ATYR

SAN DIEGO (AP) — SAN DIEGO (AP) — Atyr Pharma Inc. (ATYR) on Friday reported a loss of $10.8 million in its first quarter. The San Diego-based company said it had a loss of 11 cents per share. The company's shares closed at 56 cents. A year ago, they were trading at $3.03. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ATYR at https://www.zacks.com/ap/ATYR

Company to continue development of efzofitimod in pulmonary sarcoidosis following Type C meeting with the FDA. Company plans to submit an IND in June 2026 for a Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as primary endpoint and KSQ-Lung as key secondary endpoint. On track to complete enrollment in Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD in the first half of 2026. Ended the first quarter 2026 with $68.3 million in cash, cash equivalents, restricted cash and investments. SAN DIEGO, May 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 first quarter 2026 results and provided a corporate update. “2026 is off to a productive start, as we now have a clear path forward for efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following our recent Type C meeting with the U.S. Food and Drug Administration (FDA),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Based on feedback from the FDA, we plan to file an investigational new drug (IND) application next month for a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing forced vital capacity (FVC) as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as a key secondary endpoint. We look forward to the continued advancement of efzofitimod in this form of ILD where there remains a high unmet medical need.” First Quarter 2026 and Subsequent Period Highlights Announced plans to continue the development of efzofitimod in pulmonary sarcoidosis following a Type C meeting with the FDA to review the results of the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis. The Company plans to file an IND in June 2026 for a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as the primary endpoint of the study and the KSQ-Lung score as the key secondary endpoint. The Phase 3 trial is expected to be a global, randomized, double-blind, placeb...

Efzofitimod’s global Phase 3 EFZO‑FIT narrowly missed its primary steroid‑reduction endpoint because placebo steroid withdrawal was higher than expected, but the 5 mg/kg dose showed statistically significant quality‑of‑life improvements (KSQ lung), a positive steroid‑free+KSQ composite with dose response, preserved FVC versus placebo, and a favorable safety profile. aTyr has an FDA Type C meeting in mid‑April to review EFZO‑FIT; management says a filing would be “very challenging” after the primary miss and is preparing for the possibility the FDA will request another study, with any future trial likely to emphasize quality‑of‑life and pulmonary function endpoints by patient phenotype. The company’s platform leverages tRNA synthetase fragments to modulate innate immunity in inflammatory ILDs, is advancing ATYR0101 as a potential anti‑fibrotic and completing the Phase 2 EFZO‑CONNECT scleroderma‑ILD study, and reported roughly $80 million in cash at year‑end. Interested in aTyr Pharma, Inc.? Here are five stocks we like better. aTyr Pharma (NASDAQ:ATYR) CEO Sanjay Shukla outlined the company’s strategy to develop new therapies for inflammation and fibrosis based on tRNA synthetase biology during a presentation at the Leerink Partners Global Healthcare Conference. Shukla focused primarily on efzofitimod, the company’s lead program, including results from a global Phase 3 study in pulmonary sarcoidosis and the upcoming U.S. FDA Type C meeting planned for mid-April. Shukla said aTyr is translating biology related to tRNA synthetases—enzymes historically known for their role in attaching amino acids to tRNA—into a “new class of medicines.” He said the company’s research has identified that these enzymes can break into fragments that interact with the immune system, creating an opportunity to develop therapies that modulate inflammation and fibrosis. → Microsoft Positioned to Win AI Race With Dual-Model Strategy He positioned the approach as differentiated and focused on leveraging what he described as “evolutionary intelligence” embedded in human biology. aTyr’s near-term development focus is on interstitial lung diseases (ILDs) that have a significant inflammatory component, including sarcoidosis and scleroderma-related ILD, with a longer-term ambition to potentially expand into more fibrotic settings. Efzofitimod, a tRNA synthetase fragment-based therapy, is bei...

