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Investing.com - Cantor Fitzgerald downgraded aTyr Pharma (NASDAQ:ATYR) from Overweight to Neutral following the company’s announcement that its Phase 3 pulmonary sarcoidosis trial for efzofitimod failed to meet its primary endpoint. The $114 million market cap biotech company, which maintains a healthy balance sheet with more cash than debt and a strong current ratio of 5.63, saw its stock drop to $1.13.
The trial evaluated efzofitimod’s ability to reduce mean steroid dose from baseline at week 48, but did not achieve statistically significant results compared to placebo.
Cantor Fitzgerald cited limited confidence in the path forward for efzofitimod in pulmonary sarcoidosis, noting that all secondary endpoints were nominal, with many endpoints showing nominal p-values greater than 0.05.
The research firm also highlighted modest efficacy in key secondary endpoints, with only 10-15% improvement over placebo. For the important secondary endpoint of complete steroid withdrawal, 53% of patients in the high-dose arm were steroid-free compared to 40% on placebo.
aTyr plans to engage with the FDA to determine potential next steps for efzofitimod in pulmonary sarcoidosis despite these disappointing trial results.
In other recent news, aTyr Pharma announced that its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint. The trial, which involved 268 participants, aimed to achieve a statistically significant reduction in mean daily oral corticosteroid dose at week 48 compared to placebo. Despite the primary endpoint not being met, the study showed benefits across several secondary measures. Cantor Fitzgerald has reiterated its Overweight rating on aTyr Pharma, maintaining a positive outlook despite the trial results. Jefferies, on the other hand, raised its price target for aTyr Pharma to $17.00 from $9.00, keeping a Buy rating ahead of the Phase 3 trial results. The anticipated data from this trial is expected to be released in mid-September 2025. This trial focuses on aTyr’s lead drug candidate, efzofitimod, which targets tRNA synthetase and NRP2. The detailed findings are scheduled to be presented at the European Respiratory Society conference later that month.
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