Oncology | Phase III Developments | IRELAND

Gamida Cell

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IRELAND Ireland

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BE PHARMA 2020

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Gamida Cell Announces Two-Part Virtual Miniseries Focused on Omidubicel to Take Place in September

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).

Gamida Cell

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IRELAND Ireland

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Gamida Cell Announces Launch of Proposed Public Offering of Ordinary Shares

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.

Gamida Cell

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IRELAND Ireland

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Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies

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.

Gamida Cell

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IRELAND Ireland

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Gamida Cell Announces Completion of Patient Enrollment in Ongoing Phase 3 Clinical Study of Omidubicel

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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Gamida Cell

Gamida Cell Announces Two-Part Virtual Miniseries Focused on Omidubicel to Take Place in September

Gamida Cell

Gamida Cell Announces Launch of Proposed Public Offering of Ordinary Shares

Gamida Cell

Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies

Gamida Cell

Gamida Cell Announces Completion of Patient Enrollment in Ongoing Phase 3 Clinical Study of Omidubicel