The shares of Ocugen Inc. (OCGN) are up 3.58% to $6.67 in early trading this morning. The Ocugen stock was down by -4.17% to $6.44 at the end of the last trading session. There were 13.28 million shares traded in OCGN stock yesterday. That was below the volume of 44.31 million shares in a daily average for the past 50 days.
OCGN stock has declined 10.06 percent in the last five days; however, it has gained 5.06% over the past month. Over the last three months, the stock price of OCGN has shed -6.67% and is up 251.91% so far this year. In response to a submission to the Canadian health authority, OCGN stock is rising.
What OCGN has been submitting?
As a biopharmaceutical company, Ocugen aims to discover, develop, and commercialize gene therapies for blindness diseases and to develop a vaccine against COVID-19. OCGN’s breakthrough platform for gene therapy, which treats multiple retinal diseases with one drug, has the potential to treat multiple diseases with the same drug.
With OCGN’s novel biologic product candidate, patients with diseases like wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy will be able to receive better treatment options. Bharat Biotech’s COVAXIN, a vaccine candidate for COVID-19, is being co-developed by OCGN in the United States and Canada.
A rolling submission for COVAXIN has been made to Health Canada by Ocugen, announced the company in a press release today. Following the publication of results from Bharat Biotech’s Phase 3 clinical trial, which showed efficacy and safety in nearly 25,800 adults, OCGN intends to make this move.
The Minister of Health recommended and accepted the rolling submission process relating to the importation, sale and advertising of drugs for use with COVID-19 and transitioned to the New Drug Submission for COVID-19, which will allow companies to submit safety and efficacy information as it becomes available. Often referred to as rolling reviews, this allows Health Canada to begin its review immediately as new information becomes available, allowing the overall review process to move faster.
How OCGN will proceed?
In the rolling submission, Ocugen (OCGN) is represented by its affiliate, Vaccigen, Ltd. OCGN must submit evidence that supports the safety, effectiveness, and quality of their product to Health Canada for review. OCGN will work with Health Canada to bring another safe and effective option for the fight against COVID-19 and its Delta variant, and will be supporting Health Canada for their upcoming review of COVAXIN.