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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, a biopharmaceutical firm, announced participation in three upcoming conferences: H.C. Wainwright Global Life Sciences Conference (Mar 9-10), 33rd Annual Roth Conference (Mar 15-17), and Oppenheimer 31st Annual Healthcare Conference (Mar 16-18). CEO Dr. Shankar Musunuri will present on COVID-19 vaccine COVAXIN™ and their gene therapy. The H.C. Wainwright conference features a fireside chat, while the Roth Conference includes a panel on COVID-19 therapies. Ocugen focuses on gene therapies for retinal diseases and COVAXIN for the U.S. market.
Ocugen announced promising results from Bharat Biotech's Phase 3 trial of COVAXIN, a COVID-19 vaccine, showing 81% efficacy in preventing symptomatic infections in over 25,800 participants. The interim analysis indicated that the vaccine was well tolerated with few adverse events. COVAXIN demonstrated the ability to neutralize the UK variant, underscoring its potential in the U.S. market. Further analyses are planned as the trial continues, aiming to finalize results at 130 confirmed cases.
Ocugen (NASDAQ: OCGN) has received orphan medicinal product designation from the European Commission for its gene therapy candidate OCU400, aimed at treating retinitis pigmentosa (RP) and Leber Congenital Amaurosis (LCA). The company estimates that RP affects 165,000 and LCA approximately 40,000 patients in Europe. OCU400 leverages a modifier gene therapy platform that could address multiple inherited retinal diseases, potentially benefiting millions globally. The designation provides significant advantages, including reduced regulatory fees and a decade of market exclusivity.
Ocugen, Inc. (Nasdaq: OCGN) has successfully completed a registered direct offering of 3,000,000 shares of common stock, generating approximately $23 million in gross proceeds. The offering was facilitated by H.C. Wainwright & Co. The funds will primarily support general corporate purposes, including capital expenditures and working capital. The shares were offered under a shelf registration statement filed with the SEC, ensuring compliance with regulatory standards.
Ocugen, Inc. (Nasdaq: OCGN) announced a registered direct offering of 3,000,000 shares of common stock at $7.65 per share, expecting gross proceeds of $23 million. The offering will close around February 10, 2021, subject to customary conditions. The funds raised will be allocated for general corporate purposes, capital expenditures, and working capital. H.C. Wainwright & Co. is the exclusive placement agent for this offering. The shares are being offered under an effective shelf registration statement with the SEC, ensuring compliance with securities laws.
Ocugen has chosen to withdraw a proposal regarding an increase in authorized shares previously set for stockholder consideration. This decision leads to the cancellation of the reconvening of the annual stockholder meeting, originally scheduled for January 13, 2021. The company plans to reassess this proposal in light of the potential inclusion of COVAXIN in its pipeline and its compliance with Nasdaq Listing Rule 5550(a)(2). Other items from the proxy statement were already voted on during the annual meeting on December 23, 2020.
Ocugen has confirmed that it has regained compliance with Nasdaq Listing Rule 5550(a)(2). This follows a period during which its common stock failed to maintain a minimum bid price of $1.00. From December 23, 2020, to January 7, 2021, the stock closed at $1.00 or more for 10 consecutive trading days, fulfilling the requirement set by Nasdaq. This marks a significant achievement for the biopharmaceutical company focused on gene therapies and COVID-19 vaccine development.
MALVERN, Pa., Jan. 8, 2021 – Ocugen (NASDAQ: OCGN) announced its participation in upcoming healthcare investment conferences. Dr. Shankar Musunuri, CEO, will present virtually at the CTIC 5th Healthcare Investment Summit (Jan 9-13), H.C. Wainwright BioConnect Conference (Jan 11-14), and Noble Capital Markets 17th Annual Conference (Jan 20). Key topics include the advancement of their modifier gene therapy, biologic product candidate, and COVID-19 vaccine, COVAXIN™, aimed for the U.S. market. The company plans to initiate four Phase 1/2 clinical trials within 1-2 years.
Ocugen, a prominent biopharmaceutical company, has announced the creation of a vaccine scientific advisory board aimed at advancing the clinical and regulatory pathway for COVAXIN™, a COVID-19 vaccine developed in partnership with Bharat Biotech. The board comprises recognized experts from academia and industry, including leaders from Pfizer and the University of Pennsylvania. CEO Dr. Shankar Musunuri expressed enthusiasm about the board’s role in enhancing the vaccine's potential effectiveness and market viability in the US. COVAXIN™ is noted for its unique whole-virion inactivated approach.
Ocugen (NASDAQ: OCGN) announced the adjournment of its 2020 Annual Meeting to provide stockholders more time to vote on Item 2, which proposes amending its certificate of incorporation to reduce the authorized shares of common stock from 500 million to 400 million. The meeting will reconvene on January 13, 2021. Stockholders who have already voted do not need to vote again unless they wish to change their vote regarding Item 2. Voting for other items will remain open until December 23, 2020.