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.
Ocugen announced that the FDA placed its Phase 2/3 immuno-bridging study for COVAXIN™ on clinical hold due to a voluntary pause in dosing participants. This decision follows the World Health Organization’s inspection of Bharat Biotech's manufacturing facility. The company aims to address the FDA's questions while evaluating these findings. Ocugen remains focused on advancing its innovative therapies and will collaborate with the FDA to resolve the clinical hold for OCU-002.
Ocugen, a biotechnology company, has commenced the Phase 1/2 clinical trial of OCU400 for treating retinitis pigmentosa (RP), marking its first clinical trial in humans for its modifier gene therapy platform. The first patient has been dosed in this observer-blind trial, which aims to evaluate safety and efficacy. RP, affecting approximately two million people globally, currently has no approved therapies. The trial focuses on genetic mutations in the NR2E3 and RHO genes, with potential future expansions to target more mutations.
Ocugen, Inc. (NASDAQ: OCGN) has appointed Dr. Marna C. Whittington to its Board of Directors, effective March 21, 2022. Dr. Whittington, a seasoned financial leader, previously served as CEO of Allianz Global Investors Capital and has held positions at Morgan Stanley and the University of Pennsylvania. Her expertise is expected to bolster Ocugen's growth strategy concerning its gene therapies and vaccine candidates. The announcement follows the departure of Manish Potti, who did not seek reappointment, expressing confidence in the company's future in addressing unmet medical needs.
Ocugen, Inc. (NASDAQ: OCGN) announced the appointment of Jessica Crespo as Chief Accounting Officer and Senior Vice President, Finance, effective March 18, 2022. With over 20 years of experience, Crespo previously served as Vice President, Corporate Controller, and Treasurer at Ocugen. Her responsibilities include financial strategy development and oversight of accounting and reporting functions. Chairman Dr. Shankar Musunuri emphasized her valuable contributions, crucial to sustaining the company’s growth as it advances therapies toward regulatory approval.
Ocugen announced on March 18, 2022, that its Board of Directors approved stock options for 331,155 shares and restricted stock units (RSUs) for 90,232 shares to nine new hires. The stock options, with a ten-year term, have an exercise price of $2.87 per share, aligning with the closing price on the grant date (March 16, 2022). Both options and RSUs will vest annually over three years, contingent on continued employment. This grant supports Ocugen's focus on gene therapies for blindness and COVID-19 vaccine development.
Ocugen, Inc. (NASDAQ: OCGN) announces that Dr. Shankar Musunuri, Chairman and CEO, will present at the 34th Annual Roth Conference on March 14, 2022, at 11:00 AM PT in Dana Point, CA. The event will feature meetings, analyst chats, and industry panels from approximately 400 companies. Ocugen focuses on gene therapies for retinal diseases and co-develops the COVID-19 vaccine candidate COVAXIN™. A live audio webcast of the presentation will be available on the company’s investor relations website.
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.
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.
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.
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.