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Lead Product(s): Omidubicel
Therapeutic Area: Oncology Product Name: NiCord
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2021
Details:
The Phase 3 study for omidubicel evaluated the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.
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Lead Product(s): Omidubicel
Therapeutic Area: Oncology Product Name: NiCord
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2020
Details:
Feedback from FDA supports proceeding to BLA Submission for omidubicel with additional manufacturing requirements; the company plans to submit full BLA in second half of 2021.
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Lead Product(s): Lurbinectedin,Doxorubicin HCl
Therapeutic Area: Oncology Product Name: Zepzelca
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: PharmaMar
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
The study did not meet the pre-specified criteria of significance for the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population comparing lurbinectedin in combination with doxorubicin to the control arm.
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Lead Product(s): Omidubicel
Therapeutic Area: Oncology Product Name: NiCord
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
Phase 3 study of omidubicel, an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of bone marrow transplant, met all three of its secondary endpoints.
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Lead Product(s): Omidubicel
Therapeutic Area: Oncology Product Name: NiCord
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers).
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Lead Product(s): Omidubicel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering May 18, 2020
Details:
Gamida Cell intends to use the net proceeds from this offering to fund the preparation of a Biologics Licensing Application for omidubicel in high risk hematologic malignancies and the continued clinical development of other product candidates.
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Lead Product(s): Omidubicel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2020
Details:
The study achieved its primary endpoint. In the intent-to-treat analysis, time to neutrophil engraftment was significantly shorter for patients who received omidubicel vs comparator group.
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Lead Product(s): Omidubicel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 02, 2020
Details:
The Phase 3 study will evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood in blood cancer patients who do not have matched donor for bone marrow transplantation.
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