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Entera Bio & Opko Health is developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
Lead Product(s): Undisclosed
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Peptide
Recipient: EnteraBio Ltd
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2024
Details:
The agreement aims to advance a platform and specific candidates addressing a range of viral infectious diseases and will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology.
Lead Product(s): Undisclosed
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: DiscoveryProduct Type: Large molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 28, 2023
Details:
NGENLA (somatrogon-ghla), a once-weekly, HGH analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. it's expected to become available for U.S. prescribing in August 2023.
Lead Product(s): Somatrogon-ghla
Therapeutic Area: Endocrinology Product Name: Ngenla
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2023
Details:
ModeX and Merck will jointly advance MDX-2201 to an IND application filing, after which Merck will be responsible for clinical and regulatory activities and product commercialization. MDX-2201 leverages ModeX’s innovative biologics platform to target multiple EBV proteins.
Lead Product(s): MDX-2201
Therapeutic Area: Infections and Infectious Diseases Product Name: MDX-2201
Highest Development Status: IND EnablingProduct Type: Vaccine
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 08, 2023
Details:
ModeX Therapeutics has developed highly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, simpler manufacturing and potentially better specificity and safety, providing significant differentiation from competing platforms.
Lead Product(s): Antibody
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: OPKO Health
Deal Size: $300.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 09, 2022
Details:
The European Union marketing authorization of Ngenla (somatrogon) was supported by results from Phase 3 study which evaluated the safety and efficacy of once-weekly NGENLA compared to once-daily GENOTROPIN® (somatropin).
Lead Product(s): Somatrogon
Therapeutic Area: Endocrinology Product Name: Ngenla
Highest Development Status: ApprovedProduct Type: Peptide
Recipient: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2022
Details:
RAYALDEE extended-release capsules are indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Lead Product(s): Calcifediol
Therapeutic Area: Endocrinology Product Name: Rayaldee
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Vifor Fresenius Medical Care Renal Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2022
Details:
Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency in pediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.
Lead Product(s): Somatrogon
Therapeutic Area: Endocrinology Product Name: PF-06836922
Highest Development Status: ApprovedProduct Type: Peptide
Recipient: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2022
Details:
This approval is based on the results of a Phase 3 study conducted in Japanese subjects and a global clinical study, both of which were conducted in subjects with pediatric GHD, and compared the efficacy and safety of once-weekly NGENLA® with GENOTROPIN® (somatropin).
Lead Product(s): Somatrogon
Therapeutic Area: Endocrinology Product Name: PF-06836922
Highest Development Status: ApprovedProduct Type: Peptide
Recipient: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2022
Details:
CHMP’s positive opinion of PF-06836922 (somatrogon) is based on the results from Phase 3, the study demonstrated that treatment improved the mean overall life interference total score after 12 weeks.
Lead Product(s): Somatrogon
Therapeutic Area: Endocrinology Product Name: PF-06836922
Highest Development Status: Phase IIIProduct Type: Peptide
Recipient: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
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