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) announced a Management Fireside Chat on October 21, 2020, at 11 a.m. ET, hosted by Cantor Fitzgerald. The discussion will feature key management figures, including Dr. Shankar Musunuri and Sanjay Subramanian, focusing on their lead program OCU400 for retinal degeneration disorders. The management will share clinical outcomes published in Nature Gene Therapy and updates on upcoming clinical trials. Cantor Fitzgerald has initiated coverage of Ocugen with an 'Overweight' rating and a $1.00 price target, highlighting the potential of AAV-based gene therapies.
Ocugen has announced an agreement with Kemwell Biopharma to manufacture OCU200, its biologic candidate for treating severe sight-threatening diseases. The collaboration aims to ensure product consistency for IND-enabling toxicology studies and Phase 1/2a clinical trials, targeting a clinic entry by 1H 2022. OCU200 addresses retinal diseases affecting over 9.5 million U.S. patients, with a unique mechanism compared to traditional therapies. This partnership is expected to facilitate the development of new treatments for patients who do not respond to existing therapies.
Ocugen, a biopharmaceutical company, will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2020, at 1:40 PM ET. Dr. Shankar Musunuri, CEO, will discuss the company’s innovative gene therapy platform and its lead product candidate, OCU400, aimed at treating retinitis pigmentosa. OCU400 recently received its fourth FDA orphan drug designation. The conference runs from September 21-23. For more details, visit www.ocugen.com.
Ocugen (NASDAQ: OCGN) announced it has been granted an additional 180-day compliance period by Nasdaq to meet the minimum bid price of $1.00 per share. This extension lasts until March 8, 2021, after the company failed to comply during the initial grace period. If the company's stock price closes at or above $1.00 for 10 consecutive days within this timeframe, compliance will be regained. Should it fail again, Ocugen may face delisting, although it can appeal the decision. The current notice does not affect the stock's trading status.
Ocugen (NASDAQ: OCGN) announced its participation in the LD 500 Virtual Investor Conference on September 4, 2020, at 11 a.m. ET. CFO Sanjay Subramanian will discuss the company's breakthrough gene therapy platform and lead product candidate, OCU400, designed to treat various forms of retinitis pigmentosa. This candidate has recently received its fourth FDA orphan drug designation. The conference runs from September 1-4, featuring key players from the micro-cap sector.
Ocugen, Inc. (NASDAQ: OCGN) reported its Q2 2020 financial results, highlighting significant advancements in its gene therapy pipeline aimed at curing blindness. The company received two additional Orphan Drug Designations for its OCU400 program, making a total of four ODDs to target specific retinal degenerations. Despite the ongoing pandemic, Ocugen is on track to enter clinical trials next year. The company secured $15.4 million in funding, increasing its cash runway, although it reported a net loss of $3.6 million for the quarter, compared to a loss of $3.5 million in Q2 2019.
Ocugen, Inc. (NASDAQ: OCGN) announced it will host a conference call on August 14, 2020, at 8:30 a.m. to discuss its Q2 2020 financial results and provide a business update. The company will release earnings pre-market the same day. Investors can participate via phone or webcast, accessible on the Ocugen website. The firm focuses on developing therapies for blindness diseases, leveraging a modifier gene therapy platform aimed at treating multiple retinal conditions with a single drug.
Ocugen, Inc. (NASDAQ: OCGN) announced that the FDA has granted a third Orphan Drug Designation (ODD) for its gene therapy product OCU400, aimed at treating RHO mutation-associated retinal degeneration, a disorder affecting approximately 12% of Retinitis Pigmentosa patients in the U.S. OCU400 utilizes a functional copy of the NR2E3 gene to potentially restore retinal function across various inherited retinal diseases. This designation qualifies Ocugen for specific development incentives and reinforces the potential for OCU400 to serve multiple patients suffering from blindness-related conditions.
MALVERN, Pa., July 21, 2020 – Ocugen (NASDAQ: OCGN) announced its participation in the World Orphan Drug Congress USA 2020, scheduled virtually from August 24-27, 2020. Rasappa Arumugham, PhD, Chief Scientific Officer, will present on Ocugen's modifier gene therapy platform during the Next Generation Therapies Seminar on August 24 at 1:00 PM ET. This platform aims to treat retinal diseases with a single drug, enhancing therapeutic options for conditions like wet age-related macular degeneration and diabetic retinopathy.
Ocugen, Inc. (NASDAQ: OCGN) has announced the discontinuation of its Phase 3 trial for OCU300 targeting ocular Graft vs. Host Disease due to interim analysis results indicating it would not meet co-primary endpoints. The decision was not based on safety issues. The company plans to refocus efforts on its gene therapy programs, particularly OCU400, aimed at inherited retinal diseases, targeting clinical entry next year. OCU400 has received FDA Orphan Drug Designations. The company believes it has sufficient cash to fund operations into Q4 2020.
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