ocugen phase 3 results date

The decision to stop the trial is based on results of a pre … etwombly@lavoiehealthscience.com This technology was licensed from the Harvard Medical School. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Corporate Contact: Ocugen, Inc. Kelly Beck kelly.beck@ocugen.com +1 484-328-4698 Media Contact: LaVoieHealthScience Emmie Twombly etwombly@lavoiehealthscience.com +1 857-389-6042. About the OCU300 Phase 3 Clinical Program The pivotal clinical program consists of two randomized, double-masked, placebo-controlled Phase 3 studies designed to examine the efficacy of OCU300 in treating ocular discomfort and redness as a result of oGVHD. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. Log in or sign up to leave a comment Log In Sign Up. Or waiting for FDA Approval? They want to know the progress of the phase 2/3 trial of the age group 5-18 . S. StockMan. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. On March 3, Ocugen released interim Phase 3 results which showed that the shot was 81% effective in preventing initial cases of Covid-19. The ongoing Phase 3 study of their vaccine candidate, Covaxin, demonstrated a vaccine efficacy of 81%, Ocugen said. Ocugen, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to treat the whole eye. We will analyze the full data when it is available. 0 comments. Bharat Biotech phase 3 ends today, no side effects reported, 99.6% efficacy reported in phase 2. Host Disease (oGVHD). Ocugen, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to treat the whole eye. Posted by 15 hours ago. MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat the whole eye, today announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Shares of biotech Ocugen (NASDAQ:OCGN) have been on a rollercoaster ride this month. Media Contact: From a December 2020 low of 29 cents, OCGN stock now trades at … This modifier gene therapy platform is based on nuclear hormone receptors (“NHRs”), which have the potential to restore homeostasis, the basic biological processes in the retina and potentially rescue photoreceptors from degeneration. level 1. Sort by . PDF Version. As a result of the positive news, OCGN stock is up 0ver 13%. As a result of discontinuing this study and proceeds from our ATM program we believe that we have sufficient cash to fund our current operations into the fourth quarter of 2020. The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. Our additional pipeline products, OCU410 and OCU200, which are focused on major retinal diseases, are targeted to enter the clinic by 2022. save. March 3, 2021 at 8:00 AM EST . “We are committed to advancing our transformative therapies and will shift our resources to focus on our breakthrough modifier gene therapy platform and novel biologic programs for patients suffering from blindness diseases. Pursuing Innovative Ocular Biotherapeutics. Ocugen, Inc. We are grateful to the patients, their families and the investigators who participated in our clinical trial,” said Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. OCU400 has received two Orphan Drug Designations from the Food and Drug Administration, one for the treatment of NR2E3 mutation-associated retinal diseases and the other for the treatment of CEP290 mutation-associated retinal diseases. “This is disappointing news, especially for those who suffer from oGVHD. Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN™ for the US marketOcugen and Bharat Biotech to share US commercialization profits Ocugen … Ocugen announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Ocugen does have other candidates, ... And Bharat’s product, covaxin, has shown early promise. Data from 25,800 participants in Phase 3 trial in India, received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated and © 2021 Ocugen, Inc. All Rights Reserved. Ocugen is developing a modifier gene therapy platform to generate therapies designed to fulfill unmet medical needs in the area of retinal diseases, including inherited retinal diseases (“IRDs”). Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. “We are committed to advancing our transformative therapies and will shift our resources to focus on our breakthrough modifier gene therapy platform and novel biologic programs for patients suffering from blindness diseases. Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN, Demonstrates Efficacy of 81% Data from 25,800 participants in Phase 3 … As a result of discontinuing this study and proceeds from our ATM program we believe that we have sufficient cash to fund our current operations into the fourth quarter of 2020. Jun. OCU400 has the potential to eliminate the need for developing more than 150 individual products and provide one treatment option for all Retinitis Pigmentosa (RP) patients. MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat the whole eye, today announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Log in or sign up to leave a comment Log In Sign Up. I bought Ocugen around Christmas @2$. Our hope was to provide the first treatment for this complex, orphan disease. News Bharat biotech just announced 3rd phase results are 81% effective . Topline data anticipated in second half of 2020. The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. December 9, 2019 at 9:28 AM EST . Be the first to share what you think! Fingers are crossed . Ocugen is developing a modifier gene therapy platform to generate therapies designed to fulfill unmet medical needs in the area of retinal diseases, including inherited retinal diseases (“IRDs”). Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. Our additional pipeline products, OCU410 and OCU200, which are focused on major retinal diseases, are targeted to enter the clinic by 2022. We should get phase 3 efficacy next week which is what will send this if numbers still great. MALVERN, Pa., Dec. 09, 2019 (GLOBE NEWSWIRE) -- Ocugen, Inc., (NASDAQ: OCGN), ), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of … Several days of 50%-plus gains — along with double-digit drops — … share. Sort by. Uncategorized / By fiascojob. Our hope was to provide the first treatment for this complex, orphan disease. “This is disappointing news, especially for those who suffer from oGVHD. report. 