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New NASDAQ Alert [Inside]

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Tue, Aug 29, 2023 01:21 PM

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AwesomeStocks Hello! New Alert: OKYO Pharma Limited OKYO is our new NASDAQ high volatility alert wit

AwesomeStocks Hello! New Alert: OKYO Pharma Limited (NASDAQ: OKYO) OKYO is our new NASDAQ high volatility alert with big news this morning. OKYO is a NASDAQ listed “ophthalmology-focused bio-pharmaceutical company”. OKYO is “focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain”. OKYO is “developing OK-101 to treat dry eye disease (“DED”) to address the significant unmet need in this multi-billion-dollar market”. The company’s “immediate goal is to overcome the limitations of current dry eye treatments with the development of a first-in-class drug that combines both anti-inflammatory and pain reducing activity”. As the company further explains: “OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and NCP; and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.” Dry eye disease is a “common condition that occurs when one’s tears are unable to adequately lubricate the eyes”. As the company explains: “This condition affects approximately 49 million people in the U.S. alone and has been a difficult one to positively diagnose and to treat due to the multifactorial nature of the condition.” Furthermore: “Tear film instability typically leads to inflammation and damage to the ocular surface.” It is often a chronic problem, particularly in older adults, and is expected to become even more prevalent with the aging population and increased use of digital screens such as computers and smart phones. Despite new product approvals, dry eye disease remains a significant unmet medical need and is one of the “leading causes for patient visits to eye care specialists”. According to the company, “worldwide, ~700 million patients suffer from dry eye disease”. Sadly, “Dry Eye affects over 35% of the population aged 50+, with women representing approximately two-thirds of those affected”. In December, OKYO announced: - “OKYO Pharma Announces U.S. FDA Clearance of IND Application for OK-101 for the Treatment of Dry Eye Disease” Since then, the company has announced multiple accomplishments. As the company explains in its August 15 press release, here are the “2023 Developments Related to OK-101”: In April: - “OKYO announced the activation of the first clinical trial site in the U.S. for its phase 2, multi-center, randomized, double-blinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with DED.” In May: - “OKYO announced that the first patient has been screened for its phase 2, multi-center, randomized, double–blinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with DED.” - “OKYO announced that two presentations were to be given on OK-101 at the American Society of Cataract and Refractive Surgery (ASCRS 2023) in San Diego, CA, May 5-8, 2023.” In June: - “OKYO announced that patients were now being dosed in the randomized portion of the phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED, following the two-week placebo run-in period intended to minimize the placebo effect.” In July: - “OKYO announced a new agreement with Tufts Medical Center to conduct a 40-patient open-label clinical trial evaluating the efficacy and safety of OK-101 in patients with neuropathic corneal pain (“NCP”). The Investigational New Drug (“IND”) application for NCP is planned to be filed in Q4 of 2023, with study enrollment planned to commence shortly after IND allowance by the FDA.” Most recently, the company announced: “OKYO Pharma Limited Reports Annual Results for the Twelve Months Ended March 31, 2023” Here are the company’s comments from this press release: “Gary Jacob, Chief Executive Officer of OKYO, commented, “We are very pleased at the advancements we have made with our flagship drug OK-101 to treat DED this year. On May 2, 2023, we announced the initiation of our first clinical trial of OK-101 to treat DED. This trial is a 240 patient, phase 2, multi-center, randomized, double-masked, placebo-controlled trial in patients with DED. This summer we are expecting to see considerable enrollment of patients in the ongoing trial and are presently on track to have top line data released in Q4 2023. I am also excited about OK-101’s dual combination of anti-inflammatory ocular activity and neuropathic corneal pain (NCP) reducing activity. NCP is a debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of life for affected individuals. There is presently no FDA approved drug to treat NCP and we were pleased to recently announce our plan to open a small trial of OK-101 to treat patients with NCP at Tufts Medical Center in Boston. We remain steadfast in our dedication to advancing groundbreaking ocular solutions that have the potential to transform patients' lives. Our team's resilience and unwavering focus on research and development will continue to be the driving force behind our progress. We are actively exploring opportunities to optimize our operational efficiency and enhance our partnerships within the industry. Thank you to our employees, partners, and shareholders for their continued support as we work diligently to bring about a new treatment to benefit the many millions of patients suffering from DED."” In addition, the company announced breaking news this morning: - “OKYO Pharma Limited Regains Compliance with Nasdaq Listing Minimum Market Value Rule” OKYO could be in a position to experience increased growth. Make sure to do your own due diligence. Sources: [Presentation]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [PR8]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. 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