This section highlights FDA-related milestones and regulatory updates for drugs developed by aTyr Pharma (LIFE).
Over the past two years, aTyr Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ATYR0101, ATYR2810, and Efzofitimod. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ATYR0101 FDA Regulatory Events
ATYR0101 is a drug developed by aTyr Pharma for the following indication: For the treatment of interstitial lung disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATYR0101
- Announced Date:
- November 15, 2024
- Indication:
- For the treatment of interstitial lung disease
Announcement
aTyr Pharma, Inc. announced that the Company will present two posters related to its tRNA synthetase candidate ATYR0101 at the Keystone Symposia on Fibrosis: Inflammation, Drivers, and Therapeutic Resolution, which is scheduled to take place December 8 – 11, 2024, in Whistler, British Columbia, Canada.
AI Summary
aTyr Pharma, Inc. announced that it will showcase two posters related to its tRNA synthetase candidate ATYR0101 at the upcoming Keystone Symposia on Fibrosis: Inflammation, Drivers, and Therapeutic Resolution. The event is scheduled from December 8 to 11, 2024, in Whistler, British Columbia, Canada.
The first poster, titled "A Newly Evolved Domain of Asp-tRNA Synthetase Interacts with Latent Transforming Growth Factor Beta Binding Protein 1 (LTBP-1) to Induce Myofibroblast Apoptosis," will be presented on Monday, December 9, 2024, at 7:30 p.m. PST. The second poster, "Anti-Fibrotic Activity Observed Across Preclinical Models of Pulmonary and Renal Fibrosis for a Potential Therapeutic Based on Asp-tRNA Synthetase," is also set for the same date and time.
These presentations highlight the company’s ongoing efforts in developing innovative therapies targeting fibrosis and inflammation.
Read Announcement
ATYR2810 FDA Regulatory Events
ATYR2810 is a drug developed by aTyr Pharma for the following indication: Non-small cell lung cancer tumor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATYR2810
- Announced Date:
- April 29, 2025
- Indication:
- Non-small cell lung cancer tumor
Announcement
aTyr Pharma, Inc. announced that the Company will present a poster featuring preclinical data for ATYR2810, a monoclonal antibody targeting neuropilin-2 (NRP2), at the American Association for Cancer Research (AACR) Annual Meeting 2025, which is being held April 25 – 30, 2025, in Chicago, IL.
AI Summary
aTyr Pharma, Inc. announced that it will present important preclinical data for its experimental drug ATYR2810 at the AACR Annual Meeting 2025. ATYR2810 is a monoclonal antibody that targets neuropilin-2 (NRP2), a key protein involved in the immunosuppressive tumor environment. The poster, which will be available on aTyr’s website after the presentation, highlights data from preclinical studies where ATYR2810 improved survival rates and boosted the effectiveness of checkpoint inhibitors in aggressive cancer models like glioblastoma multiforme (GBM).
The study shows that using ATYR2810 as a single agent and in combination with other therapies can help combat drug resistance by modulating immune cells in the tumor. The presentation will take place at the AACR Annual Meeting 2025 in Chicago, IL, from April 25 to 30, 2025.
Read Announcement
Efzofitimod FDA Regulatory Timeline and Events
Efzofitimod is a drug developed by aTyr Pharma for the following indication: Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Efzofitimod
- Announced Date:
- July 22, 2025
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc. announced that the last patient has completed their last visit in the Company's Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease.
AI Summary
aTyr Pharma, Inc. announced that the last patient has finished their final visit in the global Phase 3 EFZO-FIT™ study of efzofitimod for pulmonary sarcoidosis, a major form of interstitial lung disease. This is the first worldwide Phase 3 trial and the largest interventional study ever done for sarcoidosis patients.
The 52-week, randomized, double-blind, placebo-controlled trial enrolled 268 patients across the United States, Europe, Japan and Brazil. Participants received monthly infusions of either 3.0 mg/kg or 5.0 mg/kg of efzofitimod, or a matching placebo, for a total of 12 doses. The main goal is to measure steroid reduction, while secondary measures include sarcoidosis symptoms and lung function.
aTyr expects to report topline results in the third quarter of 2025. If successful, efzofitimod could lower steroid use and improve quality of life for patients with this chronic lung disease.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- June 4, 2025
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc. announced findings from an interim analysis of eight patients in the ongoing Phase 2 EFZO-CONNECT™ study evaluating its lead therapeutic candidate, efzofitimod, in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD).
AI Summary
aTyr Pharma, Inc. recently shared promising results from an interim analysis of its ongoing Phase 2 EFZO-CONNECT™ study. The study evaluated efzofitimod in patients with limited or diffuse systemic sclerosis (SSc)-related interstitial lung disease (ILD). In this analysis of eight patients, three out of four efzofitimod-treated diffuse SSc-ILD patients showed a meaningful improvement in the modified Rodnan Skin Score (mRSS) at 12 weeks, indicating lower skin fibrosis. Additionally, all patients demonstrated stable or improved mRSS scores, and efzofitimod was generally safe and well tolerated at all doses. The company is encouraged by these early indications and plans to continue evaluating the drug as patients progress to the 24-week endpoint, which will focus on lung function improvements.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- May 19, 2025
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc. announced three poster presentations for its lead therapeutic candidate, efzofitimod, at the American Thoracic Society (ATS) 2025 International Conference, which is being held May 16 – 21, 2025, in San Francisco, CA.
AI Summary
aTyr Pharma, Inc. announced that it will present three poster presentations on its lead candidate, efzofitimod, at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, CA, from May 16 to 21, 2025. The presentations showcase recent research on pulmonary sarcoidosis, with one poster highlighting real-world treatment patterns for patients using corticosteroids, another detailing the design and baseline characteristics of the ongoing Phase 3 EFZO-FIT™ study, and a third analyzing the incidence and prevalence of pulmonary sarcoidosis in the United States.
The Phase 3 study has enrolled a balanced cohort of patients with moderate to severe pulmonary sarcoidosis, underscoring the potential for efzofitimod as a transformative therapy. aTyr Pharma looks forward to sharing topline results in the third quarter of this year, emphasizing the candidate’s promise in addressing an area with significant unmet medical need.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- March 12, 2025
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc. announced a publication demonstrating the mechanism of action for its lead therapeutic candidate, efzofitimod, in the journal Science Translational Medicine.
AI Summary
aTyr Pharma, Inc. announced a key scientific publication in the journal Science Translational Medicine that validates the unique anti-inflammatory mechanism of its lead candidate, efzofitimod. The study demonstrates that efzofitimod acts on macrophages by binding to the neuropilin-2 (NRP2) receptor, which is notably present on myeloid cells in inflamed tissues. This binding triggers the downregulation of pro-inflammatory receptors and cytokines, reducing inflammation and fibrosis in lung tissue. The comprehensive preclinical data, detailed from concept through clinical application, strengthens the scientific rationale for using efzofitimod to treat interstitial lung disease (ILD), including conditions like pulmonary sarcoidosis. According to company leaders, this publication not only confirms the drug’s immunomodulatory activity but also supports its continued clinical development as a first-in-class therapeutic agent for chronic inflammatory lung conditions.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- March 6, 2025
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc announced the outcome of a fourth, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™ study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis.
AI Summary
aTyr Pharma, Inc. announced the outcome of its fourth pre-planned interim safety analysis for the ongoing Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis. An independent data and safety monitoring board (DSMB) reviewed the study and recommended that it continue without any modifications. This positive result further reinforces the favorable safety profile observed for the lead therapeutic candidate, efzofitimod.
