Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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Applicable","upfrontCash":"Not Applicable","newsHeadline":"Regeneron Shares Preliminary Results Showing Gene Therapy Improves Auditory Responses in Child with Profound Genetic 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 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Petrichor","pharmaFlowCategory":"D","amount":"$20.0 million","upfrontCash":"Undisclosed","newsHeadline":"Fennec Announces Incremental $5 Million Investment from Petrichor","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small 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II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces Positive DSMB Recommendation for Phase 2a NOTOXIS Trial","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sound Pharma Announces Phase 3 Study Completion of SPI-1005 for Meniere\u2019s Disease","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase III"}]

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            Details:

            The agreement aims for the manufacturing of adeno-associated virus (AAV) vectors, covering the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein and aims to restore the expression of Otoferlin.

            Lead Product(s): OTOF-GT

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

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

            Partner/Sponsor/Collaborator: Sensorion

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 11, 2020

            Axplora Novasep

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            envelop Contact Supplier

            Details:

            SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx).

            Lead Product(s): Ebselen

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SPI-1005

            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 31, 2024

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            SENS-401 (R-azasetron besylate) is a 5-HT3 receptor antagonist, orally available small molecule, which is under clinical development for the treatment of Cisplatin-Induced Ototoxicity.

            Lead Product(s): R-Azasetron Besylate

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

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 22, 2024

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            SENS-401 (arazasetron) is an orally available 5-HT3 receptor antagonist, small molecule drug. It is being evaluated in phase 2 clinical trials for the treatment of hearing loss.

            Lead Product(s): R-Azasetron Besylate

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

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 15, 2024

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            Through the agreement with Cilcare to acquire the exclusive license to develop, manufacture, and commercialize CIL001 for the treatment of patients with hearing loss.

            Lead Product(s): CIL001

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: CIL001

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Shionogi

            Deal Size: $16.0 million Upfront Cash: $16.0 million

            Deal Type: Agreement June 10, 2024

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            The financing will support the advancement of a neuroplastogen, a novel, first-in-class, non-toxic, that has been found to repair cochlear synaptopathy that contribute to hidden hearing loss.

            Lead Product(s): Neuroplastogen

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

            Highest Development Status: Discovery Product Type: Small molecule

            Partner/Sponsor/Collaborator: U.S. Department of Defense

            Deal Size: $0.8 million Upfront Cash: Undisclosed

            Deal Type: Funding June 04, 2024

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            Details:

            SPI-1005 (ebselen) is a novel anti-inflammatory Glutathione Peroxidase mimetic, an enzyme critical to hearing and balance. It is being tested for residual hearing loss reduction during and after CI.

            Lead Product(s): Ebselen

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SPI-1005

            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 May 20, 2024

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            Details:

            DB-OTO is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by variants of the otoferlin 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 May 08, 2024

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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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            Details:

            AC102 targets the two suspected main causes of sudden hearing loss in the inner ear: It prevents the death of outer hair sensory cells and protects the connections between neurons and the auditory nerve. It is being evaluated for sensorineural hearing loss.

            Lead Product(s): AC102

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AC102

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 01, 2024

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