Ocugen Inc Stock Price, News & Analysis

Ocugen (NASDAQ: OCGN) has received approval from Health Canada to initiate a Phase 3 clinical trial for OCU400, its modifier gene therapy for retinitis pigmentosa (RP). The trial, named liMeliGhT, will run parallel to the U.S. FDA trial, potentially expediting a gene-agnostic treatment option for approximately 110,000 patients in the U.S. and Canada.

The study will enroll up to 50 subjects across 5 Canadian sites, targeting patients aged 8 and older with various stages of RP. The primary endpoint is the change in functional vision measured by the Luminance Dependent Navigation Assessment (LDNA). OCU400 has received orphan drug and RMAT designations from the FDA, with 2026 BLA and MAA approval targets.

Ocugen (NASDAQ: OCGN) reported its Q2 2024 financial results and provided a business update. Key highlights include:

• Active dosing in OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa
• Progression to Phase 2 of OCU410 ArMaDa clinical trial for geographic atrophy
• Expanded access program approved for OCU400
• $32.6 million net cash from public offering of common stock

The company's cash position was $16.0 million as of June 30, 2024. Total operating expenses for Q2 2024 were $16.6 million, with a net loss of $0.04 per share. Ocugen continues to advance its gene therapy pipeline and expects OCU410 preliminary safety and efficacy data later this year.

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.