SAN DIEGO (AP) — SAN DIEGO (AP) — Atyr Pharma Inc. (ATYR) on Thursday reported a loss of $14 million in its fourth quarter. On a per-share basis, the San Diego-based company said it had a loss of 14 cents. The results beat Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 18 cents per share. For the year, the company reported that its loss widened to $74.1 million, or 80 cents per share. Revenue was nearly unchanged at $190,000. In the final minutes of trading on Thursday, the company's shares hit 90 cents. A year ago, they were trading at $3.15. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ATYR at https://www.zacks.com/ap/ATYR

Company scheduled to meet with the FDA in mid-April 2026 to review the results of the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis. Phase 2 EFZO-CONNECT™ study of efzofitimod in systemic sclerosis-related interstitial lung disease (SSc-ILD) on track to complete enrollment in the first half of 2026. Ended 2025 with $80.9 million in cash, cash equivalents, restricted cash and investments. SAN DIEGO, March 05, 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 fourth quarter and full year 2025 results and provided a corporate update. “In 2025 we announced results from our Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD) where a significant proportion of patients develop chronic or progressive disease with debilitating symptoms despite current treatment options. This marked an important milestone, not only for the broader sarcoidosis community, but also for aTyr, as it was the Company’s largest and first Phase 3 study of a tRNA synthetase-derived therapy generated from our platform,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “We are ready and look forward to engaging with the U.S. Food and Drug Administration (FDA) in mid-April to review the results of the study and determine the path forward for efzofitimod in pulmonary sarcoidosis. We plan to provide an update regarding the next steps for the program following the receipt of the official FDA meeting minutes.” Fourth Quarter 2025 and Subsequent Period Highlights Announced the scheduling of a Type C meeting with the FDA in mid-April 2026 to review the results of the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis. The Company expects to provide an update regarding the outcome of the meeting following the receipt of the official meeting minutes. EFZO-FIT™ was a Phase 3 study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod or placebo in 268 patients with symptomatic pulmonary sarcoidosis. The study did not meet its primary endpoint of change from baseline in mean daily oral corticoste...

Results reported for Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis. Company plans to meet with the FDA to determine path forward for efzofitimod in pulmonary sarcoidosis in the first quarter of 2026. Company expects to complete enrollment in Phase 2 EFZO-CONNECT™ study of efzofitimod in systemic sclerosis-related interstitial lung disease (SSc-ILD) in the first half of 2026. Ended the third quarter 2025 with $92.9 million in cash, cash equivalents, restricted cash and investments. SAN DIEGO, Nov. 06, 2025 (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 third quarter 2025 results and provided a corporate update. “In September, we announced results from our Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). While we did not meet the primary endpoint, efzofitimod is the first investigational therapy to exhibit improvements in quality of life across multiple disease-related health outcomes while also reducing steroid burden in patients with pulmonary sarcoidosis,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Treatment options for pulmonary sarcoidosis are limited and can include a significant reliance on the use of oral corticosteroids, which often have significant side effects. There remains an urgent need for a new safe and effective treatment for patients with chronic, symptomatic disease.” “Based on the findings from EFZO-FIT™, we believe there is drug activity for efzofitimod as evidenced by improvements across multiple clinically relevant efficacy measures. Based on this, coupled with the ongoing high unmet medical need in pulmonary sarcoidosis, we plan to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to review the results of the study and determine the path forward for efzofitimod in pulmonary sarcoidosis. We plan to provide an update regarding the next steps for the program following that meeting.” Third Quarter 2025 and Subsequent Period Highlights Reported results from the global Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod or placebo in 268 pa...

SAN DIEGO (AP) — SAN DIEGO (AP) — Atyr Pharma Inc. (ATYR) on Thursday reported a loss of $25.7 million in its third quarter. The San Diego-based company said it had a loss of 26 cents per share. The results did not meet Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 20 cents per share. The biotherapeutics company posted revenue of $190,000 in the period. In the final minutes of trading on Thursday, the company's shares hit 77 cents. A year ago, they were trading at $3.25. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ATYR at https://www.zacks.com/ap/ATYR

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 Sarcoidosis Sarcoidosis 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 Research The 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 Pharma aTyr 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 Marketing Foundation for Sarcoidosis Research 312-341-0500 [email protected]

