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News & Updates

August 4, 2025

Clarametyx Biosciences Announces FDA Grant Of Fast Track And Qualified Infectious Disease Product Designations For CMTX-101

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June 16, 2025

Clarametyx Biosciences Announces Positive Interim Analysis in Phase 2a Study Evaluating CMTX-101 for Infections Associated with Cystic Fibrosis

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May 2, 2025

CincyTech Invests in Clarametyx to Advance Breakthrough Anti-Biofilm Therapies for Chronic Respiratory Disease

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January 28, 2025

Clarametyx Biosciences Announces Investment by Kineticos AMR Accelerator Fund

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January 7, 2025

Clarametyx Biosciences Awarded a Multi-Phased Agreement with CARB-X to Accelerate Anti-Biofilm Vaccine to Prevent Bacterial Infections

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November 19, 2024

Clarametyx Bioscience Recognized as “Infectious Disease Innovation of the Year” In 2024 BioTech Breakthrough Awards

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October 17, 2024

Clarametyx Biosciences Announces Progress on Study of Antibody Therapy CMTX-101 For Infections Associated With Cystic Fibrosis

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October 9, 2024

Clarametyx to Present on Its Anti-Biofilm Technology Platform During Antimicrobial Pipeline Session At IDWeek 2024

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May 28, 2024

Clarametyx Biosciences Appoints Renowned Experts to Augment Strategic and Scientific Advisory Boards

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Clarametyx Expanded Access Policy

Copyright © 2025 Clarametyx Biosciences. All rights reserved. Privacy Policy.

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Clarametyx
Expanded Access Policy

Clarametyx Biosciences is a clinical stage biopharmaceutical company committed to developing novel immune-enabling therapies for serious or difficult-to-treat respiratory diseases.

“Expanded access” refers to use of an investigational drug outside of a clinical trial, where the use of the drug is for treatment, rather than gathering data in support of a marketing application.

The main goal of ongoing clinical trials for our investigational agent, CMTX-101, is to gain information about the drug’s safety and efficacy to submit an application to Health Authorities in support of approval to market CMTX-101. For this reason, Clarametyx believes that direct enrollment in a clinical trial is the preferred route of access to a drug, for which we are continuing to develop data on safety, efficacy and tolerability. We believe expanded access outside of a clinical trial may interfere with the conduct of ongoing trials and may disrupt the progress of our development programs, which could potentially delay access to other patients in need.

For this reason, Clarametyx is not making its investigational drugs available on an expanded access basis at the present time. We plan to re-evaluate this policy in the future as additional information becomes available from ongoing clinical trials.

If you have any questions about this policy or would like information about how to participate in our clinical studies, please contact us at info@clarametyx.com. More information on our ongoing clinical trial is available at ClinicalTrials.gov (http://www.clinicaltrials.gov, NCT06159725).

As authorized by the 21st Century Cures Act, Clarametyx may revise this expanded access policy at any time.