aTyr Pharma Sets Timeline for FDA Meeting
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4d ago
0mins
Should l Buy ATYR?
Source: seekingalpha
- FDA Meeting Scheduled: aTyr Pharma has announced a Type C meeting with the FDA in mid-April 2026 to discuss the results of its EFZO-FIT study for the lung disease candidate efzofitimod, marking a significant step in advancing the drug's development.
- Impact of Clinical Trial Failure: In September, aTyr's efzofitimod failed in a Phase 3 trial for pulmonary sarcoidosis, leading to a drop in the company's stock price and raising concerns about its research and development capabilities in the market.
- Market Reaction: Following the announcement of the FDA meeting timeline, aTyr's shares fell approximately 8% on Tuesday, reflecting investor uncertainty about the company's future, particularly after the clinical trial failure.
- Patient Impact: Pulmonary sarcoidosis affects around 200,000 Americans, and if aTyr can successfully advance efzofitimod, it would provide a new treatment option for this patient population, carrying significant social and economic implications.
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Analyst Views on ATYR
Wall Street analysts forecast ATYR stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ATYR is 7.33 USD with a low forecast of 1.00 USD and a high forecast of 20.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
1 Buy
3 Hold
0 Sell
Hold
Current: 0.811
Low
1.00
Averages
7.33
High
20.00
Current: 0.811
Low
1.00
Averages
7.33
High
20.00
About ATYR
aTyr Pharma, Inc. is a clinical-stage biotechnology company. The Company is leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. Its lead therapeutic candidate is efzofitimod, a first-in-class 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 (NRP2) to resolve aberrant inflammation without immune suppression and potentially prevent the progression of fibrosis. ATYR0101 is a fusion protein derived from a domain of aspartyl-tRNA synthetase (DARS). ATYR0750 is a fusion protein derived from the domain of alanyl-tRNA synthetase (AARS). ATYR0750 is a novel ligand to fibroblast growth factor receptor 4 (FGFR4).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
aTyr Pharma Sets Timeline for FDA Meeting
- FDA Meeting Scheduled: aTyr Pharma has announced a Type C meeting with the FDA in mid-April 2026 to discuss the results of its EFZO-FIT study for the lung disease candidate efzofitimod, marking a significant step in advancing the drug's development.
- Impact of Clinical Trial Failure: In September, aTyr's efzofitimod failed in a Phase 3 trial for pulmonary sarcoidosis, leading to a drop in the company's stock price and raising concerns about its research and development capabilities in the market.
- Market Reaction: Following the announcement of the FDA meeting timeline, aTyr's shares fell approximately 8% on Tuesday, reflecting investor uncertainty about the company's future, particularly after the clinical trial failure.
- Patient Impact: Pulmonary sarcoidosis affects around 200,000 Americans, and if aTyr can successfully advance efzofitimod, it would provide a new treatment option for this patient population, carrying significant social and economic implications.
See More
aTyr Pharma Schedules FDA Meeting for efzofitimod Review
- FDA Meeting Scheduled: aTyr Pharma has received FDA approval for a meeting in mid-April 2026 to discuss the results of its Phase 3 EFZO-FIT™ study for efzofitimod, which is expected to provide guidance for future development pathways.
- Clinical Trial Results: Although the EFZO-FIT™ study did not meet its primary endpoint, clinical benefits were observed for efzofitimod across multiple efficacy parameters in 268 patients, particularly with improvements in the KSQ-Lung score and Fatigue Assessment Scale, achieving p=0.0479 and p=0.0226, respectively.
- Safety and Tolerability: Efzofitimod demonstrated good maintenance of lung function and a safety profile consistent with prior trials, indicating its potential application in treating pulmonary sarcoidosis.
- Market Demand and Growth Potential: With increasing demand for safe and effective treatments for lung diseases, efzofitimod, as a novel biologic immunomodulator, may open new market opportunities in the interstitial lung disease space, addressing urgent patient needs.
See More
aTyr Pharma Faces Shareholder Lawsuit Investigation Over Phase 3 Trial Disclosures
- Lawsuit Investigation Launched: Johnson Fistel, PLLP is investigating potential derivative claims on behalf of aTyr Pharma, Inc. concerning fiduciary breaches related to disclosures from November 7, 2024, to September 12, 2025, which could impact the company's reputation and shareholder interests.
- Clinical Trial Results Impact: Following negative results from the Phase 3 EFZO-FIT clinical trial, aTyr's stock price dropped significantly, indicating management failures in clinical disclosure controls that may expose the company to litigation risks.
