Strategic Early Approval Pathway for Ocular Therapeutix’s Axpaxli Bolsters Buy Rating

William Blair analyst Lachlan Hanbury Brown has maintained their bullish stance on OCUL stock, giving a Buy rating on December 5.

Lachlan Hanbury Brown has given his Buy rating due to a combination of factors surrounding Ocular Therapeutix’s strategic plans for their Axpaxli drug. The company intends to file for approval of Axpaxli for treating neovascular AMD based on the SOL-1 study results, which could significantly speed up the approval process by over a year compared to previous plans. This early submission aligns with recent FDA comments supporting approvals based on single Phase III studies, potentially positioning Axpaxli as the first long-acting TKI to market.
Despite uncertainties regarding the FDA’s requirements for this expedited pathway, the potential for early approval is seen as a significant value driver for the company. Even if the initial application encounters setbacks, such as a Complete Response Letter, it is unlikely to impact the timeline for resubmission following the SOL-R study results in 2027. Therefore, the risk associated with an early submission is considered minimal, reinforcing the Buy rating.

In another report released on December 5, Piper Sandler also maintained a Buy rating on the stock with a $31.00 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.