Welcome to our dedicated page for OKYO PHARMA news (Ticker: OKYO), a resource for investors and traders seeking the latest updates and insights on OKYO PHARMA stock.
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical-stage, ophthalmology-focused biopharmaceutical company developing novel therapies for neuropathic corneal pain (NCP), dry eye disease, and other ocular inflammatory conditions. Its news flow centers on the progress of its lead investigational drug candidate, urcosimod, and related clinical, regulatory, and corporate developments.
Visitors to this news page can review company-issued announcements about Phase 2 clinical trial results, including data showing reductions in neuropathic corneal pain and exploratory findings on corneal nerve structure in NCP patients treated with urcosimod. OKYO also reports on earlier Phase 2 results in dry eye disease, where urcosimod demonstrated statistically significant outcomes on multiple endpoints in a 240-patient trial.
In addition to clinical data, OKYO’s news releases cover planned development milestones such as the registration pathway and a proposed multiple-ascending-dose, multi-center trial in approximately 100 NCP patients, as well as references to urcosimod’s Fast-Track designation and anticipated regulatory interactions. Corporate communications include participation in ophthalmology and life science conferences, such as the Ophthalmology Innovation Summit and BIO-Europe, where management presents updates on urcosimod and the company’s pipeline.
Investors can also find announcements related to share acquisitions by Panetta Partners Limited, an entity with a beneficial interest held by OKYO’s Executive Chairman, as disclosed in both news releases and accompanying Form 6-K filings. Together, these updates provide a view into how OKYO is advancing urcosimod as a potential first-in-class therapy for neuropathic corneal pain and dry eye disease, and how it communicates key milestones to the market.
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.
OKYO Pharma provided updates on its clinical trials and financial results for the six months ended September 30, 2024. The company expects to complete enrollment of 48 patients in its Phase 2a trial of OK-101 for Neuropathic Corneal Pain (NCP) by Q2 2025, with top-line data expected in Q4 2025.
Earlier in January 2024, OKYO reported positive top-line data from its Phase 2b trial of OK-101 for Dry Eye Disease (DED). The drug showed statistically significant benefits in total conjunctival staining by Day 29 and improved symptoms like burning/stinging and blurred vision. The safety profile was favorable, with TEAEs similar to placebo.
Financially, OKYO reported total assets of $2.8 million as of September 2024, including $1.0 million in cash, with an additional $1.8 million received post-period. The company's comprehensive loss decreased to $3.1 million compared to $8.5 million in the same period last year.
OKYO Pharma (NASDAQ: OKYO) has secured $1.4 million in non-dilutive funding to advance its innovative pipeline, particularly focusing on its lead program OK-101 for treating neuropathic corneal pain (NCP). The company, which develops therapies for NCP - a severe ocular condition without FDA-approved treatments - and inflammatory dry eye disease (DED), will use this funding to support ongoing research and development initiatives.
The funding strengthens OKYO's ability to progress its development programs without diluting shareholder value. CEO Dr. Gary S. Jacob emphasized that this financial boost will contribute significantly to their mission of developing groundbreaking treatments for ophthalmic diseases while maintaining fiscal responsibility and creating value for shareholders.
OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company focused on treating neuropathic corneal pain and inflammatory dry eye disease, announces its participation in the 4th Annual Virtual BTIG Ophthalmology Day on December 2nd, 2024. CEO Gary S. Jacob will engage in one-on-one meetings and lead a fireside chat from 2:40-3:15pm.
The event will feature over 20 medical technology and biotechnology companies, discussing latest developments in ophthalmic technologies and therapeutics. OKYO is developing treatments for NCP, which currently lacks FDA-approved therapies, and DED, representing a multi-billion-dollar market opportunity.
RedChip Companies announces the airing of interviews with MUSQ Global Music Industry ETF (NYSE:MUSQ) and OKYO Pharma on Bloomberg TV. David Schulhof, MUSQ's Founder and CEO, discusses how their ETF provides exposure to the global music ecosystem through the MUSQ Global Music Industry Index (MUSQIX), covering music streaming, content, distribution, live events, radio, and equipment. Goldman Sachs projects industry revenue to reach $163.7B by 2030.
OKYO Pharma's CEO Gary Jacob discusses their Phase 2 clinical trial of OK-101, a novel non-opioid topical treatment for neuropathic corneal pain (NCP). The trial, initiated October 16, 2024, at Tufts Medical Center, aims to evaluate OK-101's effectiveness in treating NCP caused by dry eye disease, surgery, or infections.
OKYO Pharma (NASDAQ: OKYO) announces its participation in the 10th International Tear Film & Ocular Surface Society Conference in Venice, Italy from October 30 to November 2, 2024. The company will present results from their dry eye disease trial and discuss their ongoing Phase 2 trial of OK-101 for Neuropathic Corneal Pain treatment at Tufts Medical Center.
Chief Scientific Officer Dr. Raj Patil will present 'Efficacy and Safety Results of First-in-Human Phase 2 Trial of OK-101 in Dry Eye Patients' during Poster Session III on November 2, 2024. The company aims to develop treatments for both neuropathic corneal pain, which currently lacks FDA-approved therapy, and inflammatory dry eye disease, representing a multi-billion-dollar market opportunity.