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Details:
Ogsiveo (nirogacestat) is a USFDA approved oral, selective, small molecule gamma secretase inhibitor. It is being evaluated for the treatment of adults with desmoid tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: Ogsiveo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
Details:
The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: Ogsiveo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co. LLC
Deal Size: $316.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 08, 2023
Details:
The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: Ogsiveo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co. LLC
Deal Size: $275.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 05, 2023
Details:
The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: Ogsiveo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co. LLC
Deal Size: $287.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 04, 2023
Details:
Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: Ogsiveo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 27, 2023
Details:
Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: Ogsiveo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 27, 2023
Details:
PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with treatment of adults with desmoid tumors. PDUFA date has been extended by the standard extension period of three months.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
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 June 05, 2023
Details:
PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with recurrent ovarian granulosa cell tumors (OvGCT).
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2023
Details:
PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
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 February 27, 2023
Details:
PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in phase 3 clinical development for desmoid tumors and in phase 2 clinical development for ovarian granulosa cell tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
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 December 27, 2022
Details:
In this collaboration, Applied BioMath is developing a model of SpringWorks' investigational oral selective small molecule gamma secretase inhibitor, nirogacestat (PF-03084014), in combination with an agent that targets B-cell maturation antigen for multiple myeloma.
Lead Product(s): Nirogacestat,Undisclosed
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: SpringWorks Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 01, 2022
Details:
PF-03084014 (nirogacestat) is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2022
Details:
DeFi trial met its primary endpoint of improving progression-free survival, as assessed by blinded independent central review, demonstrating a statistically significant improvement for PF-03084014 (nirogacestat) over placebo, with 71% reduction in risk of disease progression.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
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 September 10, 2022
Details:
SpringWorks intends to use the net proceeds to support the anticipated U.S. launch of nirogacestat (PF-03084014) in patients with desmoid tumors, the advancement of the ongoing research and development programs, and for working capital and general corporate purposes.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: EcoR1 Capital
Deal Size: $225.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement September 07, 2022
Details:
The new agreement expands the original collaboration to include the potential for continued development and commercialization of the combination of nirogacestat (PF-03084014) and Blenrep in earlier lines of treatment, including newly diagnosed multiple myeloma.
Lead Product(s): Nirogacestat,Belantamab Mafodotin-blmf
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: $625.0 million Upfront Cash: Undisclosed
Deal Type: Expanded Collaboration September 07, 2022
Details:
PF-03084014 (nirogacestat) is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
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 August 19, 2022
Details:
The CE cohorts utilized the KVA ocular toxicity grading scale; Grade 3 ocular adverse events occurred in 1/14 (7%) patients in the low-dose BLENREP plus nirogacestat combination compared to 7/14 patients (50%) in the BLENREP monotherapy arm.
Lead Product(s): Nirogacestat,Belantamab Mafodotin-blmf
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
The DeFi trial met its primary endpoint of improving progression-free survival (PFS), demonstrating a statistically significant improvement for PF-03084014 (nirogacestat) over placebo, with a 71% reduction in risk of disease progression (hazard ratio (HR) = 0.29.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
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 May 24, 2022
Details:
Nirogacestat (PF-03084014) is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
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 May 24, 2022
Details:
Under the terms of agreement, Regeneron is responsible for the clinical development and will assume all costs associated with the study, other than expenses related to the manufacturing and supply of nirogacestat and certain expenses related to intellectual property rights.
Lead Product(s): Nirogacestat,REGN5458
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 19, 2022
Details:
ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies.
Lead Product(s): ALLO-715,Nirogacestat
Therapeutic Area: Oncology Product Name: ALLO-715
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: SpringWorks Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2022
Details:
Nirogacestat (PF-03084014), is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors.
Lead Product(s): Nirogacestat,ABBV-383
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 10, 2021
Details:
First patient has been dosed in a Phase 1b/2 trial evaluating nirogacestat, in combination with elranatamab (PF-06863135) Pfizer’s investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody, in patients with relapsed or refractory multiple myeloma.
Lead Product(s): Nirogacestat,Elranatamab
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
The collaboration is designed to further investigate nirogacestat, SpringWorks’ investigational gamma-secretase inhibitor (GSI), with anti-B-cell maturation antigen (BCMA) agents in a variety of preclinical multiple myeloma models.
Lead Product(s): Nirogacestat,Anti-B-cell Maturation Antigen
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: SpringWorks Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 30, 2021
Details:
The collaboration aims to evaluate nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with SEA-BCMA, Seagen’s investigational monoclonal antibody targeting B-cell maturation agent, in relapsed or refractory multiple myeloma.
Lead Product(s): Nirogacestat,SEA-BCMA
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Seagen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 07, 2021
Details:
U.S. FDA has cleared an Investigational New Drug application to study ALLO-715, Allogene’s BCMA AlloCAR T therapy, in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor, in patients with relapsed/refractory multiple myeloma.
Lead Product(s): ALLO-715,Nirogacestat
Therapeutic Area: Oncology Product Name: ALLO-715
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: SpringWorks Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2020
Details:
Pfizer will sponsor and conduct the Phase 1b/2 study to evaluate the safety, tolerability and preliminary efficacy of the nirogacestat and PF‐06863135 combo, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat.
Lead Product(s): Nirogacestat,Elranatamab
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 05, 2020
Details:
PBCAR269A, Precision’s allogeneic CAR-T cell therapy candidate targeting B-cell maturation antigen, will be evaluated in combination with nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in patients with relapsed or refractory multiple myeloma.
Lead Product(s): PBCAR269A,Nirogacestat
Therapeutic Area: Oncology Product Name: PBCAR269A
Highest Development Status: UndisclosedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: SpringWorks Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 21, 2020
Details:
The open-label, single arm Phase 2 study will evaluate the safety, pharmacokinetic and efficacy of nirogacestat in children and adolescents with progressive, surgically unresectable desmoid tumors.
Lead Product(s): Nirogacestat
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Children’s Oncology Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 16, 2020
Details:
Janssen will sponsor and conduct the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the Nirogacestat with Teclistamab, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat.
Lead Product(s): Nirogacestat,Teclistamab
Therapeutic Area: Oncology Product Name: PF-03084014
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 14, 2020
Details:
This agreement will evaluate ALLO-715, Allogene’s AlloCAR T therapy in combination with SpringWorks’ nirogacestat, in patients with relapsed or refractory multiple myeloma.
Lead Product(s): ALLO-715,Nirogacestat
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2020
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