- Shareholder Rights Protection: Shareholders who have continuously held aTyr shares during the investigation period may have standing to pursue derivative claims on behalf of the company, aiming to protect their investment interests and seek compensation.
- Legal Firm Background: Johnson Fistel, PLLP is a nationally recognized shareholder rights law firm specializing in securities fraud and investor rights, providing legal support to help investors recover losses, highlighting its expertise in safeguarding shareholder interests.
See More
aTyr Pharma Faces Shareholder Derivative Claims Investigation Over Phase 3 Trial Disclosures
- Investigation Launched: Johnson Fistel, PLLP is investigating potential derivative claims on behalf of aTyr Pharma, Inc. concerning fiduciary breaches related to disclosures from November 7, 2024, to September 12, 2025, which may expose shareholders to significant losses.
- Clinical Trial Controversy: Allegations suggest that aTyr made false or misleading statements regarding the design and expectations of the Phase 3 EFZO-FIT trial, leading to a substantial drop in stock price following negative trial results, indicating management failures in clinical disclosure oversight.
- Shareholder Rights Protection: Current shareholders who held aTyr shares continuously before November 7, 2024, may have standing to pursue derivative claims, aiming to protect shareholder interests and seek potential compensation for losses incurred.
- Reputational Risk Heightened: The board's failure to oversee disclosures adequately could lead to broader legal repercussions, undermining investor confidence and negatively impacting the company's future financing capabilities.
See More
aTyr Pharma Class Action Notice: Lead Plaintiff Deadline December 8
- Class Action Notice: Rosen Law Firm reminds investors who purchased aTyr Pharma stock between January 16 and September 12, 2025, to apply as lead plaintiffs by December 8, 2025, to represent other shareholders in the litigation.
- Fee Arrangement: Investors joining the class action will incur no out-of-pocket costs, as attorney fees will be covered through a contingency fee arrangement, thereby reducing the financial burden on investors.
- Lawsuit Background: The complaint alleges that aTyr Pharma misled investors by providing overwhelmingly positive statements while concealing significant adverse facts regarding the efficacy of Efzofitimod, resulting in investor losses when the truth emerged.
- Law Firm Reputation: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, demonstrating its strength and expertise in handling such cases.
See More
aTyr Pharma Shares Plunge 83.2% Following EFZO-FIT Study Results
- Stock Price Plunge: aTyr Pharma's stock plummeted 83.2% from $6.03 to $1.02 on September 15, 2025, after announcing that the EFZO-FIT study failed to meet its primary endpoint, severely undermining investor confidence.
- Investor Alert: Following the study results, the Gross Law Firm issued a notice to shareholders encouraging those who purchased shares between November 7, 2024, and September 12, 2025, to contact them for potential lead plaintiff appointment, indicating increased legal risks.
- FDA Engagement Plan: aTyr announced plans to engage with the FDA to determine a path forward, reflecting the company's strategic response to adverse results and uncertainty regarding future developments.
- Legal Action Deadline: Shareholders must register for the class action by December 8, 2025, highlighting the legal challenges the company faces that could impact its future financial performance and market reputation.
See More
aTyr Pharma Sets Timeline for FDA Meeting
- FDA Meeting Scheduled: aTyr Pharma has announced a Type C meeting with the FDA in mid-April 2026 to discuss the results of its EFZO-FIT study for the lung disease candidate efzofitimod, marking a significant step in advancing the drug's development.
- Impact of Clinical Trial Failure: In September, aTyr's efzofitimod failed in a Phase 3 trial for pulmonary sarcoidosis, leading to a drop in the company's stock price and raising concerns about its research and development capabilities in the market.
- Market Reaction: Following the announcement of the FDA meeting timeline, aTyr's shares fell approximately 8% on Tuesday, reflecting investor uncertainty about the company's future, particularly after the clinical trial failure.
- Patient Impact: Pulmonary sarcoidosis affects around 200,000 Americans, and if aTyr can successfully advance efzofitimod, it would provide a new treatment option for this patient population, carrying significant social and economic implications.
See More
aTyr Pharma Schedules FDA Meeting for efzofitimod Review
- FDA Meeting Scheduled: aTyr Pharma has received FDA approval for a meeting in mid-April 2026 to discuss the results of its Phase 3 EFZO-FIT™ study for efzofitimod, which is expected to provide guidance for future development pathways.
