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Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: HBM Healthcare Investments
Deal Size: $18.1 million Upfront Cash: Undisclosed
Deal Type: Financing December 04, 2020
Details:
The Company was previously financed to complete both the Mont Blanc Phase 3 trial for NCX 470 and the Mississippi Phase 2b trial for NCX 4251. Proceeds from this financing extend the cash runway well beyond these key inflection points.
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Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: OcuMension Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
Denali is a 3-month Phase 3 trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.
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Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Ophthalmology Product Name: Lumevoq
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ.
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Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Ophthalmology Product Name: Lumevoq
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
GenSight submitted the MAA based on the benefit-risk balance established by results from a Phase-I/IIa study, two pivotal Phase-III efficacy studies and the long-term follow up study of RESCUE and REVERSET to demonstrate the efficacy of LUMEVOQ®.
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Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Nicox completed enrollment of adaptive design patient cohort in its multicenter Mont Blanc Phase 3 trial, evaluating NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution, 0.005% for the lowering intraocular pressure in open-angle glaucoma or ocular hypertension.
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Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Ophthalmology Product Name: Lumevoq
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2020
Details:
Statistical analysis of the visual acuity in 23 REALITY subjects aged 15 or older with a mutated ND4 gene shows that on average, vision failed to recover from an initial sudden decline, even several years after vision loss.
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Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
Over 40 sites have been initiated in the first month of the Phase 3 Mont Blanc trial, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: GHO Capital
Deal Size: $5.7 million Upfront Cash: Undisclosed
Deal Type: Divestment July 10, 2020
Details:
The divestment will support Nicox's strategy for rapid advancement of their R&D pipeline and NDA submissions for their two lead product candidates, NCX 470 and NCX 4251.
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Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Ophthalmology Product Name: Lumevoq
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
The new data will reinforce GenSight Biologics’ submission of LUMEVOQ® for marketing authorization in the European Union, which it intends to file in September 2020.
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Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
Details:
The Mont Blanc trial is a multi-regional, double-masked, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension.
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