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) regularly issues news updates about its progress in gene therapies for blindness diseases, making its news flow particularly relevant for investors and observers of the ophthalmic biotechnology space. The company’s announcements often cover clinical trial milestones, licensing agreements, financing transactions, and participation in industry and investor conferences.
A major focus of Ocugen’s recent news has been its modifier gene therapy platform and associated programs. Updates include Phase 1, Phase 2, and Phase 2/3 data for investigational products such as OCU400 for retinitis pigmentosa, OCU410 for geographic atrophy secondary to dry age-related macular degeneration, and OCU410ST for Stargardt disease. Press releases describe safety and exploratory efficacy findings, such as lesion growth reduction and visual function outcomes, as well as plans for future regulatory submissions.
Ocugen’s news stream also highlights business development and capital markets activity. Examples include an exclusive license agreement with Kwangdong Pharmaceutical Co., Ltd. for OCU400 in the Republic of Korea, registered direct offerings of common stock and warrants, and updates on cash runway and financial results. In addition, the company frequently announces webcasts and conference calls to discuss quarterly results, business updates, and key clinical data readouts.
Another recurring theme in Ocugen’s news is its presence at healthcare and investor conferences, such as the J.P. Morgan Healthcare Conference, NobleCon, and rare disease–focused events. These items outline presentation topics, panel participation, and the company’s messaging around its goal of advancing multiple Biologics License Application (BLA) filings within a defined timeframe.
Investors and followers of OCGN news can use this page to monitor clinical trial progress, licensing developments, financing events, and strategic communications as Ocugen advances its gene therapy programs for major retinal diseases.
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.
Ocugen (NASDAQ: OCGN), a biotechnology company, will join the Russell 3000® Index, effective June 28, 2024, as per FTSE Russell's preliminary reconstruction. This inclusion highlights Ocugen's strong pipeline of gene and cell therapies, including the Phase 3 liMeliGhT trial of OCU400 for retinitis pigmentosa. The Russell 3000® Index tracks the performance of the largest 3,000 U.S. companies. Ocugen's addition could enhance its visibility among investors and broaden its shareholder base.
The Russell 3000® Index represents approximately 96% of the U.S. equity market and serves as a benchmark for $10.5 trillion in assets. Ocugen aims to leverage this inclusion to boost long-term shareholder value.
Ocugen announced that its Chief Scientific Officer, Arun Upadhyay, PhD, will present at the International Society for Cell & Gene Therapy's 2024 Annual Meeting in Vancouver, Canada. The presentation will focus on OCU400, a modifier gene therapy for retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA), targeting over 100 genetic mutations. The presentation will discuss safety and efficacy data from a Phase 1/2 clinical trial. The OCU400 Phase 3 liMeliGhT trial is progressing and aims for BLA and MAA approvals by 2026.
Ocugen has completed dosing in the second cohort of its Phase 1/2 GARDian clinical trial for the gene therapy OCU410ST, aimed at treating Stargardt disease. This milestone enables the company to advance to higher doses in the dose-escalation study. So far, six patients have been dosed, with three more to receive high doses in the final phase. The ongoing trial is crucial, as Stargardt disease lacks FDA-approved treatments, affecting around 100,000 people in the U.S. and Europe. Preliminary safety and efficacy data from Phase 1 will be shared soon, with a trial update expected in Q3 2024.
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