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            Lead Product(s): Dexamethasone

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

            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 May 14, 2021

            Details:

            Results demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two preclinical models that represent a range of hearing loss severity caused by GJB2 deficiency.

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            Lead Product(s): Dexamethasone

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

            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 February 22, 2021

            Details:

            The Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat population using the Negative Binomial Model.

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            Lead Product(s): Dexamethasone

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

            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 November 30, 2020

            Details:

            FDA’s review of the OTIVIDEX statistical analysis plan confirms use of the Negative Binomial model for analysis of the primary endpoint in the ongoing Phase 3 clinical trial in Ménière’s disease.

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            Lead Product(s): Sodium Thiosulfate

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

            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 August 11, 2020

            Details:

            After recent completion of a pre-approval inspection of the manufacturing facility of Fennec's drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of practices that are required to be resolved prior to the approval of PEDMARK™.

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            Lead Product(s): Dexamethasone

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable