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Details:
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.
Lead Product(s): Endoxifen
Therapeutic Area: Oncology Product Name: Endoxifen
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Atossa Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 23, 2023
Details:
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.
Lead Product(s): iNexin
Therapeutic Area: Ophthalmology Product Name: iNexin
Highest Development Status: Phase IProduct Type: Peptide
Recipient: Xequel Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 08, 2023
Details:
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.
Lead Product(s): LP352
Therapeutic Area: Neurology Product Name: LP352
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Longboard Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 05, 2023
Details:
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).
Lead Product(s): Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cingulate Therapeutics, LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 24, 2022
Details:
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.
Lead Product(s): Undisclosed
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 29, 2022
Details:
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.
Lead Product(s): Undisclosed
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 04, 2022
Details:
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.
Lead Product(s): Verapamil Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Verelan PM
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lannett Company, Inc.
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 12, 2022
Details:
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.
Lead Product(s): Raloxifene Hydrochloride
Therapeutic Area: Neurology Product Name: AD101
Highest Development Status: Phase IIProduct Type: Small molecule
Recipient: AmyriAD
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
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).
Lead Product(s): Raloxifene Hydrochloride
Therapeutic Area: Neurology Product Name: AD101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AmyriAD
Deal Size: $1.0 million Upfront Cash: Undisclosed
Deal Type: Agreement June 01, 2022
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Ritalin LA
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: InfectoPharm Drugs and Consilium
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 05, 2022