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Ocugen, Inc. - OCGN STOCK NEWS

Welcome to our dedicated page for Ocugen news (Ticker: OCGN), a resource for investors and traders seeking the latest updates and insights on Ocugen stock.

Ocugen, Inc. (NASDAQ: OCGN) is a pioneering biotechnology company that focuses on discovering, developing, and commercializing novel gene and cell therapies, as well as vaccines aimed at improving health and offering hope to patients worldwide. The company's innovative efforts are concentrated on addressing rare and underserved ocular disorders.

Ocugen's core business revolves around a robust clinical pipeline which includes:

  • OCU400: A groundbreaking gene-agnostic modifier gene therapy for retinitis pigmentosa (RP), currently in Phase 3 clinical trials. It leverages the nuclear hormone receptor gene NR2E3 to reset altered cellular gene networks and improve retinal health.
  • OCU410: A potential one-time gene therapy for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). This therapy targets multiple pathways involved in the disease, including lipid metabolism, inflammation, oxidative stress, and the complement system.
  • OCU410ST: Another modifier gene therapy in Phase 1/2 clinical trials for Stargardt disease, the most common form of inherited macular degeneration. It utilizes the AAV delivery platform for the RORA gene to regulate pathways linked to the disease.

Recent milestones include positive feedback from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the OCU400 Phase 3 liMeliGhT clinical trial, as well as the inclusion of Ocugen in the Russell 3000® Index, highlighting its market presence and growth potential.

Ocugen's commitment to innovative therapies is evident through its modifier gene therapy platforms designed to fulfill unmet medical needs related to inherited retinal diseases such as RP, Leber congenital amaurosis, and Stargardt disease. Additionally, the company is advancing research in infectious diseases to bolster public health and orthopedic diseases to meet unmet medical needs.

For the latest updates and detailed information about Ocugen, Inc., visit their official website at www.ocugen.com and follow them on X and LinkedIn.

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Ocugen reports significant progress in its pipeline with the completion of its regulatory submission for COVAXIN™ to Health Canada and ongoing FDA discussions. The company achieved a $115.8 million cash position, up from $24.2 million at year-end 2020. Major financials include research and development expenses of $18.9 million driven by a $15 million payment to Bharat Biotech, and a net loss per share of $0.13. The organization also welcomed new senior management and expanded its workforce to support growth in clinical development and commercialization.

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Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company, announced a conference call to discuss its Q2 2021 financial results and provide a business update on August 6, 2021, at 8:30 a.m. ET. A pre-market earnings announcement will precede the call. Investors can participate via dial-in or webcast. Ocugen focuses on developing gene therapies for blindness and a COVID-19 vaccine, notably co-developing the COVAXIN™ vaccine. The release highlights forward-looking statements and encourages reviewing risk factors in their SEC filings.

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Ocugen, Inc. (NASDAQ: OCGN) announced the approval of stock options for 150,750 shares and restricted stock units (RSUs) for 25,250 shares to seven new employees as of July 16, 2021. The stock options come with a ten-year term at an exercise price of $6.66 per share, aligning with the closing price on the grant date. Both the options and RSUs will vest in equal annual installments over three years, contingent on continued service. This grant aims to incentivize new talent in line with Nasdaq Listing Rule 5635(c)(4).

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Ocugen, Inc. (OCGN) announced the initiation of a rolling submission to Health Canada for COVAXIN™, its COVID-19 vaccine candidate developed in collaboration with Bharat Biotech. This decision follows positive Phase 3 clinical trial results showcasing efficacy and safety among nearly 25,800 participants. The rolling submission allows for ongoing review of data as it becomes available, potentially speeding up the approval process. COVAXIN™ has demonstrated a strong safety profile and is currently administered under emergency authorizations in 13 countries.

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Ocugen reported positive Phase 3 results for COVAXIN™, a COVID-19 vaccine candidate co-developed with Bharat Biotech. The vaccine demonstrated 77.8% efficacy against symptomatic COVID-19 and 93.4% against severe cases. Additionally, efficacy against the Delta variant stands at 65.2%. Adverse events were comparable to placebo, with 12.4% of subjects reporting mild side effects and less than 0.5% serious events. Ocugen plans to submit a Biologics License Application in the U.S. and is in discussions for approval in Canada.

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Ocugen, Inc. (NASDAQ: OCGN) has appointed Ken Inchausti as the new Head of Investor Relations & Communications. With over 25 years of experience in healthcare communications, Inchausti previously worked at Novo Nordisk, where he led corporate media relations and reputation strategy. This appointment comes as Ocugen advances its plans for COVAXIN vaccine commercialization in the U.S. and Canada, alongside the initiation of its Phase 1/2a clinical trial for OCU400. His expertise is expected to enhance Ocugen's stakeholder engagement and public health initiatives.

