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[{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics to Present at the 43rd Annual Association for Research in Otolaryngology (ARO) Conference","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Publishes Results from Early-Stage Study of Therapy Designed to Prevent Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"OrbiMed","pharmaFlowCategory":"D","amount":"$82.0 million","upfrontCash":"Undisclosed","newsHeadline":"Decibel Therapeutics Announces $82M Series D Financing to Advance Gene Therapies to Restore Hearing and Balance","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Decibel Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Decibel Therapeutics Announces Exclusive Licensing Agreements for Hearing Loss Gene Therapy Technology","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Barclays","pharmaFlowCategory":"D","amount":"$75.0 million","upfrontCash":"Undisclosed","newsHeadline":"Hearing Disorder Biotech Decibel Therapeutics Files for a $75 Million IPO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Catalent Pharma Solutions","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Decibel and Catalent Sign Development and Manufacturing Agreement for Dual-Vector Gene Therapy for the Treatment of Congenital Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"DBTX","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Hearing Disorder Biotech Decibel Therapeutics Sets Terms for $100 Million IPO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics to Present at the 44th Annual Association for Research in Otolaryngology (ARO) Conference","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Presents Promising Preclinical Findings on DB-OTO Designed to Provide Hearing to Individuals with Otoferlin Mutations","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designations for DB-OTO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Reports on Continued Progress of Lead Gene Therapy Product Candidate DB-OTO and Presents Promising Preclinical Data Supporting Importance of Cell-Selective Transgene Expression Across Gene Therapy Pipeline","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics to Present at the American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Reports Positive Data from Interim Analysis of Ongoing Phase 1b Clinical Trial of DB-020 in Patients Receiving Cisplatin Chemotherapy","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I"},{"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":"Otolaryngology (Ear, Nose, Throat)","graph2":"IND Enabling"},{"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":"Otolaryngology (Ear, Nose, Throat)","graph2":"IND Enabling"},{"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":"Otolaryngology (Ear, Nose, Throat)","graph2":"IND Enabling"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Receives European Orphan Drug Designation for Lead Gene Therapy Candidate DB-OTO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Regeneron Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Announces Approval of Clinical Trial Application by the Spanish Agency of Medicines and Medical Devices (AEMPS) to Initiate Clinical Development of Lead Gene Therapy Candidate DB-OTO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Regeneron Pharmaceuticals","pharmaFlowCategory":"D","amount":"$213.0 million","upfrontCash":"$213.0 million","newsHeadline":"Regeneron to Acquire Decibel Therapeutics, Strengthening Gene Therapy and Hearing Loss Programs","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Regeneron Pharmaceuticals","pharmaFlowCategory":"D","amount":"$213.0 million","upfrontCash":"$213.0 million","newsHeadline":"Regeneron Completes Acquisition of Decibel Therapeutics, Adding Promising Gene Therapy Programs for Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"}]

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            Details:

            Through the acquisition, Regeneron will strengthen its gene therapy and heraing loss programs by gaining Decibel's lead candidate, DB-OTO, which is currently in Phase 1/2 and is an investigational cell-selective, AAV gene therapy to treat congenital, monogenic hearing loss.

            Lead Product(s): DB-OTO

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

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: $213.0 million Upfront Cash: $213.0 million

            Deal Type: Acquisition September 25, 2023

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            Details:

            Through the acquisition, Regeneron will strengthen its gene therapy and heraing loss programs by gaining Decibel's lead candidate, DB-OTO, which is currently in Phase 1/2 and is an investigational cell-selective, AAV gene therapy to treat congenital, monogenic hearing loss.

            Lead Product(s): DB-OTO

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

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: $213.0 million Upfront Cash: $213.0 million

            Deal Type: Acquisition August 09, 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: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 12, 2023

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            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: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 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:

            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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            Details:

            DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals and is an adeno-associated virus (AAV)-based dual-vector gene therapy designed to provide durable hearing to individuals with profound congenital hearing loss caused by mutations of the otoferlin gene.

            Lead Product(s): Otoferlin

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

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 20, 2022

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            Details:

            87% of patients who experienced ototoxicity in their placebo-treated ear were protected from ototoxicity in their DB-020, a novel, proprietary formulation of sodium thiosulfate treated ear.

            Lead Product(s): Sodium Thiosulfate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-020

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 28, 2022

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            Details:

            DB-OTO is a gene therapy product candidate designed to provide durable restoration of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.

            Lead Product(s): DB-OTO

            Therapeutic Area: Genetic Disease Product Name: DB-OTO

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 02, 2022

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            Details:

            Podium presentation at ARO annual midwinter meeting highlighting DB-OTO, gene therapy cell-selective promoter to control otoferlin transgene expression in hair cells, dose-ranging studies with expression analysis, functional recovery, and tolerability data.

            Lead Product(s): DB-OTO

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

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 09, 2022

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