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[{"orgOrder":0,"company":"Akouos","sponsor":"Pivotal bioVenture Partners","pharmaFlowCategory":"D","amount":"$105.0 million","upfrontCash":"Undisclosed","newsHeadline":"Akouos Closes $105 Million Series B Financing","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Akouos"},{"orgOrder":0,"company":"Akouos","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akouos Receives FDA Clearance of its IND Application for AK-OTOF, a Gene Therapy Intended for the Treatment of OTOF-mediated Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Akouos"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Regeneron Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Announces Submission of Investigational New Drug (IND) Application for Lead Gene Therapy Candidate DB-OTO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Decibel Therapeutics"},{"orgOrder":0,"company":"Forge Biologics","sponsor":"Myrtelle","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Myrtelle and Forge Biologics Announce Viral Vector and Plasmid DNA cGMP Manufacturing Partnership","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Forge Biologics"},{"orgOrder":0,"company":"Akouos","sponsor":"Eli Lilly","pharmaFlowCategory":"D","amount":"$487.0 million","upfrontCash":"$487.0 million","newsHeadline":"Lilly to Acquire Akouos to Discover and Develop Treatments for Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Akouos"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Regeneron Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Receives FDA Clearance of IND Application for DB-OTO, a Gene Therapy Product Candidate Designed to Provide Hearing to Individuals with Otoferlin-Related Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Decibel Therapeutics"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces Approval to Initiate Amended Phase 2a Proof of Concept Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity in France","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sensorion"},{"orgOrder":0,"company":"Akouos","sponsor":"Eli Lilly","pharmaFlowCategory":"D","amount":"$1,097.0 million","upfrontCash":"$1,097.0 million","newsHeadline":"Lilly Completes Acquisition of Akouos Expanding Efforts to Help People with Genetic Diseases","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Akouos"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Lead Gene Therapy Candidate DB-OTO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Decibel Therapeutics"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Submits Clinical Trial Application for Lead Gene Therapy Candidate OTOF-GT in The UK","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Sensorion"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Submits Clinical Trial Application for OTOF-GT, its Lead Gene Therapy Candidate, in Europe","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Sensorion"},{"orgOrder":0,"company":"Sensorion","sponsor":"Redmile Group","pharmaFlowCategory":"D","amount":"$54.4 million","upfrontCash":"Undisclosed","newsHeadline":"Sensorion Announces a \u20ac50.5 Million Financing With Participation From New and Existing US and European Healthcare Specialist Investors","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Sensorion"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces Approval to Initiate Lead Gene Therapy Candidate SENS-501 (OTOF-GT) into a Phase 1\/2 Clinical Trial in some European Countries","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Sensorion"},{"orgOrder":0,"company":"Sensorion","sponsor":"Redmile Group","pharmaFlowCategory":"D","amount":"$16.2 million","upfrontCash":"Undisclosed","newsHeadline":"Sensorion Announces a \u20ac15 Million Financing, Extending Cash Runway Until the End of 2025","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Sensorion"}]

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            Details:

            The financing aims to fund the clinical development of SENS-501 (OTOF-GT) small molecule programs for the treatment and prevention of hearing loss disorders.

            Lead Product(s): OTOF-GT

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-501

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Redmile Group

            Deal Size: $16.2 million Upfront Cash: Undisclosed

            Deal Type: Financing April 08, 2024

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            Through financing, Sensorion will prioritize the development of SENS-501 ( OTOF-GT), which aims to restore hearing in individuals with Otoferlin deficiency, a prevalent form of congenital deafness.

            Lead Product(s): OTOF-GT

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-501

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Redmile Group

            Deal Size: $54.4 million Upfront Cash: Undisclosed

            Deal Type: Financing February 09, 2024

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            Details:

            SENS-501 (OTOF-GT) dual vector AAV gene therapy development program aims to restore hearing in patients with mutations in the gene coding for otoferlin protein who suffer from severe to profound sensorineural prelingual non-syndromic hearing loss.

            Lead Product(s): OTOF-GT

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-501

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 19, 2024

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            OTOF-GT is a dual AAV vector gene therapy development program aims to restore hearing in patients with mutations in OTOF who suffer from severe to profound sensorineural prelingual non syndromic hearing loss.

            Lead Product(s): SENS-501

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTOF-GT

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 19, 2023

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            Details:

            OTOF-GT is a dual AAV vector gene therapy development program aims to restore hearing in patients with mutations in OTOF who suffer from severe to profound sensorineural prelingual non syndromic hearing loss.

            Lead Product(s): OTOF-GT

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTOF-GT

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2023

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            Details:

            DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.

            Lead Product(s): DB-OTO

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 24, 2023

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            Details:

            AK-OTOF is a dual adeno-associated viral (AAV) vector-based gene therapy intended to treat patients with OTOF-mediated hearing loss by delivering transgenes encoding OTOF to the inner hair cells (IHCs) of the cochlea.

            Lead Product(s): AK-OTOF

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AK-OTOF

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Eli Lilly

            Deal Size: $1,097.0 million Upfront Cash: $1,097.0 million

            Deal Type: Acquisition December 01, 2022

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            SENS-401 (arazasetron), is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment.

            Lead Product(s): R-Azasetron Besylate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-401

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 24, 2022

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            Details:

            Proposed acquisition will accelerate gene therapies that aim to restore, improve, and preserve hearing for patients living with disabling hearing loss worldwide including lead product, AK-OTOF, a treatment of hearing loss due to mutations in the otoferlin gene.

            Lead Product(s): AK-OTOF

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AK-OTOF

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Eli Lilly

            Deal Size: $487.0 million Upfront Cash: $487.0 million

            Deal Type: Acquisition October 18, 2022

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            Details:

            DB-OTO uses a proprietary, cell-selective promoter to express the otoferlin transgene in hair cells, with the goal of enabling the ear to transmit sound to the brain and provide hearing.

            Lead Product(s): DB-OTO

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 17, 2022

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