100% Upvoted. 239. Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN, Demonstrates Efficacy of 81% . Corporate Contact: kelly.beck@ocugen.com 2 days ago. And do guys scale or sell fully ? 1, 2020, 09:20 AM. Press release content from Globe Newswire. Bag holded for some weeks. This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Covaxin's approval and recognition by different countries (Brazil, Ukraine, UK, etc..) adds up to its credibility and Imminent FDA approval. Reply Replies (5) 20. hide. Consisting of a functional copy of the nuclear hormone receptor gene NR2E3, OCU400 is delivered to target cells in the retina using an adeno-associated viral (AAV) vector. We will analyze the full data when it is available. If this is good - that’s amazing !!!! save. best. Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN, Demonstrates Efficacy of 81% – GlobeNewswire . This modifier gene therapy platform is based on nuclear hormone receptors (“NHRs”), which have the potential to restore homeostasis, the basic biological processes in the retina and potentially rescue photoreceptors from degeneration. The problem is that the collaboration announcement on Dec. 22 with Bharat Biotech does not indicate that there has been any Phase 3 clinical trial results. MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat the whole eye, today announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. LaVoieHealthScience +1 484-328-4698 MALVERN, Pa., March 03, 2021 -- Ocugen, Inc. (OCGN), a biopharmaceutical company focused on discovering, developing, and c... Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN, Demonstrates Efficacy of 81% Ocugen Announces Completion of 50% of Enrollment of its Phase 3 Clinical Trial for ocular GVHD. OCU400 has the potential to eliminate the need for developing more than 150 individual products and provide one treatment option for all Retinitis Pigmentosa (RP) patients. The study was not stopped based on safety concerns. About the OCU310 Phase 3 Program Ocugen plans to conduct two identical placebo-controlled Phase 3 trials with approximately 240 patients per study. Interim Phase 3 Results as Reported by Bharat Biotech. MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat the whole eye, today announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. share. Cautionary Note on Forward-Looking Statements. Ocugen to Discontinue Phase 3 oGVHD Trial Breakthrough Modifier Gene Therapy platform continues to advance towards clinicMALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) - Ocugen… Data from 25,800 participants in Phase 3 trial in India, received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated and demonstrated 81% efficacy in preventing … Host Disease (oGVHD). report. Host Disease (oGVHD). Shares of Ocugen at last check jumped 35% to $13.01. On March 3, 2021, Ocugen, Inc. issued a press release announcing that its co-development partner, Bharat Biotech International Limited, announced the results of the first interim analysis of its Phase 3 clinical trial of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. Kelly Beck Unlike single-gene replacement therapies, which only target one gene at a time, we believe OCU400, through its use of NHRs, represents a novel approach in that it may address multiple retinal diseases with one product. It is also currently in a Phase 3 study with 25,800 subjects enrolled. PRESS RELEASE GlobeNewswire . December 09, … Unlike single-gene replacement therapies, which only target one gene at a time, we believe OCU400, through its use of NHRs, represents a novel approach in that it may address multiple retinal diseases with one product. Any forward-looking statements that we make in this press release speak only as of the date of this press release. OCU400 has received two Orphan Drug Designations from the Food and Drug Administration, one for the treatment of NR2E3 mutation-associated retinal diseases and the other for the treatment of CEP290 mutation-associated retinal diseases. Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN, Demonstrates Efficacy of 81%. Ocugen will provide US market, and Canada & Mexico eventually. For more information, please visit www.ocugen.com. Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. This technology was licensed from the Harvard Medical School. Email Print Friendly Share. MALVERN, Pa., June 01, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat the whole eye, today announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. We remain on track to enter the clinic by next year with our first gene therapy product candidate, OCU400, which targets inherited retinal diseases. 100% Upvoted. Ocugen Provides Business Update and First Quarter 2020 Financial Results100% of planned enrollment completed in Phase 3 oGVHD study; topline results anticipated by end of 2020 - read this article along with other careers information, tips and advice on BioSpace Emmie Twombly 3… Consisting of a functional copy of the nuclear hormone receptor gene NR2E3, OCU400 is delivered to target cells in the retina using an adeno-associated viral (AAV) vector. View Entire Discussion (0 Comments) More posts from the Ocugen community. Given the early potential therapeutic benefits of brimonidine tartrate (0.2%) observed in the Phase 2 study, the Phase 3 efficacy and safety results will be assessed after 28 days of treatment (primary endpoint assessment visit). We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Ocugen to Discontinue Phase 3 oGVHD Trial. Ocugen (NASDAQ:OCGN) may be the most explosive stock on the market right now. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. 10 comments. This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Ocugen gets a head start, as COVAXIN has already been granted emergency use authorization in India. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.

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