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ATyr Pharma To Meet FDA In Mid-April On Path For Efzofitimod In Pulmonary Sarcoidosis
RTTNews· 2026-02-03 16:38
Core Viewpoint - aTyr Pharma has received FDA acceptance for a Type C meeting to discuss the Phase 3 EFZO-FIT study results for efzofitimod in pulmonary sarcoidosis [1][2] Group 1: Meeting Details - The Type C meeting is scheduled for mid-April 2026 and will focus on reviewing clinical data and determining next steps for the efzofitimod program [1][2] - aTyr plans to provide an update after receiving the official meeting minutes [2] Group 2: Study Results - The EFZO-FIT study did not meet its primary endpoint; however, a clinical benefit was observed at the 5.0 mg/kg dose across multiple secondary measures [2] - Improvements were noted in patient-reported outcomes and maintenance of lung function, with a safety profile consistent with prior studies [3] Group 3: Market Reaction - aTyr's stock closed at $0.92, reflecting an increase of $0.05 or 5.17 percent on the Nasdaq [3]
aTyr Pharma Announces Scheduling of FDA Type C Meeting to Discuss Efzofitimod Program in Pulmonary Sarcoidosis
Globenewswire· 2026-02-03 13:00
Core Insights - aTyr Pharma is preparing for a meeting with the FDA in mid-April 2026 to discuss the Phase 3 EFZO-FIT™ study results for efzofitimod in treating pulmonary sarcoidosis [1][2] Group 1: Company Overview - aTyr Pharma, Inc. is a clinical stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform [1][4] - The company's lead therapeutic candidate, efzofitimod, is a novel biologic immunomodulator aimed at treating interstitial lung disease (ILD) [3][4] Group 2: Study Results - The Phase 3 EFZO-FIT™ study involved 268 patients with symptomatic pulmonary sarcoidosis [2] - Although the study did not meet its primary endpoint of reducing mean daily oral corticosteroid dose at week 48, clinical benefits were observed in several efficacy parameters, including: - Improvement in the King's Sarcoidosis Questionnaire (KSQ)-Lung score (p=0.0479) - Improvement in the Fatigue Assessment Scale score (p=0.0226) - Improvement in the KSQ-General Health score (p=0.0197) - Complete steroid withdrawal with KSQ-Lung score improvement (p=0.0196) [2] Group 3: Mechanism and Additional Studies - Efzofitimod selectively modulates activated myeloid cells through neuropilin-2, resolving inflammation without immune suppression and potentially preventing fibrosis progression [3] - In addition to the EFZO-FIT™ study, efzofitimod is also being investigated in the Phase 2 EFZO-CONNECT™ study for systemic sclerosis-related ILD [3]
Johnson Fistel Investigates Claims on Behalf of aTyr Pharma, Inc. (ATYR) Shareholders
Globenewswire· 2025-12-11 14:56
Core Viewpoint - Johnson Fistel, PLLP is investigating potential derivative claims on behalf of aTyr Pharma, Inc. related to alleged fiduciary breaches concerning the Phase 3 EFZO-FIT clinical trial disclosures [1][2] Investigation Background - The investigation covers the period from November 7, 2024, to September 12, 2025, focusing on allegations that aTyr and certain executives made false and/or misleading statements regarding the Phase 3 trial results [2][3] - Following the negative results from the Phase 3 trial, aTyr's stock price experienced a significant decline [2] Board Oversight - The investigation is examining whether aTyr's board failed to adequately oversee clinical disclosure controls and allowed overly optimistic representations that could expose the company to litigation and reputational risks [3] Shareholder Guidance - Current aTyr shareholders who held their shares continuously before November 7, 2024, may have the standing to pursue derivative claims on behalf of the company [2]
FINAL DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of aTyr Pharma
Businesswire· 2025-12-08 18:36
Core Viewpoint - aTyr Pharma, Inc. is facing a federal securities class action lawsuit due to allegations of making false and misleading statements regarding the efficacy of its drug Efzofitimod, which led to artificially inflated stock prices [1][2]. Group 1: Allegations and Impact - The complaint claims that aTyr Pharma and its executives provided overly positive statements while concealing material adverse facts about Efzofitimod's effectiveness, particularly its ability to allow patients to taper off steroid usage completely [2]. - In the EFZO-FIT study, efzofitimod did not demonstrate a significant change in mean daily oral corticosteroid (OCS) dose at week 48, with a reduction of 2.79 mg for the drug compared to 3.52 mg for placebo. Complete steroid withdrawal was achieved in 52.6% of patients treated with efzofitimod versus 40.2% on placebo [3]. - Following the release of the study results, aTyr Pharma's stock plummeted by 83.25%, dropping from a market close of $6.03 on September 12 to $1.01 on September 15 [3]. Group 2: Legal Proceedings - The deadline for investors to seek the role of lead plaintiff in the class action is December 8, 2025. The lead plaintiff is defined as the investor with the largest financial interest who directs the litigation on behalf of the class [1][4]. - Any member of the putative class can move the court to serve as lead plaintiff or choose to remain an absent class member, with no impact on their ability to share in any recovery [4]. Group 3: Additional Information - Faruqi & Faruqi, LLP is encouraging individuals with information regarding aTyr's conduct, including whistleblowers and former employees, to come forward [5]. - For more details about the class action, interested parties can visit the law firm's website or contact them directly [6].
