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OKYO Pharma Reports New Phase 2 Data Demonstrating Meaningful Improvements in Patient-Reported Quality of Life Outcomes with Urcosimod in Neuropathic Corneal Pain
Globenewswire· 2026-03-18 11:00
Core Insights - OKYO Pharma Limited announced positive findings from an exploratory analysis of patient-reported outcomes in its Phase 2a trial of urcosimod for treating neuropathic corneal pain (NCP) [1][4] - The trial demonstrated significant improvements in pain reduction and quality of life, with results to be presented at the ARVO 2026 Annual Meeting [1][2] Group 1: Clinical Trial Results - The Phase 2a trial was randomized, double-masked, and placebo-controlled, involving 12 weeks of treatment with either 0.05% urcosimod (n=6) or placebo (n=6) [2] - Patients receiving urcosimod showed greater improvements in emotional well-being and quality of life compared to those on placebo, with notable changes in various measures [2][7] - The exploratory data suggest urcosimod may offer broader therapeutic benefits beyond pain reduction, enhancing overall life satisfaction for patients with NCP [2][3] Group 2: Unmet Medical Need - NCP is a severe, chronic ocular pain disorder with no FDA-approved treatments available, highlighting a significant unmet medical need [3][6] - The results from the trial emphasize urcosimod's potential to address this need by providing a holistic therapeutic profile [3][4] Group 3: Future Development Plans - OKYO Pharma is committed to advancing urcosimod through further development, including planned confirmatory studies and a larger multi-center Phase 2b/3 trial [4][10] - The company aims to validate the encouraging exploratory results and fully characterize urcosimod's potential in treating NCP [4][5]
OKYO Pharma Announces Pricing of $20 Million Public Offering of Ordinary Shares
Globenewswire· 2026-02-13 03:20
Core Viewpoint - OKYO Pharma Limited has announced a public offering of 10,815,000 ordinary shares at a price of $1.85 per share, aiming to raise approximately $20 million before expenses and discounts [1][2]. Group 1: Offering Details - The gross proceeds from the offering are expected to be around $20 million, with the potential to increase to approximately $23 million if the underwriter fully exercises its option to purchase additional shares [2]. - The offering is managed solely by Piper Sandler & Co., and is expected to close around February 17, 2026, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for clinical development of product candidates, general corporate purposes, and working capital [2]. Group 3: Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares traded on the Nasdaq Capital Market [6]. - The company has recently completed a successful Phase 2 trial of its lead drug, urcosimod, for NCP and plans to initiate a Phase 2b/3 study involving approximately 150 subjects in the first half of the year [6].
OKYO Pharma Announces Public Offering of Ordinary Shares
Globenewswire· 2026-02-12 21:01
Company Overview - OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases [5] - The company is listed on the Nasdaq Capital Market and is dedicated to discovering and developing novel molecules for treating ocular diseases [5] Offering Details - The company announced an underwritten public offering of its ordinary shares, with all shares to be sold by the company [1] - The underwriter, Piper Sandler & Co., will have a 30-day option to purchase up to an additional 15% of the shares sold at the public offering price [1][2] - The net proceeds from the offering will primarily be used for clinical development of product candidates, general corporate purposes, and working capital [2] Clinical Development - OKYO recently completed a successful Phase 2 trial of its flagship drug, urcosimod, in patients with NCP [5] - The company plans to initiate a Phase 2b/3 multiple-dose study of urcosimod, targeting approximately 150 subjects in the first half of the year [5] Regulatory Information - The securities are being offered under a shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) [3] - A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and is available on their website [3]
OKYO Pharma appoints Leerink Partners as sales agent for ATM equity offering
Yahoo Finance· 2026-02-11 16:03
Core Viewpoint - OKYO Pharma has appointed Leerink Partners as the new sales agent for its At-The-Market (ATM) equity offering, transitioning from B. Riley Securities, to enhance its financial flexibility and support ongoing clinical development [2][3][4]. Group 1: Appointment of Sales Agent - OKYO Pharma Ltd has transitioned its ATM equity offering facility to Leerink Partners, replacing B. Riley Securities as the exclusive sales agent [2][3]. - Leerink Partners will facilitate the sale of common shares directly into the market at prevailing prices, depending on market conditions and company discretion [3]. Group 2: Purpose and Benefits of ATM Facility - The ATM facility is designed to provide OKYO Pharma with the flexibility to raise capital opportunistically while minimizing market disruption [4]. - The CFO of OKYO Pharma emphasized that this transition enhances financial flexibility to support ongoing clinical development and corporate objectives without committing to a fixed equity raise [5]. Group 3: Financial Terms - Leerink Partners will receive a commission of 3% of gross proceeds from any shares sold under the ATM program [6].
