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Details:
The net proceeds will be used for the development of ABBV-RGX-314, being developed as a novel, one-time treatment for wet AMD that includes the NAV® AAV8 vector containing a gene encoding for a monoclonal anti-VEGF antibody fragment.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: ABBV-RGX-314
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Morgan Stanley
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 06, 2024
Details:
ABBV-RGX-314 consists of the NAV® AAV8 vector, which encodes an antibody fragment designed to inhibit VEGF. It is believed to inhibit the VEGF pathway. It is under phase 2 clinical development or the treatment of wet AMD.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: ABBV-RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2024
Details:
RGX-314 consists of the NAV® AAV8 vector, which encodes an antibody fragment designed to inhibit VEGF. It is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2023
Details:
RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF), is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
RGX-314 consists of NAV® AAV8 vector, which encodes an antibody fragment designed to inhibit VEGF, is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2022
Details:
AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: $1,750.0 million Upfront Cash: $370.0 million
Deal Type: Collaboration November 09, 2021
Details:
RGX-314 was reported to be well tolerated in the 15 patients dosed with RGX-314 in Cohort 1. One serious adverse event was reported in one patient dosed with RGX-314, which occurred in the patient's untreated fellow eye and is considered not related to RGX-314.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2021
Details:
Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: $1,750.0 million Upfront Cash: $370.0 million
Deal Type: Collaboration September 13, 2021
Details:
Company will deliver two oral presentations will be presented at the American Academy Ophthalmology (AAO) 2020 Annual Meeting. The first presentation will feature data from the RGX-314 Phase I/II subretinal trial for the treatment of wet age-related macular degeneration.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
REGENXBIO has dosed the first patient in its Phase 2 clinical trial to evaluate the suprachoroidal delivery of RGX-314, an adeno-associated virus (AAV) gene therapy, using Clearside’s SCS Microinjector® for the treatment of wet age-related macular degeneration (wet AMD).
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Regenxbio
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
Details:
Company declared clearance of the Investigational New Drug (IND) application by the U.S. FDA to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy. The IND is active, and REGENXBIO plans to begin dosing patients in a Phase II trial, ALTITUDE.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: RGX-314
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020
Details:
RGX-314 continues to be well-tolerated at all dose levels . Long-term, durable treatment effect demonstrated over two years in Cohort 3.
Lead Product(s): RGX-314
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2020
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