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Cantor Fitzgerald has reiterated its Overweight rating on aTyr Pharma (NASDAQ:ATYR) shares. The firm’s positive stance comes as aTyr Pharma anticipates a significant Phase 3 trial readout for its drug Efzofitimod, a modulator aimed at treating pulmonary sarcoidosis, a type of inflammatory lung disease, expected in the third quarter of 2025.
The analyst at Cantor Fitzgerald highlighted recent updates to the Phase 3 primary endpoint statistical analysis, made following feedback from the FDA, which could potentially increase the trial’s chances of success. According to the analyst, these modifications are crucial and may not be fully appreciated by the market. InvestingPro data shows strong analyst conviction, with price targets ranging from $9 to $35, suggesting significant upside potential.
Management at aTyr Pharma has indicated that this change is a notable positive development for the Phase 3 trial. They pointed out that the most significant benefits in steroid reduction when using Efzofitimod were observed at the conclusion of the Phase 1/2 trial.
In terms of placebo response, the company noted that by week 48, the absolute placebo steroid dose might align closely with what was seen in the Phase 1/2 trial—around 7.5 mg/day. The trial is designed with over 90% power to detect a difference in absolute steroid reduction of approximately 3 mg/day.
The company also expects that the variability in steroid reduction towards the end of the trial will decrease, which should further enhance the trial’s power. This reduction in variability is particularly important when measuring the drug’s efficacy in lowering steroid use among patients with pulmonary sarcoidosis. According to InvestingPro, aTyr maintains a healthy balance sheet with more cash than debt, though investors should note the company is currently unprofitable. Discover more insights and 8 additional ProTips by subscribing to InvestingPro’s comprehensive research platform.
In other recent news, aTyr Pharma reported its fourth-quarter and full-year 2024 financial results, revealing an earnings per share (EPS) of ($0.18) for the fourth quarter and ($0.86) for the full year. These figures surpassed both H.C. Wainwright’s estimates and consensus estimates, indicating a positive performance. The company also concluded the year with $75.1 million in cash reserves and raised an additional $18.1 million through its at-the-market offering facility, extending its cash runway beyond the anticipated EFZO-FIT readout. Meanwhile, Cantor Fitzgerald maintained its Overweight rating on aTyr Pharma, emphasizing the significance of upcoming clinical trial milestones for efzofitimod. Additionally, aTyr Pharma appointed Dalia R. Rayes as the new Head of Commercial for its global efzofitimod franchise, focusing on commercial strategy and operations. The company also received a favorable review from an independent data and safety monitoring board, recommending the continuation of its Phase 3 trial without modifications. Lastly, H.C. Wainwright reiterated a Buy rating with a $35.00 price target for aTyr Pharma, highlighting the potential impact of the forthcoming Phase 3 data.
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