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The Markets
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Pharma & Biotech

OKYO Pharma poised for breakout as Phase 2 trial nears results: analysts

Shares of OKYO Pharma Ltd (NASDAQ:OKYO) have nearly doubled since the start of the year, fueled by a string of clinical and regulatory milestones that may pave the way for a transformative treatment in the underserved field of ocular pain.

In a new note research report, Goldman Small Cap Research raised its price target on the stock to $8, up from $5, citing strong momentum, accelerated clinical progress, and growing interest from patients and clinicians alike in the company’s lead drug candidate, urcosimod.

OKYO is developing urcosimod as a potential first-in-class treatment for neuropathic corneal pain (NCP), a chronic and debilitating eye condition for which there are currently no FDA-approved therapies.

The condition affects tens of thousands worldwide and is marked by severe discomfort that resists conventional treatments.

A Phase 2 trial for urcosimod, launched in October 2024, was originally scheduled to complete enrollment of 48 patients by year-end. However, the company announced in April that it had elected to close enrollment early after treating 17 patients, in order to begin analyzing masked data and plan for the next phase of development—an unusual move analysts view as a bullish signal.

"This is a compelling set of observations that suggests a potential drug effect and illustrates the challenging condition in which the patients suffer and the need for the Fast Track designation by the FDA,” Goldman analysts wrote.

Top-line results from the trial are now expected in the first half of the third quarter, months ahead of the original schedule. If the results are favorable, OKYO is expected to request an End-of-Phase 2 meeting with the FDA, where future trial design, endpoints, and pathways to approval will be discussed.

Goldman estimates the market opportunity for NCP treatments could exceed $6.4 billion, highlighting the unmet need and the commercial potential for a first-approved therapy.

Interest in the trial has been “considerable,” according to the company, with numerous NCP patients inquiring about future participation or requesting compassionate use. OKYO is reportedly working with Tufts Medical Center to enable such access, pending FDA approval.

Looking ahead, Goldman believes that positive trial results combined with FDA engagement could fast-track urcosimod’s path to market and attract the attention of potential partners or acquirers in the ophthalmology space.

Shares of OKYO were up over 10% on Wednesday at around $2.28, meaning Goldman’s newly raised $8 price target implies significant upside from current levels.

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