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H.C. Wainwright maintained a Buy rating with a price target of $5.00 on Clearside Biomedical (NASDAQ:CLSD). The firm's optimism is tied to the recent completion of the Phase 2b ODYSSEY trial for CLS-AX, an injectable suspension aimed at treating wet age-related macular degeneration (AMD (NASDAQ:AMD)). Clearside Biomedical had announced the final participant visit for the study on August 27, 2024, and is currently in the process of cleaning and verifying the study database.
The company has indicated that it plans to release topline data from this trial during the week of October 7, 2024. This announcement comes after a review of masked safety data by the Safety Review Committee in July, which reported no drug-related serious adverse events (SAEs), including endophthalmitis or retinal vasculitis.
This safety profile is significant as it suggests a favorable risk-benefit balance for CLS-AX.
Both arms of the ODYSSEY trial have completed six months of treatment, with re-dosing occurring as per protocol in the CLS-AX arm. The data collected from this re-dosing are expected to inform the design of a future Phase 3 pivotal program, which is a critical step in the development and potential approval process for new therapeutics.
The anticipation for the upcoming data release is high, as the results could potentially position Clearside Biomedical to advance CLS-AX into late-stage clinical trials. The company's progress and the positive safety review earlier in the year have contributed to the analyst's confidence in maintaining the stock's Buy rating and price target.
Clearside Biomedical has made significant strides in its operations and financial performance.
The company's Q1 2024 financial report revealed a net loss of $11.8 million, with operating expenses at $8 million, lower than the estimated $10 million. However, Clearside ended the quarter with $35 million in cash, providing financial stability into Q3 2025. The company's leading product candidate, CLS-AX, is currently in the Phase 2b ODYSSEY trial, with data readout expected in the third quarter of 2024.
Jones Trading, H.C. Wainwright, and JMP Securities have all maintained a positive rating on Clearside Biomedical. In addition, the company has appointed Glenn C. Yiu, M.D., Ph.D., to its Scientific Advisory Board and elected three directors at its annual meeting.
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