Ocular Therapeutix's (OCUL) regulatory plans for Axpaxli in wet age-related macular degeneration remain on track, with a pre-new drug application scheduled for Q3, an NDA filing planned for Q4, and a potential commercial launch in 2027, RBC Capital Markets said in a note Monday.
RBC noted that EyePoint's (EYPT) first wet AMD readout is due soon and expects Ocular's data to receive a positive reaction if the competitor's data meets expectations or is mixed.
However, the brokerage is more cautious about the initial share reaction if EyePoint misses on efficacy or significantly exceeds expectations, according to the note.
RBC sees 20% weighted-average upside potential into the EyePoint data, and continues to see room for both tyrosine kinase inhibitors, if approved. It currently expects Axpaxli to generate peak US revenue of $1.2 billion, and assumes competition from EyePoint.
Ocular already has in-house manufacturing in place for Axpaxli, with sufficient doses to satisfy the initial launch, and plans to expand manufacturing sites further to support a future launch expansion into diabetic retinopathy, the note said.
RBC kept an outperform speculative risk rating at Ocular Therapeutix with a price target of $30.
Price: 8.57, Change: +0.16, Percent Change: +1.96
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