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

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[{"orgOrder":0,"company":"Melt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Melt Pharmaceuticals Enters the Clinical Stage of MELT-100 Development","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"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":"Melt Pharmaceuticals","sponsor":"Harrow Health","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Harrow Health Provides $13.5 Million Senior Secured Loan to Melt Pharmaceuticals","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Melt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Melt Pharmaceuticals Completes Phase 1 Study for Sublingual, Non-Opioid Pain and Sedation Drug Candidate","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Brain Therapeutics","sponsor":"Neuraxpharm","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Neuraxpharm Expands Its Business in Southeast Europe","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"GREECE","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Neuraxpharm","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Neuraxpharm Acquires Market-Leading Buccolam\u00ae For Emergency Treatment of Epileptic Children","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Crossject","sponsor":"BARDA","pharmaFlowCategory":"D","amount":"$60.0 million","upfrontCash":"Undisclosed","newsHeadline":"Agreement with BARDA on ZENEO\u00ae Midazolam","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"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":"Crossject","sponsor":"AFT Pharmaceuticals","pharmaFlowCategory":"D","amount":"$0.7 million","upfrontCash":"Undisclosed","newsHeadline":"Crossject Signs New Licensing Agreement on ZENEO\u00ae Midazolam Epilepsy Rescue Therapy with AFT Pharmaceuticals for Australia & New Zealand","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Catalent Pharma Solutions","sponsor":"Melt Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Melt Pharmaceuticals Announces Exclusive Development and License Agreement with Catalent for its Zydis\u00ae Fast-Dissolve Technology for Use in MELT-300 for Needle- and Opioid-Free Procedural Sedation","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Melt Pharmaceuticals","sponsor":"Catalent Pharma Solutions","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Melt Pharmaceuticals Announces MELT-210 Top-Line Results of Phase 1 Pharmacokinetics (PK) Study for Procedural Sedation","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Crossject","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$1.0 million","upfrontCash":"Undisclosed","newsHeadline":"Crossject signs ZEPIZURE\u00ae Commercialization Agreement for Northern Europe","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Syneos Health","sponsor":"Crossject","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Crossject engages Syneos Health for U.S. commercial launch of ZEPIZURE\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Neuraxpharm","sponsor":"Takeda Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neuraxpharm Launches First Product in Japan","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SPAIN","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Crossject","sponsor":"Heights Capital Management","pharmaFlowCategory":"D","amount":"$12.0 million","upfrontCash":"Undisclosed","newsHeadline":"Crossject Obtains a Financing up To \u201a\u00ac12 Million, in Two Tranches","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Melt Pharmaceuticals","sponsor":"Newbridge Securities Corporation","pharmaFlowCategory":"D","amount":"$24.0 million","upfrontCash":"Undisclosed","newsHeadline":"Melt Pharmaceuticals Closes $24 Million Series B Preferred Stock Financing","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Crossject","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Crossject Signs a Geographic Extension of ZEPIZURE\u00ae Commercialization Agreement in Europe","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Crossject","sponsor":"Gemmes Venture","pharmaFlowCategory":"D","amount":"$8.2 million","upfrontCash":"Undisclosed","newsHeadline":"Crossject announces highly successful closing of its \u20ac8 million rights offering","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"June 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Crossject","sponsor":"Bpifrance","pharmaFlowCategory":"D","amount":"$7.4 million","upfrontCash":"Undisclosed","newsHeadline":"Crossject Wins \u20ac69M French Government Funding to Develop ZENEO\u00ae Epinephrine","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"July 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Rafa","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rafa Receives FDA Approval For Life-saving Midazolam Autoinjector","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"ISRAEL","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Enanta Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Enanta Pharmaceuticals Presents New Preclinical Data for EDP-235, its Oral, Direct-Acting Antiviral Protease Inhibitor Specifically Designed for the Treatment of COVID-19 at IDWeek\u2122 2022","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Melt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Melt Pharmaceuticals Announces Dosing of Last Patient in Phase 2 Pivotal Efficacy and Safety Study for MELT-300","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"Crossject","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Crossject - Clinical Demonstration Of Zeneo\u00ae Efficiency For Intramuscular Injection Of Midazolam","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Melt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Melt Pharmaceuticals\u2019 MELT-300 (Midazolam 3mg and Ketamine 50mg Sublingual Tablet) Achieves Primary Sedation Endpoint in Phase 2 Pivotal Efficacy and Safety Study","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Melt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Melt Pharma Doses First Patient in Phase 3 Trial of MELT-300 for Opioid-Free Sedation","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

