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FDF","graph3":"Aytu BioPharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet, Extended Release","sponsorNew":"Aytu BioPharma \/ Aytu BioPharma","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioPharma \/ Aytu BioPharma"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Miscellaneous","year":"2022","type":"Inapplicable","leadProduct":"Amphetamine Sulfate","moa":"Norepinephrine transporter | Dopamine transporter","graph1":"Psychiatry\/Psychology","graph2":"Approved FDF","graph3":"Aytu BioPharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet, Extended Release","sponsorNew":"Aytu BioPharma \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioPharma \/ Undisclosed"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Lupin Pharma Canada","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Miscellaneous","year":"2024","type":"Agreement","leadProduct":"Amphetamine Sulfate","moa":"Norepinephrine transporter | Dopamine transporter","graph1":"Psychiatry\/Psychology","graph2":"Approved FDF","graph3":"Aytu BioPharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet, Extended Release","sponsorNew":"Aytu BioPharma \/ Lupin Pharma Canada","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioPharma \/ Lupin Pharma Canada"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Neos Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2020","type":"Merger","leadProduct":"Methylphenidate","moa":"Norepinephrine transporter | Dopamine transporter","graph1":"Psychiatry\/Psychology","graph2":"Approved FDF","graph3":"Aytu BioPharma","amount2":0.040000000000000001,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Psychiatry","amount2New":0.040000000000000001,"dosageForm":"Tablet","sponsorNew":"Aytu BioPharma \/ Aytu BioPharma","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioPharma \/ Aytu BioPharma"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2023","type":"Inapplicable","leadProduct":"Methylphenidate","moa":"Norepinephrine transporter | Dopamine transporter","graph1":"Psychiatry\/Psychology","graph2":"Approved FDF","graph3":"Aytu BioPharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet, Orally Disintegrating, Extended Release","sponsorNew":"Aytu BioPharma \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioPharma \/ Undisclosed"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Parexel","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"U.S.A","productType":"Miscellaneous","year":"2022","type":"Inapplicable","leadProduct":"Enzastaurin","moa":"Protein kinase C beta","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"Aytu BioPharma","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Aytu BioPharma \/ Parexel","highestDevelopmentStatusID":"10","companyTruncated":"Aytu BioPharma \/ Parexel"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Canaccord Genuity","pharmaFlowCategory":"D","therapeuticArea":"Genetic Disease","country":"U.S.A","productType":"Miscellaneous","year":"2022","type":"Public 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Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Aytu BioPharma \/ Undisclosed"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Lake Street Capital Markets","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Miscellaneous","year":"2025","type":"Public Offering","leadProduct":"Gepirone","moa":"Serotonin 1a (5-HT1a) receptor","graph1":"Psychiatry\/Psychology","graph2":"Approved FDF","graph3":"Aytu BioPharma","amount2":0.01,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Psychiatry","amount2New":0.02,"dosageForm":"Tablet, Extended Release","sponsorNew":"Aytu BioPharma \/ Lake Street Capital Markets","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioPharma \/ Lake Street Capital Markets"},{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Lake Street Capital Markets","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Miscellaneous","year":"2025","type":"Public Offering","leadProduct":"Gepirone","moa":"Serotonin 1a (5-HT1a) receptor","graph1":"Psychiatry\/Psychology","graph2":"Approved FDF","graph3":"Aytu BioPharma","amount2":0.02,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Psychiatry","amount2New":0.02,"dosageForm":"Tablet, Extended Release","sponsorNew":"Aytu BioPharma \/ Lake Street Capital Markets","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioPharma \/ Lake Street Capital Markets"}]

Find Clinical Drug Pipeline Developments & Deals by Aytu BioPharma

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                          01

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : The Company intends to use the proceeds to exclusively commercialize Exxua (gepirone) extended-release tablets, a novel, branded, FDA-approved treatment for MDD in the United States.

