On Tuesday, Acelyrin Inc (NASDAQ:SLRN) shares, a clinical-stage biotech company with a market capitalization of $426 million, confirmed that its Phase 2b/3 study of izokibep for the treatment of uveitis did not achieve the primary endpoint, leading H.C. Wainwright to maintain a Neutral rating and an $8.00 price target on the company's shares.
According to InvestingPro data, the stock has declined over 45% year-to-date, with analyst price targets ranging from $6 to $20. The study aimed to measure the time to treatment failure against a placebo over a 24-week period but failed to meet the required statistical significance.
The trial, which involved 96 patients, compared the effects of izokibep with a placebo. Results showed a treatment failure rate of 45% for izokibep compared to 50.7% for the placebo at the 24-week mark, which was not statistically significant. InvestingPro analysis indicates the company maintains a strong liquidity position with a current ratio of 7.15, though it's currently experiencing rapid cash burn.
Furthermore, the study did not reach significance for any secondary endpoints, nor did it demonstrate clinical benefit. However, the safety profile of izokibep was consistent with previous studies, indicating good tolerability.
The outcome of the izokibep study contrasts with that of adalimumab, the only approved therapy for uveitis, which demonstrated a significant difference in time to treatment failure when compared to a placebo. Acelyrin had previously stated that it would only move forward with Phase 3 trials if izokibep showed superior data to adalimumab, a condition that was not met in the recent study.
Despite the trial results, H.C. Wainwright's valuation of Acelyrin remains unchanged. The firm had not assigned any probability of success (POS) for izokibep in the treatment of uveitis prior to the study results, viewing it as a high-risk/high-reward opportunity.
Acelyrin has projected that its cash runway will extend into mid-2027, and the funding for the Phase 2/3 trial had been incorporated into its previous guidance and operating plan. InvestingPro subscribers can access additional insights through the comprehensive Pro Research Report, which includes detailed analysis of the company's financial health, along with 8 more key ProTips about Acelyrin's current market position and future prospects.
In other recent news, Acelyrin's financial and clinical developments have been at the forefront. TD Cowen has maintained a Buy rating on Acelyrin's shares, emphasizing the progress of the biopharmaceutical company's lead program, lonafarnib (loni), for thyroid eye disease (TED). The Phase II study has completed its first three cohorts, with the fourth currently underway.
The firm also anticipates that Acelyrin will share Phase II data and Phase III trial design details in the first quarter, following a meeting with regulatory authorities. A significant milestone is expected next month with the Phase III readout for izokibep (izo), studied for the treatment of uveitis, aiming to demonstrate superior results to Humira, a current market treatment.
On the financial front, Acelyrin's third-quarter 2024 earnings call revealed a decrease in R&D expenses and an update on year-end cash guidance. The company ended Q3 with $562.4 million in cash, with year-end cash guidance updated to $435 million to $450 million.
Furthermore, Acelyrin is preparing to acquire global rights to lonigutamab for $31 million. These recent developments highlight Acelyrin's strategic focus on advancing its clinical pipeline and maintaining financial stability.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.