OKYO PHARMA LTD Stock Price, News & Analysis

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 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.

OKYO Pharma (NASDAQ: OKYO) has filed an application for Fast Track designation with the FDA for its drug urcosimod (formerly OK-101) to treat neuropathic corneal pain. This condition, affecting tens of thousands globally, is characterized by chronic, severe eye discomfort with no current FDA-approved treatment.

The company is developing urcosimod for both neuropathic corneal pain and inflammatory dry eye disease, the latter representing a multi-billion-dollar market opportunity. Fast Track designation is designed to expedite the development and review process for drugs treating serious conditions that lack FDA-approved treatments.

OKYO Pharma (NASDAQ: OKYO) announced that its lead drug candidate OK-101 has been officially assigned the United States Adopted Name (USAN) 'urcosimod'. The drug is currently in Phase 2 clinical trials for neuropathic corneal pain (NCP), a condition without FDA-approved treatments, and has shown promising results in Phase 2 trials for inflammatory dry eye disease (DED).

Urcosimod is a lipid-conjugated small molecule designed to target ocular G-protein coupled receptors (GPCRs), combining anti-inflammatory and pain-modulating properties. The ongoing Phase 2 trial for NCP, initiated in October 2024, is expected to release top-line results in Q4 2025. The suffix '-mod' in the name reflects its role as a modulator of inflammatory and neuropathic pathways.

OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company focused on neuropathic corneal pain (NCP) and inflammatory dry eye disease (DED) treatments, has announced significant insider share purchases. CEO Gary S. Jacob acquired 10,000 ordinary shares at US$1.04 per share on NASDAQ. Additionally, Panetta Partners , connected to Executive Chairman Gabriele Cerrone, purchased 20,000 ordinary shares at the same price. Following these transactions, Cerrone's total shareholding has reached 9,871,570 shares, representing 28.96% of the company's issued share capital.

Goldman Small Cap Research has published a new research report on OKYO Pharma (NASDAQ:OKYO), highlighting its potential in the ophthalmic drugs segment. OKYO's lead drug candidate OK-101 has completed a 240-patient Phase 2 trial in Dry Eye Disease (DED) and is currently being evaluated in a 48-patient Phase 2 trial for Neuropathic Corneal Pain (NCP).

The company is notable for being the first to receive FDA approval for NCP clinical trials and launch a specific NCP patient trial. Goldman estimates the potential NCP market size at $6.4 billion, based on 160,000 US potential patients, contingent on receiving Orphan Drug designation. The report suggests OKYO could attract potential joint venture partners or acquirers in 2026/2027, with several milestones expected in 2025.