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, Inc. (NASDAQ: OCGN) has received FDA approval to begin an expanded access program (EAP) for OCU400, its modifier gene therapy candidate for retinitis pigmentosa (RP). The EAP will allow adult patients aged 18 and older with RP to access OCU400 outside of clinical trials. This development follows positive Phase 1/2 study data and an ongoing Phase 3 liMeliGhT clinical trial.
OCU400 has received orphan drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA. The European Medicines Agency (EMA) has also accepted the U.S.-based trial for submission of a Marketing Authorization Application (MAA). Ocugen aims for targeted BLA and MAA approval in 2026.
Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company focusing on gene and cell therapies and vaccines, has closed its public offering of 30,434,783 common stock shares at $1.15 per share. The offering, led by a premier mutual fund and prominent life sciences investors, raised approximately $35 million in gross proceeds. Titan Partners Group, a division of American Capital Partners, acted as the sole book-running manager.
The company plans to use the net proceeds for general corporate purposes, capital expenditures, working capital, and general and administrative expenses. The offering was made pursuant to a previously filed and effective shelf registration statement on Form S-3.
Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company, has announced the pricing of its underwritten public offering of 30,434,783 shares of common stock at $1.15 per share. This offering is expected to generate gross proceeds of $35 million before deducting underwriting discounts, commissions, and other expenses. The company has also granted the underwriter a 30-day option to purchase up to 4,565,217 additional shares. The offering is set to close around August 2, 2024.
Ocugen plans to use the net proceeds for general corporate purposes, capital expenditures, working capital, and general and administrative expenses. Titan Partners Group is acting as the sole book-running manager for this offering, which is being made pursuant to a shelf registration statement previously filed with the SEC.
Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company, has announced a proposed public offering of common stock. The company plans to grant the underwriter a 30-day option to purchase up to an additional 15% of shares. Ocugen intends to use the net proceeds for general corporate purposes, capital expenditures, working capital, and general and administrative expenses. Titan Partners Group is acting as the sole book-running manager for the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 filed with the SEC. A preliminary prospectus supplement and accompanying base prospectus will be available on the SEC's website.
Ocugen (NASDAQ: OCGN), a biotechnology company specializing in gene and cell therapies and vaccines, has announced a conference call and webcast scheduled for August 8, 2024, at 8:30 a.m. ET. The event will cover the company's second quarter 2024 financial results and provide a business update. Ocugen plans to release a pre-market earnings announcement on the same day.
Interested parties can join the call using the following details:
- U.S. callers: (800) 715-9871
- International callers: (646) 307-1963
- Conference ID: 7453742
Ocugen, Inc. (NASDAQ: OCGN) has completed dosing in the high-dose cohort of its Phase 1/2 ArMaDa clinical trial for OCU410, a novel modifier gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The trial, conducted at 14 leading retinal surgery centers in the US, has finished the Phase 1 stage with three subjects receiving the highest dose. OCU410 aims to provide a one-time treatment option for GA, which affects approximately 1 million people in the United States.
The company has now initiated a Phase 2 clinical trial to assess the safety and efficacy of OCU410 in a larger patient group, randomized into medium-dose, high-dose, or control groups. This novel approach could potentially transform GA treatment, addressing limitations of current FDA-approved therapies that require continuous intravitreal injections over several years.
Ocugen announced that the Data and Safety Monitoring Board (DSMB) has approved the enrollment in the high dose cohort 3 of the OCU410ST GARDian study for Stargardt disease. This decision follows the establishment of the medium dose as safe and tolerable in the ongoing clinical trial. OCU410ST is a gene therapy candidate aimed at treating Stargardt disease, which affects around 100,000 individuals in the U.S. and Europe. Six patients have been dosed in the Phase 1/2 trial so far, and three more will be included in the high dose cohort. No serious adverse events related to OCU410ST have been reported. The trial will eventually include up to 42 subjects with mild to moderate symptoms and is divided into two phases: a dose-escalation phase and a randomized, outcome-assessor-blinded dose-expansion phase. Currently, there are no FDA-approved treatments for Stargardt disease, and Ocugen hopes to meet this unmet medical need.
Ocugen has dosed the first patient in its Phase 3 liMeliGhT clinical trial for OCU400, a gene therapy for retinitis pigmentosa (RP). This significant milestone aims to provide a one-time treatment for RP, affecting 1.6 million globally. The trial's design builds on promising Phase 1/2 data showing visual improvements in 89% of participants. The Phase 3 study includes 150 participants, divided into two arms—one with RHO gene mutations and another gene-agnostic group. The primary endpoint is improvement in Luminance Dependent Navigation Assessment (LDNA). OCU400 has received orphan drug and RMAT designations from the FDA and is on track for 2026 approvals.
Ocugen announced a positive DSMB review for its Phase 1/2 ArMaDa clinical trial of OCU410, a gene therapy for geographic atrophy in dry age-related macular degeneration. The trial showed safety and tolerability in low and medium doses, with no serious adverse events. The DSMB approved simultaneous enrollment in the high-dose cohort and Phase 2 initiation. OCU410 aims to provide a long-term benefit with a single subretinal injection, addressing multiple pathways of dAMD. The trial involves a dose-ranging Phase 1 and a randomized, blinded Phase 2 study.
Ocugen will present at the 2024 BIO International Convention in San Diego, CA, from June 3-6, 2024. The company aims to explore partnerships and showcase advancements in their gene and cell therapy platforms. Key highlights include the OCU400 Phase 3 trial for retinitis pigmentosa, OCU410 Phase 1/2 trials for geographical atrophy and Stargardt disease, and the Phase 3-ready NeoCart® for cartilage repair. Ocugen recently completed a state-of-the-art gene therapy manufacturing facility. Dr. Shankar Musunuri, CEO, will present on June 3 at 2:15 p.m. PT.
FAQ
What is the current stock price of Ocugen (OCGN)?
What is the market cap of Ocugen (OCGN)?
What does Ocugen, Inc. specialize in?
What are Ocugen's key projects?
What recent achievements has Ocugen accomplished?
How does OCU400 work?
What is the significance of Ocugen's modifier gene therapy platform?
What are the target conditions for OCU410?
How does OCU410ST aim to treat Stargardt disease?
What is the impact of Ocugen's inclusion in the Russell 3000® Index?
What steps has Ocugen taken to ensure the success of its clinical therapy programs?