[{"orgOrder":0,"company":"Societal CDMO","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Recro Enters Development Agreement With Astex Pharmaceuticals","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"National Institutes of Health","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Recro Awarded Development and Manufacturing Contract by National Institutes of Health (NIH) to Support Novel Nasal Spray Analgesic","therapeuticArea":"Neurology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Preclinical"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"BioCorRx","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recro and BioCorRx Expand Development and Manufacturing Relationship to Support BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"InfectoPharm Drugs and Consilium","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA in Europe","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"AmyriAD","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Societal CDMO Selected By AmyriAD Pharma to Provide Clinical Trials Services to Support Pivotal Phase 3 Program For Alzheimer's Disease Treatment, AD101","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Lannett Company, Inc.","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Announces Signing of Amendment to License and Supply Agreement With Lannett for Marketing of Verapamil PM and Verelan SR Products","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"AmyriAD","pharmaFlowCategory":"D","amount":"$1.0 million","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Selected By AmyriAD Pharma to Provide Clinical Trials Services to Support Pivotal Phase 3 Program For Alzheimer\u2019s Disease Treatment, AD101","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"InfectoPharm Drugs and Consilium","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA\u00ae in Europe","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Adds Three New Customers, Signing Agreements to Provide CDMO Services Supporting Clinical Development of Several Novel Therapeutic Candidates","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Undisclosed","date":"August 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Announces Signing of Multiple Agreements With New and Existing Customers","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"Undisclosed","date":"September 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Cingulate Therapeutics, LLC","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Cingulate Announces Agreement with Societal CDMO and Provides Clinical Update","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Longboard Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Selected by Longboard Pharmaceuticals to Provide CDMO Services to Support Clinical Development of LP352","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Xequel Bio","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Selected by Xequel Bio to Provide CDMO Services to Support Ongoing Clinical Development of iNexin\u2122","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase I"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Atossa Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Enters Agreement With Atossa Therapeutics to Provide Clinical Trial Services (CTS) for Innovative Selective Estrogen Receptor Modulator","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals by Societal CDMO
Under the agreement, Societal CDMO will provide a range of its Clinical Trial Services offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, the most active metabolite of the FDA approved SERM, tamoxifen.
Under the agreement, Societal CDMO will provide to support the ongoing clinical development of iNexin™, a patented new chemical entity based on company's aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) platform.
The agreement spans a range of Societal CDMO’s offerings including technology transfer and analytical method validation activities to support Longboard’s Oral, Centrally Acting 5-HT2C Receptor Superagonist, LP352, being developed for treatment of refractory seizures.
Under the agreement, Societal CDMO will manufacture all clinical, registration, and commercial batches of Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), an investigational medication for the treatment of Attention Deficit / Hyperactivity Disorder (ADHD).
The new contracts are focused on a range of analytic method, tech transfer, formulation, manufacturing and packaging services designed to support ongoing clinical development programs, as well as planned commercial activities.
Under terms of the first new contract, Societal will execute a range of clinical trial services to support the initiation of a U.S.-based Phase 2 clinical study of a novel melatonergic antidepressant already approved for use in Europe and Australia.
Under terms of the amendment, Societal will now receive improved overall economics, including a 10% increase in the profit share component of revenue from Verapamil PM product sales, as well as immediate and scheduled increases in manufacturing prices.
AD101 (Raloxifene), a 100 Series lead compound and a novel T-type calcium channel modulator demonstrated statistically significant improvement in both core symptoms of AD in Concept Trials.
Under terms of the new contract, Societal will execute a range of clinical trial services to support the initiation of Phase 3 and Phase 4 clinical studies of AD101 (raloxifene).
Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the SODAS (Spheroidal Oral Drug Absorption System) technology.
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