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Foundation for Sarcoidosis Research Reacts to the Announcement of aTyr Pharma's Phase 3 Clinical Trial Results

1. aTyr's Phase 3 trial did not meet its primary endpoint. 2. Encouraging results indicate potential benefits for patients with pulmonary sarcoidosis. 3. efzofitimod improved steroid withdrawal rates and quality of life measures. 4. The Foundation for Sarcoidosis Research supports aTyr's continued development of efzofitimod. 5. FDA consultation planned to discuss future options for efzofitimod.

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FAQ

Why Bullish?

While missing the primary endpoint is typically negative, the encouraging secondary results may attract further interest and investment. Historically, similar cases led to eventual stock price increases due to improved outlooks and FDA consultations.

How important is it?

The trial results, while not achieving primary endpoints, still showed promise. The supportive statements from the FSR and the potential FDA engagement highlight future growth opportunities for ATYR.

Why Long Term?

Long-term impact expected as FDA discussions and follow-up studies unfold, akin to previous biotech scenarios where initial setbacks led to eventual success.

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CHICAGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- The Foundation for Sarcoidosis Research (FSR) expresses both solidarity and resolve as aTyr Pharma announced that its Phase 3 trial of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint but showed several encouraging results that suggest real potential for patients living with this rare disease. While the trial (conducted in 268 patients in the U.S., Europe, Japan, and Brazil) did not achieve the primary goal of reducing oral corticosteroid use compared to placebo, findings for other study outcome measures suggest that efzofitimod helped more patients completely withdraw from steroids and improved measures of quality of life alongside stable lung function, with a favorable safety profile. “We greatly appreciate the patients with sarcoidosis and their families who generously participated in the EFZO-FIT™ study. Their commitment made it possible to further essential research aimed at improving understanding and treatment of sarcoidosis,” said Mary McGowan, President and CEO of FSR. “FSR also thanks the investigators, clinical teams, and research partners who supported this study. FSR remains committed to advancing innovative research and ensuring patient perspectives are central to future trial design and drug development efforts. We look forward to learning more as aTyr takes deeper dives into the robust trial data that will allow us to learn more about sarcoidosis.” FSR encourages all stakeholders—patients, researchers, drug development companies, and regulators—to build upon the knowledge generated from this clinical trial as the largest interventional study completed in sarcoidosis thus far. Continued investment in patient-focused clinical trial design, natural history studies, and the inclusion of patient perspectives in defining outcome measures is essential to advance new, effective therapies. As aTyr plans to consult with the FDA regarding future options for efzofitimod, FSR looks forward to continuing to support this conversation and to ensure the inclusion of the patient perspective when considering next steps. FSR is grateful to aTyr Pharma for their commitment to prioritizing outcomes important to the patient community, as was strongly emphasized at FSR's Externally-Led Patient-Focused Drug Development meeting on sarcoidosis with the FDA in October 2024. "There remains an urgent need for a safe and effective treatment option to address the unmet needs of this underserved population," said Sanjay Shukla, aTyr CEO. “We are encouraged by the potential of efzofitimod to improve the lives of those living with sarcoidosis, and we are incredibly grateful to the patients, investigators, and patient advocacy organizations... who all contributed to this important study." FSR looks forward to exploring further into the EFZO-FIT™ trial data and collaborating with researchers, clinicians, and individuals living with sarcoidosis to learn as much as possible from this important research. This study provides valuable insights into the management of pulmonary sarcoidosis, underscoring the potential for therapies that meaningfully lessen steroid burden while preserving patient quality of life. About SarcoidosisSarcoidosis is a rare inflammatory disease characterized by granulomas—tiny clumps of inflammatory cells—that can form in one or more organs. 90% of patients living with sarcoidosis have lung involvement. Despite advances in research, sarcoidosis remains challenging to diagnose, with limited treatment options and no known cure. Approximately 175,000 people live with sarcoidosis in the United States. About the Foundation for Sarcoidosis ResearchThe Foundation for Sarcoidosis Research (FSR) is the leading international organization dedicated to finding a cure for sarcoidosis and improving care for those living with the disease through research, education, and support. For more information about FSR and its community programs, visit: www.stopsarcoidosis.org. About aTyr PharmaaTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com. Media Contact:Cathi Davis, Director of Communications and MarketingFoundation for Sarcoidosis Research312-341-0500cathi@stopsarcoidosis.org

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