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    [{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Positive Top-Line Results from Phase 1\/2 Clinical Trial of OTO-313 in Patients with Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Otonomy"},{"orgOrder":0,"company":"Pipeline Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pipeline Therapeutics Initiates Phase 1\/2a Clinical Trial of PIPE-505 in Sensorineural Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New 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Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Otonomy"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with 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":"October 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Otonomy"},{"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":"Cell and Gene therapy","graph2":"Decibel Therapeutics"},{"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":"Cell and Gene therapy","graph2":"Decibel Therapeutics"},{"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":"Cell and Gene therapy","graph2":"Decibel Therapeutics"}]

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              Decibel Therapeutics

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              Regeneron to Acquire Decibel Therapeutics, Strengthening Gene Therapy and Hearing Loss Programs

              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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              Decibel Therapeutics

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              Decibel Therapeutics Announces Approval of Clinical Trial Application by the Spanish Agency of Medicines and Medical Devices (AEMPS) to Initiate Clinical Development of Lea...

              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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              Decibel Therapeutics

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              Decibel Therapeutics Receives European Orphan Drug Designation for Lead Gene Therapy Candidate DB-OTO

              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: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 30, 2023

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              Otonomy

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              Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss

              Details:

              OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair.

              Lead Product(s): OTO-413

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

              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 October 13, 2022

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              Otonomy

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              Otonomy Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing Loss

              Details:

              40% (8 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 20% (2 out of 10) for placebo.

              Lead Product(s): Brain-Derived Neurotrophic Factor

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

              Highest Development Status: Phase I/ Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 20, 2022

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              Otonomy

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              Otonomy Initiates Expansion of Phase 1/2 Clinical Trial for OTO-413 in Hearing Loss

              Details:

              OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests in dose escalation efficacy cohort.

              Lead Product(s): Brain-Derived Neurotrophic Factor

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

              Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 15, 2021

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              Pipeline Therapeutics

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              Pipeline Therapeutics Completes $80 Million Series C Financing

              Details:

              Pipeline Therapeutics plans to use the proceeds to advance its development candidates PIPE-505, in patients with sensorineural hearing loss, and PIPE-307, in patients with multiple sclerosis.

              Lead Product(s): PIPE-505

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: PIPE-505

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Franklin Templeton

              Deal Size: $80.0 million Upfront Cash: Undisclosed

              Deal Type: Series C Financing February 11, 2021

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              Otonomy

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              Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413 in Patients with Hearing Loss

              Details:

              Otonomy believes that these higher responder rates for OTO-413 compared to placebo at two consecutive time points across multiple SIN tests demonstrates therapeutic activity and supports continued development of OTO-413 for the treatment of hearing loss.

              Lead Product(s): Brain-Derived Neurotrophic Factor

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

              Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 17, 2020

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              Pipeline Therapeutics

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              Pipeline Therapeutics Initiates Phase 1/2a Clinical Trial of PIPE-505 in Sensorineural Hearing Loss

              Details:

              PIPE-505 is the first small molecule developed specifically for the treatment of sensorineural hearing loss (SNHL) associated with speech-in-noise impairment.

              Lead Product(s): PIPE-505

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: PIPE-505

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 23, 2020

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              Otonomy

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              Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus

              Details:

              The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile.

              Lead Product(s): Gacyclidine

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 06, 2020

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              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
              Douglas Pharma, a New Zealand success story, with CDMO capabilities for softgels, liquids, tablets, capsules & powders.
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