Seqens Seqens

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[{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Announces FDA Reactivation of its Investigational New Drug Application for AD04 in Alcohol Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Commences Phase 3 Trial of AD04","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Announces Modifications to the Phase 3 Pivotal Trial","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Receives Issue Notification for Patent Covering AD04 for the Treatment of Opioid Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Provides Update on ONWARD(TM) Phase 3 Pivotal Trial","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Announces Approval to Commence Landmark ONWARD(TM) Pivotal Phase 3 Trial in Poland","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Announces Commencement of Landmark ONWARD(TM) Pivotal Phase 3 Trial in Poland","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Announces Approval to Commence Landmark ONWARD(TM) Pivotal Phase 3 Trial in Sweden and Estonia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Receives EMA Agreement on the Pediatric Investigation Plan (PIP) for AD04 in Alcohol Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Files For Expedited Review Of AD04 with The FDA","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Provides Update on its ONWARD(TM) Pivotal Phase 3 Trial of AD04 for Treatment of Alcohol Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"ImprimisRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Study on Patented Non-Opioid MKO Melt\u00ae Reported in Leading Peer-Reviewed Anesthesia Journal","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Receives Notice of Allowance for Third U.S. Patent Covering AD04 for the Treatment for Opioid Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial to File Fast Track Application for AD04 with the FDA","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Achieves 50% Enrollment in ONWARD\u2122 Phase 3 Trial","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Maxim Group LLC","pharmaFlowCategory":"D","amount":"$10.0 million","upfrontCash":"Undisclosed","newsHeadline":"Adial Pharmaceuticals Announces Closing of $10 Million Financing","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Provides Regulatory and Development Update","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The Phase 3 ONWARD\u2122 Trial Meets its Screening Target and Nears Enrollment Completion","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Reaches Full Enrollment Target for ONWARD\u2122 Phase 3 Trial of AD04 for Alcohol Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharma Reaches Enrollment Goal in Late-Stage Trial for Alcohol Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Harrow","sponsor":"iOR Partners","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Harrow and iOR Partners Expand National Product Supply Agreement","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Adenomed","pharmaFlowCategory":"D","amount":"$83.0 million","upfrontCash":"Undisclosed","newsHeadline":"Adial Pharmaceuticals Enters Into Option Agreement for Sale of Purnovate Assets to Adenomed","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$4.0 million","upfrontCash":"Undisclosed","newsHeadline":"Adial Pharmaceuticals Announces $4 Million Private Placement Priced at-the-Market Under Nasdaq Rules","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$4.0 million","upfrontCash":"Undisclosed","newsHeadline":"Adial Pharmaceuticals Announces Closing of $4 Million Private Placement Priced at-the-Market Under Nasdaq Rules","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"H.C. Wainwright & Co","pharmaFlowCategory":"D","amount":"$3.5 million","upfrontCash":"Undisclosed","newsHeadline":"Adial Pharmaceuticals Announces Exercise of Warrants for $3.5 Million Gross Proceeds","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Awarded Additional U.S. Patent Combining the Use of the Company's Proprietary Genetic Diagnostic With AD04 to Treat Alcohol and Drug Dependence","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Announces Database Lock for the ONWARD\u2122 Phase 3 Clinical Trial","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals to Announce Topline Results of ONWARD Phase 3 Trial for AD04 in Patients With Alcohol Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adial Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adial Pharmaceuticals Announces Topline Results For Onward\u2122 Phase 3 Trial for AD04 in Patients with Alcohol Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Athena Pharmaceutiques","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Athena\u2019s First Market Authorization in Brazil with Ondansetron ODT","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"}]

Find Clinical Drug Pipeline Developments & Deals for Prestwick3_001058

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            Details:

            Ondansetron Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water,is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment.

            Lead Product(s): Ondansetron

            Therapeutic Area: Gastroenterology Product Name: Ondansetron-Generic

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 15, 2022

            Details:

            The net proceeds will be used in the clinical development of AD04 (ondansetron), which is a Serotonin 5-HT3a receptor antagonist. It is being evaluated in the clinical trial studies for patients with alcohol use disorder.

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co

            Deal Size: $3.5 million Upfront Cash: Undisclosed

            Deal Type: Public Offering March 01, 2024

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            Details:

            The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $4.0 million Upfront Cash: Undisclosed

            Deal Type: Private Placement October 24, 2023

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            The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $4.0 million Upfront Cash: Undisclosed

            Deal Type: Private Placement October 20, 2023

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            Details:

            The Company’s lead investigational new drug product, AD04 (ondansetron), is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients.

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Adenomed

            Deal Size: $83.0 million Upfront Cash: Undisclosed

            Deal Type: Divestment February 01, 2023

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            The MKO melt (midazolam) is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally.

            Lead Product(s): Midazolam,Ketamine Hydrochloride,Ondansetron

            Therapeutic Area: Ophthalmology Product Name: MKO Melt

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: iOR Partners

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement November 30, 2022

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            Details:

            AD04 (ondansetron) achieved statistically significant mean reduction in heavy drinking days among pre-specified group of heavy drinkers, compared to placebo, with an approximately 79% reduction from baseline drinking.

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            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 20, 2022

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            Details:

            In studies of Zofran, patients were given AD04 (ondansetron) acutely at dosages up to almost 100 times dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously which results in almost twice exposure level as oral dosing.

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            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 18, 2022

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            Details:

            Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 (ondansetron) in patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes.

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            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 June 27, 2022

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            Details:

            Clinical trial of AD04 (Ondansetron) for treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking, and no overt safety concerns (there were no statistically significant serious adverse events reported).

            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            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 June 14, 2022

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