                          Product Name : Exxua

                          Product Type : Miscellaneous

                          Upfront Cash : Undisclosed

                          June 09, 2025

                          Lead Product(s) : Gepirone

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved FDF

                          Sponsor : Lake Street Capital Markets

                          Deal Size : $16.6 million

                          Deal Type : Public Offering

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                          02

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : The Company intends to use the proceeds to exclusively commercialize Exxua (gepirone) extended-release tablets, a novel, branded, FDA-approved treatment for MDD in the United States.

                          Product Name : Exxua

                          Product Type : Miscellaneous

                          Upfront Cash : Undisclosed

                          June 06, 2025

                          Lead Product(s) : Gepirone

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved FDF

                          Sponsor : Lake Street Capital Markets

                          Deal Size : $14.4 million

                          Deal Type : Public Offering

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                          03

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : The agreement aims for the distribution and supply for Aytu's Adzenys XR-ODT and Cotempla XR-ODT product lines for the treatment of ADHD in Canada.

                          Product Name : Adzenys XR-ODT

                          Product Type : Miscellaneous

                          Upfront Cash : Undisclosed

                          October 01, 2024

                          Lead Product(s) : Amphetamine Sulfate

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved FDF

                          Sponsor : Lupin Pharma Canada

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          04

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

                          Product Name : Cotempla

                          Product Type : Controlled Substance

                          Upfront Cash : Inapplicable

                          October 26, 2023

                          Lead Product(s) : Methylphenidate

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved FDF

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          05

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : Under the agreement, Medomie will commercialize Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) in Israel and the Palestinian Authority.

                          Product Name : Adzenys XR

                          Product Type : Miscellaneous

                          Upfront Cash : Undisclosed

                          July 31, 2023

                          Lead Product(s) : Amphetamine Sulfate

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved FDF

                          Recipient : Medomie

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          06

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : XR-ODT is FDA-Approved as Bioequivalent to Adderall XR is the only FDA-approved, extended-release, orally-disintegrating tablet formulation of amphetamine,indicated for the treatment of ADHD in patients six years and older.

                          Product Name : Adzenys XR-ODT

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          October 05, 2022

                          Lead Product(s) : Amphetamine Sulfate

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved FDF

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : AR101 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K and AKT pathways.

                          Product Name : Undisclosed

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          August 16, 2022

                          Lead Product(s) : Enzastaurin

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          08

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : The Company intends to use the net proceeds from the Offering for advancing the development of its pipeline assets, including for advancing the PREVEnt Trial evaluating AR101 for the treatment of vascular Ehlers-Danlos Syndrome (VEDS).

                          Product Name : Undisclosed

                          Product Type : Miscellaneous

                          Upfront Cash : Undisclosed

                          August 15, 2022

                          Lead Product(s) : Enzastaurin

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Canaccord Genuity

                          Deal Size : $10.0 million

                          Deal Type : Public Offering

                          blank

                          09

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : Enzastaurin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Ehlers-Danlos Syndrome, Type IV.

                          Product Name : Undisclosed

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          July 19, 2022

                          Lead Product(s) : Enzastaurin

                          Therapeutic Area : Rare Diseases and Disorders

                          Highest Development Status : Phase III

                          Sponsor : Parexel

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          ISPE Annual Meeting
                          Not Confirmed
                          ISPE Annual Meeting
                          Not Confirmed

                          Details : Acerus will acquire all remaining rights to Natesto in the United States from Aytu. Acerus will assume all product responsibilities associated with Natesto.

                          Product Name : Natesto

                          Product Type : Hormone

                          Upfront Cash : $7.5 million

                          April 01, 2021

                          Lead Product(s) : Testosterone

                          Therapeutic Area : Endocrinology

                          Highest Development Status : Approved FDF

                          Sponsor : Acerus Pharmaceuticals

                          Deal Size : $7.5 million

                          Deal Type : Divestment

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