H.C. Wainwright has reiterated its Buy recommendation and kept a $7.00 price target on OKYO Pharma Ltd. (NASDAQ:OKYO) following a productive Type C meeting with the U.S. Food and Drug Administration concerning the company’s Phase 2b/3 trial of urcosimod for neuropathic corneal pain (NCP).
Summary of regulatory feedback
During the meeting, FDA reviewers confirmed that OKYO’s proposed primary endpoint - reduction in pain measured by the Visual Analogue Scale (VAS) at Week 12 - is clinically meaningful. The agency specifically acknowledged that a ≥2-point improvement on the VAS scale constitutes a meaningful treatment effect. Regulators also provided statistical guidance intended to strengthen the study’s robustness, and they endorsed the overall trial design, including the company’s proposed sample size of 120 patients and the associated powering assumptions. In addition, the FDA agreed that the Ocular Pain Assessment Survey (OPAS) is appropriate to use as supportive quality-of-life evidence.
The agency reported alignment with OKYO Pharma on Chemistry, Manufacturing and Controls (CMC) strategy and key clinical elements, noting no material issues were raised during the meeting. With the FDA’s affirmative feedback in hand, OKYO plans to initiate the Phase 2b/3 trial in the first half of 2026.
Clinical access and mechanism notes
Separately, the FDA authorized a single-patient expanded access Investigational New Drug application for urcosimod at the University of South Florida, permitting compassionate use for a patient with severe NCP. OKYO has described urcosimod’s potential dual mechanism as targeting both immune-mediated inflammation and dysfunctional nerve signaling; the expanded access authorization was highlighted as consistent with that therapeutic rationale.
Market and financial snapshot
OKYO is currently trading at $2.19 and carries a market capitalization of $82.37 million. Analyst target prices for the stock range from $5 to $13, based on InvestingPro data. The company has not been profitable over the last twelve months, though it has delivered a 104.67% return over the past year. InvestingPro’s Fair Value metrics currently categorize OKYO as overvalued. OKYO’s next scheduled earnings report is expected on February 25, 2026. Additional financial details and six more ProTips are available through an InvestingPro subscription.
Implications
The FDA’s confirmation of the primary endpoint and endorsement of study design elements reduces a key regulatory unknown for OKYO’s clinical program in NCP and clears the path toward initiating the Phase 2b/3 study in the first half of 2026. The single-patient expanded access authorization provides a limited instance of real-world use under compassionate grounds, which the company has connected to urcosimod’s proposed mechanisms of action.
Summary
H.C. Wainwright’s maintained Buy rating and $7 price target come after the FDA validated OKYO’s primary endpoint, agreed with the proposed trial design and sample size, and raised no material concerns about CMC or other key elements. The company will move forward with its Phase 2b/3 trial in H1 2026 while managing financial and valuation considerations.
Key points
- FDA confirmed VAS pain reduction at Week 12 as a clinically meaningful primary endpoint; a ≥2-point improvement is considered meaningful.
- Regulators endorsed the study design, including a 120-patient sample size and powering assumptions, and agreed that OPAS can serve as supportive quality-of-life evidence.
- OKYO is trading at $2.19 with a market cap of $82.37 million; analyst targets range from $5 to $13 per InvestingPro data.
Risks and uncertainties
- Financial performance - The company was not profitable over the last twelve months, which may affect funding and operational flexibility.
- Valuation - InvestingPro’s Fair Value metrics list OKYO as overvalued, presenting market valuation risk for investors.
- Limited real-world data - The FDA-authorized expanded access is for a single patient, providing only a narrow instance of compassionate use and limited additional clinical evidence.