Associated tags: Retina, Health, Patient, Public, Vaccine, Infection, Research, Hope, Pharmaceutical industry
Locations: BOSTON, NORTH AMERICA, NJ, EU, WI, MALVERN, PA, US, GA, UNITED STATES
MALVERN, Pa., May 03, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2024 financial results and provide a business update at 8:30 a.m.
Key Points:
- MALVERN, Pa., May 03, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2024 financial results and provide a business update at 8:30 a.m.
- ET on Tuesday, May 14, 2024.
- Ocugen will issue a pre-market earnings announcement on the same day.
- Attendees are invited to participate on the call using the following details:
FDA,
Safety,
Inflammation,
Oxidative stress,
United,
Armada,
MD,
Vaccine,
Disease,
Lipid metabolism,
Gundersen Health System,
Geographic atrophy,
Clinical trial,
Pharmaceutical industry “We are very enthusiastic about the potential of OCU410 as a one-time, gene-agnostic option for the treatment of GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen.
Key Points:
- “We are very enthusiastic about the potential of OCU410 as a one-time, gene-agnostic option for the treatment of GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen.
- Up to 13 leading retinal surgery centers across the United States are participating in the ArMaDa clinical trial.
- The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases.
- The Company will continue to provide clinical updates on an ongoing basis.
MALVERN, Pa., April 12, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will participate in a fireside chat during the Emerging Growth Virtual Healthcare Equity Conference, presented by Noble Capital Markets, taking place from April 17 – 18, 2024.
Key Points:
- MALVERN, Pa., April 12, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will participate in a fireside chat during the Emerging Growth Virtual Healthcare Equity Conference, presented by Noble Capital Markets, taking place from April 17 – 18, 2024.
- Details of the fireside chat are as follows:
During the fireside chat and one-on-one sessions, Dr. Musunuri will showcase the Company’s recent business and clinical development progress including FDA clearance to initiate a Phase 3 clinical trial for OCU400—a modifier gene therapy for patients battling retinitis pigmentosa (RP).
- OCU400 is the first gene therapy to enter a late-stage trial with a broad RP indication.
- The webcast will be archived on the Company's website for 90 days following the event.
Retrieved on:
Wednesday, April 10, 2024
FDA,
RP,
Retinitis pigmentosa,
Safety,
Marketing,
MAA,
CHMP,
Vaccine,
U.S. FDA,
Arm,
IND,
Patient,
EMA,
Committee,
RHO,
BLA,
Clinical trial,
Leber congenital amaurosis,
European Medicines Agency EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.
Key Points:
- EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.
- In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively.
- The positive scientific advice from EMA is in alignment with U.S. FDA clearance of the IND amendment to initiate the Phase 3 liMeliGhT clinical trial of OCU400.
- OCU400 is the first gene therapy to enter Phase 3 with a broad RP indication.
Arm,
Retinitis pigmentosa,
Disease,
Patient,
Lux,
RP,
IND,
Clutch (eggs),
Vaccine,
Food,
RHO,
FDA,
BLA,
Pharmaceutical industry “OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.
Key Points:
- “OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.
- Until now, there has been only one marketed product to treat one of the 100 gene mutations associated with RP.
- In the Phase 1/2 OCU400 clinical trial, a Multi-Luminance Mobility Testing (MLMT) scale was the primary functional endpoint.
- With the initiation of the Phase 3 clinical trial, OCU400 remains on track for the 2026 BLA approval target.
Retina,
Disease,
Inflammation,
Patient,
Data,
Cohort,
Șaeș,
Life,
Clinical trial,
Armada,
MPH,
Injection,
Safety,
DSMB,
FACS,
Vaccine,
Lipid metabolism,
Geographic atrophy,
Oxidative stress,
Pharmaceutical industry Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.
Key Points:
- Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.
- An additional three subjects will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410 in the dose-escalation phase.
- “The DSMB has recommended moving forward to medium dose for dosing subjects with GA,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial.
- Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)].
Stargardt disease,
Disease,
Safety,
Webcast,
Inflammation,
Patient,
CGMP,
Data,
Inhalation,
Cohort,
RP,
Life,
Bank statement,
Investment,
Clinical trial,
NIAID,
Injection,
AMD,
Vaccine,
Nextgen,
Geographic atrophy,
RHO,
FDA,
Lipid metabolism,
Government,
Oxidative stress,
Pharmaceutical industry Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively
Key Points:
- Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively
MALVERN, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today provided a general business update with certain financials for the year ending 2023.
- During the fourth quarter of 2023, the Company announced its mucosal vaccine candidate, OCU500, was chosen for the multi-billion-dollar NIAID Project NextGen initiative.
- The first patient was dosed in the Phase 1/2 trials to assess the safety and efficacy of OCU410ST for Stargardt disease in November 2023.
- Ocugen’s cash, cash equivalents, and investments totaled $39.5 million as of December 31, 2023, compared to $90.9 million as of December 31, 2022.
Stargardt disease,
Gardian,
Patient,
Cohort,
Șaeș,
Clinical trial,
MPH,
Safety,
DSMB,
FACS,
Vaccine,
FDA,
Pharmaceutical industry Three patients with Stargardt disease were dosed in the Phase 1/2 clinical trial to date.
Key Points:
- Three patients with Stargardt disease were dosed in the Phase 1/2 clinical trial to date.
- An additional three patients will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410ST in the dose-escalation phase.
- “The DSMB has recommended moving forward to medium dose for dosing subjects with Stargardt disease,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410ST clinical trial.
- Phase 1 is a multicenter, open-label, dose ranging study consisting of three dose levels [low dose (3.75×1010 vg/mL), medium dose (7.5×1010 vg/mL), and high dose (2.25×1011 vg/mL)].
MALVERN, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to provide a business update with certain financials for the year ending December 31, 2023 at 8:30 a.m.
Key Points:
- MALVERN, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to provide a business update with certain financials for the year ending December 31, 2023 at 8:30 a.m.
- ET on Tuesday, April 2, 2024.
- Ocugen will issue a pre-market earnings announcement on the same day.
- Attendees are invited to participate on the call using the following details:
Neurology,
University of Pennsylvania,
Sarcoma,
Cardiology,
Ivy League,
Protocol,
University,
Rheumatology,
Dermatology,
Infection,
Harvard University,
FSD,
Melanoma,
CMO,
Vaccine,
FDA,
GU,
Women's health,
Yale University,
Pharmaceutical industry MALVERN, Pa., March 18, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the appointment of Dr. Huma Qamar as Chief Medical Officer (CMO).
Key Points:
- MALVERN, Pa., March 18, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the appointment of Dr. Huma Qamar as Chief Medical Officer (CMO).
- “I’m very pleased to name Dr. Qamar as the CMO at Ocugen,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.
- Her expertise encompasses the development of Phase I-IV clinical protocols and execution of clinical studies, FDA inspections, and effective leadership of medical affairs teams.
- “Dr.
