About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

Flavio Mantelli, MD, PhD, OKYO Pharma Chief Medical Officer Dr. Mantelli will lead the clinical and regulatory strategy to advance the company’s development program in neuropathic corneal pain (NCP), leveraging urcosimod’s FDA Fast Track designation Dr. Mantelli, former Chief Medical Officer at Dompé, spearheaded the successful clinical development program and FDA approval of Oxervate®, a blockbuster orphan therapy in corneal diseaseDr. Mantelli will lead the clinical and regulatory strategy to advance ...

Core Insights - OKYO Pharma Ltd is set to launch a Phase 2b/3 clinical trial for neuropathic corneal pain after a successful Type C meeting with the FDA, indicating a clear path forward for the program [1][3]. Regulatory Meeting - The Type C meeting with the FDA allowed OKYO Pharma to engage directly with the agency, addressing critical components such as primary endpoints, manufacturing, and statistical plans [3]. - The feedback from the FDA was positive, providing guidance to proceed with the clinical study without unexpected surprises [4]. Next Steps - The company plans to finalize site selection and budget, with guidance to enroll 120 subjects and clarity on the primary endpoint, allowing for protocol finalization [5]. - The goal is to initiate the first patient visit by mid-year, aiming to complete the study by year-end and target top-line results in Q1 2027 [5]. Patient Impact - The company emphasizes the significant unmet need in neuropathic corneal pain, motivated by direct feedback from patients regarding the severe impact of the condition on their quality of life [6].

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

LONDON and NEW YORK, Jan. 30, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announces that an abstract on its lead candidate, urcosimod (formerly OK-101), has been accepted for presentation at the prestigious 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The accepted paper, titled "Evalua ...

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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]

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Core Insights - OKYO Pharma Limited has received FDA authorization for a single-patient expanded access IND application for urcosimod, aimed at treating neuropathic corneal pain (NCP) [1][2] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for NCP and inflammatory eye diseases, with shares traded on the Nasdaq Capital Market [6] - The company plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod for NCP this year [6] Product Information - Urcosimod is a lipid conjugated chemerin peptide agonist targeting the ChemR23 receptor, which is involved in inflammatory responses and pain signaling [5] - Positive results were reported from a Phase 2 trial showing significant pain reduction in NCP patients, with urcosimod demonstrating statistical significance in multiple endpoints [5] Disease Context - Neuropathic corneal pain is a chronic condition characterized by severe eye pain and sensitivity, often resulting from corneal nerve damage and inflammation [4] - There are currently no FDA-approved treatments specifically for NCP, leading to limited therapeutic options for patients [4]