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Oragenics Inc. (NYSE American: OGEN) is a publicly-traded biopharmaceutical company specializing in innovative, proprietary technologies aimed at improving human health. Based in Sarasota, Florida, Oragenics is renowned for its cutting-edge research and development in the fields of neurology and infectious diseases. The company’s core business revolves around the development of novel pharmaceutical treatments, including nasal delivery medications, which promise significant advancements in therapeutic efficacy and patient outcomes.
Oragenics’ flagship product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid. Designed to cross the blood-brain barrier effectively, ONP-002 targets mild Traumatic Brain Injury (mTBI), commonly known as concussion. The drug reduces swelling, oxidative stress, and inflammation while restoring proper blood flow through gene amplification. This revolutionary approach positions ONP-002 as a potential game-changer in treating brain injuries.
In addition to ONP-002, Oragenics boasts a diverse product pipeline, including therapies targeting Niemann-Pick Disease Type C (NPC) and other infectious diseases. The company is also recognized for its ProBiora3 technology, which is the foundation of products like evoraplus™—a unique probiotic mint that promotes oral health by supporting gums, freshening breath, and whitening teeth.
Recent achievements highlight Oragenics' relentless pursuit of excellence. The company is preparing to initiate a Phase II clinical trial for ONP-002, with advancements in drug formulation aimed at optimizing intranasal delivery. Collaborating with Avance Clinical Pty Ltd, Oragenics is focused on conducting this trial in emergency departments at level one trauma centers, ensuring robust and well-structured studies.
The leadership team at Oragenics, led by President Michael Redmond and Chief Medical Officer Dr. James Kelly, emphasizes the importance of partnerships and advanced research. Their dedication is reflected in Oragenics' preclinical studies, which have shown significant improvements in molecular and behavioral outcomes following brain injury. The company's innovative approach to intranasal delivery as nanoparticles has further enhanced brain exposure and metabolism.
Oragenics' commitment to addressing unmet medical needs, such as concussions—which affect millions globally each year—has positioned the company as a pivotal player in the biopharmaceutical industry. Through continuous innovation and strategic collaborations, Oragenics aims to provide effective treatments for neurological disorders and improve patient outcomes worldwide.
For more information, visit www.oragenics.com.
Oragenics, Inc. (NYSE American: OGEN) announced findings from its GLP toxicology study of the NT-CoV2-1 intranasal vaccine candidate, reporting no toxicity signals or adverse events. The study supports the company's plan to file for regulatory approval for a Phase 1 clinical study. With no toxicity observed, the vaccine demonstrates a favorable safety and immunogenicity profile. Oragenics aims to address the unmet need for intranasal COVID-19 vaccines, with positive preclinical data indicating strong immune responses against various SARS-CoV-2 variants.
Oragenics, Inc. (AMEX:OGEN) has received a compliance notice from NYSE American, indicating that its stock price has been low for an extended period. The company must improve its stock price or undertake a reverse stock split by June 19, 2023, to regain compliance. The notice does not lead to immediate delisting and stocks will continue trading with a designation of 'BC'. Oragenics remains dedicated to developing its intranasal COVID-19 vaccine and lantibiotics, although the notice may impact future financing efforts.
On December 16, 2022, Oragenics, Inc. (AMEX: OGEN) announced the appointment of Charles Pope as Chairman of the Board, succeeding Dr. Frederick W. Telling. Dr. Telling will remain on the Board as an independent director. Mr. Pope expressed gratitude for Dr. Telling's long service and looks forward to continuing the company's advancement in developing its product candidates, including an intranasal vaccine for COVID-19. Oragenics focuses on combating infectious diseases and is working on new antibiotic solutions.
Oragenics, Inc. (NYSE American: OGEN) is participating in the 2022 BioFlorida Annual Conference from November 2-4 in Miami. The company's President and CEO, Kim Murphy, will speak on a panel titled “BioTrends: Learning from the Pandemic: The Fight Against Infectious Diseases” on November 3 at 2:05 p.m. Eastern Time, held at the Hyatt Regency Miami. Murphy will also engage in one-on-one meetings with investors. Oragenics is focused on developing therapies for infectious diseases, including an intranasal COVID-19 vaccine candidate.
Oragenics, Inc. (NYSE American: OGEN) announced its plans for NT-CoV2-1, an intranasal COVID-19 vaccine, which aims to enhance mucosal immunity. The company is progressing into human clinical trials in early 2023 after favorable results from preclinical studies, including a pivotal toxicology study expected to conclude this year. With advantages like easier administration and greater storage efficiency, Oragenics anticipates NT-CoV2-1 will be pivotal in combating COVID-19 variants. The company plans to submit a Clinical Trial Application to Health Canada following the toxicology report.
Oragenics, Inc. (NYSE American: OGEN) announced preliminary positive results from a GLP toxicology study for its NT-CoV2-1 intranasal COVID-19 vaccine candidate. The data indicates a favorable safety profile and immune response, supporting regulatory filings for a Phase 1 clinical study expected to start by early 2023. Notably, the vaccine candidate has shown strong preclinical immune responses against various SARS-CoV-2 variants, highlighting its potential as a needle-free option to reduce COVID-19 transmission.
Oragenics, Inc. (NYSE American: OGEN) has appointed Kimberly M. Murphy as President and CEO effective June 23, 2022. Murphy, a seasoned vaccine industry leader with over 25 years of experience, has previously held significant roles at companies like Merck and GSK. Her appointment is expected to enhance Oragenics' strategic vision and accelerate growth, particularly in their ongoing vaccine development efforts against infectious diseases, including COVID-19. As a board member since 2020, her insights have already contributed to the company’s strategies.
Oragenics (AMEX:OGEN), a biotech firm, announced the publication of a study on its intranasal COVID-19 vaccine candidate, NT-CoV2-1, in Scientific Reports. Co-authored with Inspirevax and the National Research Council of Canada, the study demonstrated efficacy in mice and hamsters, highlighting robust immune responses. The company aims to use this data, alongside ongoing toxicology studies, to support its application for human clinical trials. Oragenics focuses on developing treatments for infectious diseases, emphasizing innovative vaccine delivery methods.
Oragenics, Inc. (AMEX: OGEN) shared a letter from Executive Chairman Frederick W. Telling, Ph.D., outlining the company’s vaccine development strategy, particularly its intranasal COVID-19 vaccine candidate, NT-CoV2-1. The vaccine aims to address both pandemic and endemic phases of COVID-19. Oragenics has made progress in preclinical studies and plans to initiate a Phase 1 clinical study in North America. The company is positioning NT-CoV2-1 as a single-dose booster to meet evolving market demands, highlighting its advantages in mucosal immunity, needle-free administration, and logistical ease.
Oragenics, Inc. (NYSE American: OGEN) announced its participation in the World Vaccine Congress Washington from April 18-22, showcasing its lead product, NT-CoV2-1, an intranasal COVID-19 vaccine candidate. The vaccine aims for patient-friendly administration and robust immune response. NT-CoV2-1 has shown promising results in animal studies, with a Phase 1 trial expected to begin this year. Kimberly Murphy, a board member and former GSK executive, will represent the company. Oragenics focuses on combating infectious diseases, leveraging research from NIH and NRC.
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