OKYO Pharma Announces Transition of At-The-Market Equity Offering Facility to Leerink Partners
Globenewswire· 2026-02-11 15:09
Core Insights - OKYO Pharma Limited has transitioned its At-The-Market (ATM) equity offering facility to Leerink Partners LLC, enhancing its ability to access capital markets efficiently [1][2] - The new partnership with Leerink Partners is expected to provide financial flexibility to support ongoing clinical development, particularly for its lead candidate urcosimod for neuropathic corneal pain [2] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares listed on the Nasdaq Capital Market [4] - The company recently completed a successful Phase 2 trial of urcosimod and plans to initiate a Phase 2b/3 multiple-dose study involving approximately 150 subjects in the first half of the year [4]
OKYO Pharma Announces Transition of At-The-Market Equity Offering Facility to Leerink Partners
Globenewswire· 2026-02-11 15:09
Core Insights - OKYO Pharma Limited has transitioned its At-The-Market (ATM) equity offering facility to Leerink Partners LLC, enhancing its ability to access capital markets efficiently [1][2] - The new partnership with Leerink Partners is expected to provide financial flexibility to support ongoing clinical development, particularly for its lead candidate urcosimod for neuropathic corneal pain [2] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares listed on the Nasdaq Capital Market [4] - The company recently completed a successful Phase 2 trial of urcosimod and plans to initiate a Phase 2b/3 multiple-dose study involving approximately 150 subjects in the first half of the year [4]
OKYO Pharma Strengthens World Class Leadership Team with Appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer
Globenewswire· 2026-02-10 13:00
Core Insights - OKYO Pharma Limited has appointed Dr. Flavio Mantelli as Chief Medical Officer, who has extensive experience in ocular surface drug development and previously led the successful launch of Oxervate® [1][2][4] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares traded on the Nasdaq Capital Market [14] - The company recently completed a successful Phase 2 trial of its drug urcosimod for NCP and plans to initiate a Phase 2b/3 study involving approximately 150 subjects in the first half of 2026 [14] Leadership and Strategy - Dr. Mantelli will oversee the clinical development strategy for urcosimod, aiming to advance it through planned clinical trials and leverage its FDA Fast Track designation [3][12] - The appointment of Dr. Mantelli follows the recent hiring of CEO Robert Dempsey, strengthening the leadership team in ophthalmology [4][12] Product Development - Urcosimod is a lipid-conjugated chemerin peptide agonist that has shown anti-inflammatory and pain-reducing effects in preclinical models for dry eye disease and neuropathic corneal pain [9] - There are currently no FDA-approved therapies specifically for NCP, highlighting the unmet medical need that urcosimod aims to address [8] Market Context - Neuropathic corneal pain is a chronic condition characterized by severe eye pain and sensitivity, often resulting from damage to corneal sensory nerves, and is inadequately treated with existing medications [8]
OKYO Pharma to present urcosimod Phase 2 results at ASCRS 2026 annual meeting
Proactiveinvestors NA· 2026-01-30 17:16
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
OKYO Pharma Announces Acceptance of Urcosimod Phase 2 Study Results for Presentation at Prestigious ASCRS Annual Meeting
Globenewswire· 2026-01-30 16:30
Core Insights - OKYO Pharma Limited has announced that an abstract on its lead candidate, urcosimod, has been accepted for presentation at the 2026 ASCRS Annual Meeting, highlighting the company's progress in developing therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases [1][2][3] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing innovative therapies for NCP and inflammatory eye diseases, with its shares listed on the Nasdaq Capital Market [8] - The company recently completed a successful Phase 2 trial of urcosimod in patients with NCP and plans to initiate a 150-patient Phase 2b/3 multiple-dose study in the first half of 2026 [5][8] Product Details - Urcosimod, formerly known as OK-101, is a lipid conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, which is involved in the inflammatory response and pain reduction [7] - The drug has shown positive efficacy signals in reducing pain and improving corneal nerve health in a proof-of-concept Phase 2 study, with statistical significance in multiple endpoints [4][7] Industry Context - Neuropathic corneal pain is a chronic condition with no FDA-approved therapies specifically for its treatment, leading to a significant unmet medical need [6] - The acceptance of the abstract at the ASCRS Annual Meeting underscores the potential of urcosimod as a first-in-class therapeutic option for patients suffering from NCP [3][4]
OKYO Pharma Announces Successful Type C Meeting with the FDA
Globenewswire· 2026-01-28 12:40
Core Insights - OKYO Pharma Limited has successfully held a Type C meeting with the FDA regarding the Phase 2b/3 clinical trial of urcosimod for treating neuropathic corneal pain (NCP) [1][2] - The FDA's alignment on the clinical development program for urcosimod is seen as a significant step forward in addressing the unmet medical need for patients suffering from NCP [2][6] - Urcosimod has received the first IND to treat NCP and has been granted fast track designation by the FDA, with a 120-patient Phase 2b/3 study expected to begin in the first half of the year [2][7] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain and inflammatory eye diseases, with its shares traded on the Nasdaq Capital Market [7] - The company has recently completed a successful Phase 2 trial of urcosimod in NCP patients and is preparing for further clinical studies [7] Neuropathic Corneal Pain (NCP) - NCP is a chronic condition characterized by severe eye pain and sensitivity, often resulting from damage to corneal sensory nerves, with no FDA-approved therapies currently available [3] - Patients with NCP often rely on off-label treatments with limited success [3] Urcosimod Details - Urcosimod is a lipid-conjugated chemerin peptide agonist that has demonstrated anti-inflammatory and pain-reducing effects in preclinical models [4] - Positive data from a Phase 2 trial indicated significant pain reduction in NCP patients, supporting its potential as a treatment option [4] FDA Meeting Highlights - The FDA confirmed that the proposed primary endpoint of Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, with a ≥2-point improvement indicating a significant treatment effect [6] - The FDA provided guidance on statistical analysis and endorsed the study design, sample size, and powering assumptions, which de-risks the pathway to a pivotal trial [6]