organization.
  • Ms. Blum is a Certified Public Accountant, currently serves as a member of the BioNJ Cybersecurity Committee and holds a B.S.

Kamari Pharma Announces Abstracts Accepted for Presentation at the 81st Annual Meeting of the Society for Investigative Dermatology

Retrieved on: 
Mardi, avril 16, 2024

NESS ZIONA, Israel, April 16, 2024 (GLOBE NEWSWIRE) -- Kamari Pharma, a privately-held clinical stage biotechnology company developing first and best-in-class treatments for rare and severe genetic skin diseases, today announced two abstracts reporting results for its novel TRPV3 inhibitors, KM-001(topical) and KM-023 (oral), have been selected for presentation at the 81st Annual Meeting of the Society for Investigative Dermatology (SID), being held May 15-18, 2024 in Dallas, TX, USA.

Key Points: 
  • TRPV3 plays a central role in skin disease as it regulates proliferation, differentiation and barrier function of human skin.
  • KM-001 and KM-023 are specific and selective TRPV3 inhibitors that address both molecular and local damage to the skin by regulating Ca²⁺ influx into the cell, thereby reconstructing the skin barrier and reducing inflammation.
  • Kamari is currently developing KM-001 for the treatment of palmoplantar keratoderma and KM-023 for the treatment of Olmstead syndrome, severe keratoderma and Ichthyosis.
  • The details of the presentations are as follows:
    Title: Novel TRPV3 inhibitors developed for the treatment of palmoplantar keratodermas, demonstrate safety and efficacy in preclinical models

Bioforum the Data Masters Introduces SUBMIT24: A Free of Charge and Revolutionary CDISC CORE-Based Clinical Data Validation Tool

Retrieved on: 
Mercredi, avril 24, 2024

NESS ZIONA, Israel, April 24, 2024 /PRNewswire/ -- Bioforum, the Data Masters, a leading contract research organization (CRO) focused on the delivery of biometric services and solutions to the global clinical trials industry, today announced the launch of SUBMIT24 in its beta version during Q3 2024, a groundbreaking free of charge CDISC CORE-based clinical data validation tool. SUBMIT24 offers a revolutionary approach to data validation, providing users with a downloadable platform.

Key Points: 
  • SUBMIT24 is proud to align with the Clinical Data Interchange Standards Consortium (CDISC), a global nonprofit organization that develops and maintains standards for clinical research.
  • Built on the CDISC standards, SUBMIT24 is designed to streamline the data validation process and enhance efficiency in clinical research.
  • With its user-friendly interface and advanced features, SUBMIT24 empowers users to validate clinical data with ease and accuracy.
  • "We believe that clinical data conformance shouldn't come with a price tag and therefor introduce this innovative free of charge tool which represents a significant step forward in data validation."

Bioforum the Data Masters Introduces SUBMIT24: A Free of Charge and Revolutionary CDISC CORE-Based Clinical Data Validation Tool

Retrieved on: 
Mercredi, avril 24, 2024

NESS ZIONA, Israel, April 24, 2024 /PRNewswire/ -- Bioforum, the Data Masters, a leading contract research organization (CRO) focused on the delivery of biometric services and solutions to the global clinical trials industry, today announced the launch of SUBMIT24 in its beta version during Q3 2024, a groundbreaking free of charge CDISC CORE-based clinical data validation tool. SUBMIT24 offers a revolutionary approach to data validation, providing users with a downloadable platform.

Key Points: 
  • SUBMIT24 is proud to align with the Clinical Data Interchange Standards Consortium (CDISC), a global nonprofit organization that develops and maintains standards for clinical research.
  • Built on the CDISC standards, SUBMIT24 is designed to streamline the data validation process and enhance efficiency in clinical research.
  • With its user-friendly interface and advanced features, SUBMIT24 empowers users to validate clinical data with ease and accuracy.
  • "We believe that clinical data conformance shouldn't come with a price tag and therefor introduce this innovative free of charge tool which represents a significant step forward in data validation."

BiomX Announces Compliance with NYSE Guidelines on Audit Opinion Disclosure

Retrieved on: 
Jeudi, avril 4, 2024

CAMBRIDGE, Mass.

Key Points: 
  • CAMBRIDGE, Mass.
  • and NESS ZIONA, Israel, April 04, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that, as previously disclosed in its annual report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission on April 4, 2024, the audit opinion contained a going concern qualification from the Company's independent registered public accounting firm.
  • This announcement is being made solely to comply with the NYSE American Company Guide Sections 401(h) and 610(b), which require separate disclosure of receipt of an audit opinion that contains a going concern qualification.
  • This announcement does not represent any change or amendment to the Company's 2023 audited financial statements or to its 2023 annual report on Form 10-K.

BiomX Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Mercredi, avril 3, 2024

CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Initial top line results of the Phase 2 trial are expected in the first quarter of 2025.
  • However, our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
  • ET to discuss its fourth quarter and full year 2023 financial results and to provide a corporate update.

Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream

Retrieved on: 
Lundi, avril 1, 2024

On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.

Key Points: 
  • On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.
  • Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024, as measured by IQVIA.
  • Should its ANDA for Roflumilast Cream, 0.3% be approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusivity.
  • Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis.