aTyr Pharma to Present Subgroup Analysis of Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis at WASOG 2026
Rhea-AI Summary
aTyr Pharma (Nasdaq: ATYR) reported a post hoc subgroup analysis from the Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, focusing on 44 patients with prespecified restrictive lung disease (FVC percent predicted ≤ 80%, FEV1/FVC ≥ 0.7).
According to aTyr Pharma, patients receiving 5.0 mg/kg efzofitimod showed a placebo-adjusted week 48 change from baseline in FVC of 123.8 ml using a random coefficient regression model, along with improvements across multiple patient-reported outcomes including KSQ-Lung, KSQ-General Health, Fatigue Assessment Scale and Leicester Cough Questionnaire. Steroid reduction in this dose arm was similar to placebo, and efzofitimod was generally well tolerated. In June 2026, the company submitted to the FDA a protocol for a planned Phase 3 study in chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease, using FVC as the primary endpoint and KSQ-Lung as the key secondary endpoint.
Positive
- 123.8 ml FVC benefit at week 48 for 5.0 mg/kg vs placebo by RCRM
- Multiple PROs improved (KSQ-Lung, KSQ-General Health, fatigue, cough) vs placebo at week 48
- Generally well tolerated safety profile in restrictive subgroup, similar to ITT population
- Protocol submitted to FDA in June 2026 for planned Phase 3 in restrictive pulmonary sarcoidosis
- Restrictive subgroup defined (FVCpp ≤ 80%, FEV1/FVC ≥ 0.7) with 44 patients analyzed
Negative
- Steroid reduction magnitude in 5.0 mg/kg arm was similar to placebo
- Efficacy signals based on post hoc analysis of a 44-patient restrictive subgroup
Market reaction after Phase 3 EFZO-FIT subgroup data: ATYR +9.94% in the Jul 15 session
In the Jul 15 session, ATYR gained 9.94%, reflecting a notable positive market reaction. Argus tracked a peak move of +4.4% during that session. Argus tracked a trough of -18.1% from its starting point during tracking. Our momentum scanner triggered 42 alerts that day, indicating elevated trading interest and price volatility. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Sep 30 | Phase 3 data update | Positive | -9.3% | Additional EFZO-FIT findings showed significant benefits on multiple secondary endpoints. |
| Sep 15 | Topline Phase 3 results | Negative | -83.2% | EFZO-FIT missed its primary endpoint on steroid dose reduction despite some positive secondary data. |
| Jul 22 | Trial milestone update | Neutral | -8.2% | Last patient visit completed in EFZO-FIT, the first global Phase 3 sarcoidosis trial. |
| Jun 04 | Phase 2 interim data | Positive | -4.6% | Interim EFZO-CONNECT data showed clinically important improvement in skin scores and safety. |
| Apr 29 | Preclinical oncology data | Positive | +3.4% | ATYR2810 preclinical GBM data showed anti-tumor activity and survival benefits in models. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial headlines have historically been followed by predominantly negative price moves for this stock, with an average move of -20.39% around such events.
Key Terms
forced vital capacity medical
fev1/fvc medical
patient-reported outcomes medical
intent-to-treat medical
mixed model for repeated measures technical
random coefficient regression model technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Patients with restrictive lung disease demonstrate clinically meaningful benefit in FVC and improvements in multiple PROs for 5.0 mg/kg efzofitimod compared to placebo.
Company submitted protocol to FDA in June 2026 for planned Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease.
SAN DIEGO, July 15, 2026 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the Company will present a subgroup analysis of the Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease, at the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) 2026 Congress, which is scheduled to take place July 15 – 17, 2026, in Porto, Portugal.
“This subgroup analysis of patients from EFZO-FIT™ with restrictive lung disease presents clear evidence that those treated with efzofitimod experienced a clinically meaningful benefit in lung function and positive trends of improvement in multiple patient-reported outcomes (PROs) while removing steroids,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr Pharma. “Following our recent interactions with the U.S. Food and Drug Administration (FDA), last month we submitted a protocol for a planned Phase 3 study in pulmonary sarcoidosis patients with restrictive lung disease (defined as forced vital capacity, or FVC, percent predicted ≤
Details of the poster presentation appear below. The poster will be available on the aTyr website once presented.
Title: Evaluating Efzofitimod in a Subset of Sarcoidosis with the Restrictive Phenotype
Authors: Vis Niranjan, Pavithra Ramesh, Sanjay Shukla, Nelson Kinnersley, Daniel A. Culver. RxMD, aTyr Pharma, Octa Consulting Services, Cleveland Clinic.
Poster Number: PO123
Session: Controversies in Sarcoidosis Treatment and Disease Progression
Date and Time: Thursday, July 16, 2026, at 1:15pm WEST
Location: Porto, Portugal
EFZO-FIT™ included 264 pulmonary sarcoidosis patients with all lung phenotypes who were enrolled and treated (intent-to-treat, or ITT). The post hoc analysis included a subset of 44 patients with prespecified restrictive lung disease (FVCpp ≤
About the EFZO-FIT™ study
EFZO-FIT™ was a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis with all lung phenotypes. The 52-week study consisted of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study enrolled 268 subjects (264 enrolled and treated) with pulmonary sarcoidosis at multiple centers in the United States, Europe, Japan and Brazil. The trial design incorporated a forced steroid taper. The primary endpoint of the study was steroid reduction at week 48. Secondary endpoints included measures of sarcoidosis symptoms and lung function at week 48.
About Pulmonary Sarcoidosis
Pulmonary sarcoidosis is an inflammatory disease characterized by the formulation of granulomas, clumps of inflammatory cells, in one or more organs of the body. Approximately 160,000 Americans are diagnosed with pulmonary sarcoidosis and the prognosis ranges from benign and self-limiting to chronic, debilitating disease, permanent loss of lung function and death. Current treatment options include corticosteroids and other immunosuppressive therapies, which have limited efficacy and are associated with serious side-effects that many patients cannot tolerate long-term.
About Efzofitimod
Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr recently submitted a protocol to the FDA for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
About aTyr
aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a novel 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as "anticipate," “believes,” “can,” “could,” “designed,” “expects,” “intends,” “may,” “plans,” “potential,” “upcoming,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, among others, statements regarding our continued development of efzofitimod in pulmonary sarcoidosis, the potential therapeutic benefits and applications of efzofitimod, our timelines and plans with respect to certain development activities and goals, the proposed design of our planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, including the success of the targeted endpoints and strategy to focus on a more limited patient population in demonstrating the potential for efzofitimod to improve lives, and our interpretation of the results of the EFZO-FIT™ study and the meaning of those interpretations for our planned Phase 3 study. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty related to interactions with the FDA in general, uncertainty regarding geopolitical and macroeconomic events, risks associated with the discovery, development and regulation of efzofitimod, the risks associated with targeting a more limited patient population in our planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, the risk that we or our partners may cease or delay preclinical or clinical development activities for efzofitimod for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing or future collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
| Contact: |
| Ashlee Dunston |
| Sr. Director, Investor Relations and Public Affairs |
| adunston@atyrpharma.com |
