[Breaking News] Today's New NYSE Alert

AwesomeStocks Don’t want emails from us anymore? Click [here]( to unsubscribe. Hello! This is a reminder that our new NYSE alert today is OGEN. This morning, the company released breaking news that could be another growth catalyst. Here is the breaking news from this morning: “Oragenics, Inc. Announces Concussion Drug Successfully Completes FDA-Required Genotoxicity Study” Here are the highlights from this press release: - “ONP-002 showed no cancer-causing DNA damage” - “Phase II clinical trial being planned” “SARASOTA, Fla., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion, ONP-002, successfully completed a study that indicates it does not cause DNA damage and genotoxicity in an animal model. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial, the U.S. Food and Drug Administration (FDA) requires that pharmaceuticals be tested on cells and animals to ensure they do not cause damage affecting cell division.” As the company further explains: “Oragenics conducted an in vivo (animal) study to determine if multi-day treatments of ONP-002 cause DNA damage and increased risk of cancer. Three concentrations of ONP-002 were used at a low, medium and high dose. Animal bone marrow was dissected and analyzed for DNA damage. The results showed no evidence of genetic mutations, suggesting that ONP-002 does not affect the cell cycle and therefore does not disrupt cell division that could be cancer-causing. Oragenics partnered with VivoPharm, Inc. to conduct this study under Good Laboratory (GLP) conditions. These results suggest that multi-day treatment for concussion using ONP-002 will not cause genotoxicity.” Here are the company’s comments from this press release: ““We continue to be pleased with the safety profile of ONP-002. We have now shown a safety margin in our two-species toxicology program, cardiac safety with GLP hERG testing and no issue with cancer-causing DNA damage using the in vivo micronucleus assay. Oragenics strongly believes that ONP-002 will be safe for concussed patients in our planned Phase II clinical trial. We will continue to monitor systemic and intranasal safety parameters throughout the drug development program,” commented Michael Redmond, President of Oragenics.” Here are a couple of the highlights from our profile of OGEN: - OGEN has experienced big gains over the past few days after the company released breaking news on Thursday. - Since Thursday, the company has rallied from 1.03 to a high of 1.43 on Friday, up 38%. - OGEN closed Friday near the high of the day at 1.40 and could present a continued breakout opportunity. - OGEN has a 200 day moving average of 2.61, more than 86% from Friday’s close. - OGEN has a history of experiencing significant upside. - In May, the company rallied from around 1.00 to a high upwards of 3.00 in just weeks. In the event that OGEN holds above its 50 day moving average of 1.28, there exists potential for continued momentum higher. Full profile below: New Alert: Oragenics, Inc. (NYSE American: OGEN) OGEN is a NYSE listed “development-stage biotechnology company”. OGEN is “focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases”. This includes “drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device”. Sadly, “concussion is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide”. “According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds $40.6 billion.” As the company further explains: “Concussions have been associated with other neurological disorders, such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE).” “Additionally, post-concussion symptoms, which can occur in up to 20% of affected individuals, are linked to long-term disability.” OGEN has announced several big accomplishments over the past few months. In June, the company announced: “Oragenics Develops Automated Intranasal Device for Treating Concussed Patients” - “The device is intended for initial treatment in the acute setting” As the company further explains: “Loss of consciousness along with acute memory impairment are linked to prolonged post-concussion symptoms and poor clinical outcomes.” Additionally: “Oragenics’ breath-propelled device requires the patient to administer ONP-002 into the nose. Concussed patients with an acute altered mental state may not be capable of following these instructions. Oragenics intends to use its breath-propelled device in the planned Phase II trial, which calls for multiple days of treatment. However, for those patients who have a loss of consciousness or altered mental status early on, the current automated prototype is being developed for their initial treatment by medical staff during the period in which they may struggle to follow directions for blowing.” Here are some of the company’s comments from this press release: “We are excited about this new automated technology as it allows us to treat the full range of concussive injuries. Both devices offer advantages and can deliver our nanoparticle powder. Given the early mental alterations many concussed patients experience, we aim to provide them the best drug delivery route to improve their clinical outcomes,” stated Michael Redmond, President at Oragenics. In July, the company announced: “Oragenics Improves Intranasal Drug Formulation for Treating Concussed Patients” As the company explained in this press release: OGEN “believes the nasal cavity provides access for Oragenics’ novel neurosteroid formulation to enter the brain in minutes”. “Given the difficulty of getting neurosteroids into solution, unique formulations must be developed to achieve therapeutic levels.” Furthermore: - “Oragenics believes that its recent work has increased the final dose levels significantly while also providing for improved intranasal drug adhesion and, thus, longer absorption times.” - “Oragenics believes it has successfully completed an improved formulation of ONP-002 that should significantly increase the bioavailability of the intranasal drug formulation.” - “The enhanced drug percentages in this novel formulation have been developed by Oragenics as part of its platform for acute-field delivery of the drug.” - “Oragenics’ newly developed intranasal drug formulation is intended to reduce the duration of initial concussion symptoms and prevent long-lasting symptoms that can be debilitating after a concussion.” Most recently, on Thursday, the company announced big news: “Oragenics Inc. Announces Concussion Drug, ONP-002, Successfully Clears FDA-Required Cardiotoxicity Testing” - “The potential addressable market opportunity for ONP-002 includes an estimated 69 million concussions globally” As the company further explained: “today announced its lead candidate for treating concussion successfully completed a study that indicates ONP-002 does not cause cardiotoxicity”. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial, the U.S. Food and Drug Administration (FDA) requires pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations” Importantly: “Oragenics conducted hERG (human Ether-à -go-go-Related Gene) ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories. Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar. Based on Phase I ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia.” Here are some of the company’s comments from this press release: “We are pleased that ONP-002 has demonstrated a strong safety margin for the heart, enabling us to continue planning the Phase II trials. Safety remains our top priority, and we will continuously monitor all safety parameters throughout the trials,” stated Michael Redmond, President of Oragenics. “Furthermore, a Phase II study is being planned to further evaluate the drug in concussed patients.” Make sure to do your own due diligence. Sources: [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [Website]( [Chart]( Happy Trading! 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