ATYR DEADLINE ALERT: Hagens Berman Alerts aTyr Pharma (ATYR) Investors of Today's Lead Plaintiff Deadline in Securities Class Action
Globenewswire· 2025-12-08 18:02
Core Viewpoint - The article discusses a securities class action lawsuit against aTyr Pharma, Inc. following an 83% stock collapse due to the failure of its drug trial, highlighting allegations of misleading information provided by the company regarding the efficacy of its drug, Efzofitimod [1][2]. Legal Allegations - The lawsuit claims that aTyr and its executives misrepresented the efficacy of Efzofitimod, leading to inflated stock prices and subsequent losses for investors [2][3]. - The core issue revolves around whether the company accurately represented its clinical trial data and design, particularly regarding the drug's ability to allow patients to taper off steroid usage [3][4]. Trial Performance and Impact - The primary endpoint of the Phase 3 EFZO-FIT study was not met, specifically regarding the change in mean daily oral corticosteroid dose [5]. - Allegations include the concealment of adverse facts about the drug's performance, which could mislead investors about its true efficacy [5]. - Following the announcement of the trial results, aTyr's stock plummeted from $6.03 to $1.02, representing an 83.2% loss on September 15, 2025 [5]. Investor Guidance - Hagens Berman is advising investors who purchased aTyr shares between November 7, 2024, and September 12, 2025, and suffered losses to submit their claims by the December 8, 2025, deadline [6]. - The firm has a history of securing over $2.9 billion in settlements for investors in similar cases, emphasizing the importance of accurate disclosures in clinical trials [6][7].
ATYR LAWSUIT ALERT: The Gross Law Firm Notifies aTyr Pharma, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline
Prnewswire· 2025-12-08 14:00
Core Viewpoint - aTyr Pharma, Inc. is facing a class action lawsuit due to allegations of misleading statements regarding the efficacy of its drug Efzofitimod, which led to a significant stock price decline after the failure of a key clinical study [1][2]. Group 1: Allegations and Impact - The lawsuit claims that aTyr Pharma provided overly positive statements about Efzofitimod while concealing material adverse facts about its efficacy, particularly regarding the drug's ability to allow patients to taper off steroids completely [1]. - The truth about the drug's performance was revealed on September 15, 2025, when aTyr announced that the EFZO-FIT study did not meet its primary endpoint, specifically the change from baseline in mean daily OSC dose at week 48 [1]. - Following the announcement, aTyr's stock price plummeted from $6.03 per share on September 12, 2025, to $1.02 per share on September 15, 2025, marking a decline of 83.2% in just one day [1]. Group 2: Next Steps for Shareholders - Shareholders who purchased shares of aTyr during the specified class period are encouraged to register for the class action, with a deadline set for December 8, 2025 [2]. - Once registered, shareholders will be enrolled in a portfolio monitoring software to receive updates throughout the case lifecycle [2]. - There is no cost or obligation for shareholders to participate in the case [2]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors who have suffered due to deceit and illegal business practices [3]. - The firm aims to ensure that companies adhere to responsible business practices and seeks recovery for investors affected by misleading statements that artificially inflated stock prices [3].