The EFZO-FIT™ study is designed as a global, randomized, double-blind, placebo-controlled trial evaluating two different doses of efzofitimod administered once a month for 52 weeks. The key aim is to test the potential of efzofitimod as a chronic maintenance therapy that could reduce or eliminate the use of oral corticosteroids in pulmonary sarcoidosis patients. aTyr Pharma looks forward to sharing topline results in the third quarter of this year as the study continues to progress.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- December 10, 2024
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc announced the outcome of a third, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™ study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis.
AI Summary
aTyr Pharma announced positive results from a pre-planned interim safety analysis of its Phase 3 EFZO-FIT™ study, which is evaluating the safety and efficacy of efzofitimod in patients with pulmonary sarcoidosis. An independent data and safety monitoring board (DSMB) reviewed the study data from 268 patients around the globe and recommended that the study continues without any changes. This finding confirms that efzofitimod, the company’s lead therapeutic candidate and a first-in-class biologic immunomodulator, has demonstrated a favorable safety profile so far. The study aims to assess the drug’s potential to reduce or replace the toxic effects of traditional treatments like oral corticosteroids, possibly offering a better quality of life for patients with this chronic lung disease. The global trial is ongoing, involving multiple centers in the United States and other countries.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- October 2, 2024
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc. announced the publication of a post hoc analysis of the Phase 1b/2a clinical trial of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease, in the European Respiratory Journal.
AI Summary
aTyr Pharma, Inc. announced the publication of a post hoc analysis of their Phase 1b/2a trial in the European Respiratory Journal. The study focused on efzofitimod, their lead therapeutic candidate for treating pulmonary sarcoidosis, a common form of interstitial lung disease. The analysis compared patients receiving therapeutic doses (3.0 and 5.0 mg/kg) with those receiving subtherapeutic doses (1.0 mg/kg and placebo). Results showed that only 7.7% of patients in the therapeutic group experienced a relapse in corticosteroid use, versus 54.4% in the subtherapeutic group. Moreover, the time-to-first-relapse was significantly longer in the therapeutic group, suggesting that efzofitimod may help maintain disease control while reducing or even discontinuing corticosteroid use. This finding is important as it could lead to a treatment option that avoids the long-term side effects commonly associated with corticosteroids.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- July 22, 2024
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc. announced that Topline data from the study are expected in the third quarter of 2025.
AI Summary
aTyr Pharma, Inc. has completed enrollment for its global Phase 3 EFZO-FIT study, enrolling 268 patients across 85 centers in 9 countries. This study is the largest interventional trial ever conducted in pulmonary sarcoidosis, a serious form of interstitial lung disease with few treatment options. The therapy under investigation, efzofitimod, is designed to target activated myeloid cells to reduce inflammation without suppressing the immune system.
Topline data from the trial are expected in the third quarter of 2025. The upcoming results will be crucial in understanding efzofitimod’s safety and effectiveness in treating pulmonary sarcoidosis, potentially offering a groundbreaking option for patients who face limited alternatives. This milestone marks an important step forward in developing new treatment approaches for a condition that has long been associated with significant unmet medical needs.
Read Announcement- Drug:
- Efzofitimod
- Announced Date:
- July 22, 2024
- Indication:
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Announcement
aTyr Pharma, Inc. announced that it has completed enrollment in its global pivotal Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease with limited treatment options
AI Summary
aTyr Pharma, Inc. announced that it has successfully completed enrollment in its global pivotal Phase 3 EFZO-FIT™ study for efzofitimod, its lead candidate for treating pulmonary sarcoidosis. This condition is a major form of interstitial lung disease that currently offers limited treatment options. The study enrolled 268 patients from 85 centers across nine countries, marking the largest interventional study ever conducted in pulmonary sarcoidosis.
Researchers plan to release topline data in the third quarter of 2025. Efzofitimod is a tRNA synthetase–derived therapy that aims to reduce inflammation without causing immune suppression, potentially preventing further lung scarring. Study leaders and aTyr Pharma executives are hopeful that the trial will deliver valuable insights and offer a grounding for a transformative treatment option to address a significant unmet need in the sarcoidosis community.
Read Announcement
