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🚨Trade Alert 🚨 OKYO

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Fri, Jul 28, 2023 11:01 AM

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FDA Approval Incoming? Here's the scoop... ͏  ͏  ͏  ͏  ͏ ?

FDA Approval Incoming? Here's the scoop... ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ Could FDA approval for this company’s game-changing first-in-class drug treatment be on the way? Greetings Investors, Earlier this year one of the biggest headlines in biotech was the announcement from Astellas Pharma about agreeing to buy U.S. drugmaker Iveric Bio Inc for about [$5.9 billion](. Well, this massive acquisition just [closed this month!]( It is the biggest acquisition for Astellas yet, giving it access to a range of ophthalmology treatments….The sheer magnitude of this deal has emphasized just how important the eye healthcare market is. There is one quietly trading biopharma company that could be trading at a PREMIUM right now, as it leads the way in eye care advancements. Still in the early stages of its growth story and trading at a little under $2 a share, OKYO Pharma Limited (NASDAQ: OKYO) is developing first-in-class pharmaceutical therapies to treat inflammatory eye diseases! We are able to do so much with our eyes, but the complexity of our eyes also comes with dangers, and they are susceptible to many different problems. It only gets worse as we age and the more screen time, we take part in. The broader eyecare market was worth $6.6 billion in 2021 according to a[research report]( from Reports and Data. From this, the firm expects the market to grow at a 3.8% CAGR to 2030 and be worth an estimated $42.5 billion by the end of the forecast period! The research firm believes that one of the primary drivers of growth in this market is the growth in screen time for both younger and older adults, especially since computer screens and other products are regularly used for a wide variety of uses including entertainment and work. So why pay attention to OKYO in particular? Several reasons. First, bullish sentiment is mounting. The stock not only has a “STRONG BUY” rating from [Investing.com]( but a “STAY LONG” rating from [AmericanBulls.com.]( Additionally, the company had coverage initiated on it by Goldman Small Cap Research, who published a research report back in May which carries a price target of $5.50! You can read the full report [HERE.]( This is more than DOUBLE compared to where the company now trades. Plus, it wasn’t that long ago that the U.S. Food and Drug Administration (FDA) cleared OKYO’s Investigational New Drug (IND) to initiate a Phase 2, first-in-human, clinical study of OK-101 for the treatment of Dry Eye Disease (DED)! This trial is now underway and takes it closer and closer to a possible FDA approval! OK-101, the company’s game-changing drug candidate could put OKYO on the map. “One of the most exciting aspects of this innovative clinical program is that we can get a rapid and informative answer on both safety and efficacy of OK-101 by the end of the year,” said Gabriele Cerrone, Executive Chairman and Founder of OKYO Pharma. “Furthermore, positive results would allow us to expedite the program towards FDA approval by leveraging results from this phase 2 dry eye trial in lieu of one of the two required phase 3 trials needed to support U.S. marketing authorization. OKYO remains well-positioned as novel ophthalmic compounds in large markets represent promising acquisition targets as evidenced by the recent $5.9 billion Iveric deal.” If OKYO’s OK-101 phase 2 trial is successful, it may serve as one of two required phase 3 studies necessary to support FDA approval! The top-line data from the trial is anticipated before the year ends… keep an eye out for this!! [www.okyopharma.com]( Company Overview: OKYO Pharma Limited is a life sciences company focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases (DED) and chronic pain. The company’s therapeutic approach is focused on targeting inflammatory and pain modulation pathways that drive these conditions. OKYO is focused on the development of OK-101 to treat ocular diseases, including dry eye, uveitis, allergic conjunctivitis, and ocular pain. The company is concentrating on the development of its drug candidate OK-101 to treat ocular diseases, including: - Dry eye (DED) uveitis - Allergic conjunctivitis - Ocular pain OK-101 OK-101 is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. ChemR23 receptor on leukocytes targeted by OK-101 is also expressed on neurons and glial cells in the dorsal root ganglion and spinal cord. Such patients would benefit from a drug that comprises anti-inflammatory and neuropathic pain-reducing characteristics. The drug candidate has been shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the drug molecule to enhance the residence time of OK-101 within the ocular environment. As a Drug Candidate - Inflammation and pain are the most common symptoms of dry eye - OK-101 is a novel class of chemerin receptor agonist that produces an anti-inflammatory action and reduction in neuropathic pain - Inclusion of a lipid ‘anchor’ within the OK-101 drug molecule is designed to decrease washout due to tearing and blinking, and to enhance the ocular residence time of OK-101 Rapid Clinical Development - IND application cleared in Q4 2022 - Able to skip Phase 1 safety trial and go directly to Phase 2 safety and efficacy trial in dry eye disease patients - Phase 2 trial in dry eye disease patients started May 2023 - Topline data expected in Q4 2023 About the Phase 2 Trial DesignPatients are now being dosed in a 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. This phase 2, multi-center, randomized, double–blinded, placebo-controlled study is planned to enroll approximately 240 subjects with DED who will be randomly divided into 3 cohorts of 80 patients. Participants will be selected based on specific inclusion and exclusion criteria. The three cohorts will be comprised of one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101. The drug and placebo will be administered in both eyes twice daily