unpathedhaunt
2 years ago
3/22 Oragenics Initiates a Pivotal IND-Enabling Toxicology Study on its Intranasal COVID-19 Vaccine Candidate, NT-CoV2-1
"βWe are thrilled to have begun this pivotal study with Frontage, a premier drug development contract research organization, and are thankful to the acceleration Frontage has offered our important IND-enabling study. We believe the results from this rabbit toxicology study will support our development strategy for our intranasal COVID-19 vaccine candidate, NT-CoV2-1. The intranasal delivery route is particularly relevant as it may further reduce transmission of the virus and provide a needle-free delivery option. The findings from this preclinical toxicology study will be a part of our Investigational New Drug filing to the U.S. Food and Drug Administration,β said Frederick W. Telling, Ph.D., Executive Chairman of Oragenics."
https://ir.oragenics.com/press-releases/detail/142
alisher
3 years ago
Oragenics (OGEN) Extends Collaboration with the National Research Council of Canada to Develop Vaccine against the Omicron Variant
Agreement extends current licensing and collaboration agreement to include rapid production of Omicron-specific intranasal vaccine candidates
TAMPA, Fla., December 20, 2021--(BUSINESS WIRE)--Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company") today announced it has extended a licensing and collaboration agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue an intranasal vaccine designed to protect against the SARS-CoV-2 Omicron variant. The NRC cell expression technologies provide Oragenics with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern. This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRCβs Pandemic Response Challenge program, will expedite the evaluation of an Omicron-specific Terra-CoV-2 candidate in preclinical and clinical studies.
"Oragenics is well-positioned to develop an Omicron-specific intranasal vaccine thanks to our successful, on-going collaboration with the NRC," said Frederick W. Telling, Ph.D., Oragenicsβ Executive Chairman. "We had anticipated the need for rapid development of COVID-19 vaccine candidates against new variants and can leverage the NRC cell expression platform to address Omicron and future variants."
Oragenics recently demonstrated the protection of hamsters against SARS-CoV-2 with the intranasal Terra-CoV-2 candidate, which strongly supports the further development into an IND-enabling GLP toxicology study and a first-in-human Phase 1 clinical study.
https://finance.yahoo.com/news/oragenics-extends-collaboration-national-research-130000929.html
alisher
3 years ago
Oragenics Announces Positive COVID-19 Challenge Study Results
Oragenics Announces Positive COVID-19 Challenge Study Results Evaluating Multiple Formulations of its SARS-CoV-2 Vaccine Candidate
Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company") today announced the results from its study to evaluate the immunogenicity and viral load reduction impact of its SARS-CoV-2 vaccine candidate in a hamster challenge study. The study provided preclinical data for formulations designed for both intranasal and intramuscular administration.
Both formulations generated robust immune responses and reduced the SARS-CoV-2 viral loads to undetectable levels in the nasal passages and lungs five days following a viral challenge. By contrast, hamsters in the control groups that had received saline or adjuvants alone had no detectable immune response and substantial viral loads. The vaccines delivered by intranasal and intramuscular routes generated immune responses as measured by multiple assays.
"The very positive results from this hamster challenge study fully support our further development of either the intranasal or intramuscular routes of administration, however we plan to focus on the intranasal delivery route for the Terra CoV-2 vaccine due to the relative lack of competition and anticipated advantages of intranasal vaccine delivery, such as reducing viral transmission, needle-free administration, and ease of distribution, as well as the potential for conferred mucosal immunity which is presently being studied. The findings from this second preclinical study will be a part of our Investigational New Drug filing to the U.S. Food and Drug Administration, expected to be made in the second quarter of 2022, and should facilitate advancement of the program into human clinical studies," said Frederick W. Telling, Ph.D., Executive Chairman of Oragenics.
https://finance.yahoo.com/news/oragenics-announces-positive-covid-19-130000711.html
trendzone
3 years ago
Breaking news OGEN upgraded with a $2.75 PT
After-Hours Stock Movers 03/24: (RH) (OGEN) (FUL) Higher; (RAD) (EVFM) (KBH) Lower (more...)
March 24, 2021 5:40 PM
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After-Hours Stock Movers
Rite Aid Corporations (NYSE: RAD) 17.9% LOWER; fourth quarter 2021 financial results were significantly impacted by a soft cough, cold and flu season, ongoing impacts related to COVID-19 and challenging weather conditions. As a result, the Company is updating its guidance for the fiscal year ended February 27, 2021.
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Evofem Biosciences, Inc. (NASDAQ: EVFM) 11.2% LOWER; announced that it intends to offer and sell, subject to market and other conditions, $30 million of shares of its common stock in an underwritten public offering
RH (NYSE: RH) 9.4% HIGHER; reported Q4 EPS of $5.07, $0.31 better than the analyst estimate of $4.76. Revenue for the quarter came in at $812.4 million versus the consensus estimate of $797.27 million.
Oragenics (NYSE: OGEN) 8% HIGHER; Ascendiant Capital assumes coverage with a Buy rating and a price target of $2.75.
H.B. Fuller (NYSE: FUL) 6.2% HIGHER; reported Q1 EPS of $0.66, $0.18 better than the analyst estimate of $0.48. Revenue for the quarter came in at $726 million versus the consensus estimate of $680.98 million.
KB Home (NYSE: KBH) 5.8% LOWER; reported Q1 EPS of $1.02, $0.10 better than the analyst estimate of $0.92. Revenue for the quarter came in at $1.14 billion versus the consensus estimate of $1.21 billion.
D8 Holdings Corp (NYSE: DEH) 2.7% HIGHER; Vicarious Surgical, a developer of medical robot tech that's backed by Bill Gates, is in talks to go public through a merger with blank-check firm D8 Holdings Corp (NYSE: DEH), according to a report from Bloomberg, citing a person with knowledge of the matter.
Full House Resorts, Inc. (Nasdaq: FLL) 2.7% LOWER; announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
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