Strong Buy Rating for Ocular Therapeutix Backed by Enhanced Regulatory Pathway and Promising Axpaxli Trial Data

Needham analyst Serge Belanger has maintained their bullish stance on OCUL stock, giving a Buy rating on December 12.

Serge Belanger has given his Buy rating due to a combination of factors including the updated regulatory approach for Ocular Therapeutix’s key development candidate, Axpaxli, in treating wet age-related macular degeneration (wAMD). The company’s regulatory strategy aligns with the FDA’s revised requirements, which streamline the approval pathway by necessitating only a single registrational trial. This adjustment enhances the significance of the Phase 3 SOL-1 trial, whose results are expected in the first quarter of 2026.
The trial’s design, supported by the Special Protocol Assessment (SPA), increases the likelihood of achieving its primary endpoint of visual acuity maintenance at nine months. If Axpaxli demonstrates approximately a 15% improvement over its comparator, Eylea, it could secure FDA approval and a superiority claim, potentially boosting investor confidence. Belanger considers this clinical data crucial, as achieving performance metrics like 50%-70% visual acuity maintenance would underline Axpaxli’s competitive advantages, particularly its extended duration of efficacy. These factors collectively establish a strong case for recommending Ocular Therapeutix’s stock with a Buy rating.

In another report released on December 12, Bank of America Securities also maintained a Buy rating on the stock with a $21.00 price target.

Based on the recent corporate insider activity of 42 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of OCUL in relation to earlier this year.