-- Ocular Therapeutix (OCUL) is moving closer to a potential US Food and Drug Administration filing for axpaxli, its long-acting treatment for wet age-related macular degeneration, as regulators begin formal discussions on a single-trial approval path, RBC Capital Markets said Tuesday in a report.
Management said talks with the FDA are now ongoing, raising the possibility of submitting an application based on the company's successful pivotal study, rather than waiting for a second trial that is due to read out in early 2027, RBC said.
The company plans to provide additional regulatory and program updates at an investor day on June 17, RBC said.
Ocular continues to target a potential 2027 launch for axpaxli under a single-trial filing strategy, and RBC reiterated its view that the drug has a "positive benefit/risk profile."
RBC maintained its rating of outperform, speculative risk, on Ocular stock with a $30 price target.
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