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ATyr Pharma, Inc. (ATYR) Announces Top Line Results For The Phase III EFZO-FIT Study Of Efzofitimod In Pulmonary Sarcoidosis (Transcript)
Seeking Alpha· 2025-09-15 17:16
PresentationIt is now my pleasure to hand the conference call over to Ashlee Dunston, aTyr's Senior Director of Investor Relations and Public Affairs. Ms. Dunston, you may begin.Good morning, ladies and gentlemen, and welcome to aTyr Pharma conference call to review the top line results for the Phase III EFZO-FIT study of efzofitimod in pulmonary sarcoidosis. [Operator Instructions] As a reminder, this conference is being recorded for replay purposes.Ashlee DunstonDirector of Investor Relations & Corporate ...
aTyr Pharma, Inc. Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – ATYR
Businesswire· 2025-09-15 16:06
LOS ANGELES--(BUSINESS WIRE)---- $ATYR--aTyr Pharma, Inc. Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – ATYR. ...
ATyr Pharma Stock Sinks, Plans FDA Review After Mixed Phase 3 Results
Benzinga· 2025-09-15 15:24
Biotech firm aTyr Pharma Inc. ATYR plummeted over 81% at last check on Monday, with a session volume of 34.7 million compared to the average volume of 4.83 million as per data from Benzinga Pro.In other words, many investors are selling. Why? The company’s Phase 3 trial results of its drug efzofitimod for pulmonary sarcoidosis, and the trial failed its primary endpoint.The trial involved 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease. ATyr will reportedly engage the Feder ...
BREAKING: aTyr Pharma Shares Plummet 80%; Investors Should Contact Block & Leviton to Potentially Recover Losses
Globenewswire· 2025-09-15 14:57
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 ...
aTyr Pharma (NasdaqCM:ATYR) Update / Briefing Transcript
2025-09-15 13:32
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.
New Mountain Finance, Texas Instruments, Analog Devices And Other Big Stocks Moving Lower In Monday's Pre-Market Session
Benzinga· 2025-09-15 12:05
U.S. stock futures were higher this morning, with the Dow futures gaining more than 50 points on Monday.Shares of New Mountain Finance Corporation NMFC fell sharply in pre-market trading.B of A Securities analyst Derek Hewett downgraded New Mountain Finance from Buy to Underperform and cut the price target from $11.75 to $10.New Mountain Finance shares dipped 4.4% to $10.01 in the pre-market trading session.Here are some other stocks moving lower in pre-market trading.Kindly MD Inc NAKA shares tumbled 37.1% ...
aTyr Pharma's lung disease drug misses main goal in late-stage trial
Reuters· 2025-09-15 11:55
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... ...
aTyr Pharma Announces Topline Results from Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis
Globenewswire· 2025-09-15 11:30
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 ...
Lead Therapy Trial Fuels aTyr Pharma’s (ATYR) Promising Upside, Leerink Stays Bullish
Yahoo Finance· 2025-09-11 07:31
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 ...
aTyr Pharma, Inc.(ATYR) - 2025 Q2 - Quarterly Report
2025-08-07 20:07
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 ...