Study did not meet primary endpoint in change from baseline in mean daily oral corticosteroid (OCS) dose at week 48, although clinical benefit for efzofitimod observed across multiple study parameters. 52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48 vs 40.2% on placebo (p=0.0919). Clinical improvement in King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 observed in the 5.0 mg/kg efzofitimod treatment group vs placebo (p=0.0479). Greater proportion of patients achieved complete steroid withdrawal at week 48 with a KSQ-Lung score improvement in the 5.0 mg/kg efzofitimod treatment group (29.5%) vs placebo (14.4%) (p=0.0199). Efzofitimod was well-tolerated with a consistent safety profile. Company plans to engage with the U.S. Food and Drug Administration (FDA) to determine the path forward for efzofitimod in pulmonary sarcoidosis. Management to host conference call and webcast today at 8:30am ET / 5:30am PT. SAN DIEGO, Sept. 15, 2025 (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 topline results from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease. The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid (OCS) dose at week 48. The change from baseline in mean daily OCS dose reduced to an average of 2.79 mg for 5.0 mg/kg efzofitimod vs 3.52 mg for placebo (p=0.3313). The study’s statistical analysis plan was designed on a hierarchical assessment basis, as such since the primary endpoint was not met, all subsequent statistical testing is reported as nominal findings. The study demonstrated a clinical improvement in the King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 for 5.0 mg/kg efzofitimod compared to placebo (p=0.0479), with a responder analysis of patients who achieved complete steroid withdrawal at week 48 with an improved KSQ-Lung score also showing improvement in patients treated with 5.0 mg/kg efzofitimod compared to placebo (p=0.0199). Lung function as measured by forced vital capacity (FVC) at week 48 was maintained. Based on these findings, which we bel...

aTyr Pharma, Inc. (NASDAQ:ATYR) is one of the Top 10 Stocks Under $10 That Could Triple. On August 22, Jefferies increased its price target for aTyr Pharma, Inc. (NASDAQ:ATYR) from $9 to $17 while keeping a Buy rating. This decision comes ahead of the Phase 3 trial results for aTyr Pharma, Inc.’s (NASDAQ:ATYR) lead candidate, efzofitimod. The company plans to release topline data from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis in mid-September 2025. Jefferies outlined three possible outcomes for the trial results. The firm sees a 37% chance of a strong positive result, showing a drop of more than 3mg in daily oral corticosteroid dose. According to the firm, this could cause aTyr Pharma, Inc.’s (NASDAQ:ATYR) stock price to rise by 3 to 5 times. The firm sees a 23% chance for base case results, with a 1.87 to 3mg reduction, which could push the stock price 1 to 3 times higher. Jefferies assigned a 40% probability to negative results from the study, which could see the stock price fall by up to 75%. Jefferies pointed out that there is a big unmet need for treatments for pulmonary sarcoidosis, which does not have any approved therapies yet. The firm noted that early Phase 1 and 2 proof-of-concept data showed encouraging signs, offering hope for positive outcomes in the Phase 3 trial. aTyr Pharma, Inc. (NASDAQ:ATYR) is a clinical-stage biotechnology company focused on using evolutionary intelligence and tRNA synthetase biology to develop new treatments for diseases involving fibrosis and inflammation. While we acknowledge the potential of ATYR as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Hot Mid Cap Stocks to Buy Now and 10 Best Affordable Stocks Under $50 to Buy. Disclosure: None. This article is originally published at Insider Monkey.

SAN DIEGO (AP) — SAN DIEGO (AP) — Atyr Pharma Inc. (ATYR) on Thursday reported a loss of $19.5 million in its second quarter. The San Diego-based company said it had a loss of 22 cents per share. The results missed Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of 18 cents per share. Atyr Pharma shares have climbed 45% since the beginning of the year. In the final minutes of trading on Thursday, shares hit $5.24, nearly tripling in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ATYR at https://www.zacks.com/ap/ATYR

Last patient visit completed in Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis; topline results expected in mid-September 2025. SAN DIEGO, Aug. 07, 2025 (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 second quarter 2025 results and provided a corporate update. “With the recent completion of the last patient visit in our Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), we are on track to report topline data in mid-September,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This upcoming readout represents a major inflection point for aTyr, our clinical program for efzofitimod in ILD, and the broader sarcoidosis community, and we look forward to sharing the results.” Second Quarter 2025 and Subsequent Period Highlights Completed the last patient visit in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. Topline data from the study are expected in mid-September 2025. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo administered intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis across 85 centers in nine countries. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction measured as the absolute change from baseline to week 48. Secondary endpoints include measures of sarcoidosis symptoms and lung function. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program. Announced interim data from the ongoing Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of thr...