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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, Inc. (NASDAQ: OCGN) announced that the FDA has declined to issue an Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate, COVAXIN™, for individuals aged 2 to 18. The company plans to collaborate with the FDA to explore regulatory pathways for pediatric use. Ocugen is dedicated to developing gene therapies for blindness diseases and furthering its vaccine initiative. The ongoing efforts reflect Ocugen's commitment to advancing solutions in both ocular diseases and infectious diseases.

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Ocugen reported significant progress in its COVAXIN™ development, with the FDA lifting the clinical hold on its IND application, enabling the commencement of Phase 2/3 trials. The company submitted a substantial safety database involving over 36 million vaccinated teens to support its pediatric EUA request. Additionally, Ocugen initiated a Phase 1/2 trial for its OCU400 gene therapy. Despite increased R&D and administrative expenses, cash reserves expanded to $95.1 million. The company announced a public offering of 16 million shares to further support its development pipeline.

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Ocugen, Inc. (Nasdaq: OCGN) announced a public offering of approximately 15.97 million shares of common stock, priced for gross proceeds of about $53.5 million. The offering is set to close on or about February 25, 2022. An additional 2.39 million shares may be purchased by the underwriter within 30 days. Proceeds will be used for corporate purposes, including working capital. Cantor Fitzgerald & Co. is the sole book-running manager for this offering, which is conducted under a previously filed shelf registration with the SEC.

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Ocugen, Inc. (Nasdaq: OCGN) has initiated an underwritten public offering of its common stock, with an option for underwriters to purchase an additional 15% of shares. The proceeds will be utilized for general corporate necessities, including capital expenditures and working capital. The offering is contingent upon market conditions and other customary closing prerequisites, with no assurance of completion or specific terms. Cantor Fitzgerald & Co. serves as the sole book-running manager. The offering is registered under a previously filed shelf registration statement.

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Ocugen, Inc. (NASDAQ: OCGN) announced a conference call scheduled for February 25, 2022, at 8:30 a.m. ET to discuss its fourth quarter and full year 2021 financial results. A pre-market earnings announcement will be issued on the same day. Investors can participate via a toll-free dial-in number and a webcast. Ocugen focuses on gene therapies for blindness and co-developing Bharat Biotech’s COVAXIN™ vaccine for COVID-19. The company emphasizes its innovation in treating retinal diseases and seeks to provide updates on its business and financial performance.

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Ocugen, Inc. (NASDAQ: OCGN) announced that the FDA has lifted the clinical hold on its IND application to evaluate the COVID-19 vaccine candidate COVAXIN™ (BBV152). COVAXIN™ is a whole-virion inactivated vaccine developed by Bharat Biotech and has been administered in over 200 million doses worldwide. It’s authorized for emergency use in 20 countries, with pending applications in more than 60 others. Ocugen aims to provide an alternative COVID-19 vaccine, emphasizing the importance of diverse approaches to pandemic management.

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Ocugen's recent survey, conducted by The Harris Poll, reveals strong public interest in alternative COVID-19 vaccines developed through traditional methods. Key findings indicate that 73% of Americans prefer more conventional vaccine options, and 40% of unvaccinated parents would consider vaccinating their children if a new, more traditional vaccine were available. Additionally, 38% of parents with children under 5 are hesitant about existing vaccines. This data highlights the demand for diverse vaccine options amidst ongoing discussions about childhood vaccinations.

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Ocugen has signed a non-binding letter of intent to acquire a dormant vaccine manufacturing site in Belleville, Ontario from Liminal BioSciences. This facility aims to enhance Ocugen's manufacturing and R&D capabilities, particularly for its COVID-19 vaccine candidate, COVAXIN™ (BBV152). The renovated site will serve as a hub for breakthrough gene therapies and is expected to stimulate regional economic growth and job creation in Ontario. The acquisition, however, is subject to due diligence and final agreements, with no assurance of completion.

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Ocugen, Inc. (NASDAQ: OCGN) announces the appointment of Dr. Nirdosh Jagota as Senior Vice President of Regulatory Affairs. He brings 30 years of experience in the biopharmaceutical sector, previously serving at Arcturus Therapeutics and holding senior roles at major companies like Genentech and Pfizer. Dr. Jagota is tasked with overseeing regulatory strategies for Ocugen’s gene therapy and vaccine development. His extensive background includes the successful approval of over 30 vaccines and therapeutics. The company aims to enhance its regulatory capabilities and expedite product commercialization.

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Ocugen, Inc. (NASDAQ: OCGN) announced the approval of stock options and restricted stock units (RSUs) totaling 787,268 shares and 217,681 shares, respectively, for three new hires. The grants were made on January 10 and January 17, 2022, as incentives for employment in compliance with Nasdaq Listing Rule 5635(c)(4). The stock options have a ten-year term with exercise prices of $4.32 and $4.25. They will vest in equal installments over three years, contingent upon continued service. Ocugen focuses on gene therapies for blindness diseases and the COVAXIN vaccine for COVID-19.

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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