OKYO PHARMA LTD Stock Price, News & Analysis

OKYO Pharma (NASDAQ: OKYO) has announced plans for an expanded clinical trial of urcosimod, its lead drug candidate for treating neuropathic corneal pain (NCP). Following successful Phase 2 results where 75% of patients showed over 80% pain reduction, the company will conduct a 100-patient multi-center clinical trial across multiple U.S. sites.

The new multiple-ascending-dose (MAD) trial aims to identify optimal dosing for Phase 3 trials and further understand urcosimod's micellar characteristics. The company expects topline data in 2026. With Fast-Track designation from the FDA, OKYO is preparing for regulatory discussions to define primary endpoints for potential registration.

OKYO Pharma (NASDAQ: OKYO) has secured $1.9 million in non-dilutive funding to accelerate the development of urcosimod, its lead drug candidate for treating Neuropathic Corneal Pain (NCP). The funding will support ongoing R&D programs and advance clinical milestones without impacting existing shareholder equity.

NCP is a severely debilitating ocular condition characterized by chronic nerve-related pain that currently has no FDA-approved treatments. The company will use the funds to advance clinical development, expand R&D efforts, and progress urcosimod's regulatory pathway, demonstrating its commitment to fiscal responsibility while developing innovative therapies.

OKYO Pharma (NASDAQ: OKYO) has announced positive Phase 2 clinical trial results for urcosimod in treating neuropathic corneal pain (NCP). The trial demonstrated that 75% of per-protocol patients receiving 0.05% urcosimod achieved over 80% reduction in pain after 12 weeks of treatment.

Key findings include a statistically significant reduction in mean pain scores (p-value = 0.025) for the 0.05% urcosimod group, with efficacy observed as early as Week 4. The drug showed particularly strong results in patients with moderate to severe NCP pain scores. Importantly, no serious adverse events were reported among the 18 trial participants.

The company plans to meet with the FDA to discuss next steps for urcosimod, which has already received Fast Track designation. OKYO is also planning to arrange an Expanded Access program for the drug, pending FDA approval.

Goldman Small Cap Research has issued an updated research report on OKYO Pharma Limited (NASDAQ:OKYO), raising its price target from $5.00 to $8.00. OKYO, a clinical-stage biopharma company focused on treatments for neuropathic corneal pain (NCP) and dry eye disease (DED), has seen its stock price double since January 2025. The company's lead drug candidate urcosimod received Fast Track designation and completed two Phase 2 trials - a 240-patient trial for DED and a 17-patient trial for NCP, with the latter concluding earlier than expected. Top-line results are now anticipated in Q3 2025, ahead of schedule. The early trial completion and accelerated data release timeline are viewed positively by analysts, who note the company's potential in the multi-billion-dollar ocular market and possibility for M&A activity in the space.

OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company, announced that CEO Gary S. Jacob will present at the Bio International Convention 2025 in Boston. The presentation will focus on urcosimod, the company's lead clinical drug candidate being developed to treat neuropathic corneal pain (NCP). NCP is a severe ocular condition affecting tens of thousands globally, causing chronic and severe eye discomfort, with no current FDA-approved treatment. The presentation will take place during the convention scheduled for June 16-19, 2025, at the Boston Convention & Exhibition Center.

OKYO Pharma (NASDAQ: OKYO) announced that CEO Gary S. Jacob will present at the 4th Annual GPCRs-Targeted Drug Discovery Summit in Boston on May 22, 2025. The presentation will focus on the development of urcosimod, the company's lead clinical drug candidate for treating neuropathic corneal pain (NCP).

NCP is a debilitating condition affecting tens of thousands worldwide, characterized by chronic, severe eye discomfort. Currently, there is no FDA-approved therapy for this condition. The presentation will take place at the Revere Hotel Boston Common and will detail urcosimod's targeting of CMKLR1 (ChemR23) for NCP treatment.

OKYO Pharma (NASDAQ: OKYO) has received Fast Track designation from the FDA for urcosimod (formerly OK-101) to treat neuropathic corneal pain (NCP). This designation will help expedite the development and review of urcosimod, potentially accelerating its path to market. NCP is a serious condition causing severe eye pain due to nerve damage, currently lacking FDA-approved treatments. The Fast Track status provides several benefits including more frequent FDA meetings, eligibility for Accelerated Approval and Priority Review, and possible Rolling Review of the New Drug Application. CEO Gary S. Jacob expressed enthusiasm about this milestone, emphasizing the company's commitment to advancing innovative therapies for patients.

OKYO Pharma announces plans to accelerate the development of urcosimod for treating Neuropathic Corneal Pain (NCP). The company is closing its Phase 2 trial early after 17 patients completed the study at Tufts Medical Center in Boston.

The trial, initiated in October 2024, was designed as a double-masked, randomized, 12-week placebo-controlled study. The decision to end early stems from OKYO's desire to analyze the current data and expand to a multicenter trial. Several patients who completed the trial have requested continued compassionate use of urcosimod.

The company expects data analysis to take approximately 6 weeks and plans to meet with the FDA to discuss accelerated development plans. Urcosimod has already shown favorable safety and placebo-like tolerability in a previous 240-patient Phase 2 trial. NCP currently has no FDA-approved therapy, making this development significant for patients who have had limited success with other treatments.

OKYO Pharma (NASDAQ: OKYO) has announced significant stability data for its drug candidate urcosimod, currently in Phase 2b clinical trials for Neuropathic Corneal Pain (NCP). The drug has demonstrated remarkable stability in single-use ampoules over a 2½-year period under refrigerated conditions, with stability rates of 94.8% for 0.05% concentration and 97.4% for 0.1% concentration.

The stability testing is a important requirement for FDA approval, addressing shelf-life concerns for the drug. Additionally, room temperature stability testing has shown promising early results, with 3-month stability rates at or above 100%. The company notes that single-use ampoules are increasingly preferred for ophthalmic drugs over plastic bottles, offering better sterility control for long-term daily administration.

Urcosimod is being evaluated in a randomized, placebo-controlled, double-masked trial involving 48 patients for NCP, a severe ocular condition currently lacking FDA-approved treatments. The drug has also shown potential in treating inflammatory dry eye disease (DED), a multi-billion-dollar market opportunity.