ATYR DEADLINE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of aTyr Pharma
Newsfile· 2025-12-07 14:02
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against aTyr Pharma, Inc. due to allegations of misleading statements regarding the efficacy of its drug Efzofitimod, which led to significant financial losses for investors [2][4]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in aTyr between January 16, 2025, and September 12, 2025, to discuss their legal rights [1]. - There is a deadline of December 8, 2025, for investors to seek the role of lead plaintiff in a federal securities class action against aTyr [2]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [3]. Group 2: Allegations Against aTyr - The complaint alleges that aTyr and its executives violated federal securities laws by making false and misleading statements about Efzofitimod, particularly regarding its ability to allow patients to taper off steroid usage [4]. - In the EFZO-FIT study, efzofitimod showed no significant change in mean daily oral corticosteroid (OCS) dose at week 48, with a reduction of 2.79 mg for the drug compared to 3.52 mg for placebo [5]. - The study reported that complete steroid withdrawal was achieved in 52.6% of patients treated with efzofitimod versus 40.2% on placebo [5]. Group 3: Market Impact - Following the release of the study results, aTyr's stock price plummeted by 83.25%, dropping from a market close of $6.03 on September 12 to $1.01 on September 15 [5].
ATYR DEADLINE MONDAY: ROSEN, A GLOBALLY RESPECTED LAW FIRM, Encourages aTyr Pharma, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important December 8 Deadline in Securities Class Action - ATYR
Globenewswire· 2025-12-05 22:57
Core Viewpoint - Rosen Law Firm is reminding investors who purchased aTyr Pharma, Inc. common stock during the specified Class Period of the upcoming lead plaintiff deadline on December 8, 2025 [1]. Group 1: Class Action Details - Investors who bought aTyr Pharma common stock between January 16, 2025, and September 12, 2025, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - To participate in the class action, investors can visit the provided link or contact the law firm for more information [3][6]. - A lead plaintiff must file a motion with the Court by December 8, 2025, to represent other class members in the litigation [3]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in this area [4]. - The firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company, and has consistently ranked highly in terms of settlements since 2013 [4]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering funds for clients [4]. Group 3: Case Background - The complaint alleges that aTyr Pharma provided misleading statements regarding the efficacy of its drug Efzofitimod, particularly concerning its ability to allow patients to taper steroid usage completely [5]. - The lawsuit claims that when the true information became public, investors suffered damages due to the misleading nature of the statements made by the company [5].
ATYR 3-DAY DEADLINE ALERT: Hagens Berman Urges aTyr Pharma Investors to Act by Dec. 8 Deadline in Suit Over Trial Failure
Prnewswire· 2025-12-05 13:04
Core Viewpoint - A securities class action lawsuit has been filed against aTyr Pharma, Inc. following an 83% drop in stock price after the failure of its drug trial for Efzofitimod, which did not meet its primary endpoint [1][2][3]. Summary by Relevant Sections Allegations - The lawsuit claims that aTyr and its executives provided materially false and misleading information regarding the efficacy of Efzofitimod, leading to inflated stock prices [2][3]. - The firm alleges that aTyr concealed critical adverse facts about the drug's ability to allow patients to taper off steroids, which is a key measure of its efficacy [3][4]. Legal Focus - The primary legal focus is whether aTyr misrepresented the drug's true ability to help patients reduce steroid dependency, particularly in light of the failed primary endpoint in the Phase 3 EFZO-FIT study [5]. - The investigation is centered on the discrepancy between the company's optimistic public statements and the actual performance of the drug in clinical trials [4][5]. Market Impact - Following the announcement of the trial failure, aTyr's stock plummeted from $6.03 to $1.02, representing an 83.2% loss on September 15, 2025 [5]. - The lawsuit seeks to determine if investors are entitled to damages due to the alleged wrongful acts and omissions by the company [5]. Next Steps for Investors - Investors who purchased aTyr shares during the class period (November 7, 2024, through September 12, 2025) and experienced significant losses are encouraged to submit their claims by the December 8, 2025 deadline [6].
Deadline Soon: aTyr Pharma Inc. (ATYR) Shareholders Who Lost Money Urged To Contact The Law Offices of Frank R. Cruz About Securities Fraud Lawsuit
Businesswire· 2025-12-04 17:39
Group 1 - The article highlights the upcoming deadline of December 8, 2025, for investors to participate as lead plaintiffs in a securities fraud class action lawsuit against aTyr Pharma Inc. [1] - The lawsuit is on behalf of investors who acquired aTyr Pharma Inc. common stock during the class period from November 7, 2024, to September 12, 2025 [1] - The notice serves as a reminder for investors who lost money on aTyr Pharma Inc. to take action [1]