OCUL Stock Surges Overnight Ahead Of Crucial Wet AMD Data Readout, Sanofi Takeover Buzz Builds

• The company is set to release topline results from its Phase 3 superiority trial of Axpaxli in wet AMD on Tuesday.
• Ocular previously said that positive results could support a New Drug Application submission shortly after year-one data.
• Axpaxli is designed to reduce the frequency of eye injections by delivering longer-lasting treatment.

Shares of Ocular Therapeutix, Inc. (OCUL) surged nearly 40% in overnight trading on Monday ahead of the company’s release of late-stage clinical data in wet age-related macular degeneration (AMD), a catalyst that analysts and investors have been closely tracking for months.

The results come at a time when Ocular Therapeutix has also been in focus following reports that Sanofi (SNY) is revisiting a potential acquisition of the eye drug developer, after an earlier approach at $16 per share was declined when the stock was trading near $10.5, implying a valuation of about $2.2 billion.

Phase 3 Wet AMD Readout Set for Tuesday

Ocular Therapeutix said it will announce topline results from its Phase 3 superiority trial evaluating Axpaxli for the treatment of wet AMD on Tuesday. 

The study is testing whether Axpaxli works better than a single injection of Aflibercept at helping patients maintain their vision. The company said in December that, if results are positive, it intends to submit a New Drug Application for Axpaxli in wet AMD shortly after year-one data from the Phase 3 study.

How Axpaxli Targets Wet AMD

Axpaxli is an experimental eye treatment delivered through an injection that slowly releases axitinib, a drug that helps block abnormal blood vessel growth. It is being developed to reduce how often patients need eye injections, potentially extending treatment intervals to six months or longer.

Ocular said the therapy could be the first of its kind for wet AMD, offering longer-lasting effects without changing how doctors currently give eye injections.

The company also said it plans to pursue a regulatory pathway that could potentially shorten the FDA review timeline. The Phase 3 program is being conducted under a Special Protocol Assessment agreement with the FDA, and the trial is focused on showing stronger results than the standard therapy, not just comparable outcomes.

Axpaxli Draws Strong Wall Street Support

Wall Street has steadily grown optimistic on Ocular Therapeutix ahead of the readout. Bank of America Securities, which reiterated a ‘Buy’ rating in December, said it remains “bullish” on Axpaxli’s differentiated value proposition in wet AMD and the potential for accelerated timelines, adding that CEO Pravin Dugel expressed “high confidence” ahead of the Axpaxli’s Phase 3 trial readout.

TD Cowen, which raised its price target to $20 from $14 in October while maintaining a ‘Buy’ rating, said optimism among key opinion leaders supports Axpaxli’s potential superiority label in wet AMD and added that its $1 billion peak sales estimate is conservative.

Among other analyst revisions in October, Piper Sandler lifted its price target to $31 from $21 and kept an ‘Overweight’ rating, cited increased confidence in Axpaxli’s wet AMD and diabetic retinopathy programs and raised its peak risk-adjusted sales estimates. Citizens JMP hiked its price target to $29 from $20 and maintained an ‘Outperform’ rating, saying Axpaxli represents a “potential blockbuster opportunity,” while wet AMD pivotal readouts are expected to drive near-term value creation.

Analysts from TD Cowen, Baird, and H.C. Wainwright have also pointed to Axpaxli’s durability profile, superiority trial design, and potential to reduce treatment burden in wet AMD as key drivers of their positive outlooks.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment for OCUL was in ‘extremely bullish’ territory amid ‘extremely high’ levels of message volume.

One user said, “will very likely announce positive topline data tomorrow. if buyout offer will be made i expect $22-28/share”

Another user said OCUL shares have hovered between $12 and $13 for months as investors positioned ahead of the Phase 3 wet AMD data, adding that the stock “could see a significant rise in PM BEFORE the results in anticipation of the release pop potential upon showing of superiority.”

OCUL stock has risen 19% over the past 12 months.

For updates and corrections, email newsroom[at]stocktwits[dot]com.

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