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The story of how a Swiss runner's pursuit of a new running sensation became On, aiming to be the most premium global sportswear brand worldwide.
aTyr Pharma (ATYR) investor relations material
aTyr Pharma Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary2 Dec, 2025
Key data presentations and findings
Full topline EFZO-FIT results were presented, including steroid reduction, withdrawal, and three key PROs: KSQ Lung, KSQ General Health, and Fatigue Assessment Score, plus safety data and treatment discontinuations.
The trial showed over 70% steroid reduction and more than 50% of patients off steroids, but placebo also had a high response, attributed to rigorous protocol and frequent patient monitoring.
Quality of life improvements were observed only in the treatment group, with significant benefits in fatigue, cough, and shortness of breath.
FVC changes were minimal and within expected variability, with the largest declines seen in placebo, not the treatment group.
Experts view the data as demonstrating durable clinical benefit, with improvements in quality of life evident from 8-12 weeks and sustained throughout the study.
Regulatory strategy and next steps
Pre-specified endpoints included steroid reduction, withdrawal, PROs, safety, and FVC; post hoc analyses are exploring subpopulations, phenotypes, and biomarkers.
The team is preparing a comprehensive data package for an FDA meeting in Q1 2026, ready for scenarios including BLA filing or a confirmatory study.
If a new trial is required, the protocol will be ready, with potential for endpoints like KSQ Lung if validated, and a focus on quality of life as a primary measure.
Patient interest in future trials is high, with quality of life and steroid withdrawal as top priorities.
Timelines for a new trial depend on size, inclusion criteria, and endpoint selection, but increased patient interest may accelerate enrollment.
Pipeline and future outlook
EFZO-CONNECT study in SSC ILD is expected to complete enrollment in the first half of the year, with data anticipated in the second half.
Interim data from EFZO-CONNECT showed promising skin improvement, a key quality of life factor for SSC patients.
The field is shifting treatment guidelines based on these results, with experts now recommending lower steroid doses.
The team remains optimistic about regulatory discussions and the potential for efzofitimod to address unmet needs in sarcoidosis.
KSQ Lung as primary endpoint for next trial
Mitigate high placebo response in future studies
Efzofitimod efficacy in severe sarcoidosis patients
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Next aTyr Pharma earnings date
Q4 202516 Mar, 2026
Next aTyr Pharma earnings date
Q4 202516 Mar, 2026
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Frequently asked questions
aTyr Pharma Inc. is a biotherapeutics company focused on the discovery and development of innovative medicines based on extracellular proteins to treat rare immune, inflammatory, and fibrotic diseases. The company's research is centered around the therapeutic potential of tRNA synthetase biology. aTyr's lead clinical program targets lung diseases with unmet medical needs, particularly those related to inflammation and fibrosis. The company aims to advance novel treatments that address the underlying causes of these conditions. The company is headquartered in San Diego, California, USA, and its shares are listed on the NASDAQ.
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