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Details:
The acquisition of Miromatrix will expand United Therapeutics’ platform of organ manufacturing programs and regenerative medicine and upon the achievement of clinical development milestone to Miromatrix’s development-stage, manufactured kidney product known as mirokidney™.
Lead Product(s): Undisclosed
Therapeutic Area: Nephrology Product Name: Mirokidney
Highest Development Status: PreclinicalProduct Type: Undisclosed
Recipient: United Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 13, 2023
Details:
Tyvaso (treprostinil) inhalation solution is an approved prostacyclin mimetic indicated for the treatment of Pulmonary arterial hypertension. It is under phase 3 clinical development for progressive pulmonary fibrosis.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2023
Details:
The acquisition of Miromatrix will expand United Therapeutics’ platform of organ manufacturing programs and regenerative medicine and upon the achievement of clinical development milestone to Miromatrix’s development-stage, manufactured kidney product known as mirokidney™.
Lead Product(s): Undisclosed
Therapeutic Area: Nephrology Product Name: Mirokidney
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: United Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 30, 2023
Details:
Through the acquisition, United Therapeutics gains access to Miromatrix’s development-stage, fully-implantable manufactured kidney product known as mirokidney.
Lead Product(s): Undisclosed
Therapeutic Area: Nephrology Product Name: Mirokidney
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: United Therapeutics
Deal Size: $91.0 million Upfront Cash: $91.0 million
Deal Type: Acquisition October 30, 2023
Details:
As part of the collaboration, Miromatrix has created a new liver therapy called miroliverELAP that combines a Miromatrix single-use bioengineered liver with Baxter’s PrisMax system for patients with acute liver failure (ALF) in need of organ support therapies.
Lead Product(s): MiroliverELAP
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MiroliverELAP
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Baxter Healthcare Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 01, 2023
Details:
MiroliverELAP is a single-use bioengineered liver which is designed to provide therapeutic support to ALF patients in hopes their native livers will regenerate themselves back to health.
Lead Product(s): MiroliverELAP
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MiroliverELAP
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
The miroliverELAP IND application was submitted in mid-November. The FDA indicated they will provide an official clinical hold letter to Miromatrix within 30 days. Miromatrix plans to provide additional updates pending communication with the FDA.
Lead Product(s): miroliverELAP
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: miroliverELAP
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2022
Details:
Remodulin (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Remodulin
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2022
Details:
Data from the FREEDOM-EV open label extension study of Orenitram® details an association with improved survival and, separately, its effects as part of a combination therapy regimen in patients with pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2022
Details:
TYVASO (treprostinil) inhalation solution and TYVASO DPI (treprostinil) inhalation powder are prostacyclin mimetics indicated for the treatment of Pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2022