for 12 weeks. The duration of a patient’s treatment will be approximately 14 weeks, including a 2-week run-in period and 12 weeks of treatment. The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. Further details regarding the specifics of the trial are posted on the clinicaltrials.gov public website (clinicaltrials.gov Identifier: NCT05759208 or [. “A two-week placebo run-in period involving topical ocular dosing of placebo is an innovative approach used by our clinical development partner, Ora Inc. This design feature reduces the well-known placebo effect for ocular trials such as ours that include an ocular discomfort readout,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “This run-in period enables us to evaluate potential patients for the placebo effect during the run-in screening period, improving patient selection for the randomized treatment portion of the trial. Importantly, this first clinical study is also designed to include two pre-specified primary efficacy endpoints which are the hallmark of phase 3 registration trials, and one of the efficacy endpoints deals specifically with ocular discomfort.” The Market: The healthcare arena is just what the doctor ordered for 2023 as inflation continues and a recession looms. Healthcare is one of the most stable industries, and people will continue to spend money on medicine regardless of how the economy is doing. Dry eye disease is a common condition that occurs when one’s tears are unable to adequately lubricate the eyes. 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! Dry eyes are one of the most common eye conditions. It’s no surprise that the market has become extensive for dry eye drugs including brand names like Novartis’ Xiidra and Allergan’s Restasis. Highlights from the Goldman Small Cap Research Report: In the [Opportunity Research report]( analyst Rob Goldman reviews OKYO's lead candidate OK-101, the company's positioning, inherent opportunities in the industry vi-a-vis current therapies, upcoming milestones and how these milestones and the flurry of M&A in the segment can favorably impact its near-term and long-term valuations. - OKYO is poised to emerge as a key player in the Dry Eye Disease (DED) treatment market. Based on its preclinical studies, Goldman Small Cap Research believes the company could offer advantages over existing therapies, which are not viewed favorably by clinicians. These include fewer side effects, along with reduced inflammation and pain. - The ocular company industry and the DED sub- segment, are huge and growing at a rapid rate. The global DED market is expected to reach $6.54 billion in 2027, up from about $5.2 billion in 2019. - OKYO just commenced a Phase II clinical trial with the objective of measuring safety and efficacy of OK-101 in DED patients, along with secondary endpoints such as ocular pain. A serious issue among a number of DED sufferers, there is no FDA approved product for neuropathic pain!!! - Top-line data from the trial is scheduled for release by year-end 2023 and serves as a major milestone for OKYO. Goldman Small Cap Research believes it is the catalyst for a re- valuation for the stock and for a mid-tier or top-tier firm to enter into a partnership with OKYO. - Our 6–9-month price target for OKYO is $5.50.This target is based on the NPV of forecasted sales, a discounted price/sales multiple, discounted back five years at a reasonable discount rate. - The ocular treatment segment has garnered major attention. A flurry of M&A has occurred at high valuations, and OKYO’s peers also reflect these high valuation characteristics. Goldman Small Cap Research believes OKYO could emulate this trend in the future. In summary… The growing eye industry is something investors can’t ignore much longer. OKYO’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. This would be a FIRST! Dry eye patients suffer from corneal neuropathic pain, making their condition more resistant to anti-inflammatory drugs. Currently, there is NO FDA-approved topical treatment for ocular pain. What makes OKYO stand out in the massive eye treatment space is a new chemical entity that targets BOTH inflammation and ocular pain in dry eye disease! Something that has yet to be done!Such a solution opens a wide door for OKYO to tap into an underserved niche market and creates a substantial potential for shareholder growth. Could there be FDA approval in OKYO’s future for OK-101? Start your research right away! Copyright 2023 © SCDalerts.com is owned and operated by the owner of SCD Media LLC. Disclaimer and Privacy For more Information please contact info@smallcapsdaily.com This website provides information about the stock market and other investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. This website is for informational purposes only. The Author of this website is not a registered investment advisor and does not offer investment advice. You, the reader, bear responsibility for your own investment decisions and should seek the advice of a qualified securities professional before making any investment. 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Losses can be larger than expected if the company experiences any problems with liquidity or wide spreads. Our website and newsletter are for entertainment purposes only. Never invest purely based on our alerts. Gains mentioned in our newsletter and on our website may be based on end-of-day or intraday data. This publication and its owners and affiliates may hold positions in the securities mentioned in our alerts, which we may sell at any time without notice to our subscribers, which may have a negative impact on share prices. If we own any shares, we will list the information relevant to the stock and the number of shares here. We do not own any shares in OKYO. We have been currently compensated up to Twenty Five Thousand Dollars Cash ($25,000) via bank wire transfer from a third-party IA Media, LLC for a 1 Day Marketing Program regarding OKYO with a start date of 7/28/2023. SCD’s business model is to receive financial compensation to promote public companies. 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