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            Details:

            The proceeds will support development of crossject's ZENEO® Epinephrine needle-free autoinjector, for treatment of severe allergic reactions (anaphylactic shock).

            Lead Product(s): Midazolam

            Therapeutic Area: Neurology Product Name: Zeneo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bpifrance

            Deal Size: $7.4 million Upfront Cash: Undisclosed

            Deal Type: Financing July 10, 2024

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            MELT-300, a non-intravenous, non-opioid tablet that blends fixed doses of midazolam and ketamine is being investigated for procedural sedation during cataract surgery.

            Lead Product(s): Midazolam,Ketamine Hydrochloride

            Therapeutic Area: Neurology Product Name: MELT-300

            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 06, 2024

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            The net proceeds will be used to support Crossject’s activities in bringing its Zepizure (midazolam), a short-acting hypnotic-sedative epileptic rescue therapy, to market.

            Lead Product(s): Midazolam

            Therapeutic Area: Neurology Product Name: Zepizure

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Gemmes Venture

            Deal Size: $8.2 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 04, 2024

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            Under the terms of the agreement, Crossject Zepizure (midazolam) will be commercialized in the European market for the treatment of epileptic seizures.

            Lead Product(s): Midazolam

            Therapeutic Area: Neurology Product Name: Zepizure

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement May 02, 2024

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            The funding is intended to support the clinical advancement of MELT-300, a non-intravenous, non-opioid tablet that blends fixed doses of midazolam and ketamine. This medication is designed for procedural sedation during cataract surgery.

            Lead Product(s): Midazolam,Ketamine Hydrochloride

            Therapeutic Area: Neurology Product Name: MELT-300

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Newbridge Securities Corporation

            Deal Size: $24.0 million Upfront Cash: Undisclosed

            Deal Type: Series B Financing April 02, 2024

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            The financing aims to support the clinical development of Zepizure (midazolam), a short-acting hypnotic-sedative medication currently undergoing evaluation in patients for the treatment of epileptic seizures.

            Lead Product(s): Midazolam

            Therapeutic Area: Neurology Product Name: Zepizure

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Heights Capital Management

            Deal Size: $12.0 million Upfront Cash: Undisclosed

            Deal Type: Financing February 27, 2024

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            Under the agreement, Syneos Health will provide support in all pre-launch and launch activities for Zepizure (midazolam), an epileptic rescue therapy for epileptic seizures.

            Lead Product(s): Midazolam

            Therapeutic Area: Neurology Product Name: Zepizure

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Crossject

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement January 04, 2024

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            The agreement aims for the commercialization of Crossject's innovative rescue therapy for epileptic seizures Zepizure (midazolam), previously known as ZENEO® Midazolam, in northern Europe covering Germany, the UK, Denmark, Sweden, Finland and Norway.

            Lead Product(s): Midazolam

            Therapeutic Area: Neurology Product Name: Zepizure

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $1.0 million Upfront Cash: Undisclosed

            Deal Type: Agreement December 22, 2023

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            Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery.

            Lead Product(s): Midazolam,Ketamine Hydrochloride

            Therapeutic Area: Neurology Product Name: Melt-300

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Melt Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement September 26, 2023

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            Under the agreement, AFT will commercialise ZENEO® Midazolam, a combination of the single use needle-free auto injector ZENEO® and the drug product midazolam, in epileptic seizures in Australia and New Zealand.

            Lead Product(s): Midazolam

            Therapeutic Area: Neurology Product Name: Zeneo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: AFT Pharmaceuticals

            Deal Size: $0.7 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 20, 2023

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