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Ocugen announced the grant of stock options and restricted stock units (RSUs) to four new employees as part of their compensation package. The stock options total 157,450 shares with an exercise price of $6.26, reflecting the stock's closing price on the grant date, June 15, 2021. The RSUs cover 26,300 shares, and both will vest over three years. These grants were made as inducements for employment per Nasdaq rules. Ocugen focuses on gene therapies for blindness and COVID-19 vaccine development, co-developing Bharat Biotech’s COVAXIN in the U.S.

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Ocugen, Inc. (NASDAQ: OCGN) announced its inclusion in the Russell 3000® Index effective June 28, 2021. This recognition places Ocugen among the largest US companies, representing 98% of the investable US equity market. The Russell indexes are vital for investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them. Ocugen develops gene therapies for retinal diseases and COVAXIN™ for COVID-19, showcasing its commitment to innovative biopharmaceutical solutions.

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Ocugen has announced a partnership with Jubilant HollisterStier for the manufacturing of COVAXIN™ in the US and Canada. This collaboration aims to prepare for potential commercial manufacturing of the COVID-19 vaccine, enhancing its availability in North America. Senior Vice President, J.P. Gabriel, emphasized the importance of securing US-based manufacturing capability as they approach regulatory submissions to the FDA and Health Canada. COVAXIN™ boasts a vaccine efficacy of 78% overall, with 100% against severe disease in clinical trials.

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Ocugen, Inc. (NASDAQ: OCGN) has appointed Michael Shine as Senior Vice President, Commercial, enhancing its leadership ahead of potential COVAXIN commercialization in the US and Canada. Shine brings nearly 35 years of experience, including successful roles at Pfizer Vaccines, where he led the $6 billion Prevnar franchise. His expertise in marketing and sales is expected to drive Ocugen's vaccine and ophthalmic product launches, contingent on regulatory approvals. The company's focus remains on gene therapies for blindness and COVID-19 vaccine development.

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FAQ

What is the current stock price of Ocugen (OCGN)?

The current stock price of Ocugen (OCGN) is $0.7743 as of December 20, 2024.

What is the market cap of Ocugen (OCGN)?

The market cap of Ocugen (OCGN) is approximately 223.7M.

What does Ocugen, Inc. specialize in?

Ocugen specializes in discovering, developing, and commercializing novel gene and cell therapies, as well as vaccines aimed at improving health and offering hope to patients worldwide.

What are Ocugen's key projects?

Ocugen's key projects include OCU400 for retinitis pigmentosa, OCU410 for geographic atrophy, and OCU410ST for Stargardt disease. These therapies focus on modifying gene functions to treat retinal diseases.

What recent achievements has Ocugen accomplished?

Recent achievements include EMA and FDA clearance for the OCU400 Phase 3 clinical trial and inclusion in the Russell 3000® Index, signifying its market relevance and growth potential.

How does OCU400 work?

OCU400 is a gene-agnostic modifier gene therapy that uses the NR2E3 gene to reset altered cellular gene networks, aiming to improve retinal health in patients with retinitis pigmentosa.

What is the significance of Ocugen's modifier gene therapy platform?

Ocugen's modifier gene therapy platform is designed to treat multiple retinal diseases with a single product by addressing broader genetic conditions, offering hope to patients with complex inherited retinal disorders.

What are the target conditions for OCU410?

OCU410 targets geographic atrophy (GA), an advanced stage of dry age-related macular degeneration, by addressing multiple pathways involved in the disease such as lipid metabolism, inflammation, and oxidative stress.

How does OCU410ST aim to treat Stargardt disease?

OCU410ST uses the RORA gene delivered via an AAV platform to regulate pathways linked to Stargardt disease, targeting factors like oxidative stress and inflammation to preserve photoreceptor cells in the retina.

What is the impact of Ocugen's inclusion in the Russell 3000® Index?

Inclusion in the Russell 3000® Index enhances Ocugen's visibility within the investment community, supports long-term shareholder value, and broadens its shareholder base.

What steps has Ocugen taken to ensure the success of its clinical therapy programs?

Ocugen has received regulatory clearances for pivotal clinical trials, engaged in continuous safety and efficacy assessments, and is leveraging strategic partnerships to support its entire pipeline.

Where can I learn more about Ocugen's latest news and developments?

For the latest news and updates about Ocugen, visit their official website at www.ocugen.com and follow them on X and LinkedIn.

Ocugen, Inc.

Nasdaq:OCGN

OCGN Rankings

OCGN Stock Data

223.70M
287.21M
1.41%
27.53%
18.67%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
MALVERN