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OKYO Pharma Limited (NASDAQ: OKYO) is a clinical-stage biopharmaceutical company dedicated to developing groundbreaking therapies for inflammatory eye diseases and chronic pain conditions. The company is at the forefront of creating innovative treatments for Dry Eye Disease (DED) and Neuropathic Corneal Pain (NCP), both of which represent significant unmet medical needs in the ophthalmology sector.
One of OKYO Pharma's hallmark achievements is its development of the OK-101 ophthalmic solution. This drug candidate has shown promising results in pre-clinical studies, demonstrating dual-action anti-inflammatory and neuropathic corneal pain-reducing activities. The ongoing Phase 2 clinical trials are aimed at establishing the safety and efficacy of OK-101 in treating DED and NCP. Notably, these trials have successfully completed patient enrollment, with top-line results expected soon.
OKYO Pharma's approach leverages a unique membrane-anchored-peptide technology to ensure the prolonged presence of the drug in the ocular environment, thereby enhancing its therapeutic impact. In recent studies, OK-101 has exhibited statistically significant improvements in multiple dry eye-related symptoms, including stinging, burning, and blurred vision, as well as a notable reduction in conjunctival staining. These promising outcomes pave the way for future Phase 3 registration trials.
Financially, OKYO Pharma is well-positioned, with its ordinary shares listed on the NASDAQ Capital Market. The company continues to forge strategic partnerships and collaborations to bolster its research and development efforts. With a robust pipeline and a commitment to addressing the complex biology of eye diseases, OKYO Pharma stands as a pioneering entity in the biopharmaceutical landscape.
The latest developments include positive safety and efficacy results from the Phase 2 trials of OK-101, and the recent FDA clearance for OK-101's Investigational New Drug (IND) application for treating NCP. These milestones underscore the potential of OKYO Pharma's innovative solutions to significantly improve patient outcomes.
OKYO Pharma Limited (Nasdaq: OKYO; LSE: OKYO) has announced a voluntary delisting of its Ordinary Shares from the London Stock Exchange due to negligible trading volumes and associated costs. The delisting is expected to become effective on May 12, 2023. The company will consolidate 65 existing Ordinary Shares into one new ordinary share, aligning with its current American Depositary Shares (ADS) ratio. Following the delisting, current ADS holders will automatically receive the new ordinary shares without needing to take action. Further details will be provided in a circular to shareholders prior to the delisting.
OKYO Pharma Limited (NASDAQ: OKYO; LSE: OKYO) announced that Panetta Partners Limited, associated with Executive Chairman Gabriele Cerrone, purchased 12,500 American Depositary Shares (ADSs) on NASDAQ for $1.32 each on March 27, 2023. This transaction reflects a significant investment in the company focused on developing OK-101, a treatment for dry eye disease aimed at addressing unmet needs in a multi-billion-dollar market. The purchase indicates the confidence of the Chairman in the company's potential, as it expands its focus on ophthalmology and chronic pain treatments.
OKYO Pharma Limited (Nasdaq: OKYO; LSE: OKYO) announced a purchase of 10,000 American Depositary Shares (ADSs) at $1.40 each by Panetta Partners Limited, associated with Executive Chairman Gabriele Cerrone. This transaction, valued at $14,000, is significant in the context of OKYO's development of OK-101, a treatment for dry eye disease in a burgeoning market. The purchase reflects confidence in OKYO’s strategy amidst the pressing need for innovative solutions in ophthalmology. The transaction took place on March 23, 2023, on the NASDAQ.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company, announced the posting of its planned clinical trial for OK-101 to treat dry eye disease (DED) on ClinicalTrials.gov (Identifier: NCT05759208). The company is activating clinical sites and preparing the trial drug for shipment, anticipating the first-patient visit in early Q2 2023, with top-line data expected in Q4 2023. CEO Gary S. Jacob expressed optimism about OK-101 providing a new treatment option for DED patients who lack effective therapies.
OKYO Pharma Limited (Nasdaq: OKYO; LSE: OKYO) has announced a global private placement to raise approximately $5.4 million through the issuance of new American Depositary Shares (ADSs) and ordinary shares. The company will issue 3,503,665 new ADSs at $1.50 each, representing 227,738,225 ordinary shares, and 8,673,658 ordinary shares at $0.23 each. Proceeds will be utilized for advancing the Phase 2 clinical trial of OK-101 for dry eye disease (DED) and other corporate purposes. The closing of the U.S. Offering is expected on March 14, 2023, with shares expected to be listed on the London Stock Exchange shortly thereafter.
On March 13, 2023, OKYO Pharma announced a public offering of 3,503,665 American Depositary Shares (ADSs) at $1.50 each, aiming to raise approximately $5.3 million. The offering is set to close on March 15, 2023. The funds will primarily support the Phase 2 clinical trial of OK-101 for inflammatory dry eye diseases and will also cover general corporate expenses. Additionally, the company completed a concurrent offering in the UK, securing $0.3 million from the sale of 13,836,156 ordinary shares to management and directors. The registration statement for the ADSs was filed with the SEC and became effective on March 8, 2023.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that its GMP packaged drug OK-101 for treating dry eye disease (DED) has cleared customs in the U.S. The company is preparing for its first-in-human Phase 2 clinical trial, with randomization codes being generated and clinical sites being authorized. Anticipated timelines include the first patient visit in Q1 2023 and top-line data release in Q4 2023. OK-101 aims to address significant unmet needs in the multi-billion-dollar DED market, leveraging its unique design to enhance drug retention in the ocular environment.
OKYO Pharma has appointed Dr. Jay S. Pepose, a leading ophthalmologist, to its Scientific Advisory Board to guide clinical programs for OK-101, a treatment for dry eye disease. Dr. Pepose brings nearly 40 years of experience and a robust background in clinical trials for ophthalmic conditions. The company plans to initiate enrollment for its Phase 2 clinical trial for OK-101 within Q1 2023. This strategic appointment aims to enhance the profile of OK-101 amidst a multi-billion-dollar market with significant unmet needs. Dr. Pepose's insights on ocular inflammation and pain management are expected to drive the development of this promising therapy.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that CEO Gary S. Jacob, Ph.D., will present on the therapeutic potential of OK-101 for dry eye disease at the GPCRs-Targeted Drug Discovery Summit on February 22, 2023, in Boston. His presentation follows that of Dr. Alan Kopin, who will share insights on the discovery and testing of OK-101. Recently, OKYO received FDA clearance for its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial for OK-101, aiming to address the significant unmet need in treating dry eye disease.
OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO) has announced its interim results for the six months ending September 30, 2022. The company has achieved FDA IND clearance for its Phase 2 trial of OK-101 to treat Dry Eye Disease (DED), expected to begin in Q1 2023. Financially, OKYO reported total assets of £1.6 million and cash of £0.6 million, with a comprehensive loss of £4.6 million. The company has halted further development of OK-201 to focus resources on OK-101.
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