- Clinical Trial Results: Although the EFZO-FIT™ study did not meet its primary endpoint, clinical benefits were observed for efzofitimod across multiple efficacy parameters in 268 patients, particularly with improvements in the KSQ-Lung score and Fatigue Assessment Scale, achieving p=0.0479 and p=0.0226, respectively.
- Safety and Tolerability: Efzofitimod demonstrated good maintenance of lung function and a safety profile consistent with prior trials, indicating its potential application in treating pulmonary sarcoidosis.
- Market Demand and Growth Potential: With increasing demand for safe and effective treatments for lung diseases, efzofitimod, as a novel biologic immunomodulator, may open new market opportunities in the interstitial lung disease space, addressing urgent patient needs.
See More
aTyr Pharma Faces Shareholder Lawsuit Investigation Over Phase 3 Trial Disclosures
- Lawsuit Investigation Launched: Johnson Fistel, PLLP is investigating potential derivative claims on behalf of aTyr Pharma, Inc. concerning fiduciary breaches related to disclosures from November 7, 2024, to September 12, 2025, which could impact the company's reputation and shareholder interests.
- Clinical Trial Results Impact: Following negative results from the Phase 3 EFZO-FIT clinical trial, aTyr's stock price dropped significantly, indicating management failures in clinical disclosure controls that may expose the company to litigation risks.
- Shareholder Rights Protection: Shareholders who have continuously held aTyr shares during the investigation period may have standing to pursue derivative claims on behalf of the company, aiming to protect their investment interests and seek compensation.
- Legal Firm Background: Johnson Fistel, PLLP is a nationally recognized shareholder rights law firm specializing in securities fraud and investor rights, providing legal support to help investors recover losses, highlighting its expertise in safeguarding shareholder interests.
See More
aTyr Pharma Faces Shareholder Derivative Claims Investigation Over Phase 3 Trial Disclosures
- Investigation Launched: Johnson Fistel, PLLP is investigating potential derivative claims on behalf of aTyr Pharma, Inc. concerning fiduciary breaches related to disclosures from November 7, 2024, to September 12, 2025, which may expose shareholders to significant losses.
- Clinical Trial Controversy: Allegations suggest that aTyr made false or misleading statements regarding the design and expectations of the Phase 3 EFZO-FIT trial, leading to a substantial drop in stock price following negative trial results, indicating management failures in clinical disclosure oversight.
- Shareholder Rights Protection: Current shareholders who held aTyr shares continuously before November 7, 2024, may have standing to pursue derivative claims, aiming to protect shareholder interests and seek potential compensation for losses incurred.
- Reputational Risk Heightened: The board's failure to oversee disclosures adequately could lead to broader legal repercussions, undermining investor confidence and negatively impacting the company's future financing capabilities.
See More
aTyr Pharma Class Action Notice: Lead Plaintiff Deadline December 8
- Class Action Notice: Rosen Law Firm reminds investors who purchased aTyr Pharma stock between January 16 and September 12, 2025, to apply as lead plaintiffs by December 8, 2025, to represent other shareholders in the litigation.
- Fee Arrangement: Investors joining the class action will incur no out-of-pocket costs, as attorney fees will be covered through a contingency fee arrangement, thereby reducing the financial burden on investors.
- Lawsuit Background: The complaint alleges that aTyr Pharma misled investors by providing overwhelmingly positive statements while concealing significant adverse facts regarding the efficacy of Efzofitimod, resulting in investor losses when the truth emerged.
- Law Firm Reputation: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, demonstrating its strength and expertise in handling such cases.
See More
aTyr Pharma Shares Plunge 83.2% Following EFZO-FIT Study Results
- Stock Price Plunge: aTyr Pharma's stock plummeted 83.2% from $6.03 to $1.02 on September 15, 2025, after announcing that the EFZO-FIT study failed to meet its primary endpoint, severely undermining investor confidence.
- Investor Alert: Following the study results, the Gross Law Firm issued a notice to shareholders encouraging those who purchased shares between November 7, 2024, and September 12, 2025, to contact them for potential lead plaintiff appointment, indicating increased legal risks.
- FDA Engagement Plan: aTyr announced plans to engage with the FDA to determine a path forward, reflecting the company's strategic response to adverse results and uncertainty regarding future developments.
- Legal Action Deadline: Shareholders must register for the class action by December 8, 2025, highlighting the legal challenges the company faces that could impact its future financial performance and market reputation.
See More
