BOSTON, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating aTyr Pharma, Inc. (Nasdaq: ATYR) for potential securities law violations. Investors who have lost money in their aTyr Pharma, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/atyr. What is this all about? Block & Leviton is investigating aTyr Pharma after the company announced that its Phase 3 trial for efzofitimod, an experimental ...

Summary of aTyr Pharma Conference Call on EFZO-FIT Study Results Company and Industry - **Company**: aTyr Pharma - **Industry**: Biopharmaceuticals, specifically focusing on treatments for pulmonary sarcoidosis Core Findings and Arguments 1. **Study Overview**: The Phase 3 EFZO-FIT study evaluated efzofitimod in patients with pulmonary sarcoidosis, a significant form of interstitial lung disease [4][7] 2. **Primary Endpoint**: The study did not meet its primary endpoint of reducing mean daily oral corticosteroid (OCS) dose at week 48, despite showing positive impacts on quality of life and lung function [4][19] 3. **Steroid Withdrawal**: 52.6% of patients on 5 mg/kg efzofitimod achieved complete steroid withdrawal at week 48, compared to 40.2% on placebo [4][11] 4. **Quality of Life Improvement**: The King's Sarcoidosis Questionnaire (KSQ) Lung Score showed significant improvement, with a 10.36 point increase in the 5 mg/kg group versus 6.19 points in placebo [13][15] 5. **Lung Function Maintenance**: Forced Vital Capacity (FVC) was largely maintained across treatment groups, with minimal declines observed [16][17] 6. **Safety Profile**: Efzofitimod was well tolerated, with adverse events mostly mild to moderate and balanced across treatment groups [17][18] 7. **High Placebo Response**: A higher than expected placebo response (40.2% achieving steroid-free status) impacted the primary endpoint results, attributed to the rigorous protocol of bi-weekly assessments [12][23] Additional Important Insights 1. **Regulatory Engagement**: aTyr Pharma plans to engage with the FDA to discuss the path forward for efzofitimod, emphasizing the need for effective treatments in an underserved patient population [19][29] 2. **Protocol Rigor**: The study's design, including bi-weekly patient assessments, may have contributed to the high placebo response and could influence future treatment guidelines [12][60] 3. **Future Directions**: The company aims to analyze additional data, including quality of life and biomarker assessments, before meeting with the FDA [37][64] 4. **Cash Position**: aTyr Pharma reported having $113 million in cash, indicating a strong financial position for ongoing operations and regulatory discussions [42] This summary encapsulates the key points from the conference call regarding the Phase 3 EFZO-FIT study results, highlighting both the achievements and challenges faced by aTyr Pharma in the development of efzofitimod for pulmonary sarcoidosis.

Group 1: Market Overview - U.S. stock futures were higher, with Dow futures gaining more than 50 points on Monday [1] - New Mountain Finance Corporation shares fell sharply in pre-market trading, dipping 4.4% to $10.01 after a downgrade from Buy to Underperform by B of A Securities analyst Derek Hewett, with a price target cut from $11.75 to $10 [1] Group 2: Notable Stock Movements - Kindly MD Inc shares tumbled 37.1% to $1.75 in pre-market trading after a 30% drop on Friday [3] - aTyr Pharma Inc shares fell 19.7% to $4.84 after gaining around 15% on Friday [3] - GlucoTrack, Inc. shares dipped 17.4% to $8.73 after a significant jump of 117% on Friday due to a purchase agreement announcement [3] - Hang Feng Technology Innovation Co., Ltd. shares declined 17.4% to $10.16 after a 209% gain on Friday following its IPO pricing [3] - Akso Health Group shares fell 16.4% to $1.60 after a more than 4% gain on Friday [3] - YD Bio Ltd shares declined 9.1% to $21.00 after a 13% gain on Friday [3] - Texas Instruments Incorporated shares declined 2.9% to $177.35 amid reports of an anti-dumping investigation by the Chinese Ministry of Commerce into American-made analog IC chips [3] - Analog Devices, Inc. shares fell 2.7% to $238.63, also related to the same anti-dumping investigation [3]

aTyr Pharma said on Monday its experimental drug had failed to meet the main goal in a late-stage study testing it in patients with a type of lung disease known as pulmonary sarcoidosis, a disease imp... ...

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 proport ...

aTyr Pharma Inc. (NASDAQ:ATYR) is one of the best multibagger stocks to invest in right now. On August 22, Leerink Partners’ Faisal Khurshid reiterated a Buy rating on aTyr Pharma Inc. (NASDAQ:ATYR) with a $16 price target. His view reflects optimism around the EFZO-FIT trial, which is testing efzofitimod as a potential treatment for pulmonary sarcoidosis. Lead Therapy Trial Fuels aTyr Pharma (ATYR) Promising Upside, Leerink Stays Bullish Tonhom1009/Shutterstock.com Khurshid highlights that feedback fro ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37378 ATYR PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-3435077 (State or other jurisdiction ...

Topline results expected in the third quarter of 2025. SAN DIEGO, July 22, 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 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 ...

Efzofitimod for Interstitial Lung Disease (ILD) - Efzofitimod is a first-in-class biologic immunomodulator in Phase 3 development for ILD, addressing a significant unmet medical need[10] - aTyr is advancing Efzofitimod as the standard-of-care for ILD, which encompasses over 200 types of rare lung diseases[11, 13] - The company's current focus is estimated at a $2-5 billion global market opportunity[13] - Efzofitimod is positioned to be the first approved product for sarcoidosis in over 60 years[31] Clinical Development and Trial Design - Phase 3 catalyst for multi-billion dollar indication in Q3 2025[6] - The Phase 3 EFZO-FIT study in pulmonary sarcoidosis is fully enrolled with 268 patients, and topline data is expected in Q3 2025[50] - Interim data from the Phase 2 EFZO-CONNECT study in SSc-ILD is expected in Q2 2025[70] - The addressable population for Efzofitimod in sarcoidosis is estimated to be 50-75% of all sarcoidosis patients[28] Financial Position and Pipeline - The company had approximately $68.9 million in cash, restricted cash, cash equivalents, and investments as of Q3 2024, with an additional $19.4 million raised subsequently[70] - The company's cash runway extends through the filing of a Biologics License Agreement (BLA) for efzofitimod in pulmonary sarcoidosis[70]

Group 1 - aTyr Pharma, Inc. is expected to be added to the Russell 2000 Index and the Russell 3000 Index effective after the U.S. market close on June 27, 2025, as part of the 2025 Russell U.S. Indexes annual reconstitution [1] - The Russell 3000 Index tracks the performance of the largest 3,000 publicly traded U.S. companies, while the Russell 2000 Index focuses on small-cap companies [2] - Membership in the Russell Indexes lasts for one year and results in automatic inclusion in appropriate growth and value style indexes, which are utilized by investment managers and institutional managers [2] Group 2 - aTyr is a clinical stage biotechnology company that focuses on developing first-in-class medicines from its proprietary tRNA synthetase platform [4] - The company's lead therapeutic candidate is efzofitimod, which is in clinical development for treating interstitial lung disease, a group of immune-mediated disorders [4]