Ocugen, Inc. - OCGN STOCK NEWS

Ocugen, Inc. (NASDAQ: OCGN) announced that the FDA has lifted the clinical hold on the investigational new drug application for the Phase 1 clinical trial of OCU200, a recombinant fusion protein designed to treat diabetic macular edema (DME). OCU200 targets the integrin pathway and could potentially benefit all DME patients, including those unresponsive to current anti-VEGF therapies.

The trial is a multicenter, open-label, dose-ranging study with three cohorts in the dose-escalation portion and a fourth cohort combining OCU200 with anti-VEGF therapy. DME affects approximately 746,000 people in the United States. Ocugen plans to explore additional indications for OCU200, including diabetic retinopathy and wet age-related macular degeneration, which collectively impact nearly nine million Americans.

Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company, announced that its Chairman, CEO, and Co-founder, Dr. Shankar Musunuri, will present at the 2024 Cell & Gene Meeting on the Mesa on October 7, 2024, at 1:30 p.m. MST in Phoenix, AZ. The presentation will focus on Ocugen's first-in-class modifier gene therapy platform, including:

• OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa
• OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy
• OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease

OCU400 is on track for its 2026 BLA and MAA approval targets. The company's executive team will also conduct one-on-one meetings to discuss business and clinical development strategies. Virtual attendance options are available for the conference.

Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company specializing in gene and cell therapies and vaccines, has announced its participation in Chardan's 8th Annual Genetic Medicines Conference. The event will take place on September 30-October 1, 2024 in New York.

Dr. Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, will engage in an in-person fireside chat on September 30 at 10:30 a.m. ET. The session, moderated by Daniil Gataulin, PhD, Senior Biotech Research Analyst, will focus on Ocugen's modifier gene therapy approach for retinal diseases and the progress of ongoing clinical trials for retinitis pigmentosa, geographic atrophy, and Stargardt disease.

The fireside chat will be accessible via a live video webcast on the Ocugen investor site. Additionally, Ocugen's executive team will conduct one-on-one meetings with investors to discuss the company's business and clinical development strategy.

Ocugen's Chairman, CEO, and Co-founder, Dr. Shankar Musunuri, is set to speak at a U.S.-India biotechnology cooperation workshop in New Delhi from September 9-11, 2024. The event, titled 'U.S.-India Biotechnology Cooperation: Realizing Benefits, Reducing Risks,' is part of the U.S.-India Initiative on Critical and Emerging Technology.

Dr. Musunuri will participate in a panel discussion on 'Persistent Challenges: Right-Sizing Regulations and Setting Standards Beyond the Biomedical Sphere' on September 10. The workshop series, organized by the U.S. National Academies of Sciences, Engineering, and Medicine and the Indian National Science Academy, aims to identify opportunities for collaboration in biotechnology between the two countries.

Ocugen, a NASDAQ-listed biotechnology company (OCGN), focuses on gene and cell therapies, and vaccines. With its new site in Hyderabad, India, Ocugen is actively contributing to strengthening U.S.-India biotechnology cooperation.

Ocugen's Chief Scientific Officer, Dr. Arun Upadhyay, is set to participate in the 5th Annual Gene Therapy for Ophthalmic Disorders Summit in Boston from September 10-12, 2024. Dr. Upadhyay will moderate a workshop on regulatory pathways for ophthalmic gene therapies on September 10 and deliver a presentation on Ocugen's clinical program updates on September 12.

Ocugen (NASDAQ: OCGN) is a biotechnology company focused on gene and cell therapies, and vaccines. Dr. Upadhyay emphasized the potential of gene therapy in treating rare retinal diseases and widespread ophthalmic conditions. The conference provides an opportunity for Ocugen to showcase its modifier gene therapy platform and stay updated on industry advancements.

Ocugen Inc. (NASDAQ: OCGN), a biotechnology company specializing in gene and cell therapies and vaccines, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024 in New York. Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen, will engage in a fireside chat on Monday, September 9, 2024, at 1:30 p.m. ET at the Lotte New York Palace Hotel.

The event provides an opportunity for Ocugen to showcase its recent corporate achievements and upcoming milestones. Additionally, the company's executive team will conduct one-on-one meetings with registered investors to discuss Ocugen's business and clinical development strategy, particularly focusing on its unique modifier gene therapy platform.

A live video webcast of the presentation will be available on Ocugen's investor site, with a replay archived for 90 days following the event.

Ocugen (NASDAQ: OCGN) has completed dosing in the third cohort of its Phase 1/2 GARDian clinical trial for OCU410ST, a modifier gene therapy for Stargardt disease. The trial, conducted at six U.S. retinal surgery centers, has finished Phase 1 of the dose-escalation portion. Three subjects received the highest dose (2.25×1011 vg/mL) via subretinal injection. The GARDian trial aims to assess safety and efficacy of OCU410ST in Stargardt patients, who currently lack FDA-approved treatments. Dr. Charles Wykoff, lead investigator, noted an encouraging safety and tolerability profile. The trial includes three dose levels, and Ocugen plans to provide periodic clinical updates as it advances this potential one-time treatment option.

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.