API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
The acquisition of Forma Therapeutics, including its lead development candidate, etavopivat (FT-4202), is aligned with Novo Nordisk’s strategy to complement and accelerate its scientific presence and pipeline in haemoglobinopathies.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novo Nordisk
Deal Size: $1,100.0 million Upfront Cash: $1,100.0 million
Deal Type: Acquisition October 14, 2022
Details:
With the acquisition, Novo Nordisk will gain access to Forma’s lead development candidate, etavopivat being developed in SCD to expand presence in sickle cell disease, rare blood disorders and haemoglobinopathies.
Lead Product(s): Etavopivat
Therapeutic Area: Hematology Product Name: FT-4202
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novo Nordisk
Deal Size: $1,100.0 million Upfront Cash: $1,100.0 million
Deal Type: Acquisition September 01, 2022
Details:
FT-4202 (etavopivat) is designed to activate PKR and thereby modulate RBC metabolism by impacting two critical pathways in RBCs, will investigate whether decreasing 2,3-DPG may help oxygen bind to hemoglobin and thereby increase ATP and impact RBC function.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
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 June 10, 2022
Details:
Etavopivat, the company's investigational oral, once-daily, selective pyruvate kinase-R activator, significantly improved anemia and red blood cell health with a favorable tolerability and safety profile in patients with SCD.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
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 December 11, 2021
Details:
E-poster presentation includes initial data from the open-label extension cohort showing etavopivat improved and sustained hematologic and hemolytic parameters for patients living with sickle cell disease receiving 400 mg etavopivat once-daily for at least 2 to 12 weeks.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Doubling the dose of FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg cohort was well-tolerated with no dose-limiting toxicities or treatment-related adverse events observed.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2021
Details:
Funds to be used in the development of its lead program FT-4202 in sickle cell disease and completion of Phase 1 clinical trial, advancement of FT-7051 in metastatic castration-resistant prostate cancer, pre-approval activities for FT-2102 in AML.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering December 08, 2020
Details:
FT-4202 is a novel, investigational, selective red blood cell pyruvate kinase-R activator in development as a potential disease-modifying therapy for SCD. 6 of 7 (86%) patients on 300 mg of FT-4202 for 14 days achieved a hemoglobin increase > 1 g/dL from baseline.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
Details:
In a cohort of nine patients, six of seven patients (86%) who received FT-4202 achieved a hemoglobin increase of greater than 1 g/dL from baseline with once-daily dosing at 300 mg for 14 days.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
Details:
European Commission granted Orphan Drug designation to Forma’s FT-4202 for the treatment of sickle cell disease (SCD), based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA).
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
The oral presentation will feature clinical data from the multiple ascending dose cohort of a randomized, multi-center, placebo-controlled Phase 1 trial of FT-4202 in people living with sickle cell disease (SCD).
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: FT-4202
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
The data, presented at the Virtual Edition of the 25th European Hematology Association Annual Congress, demonstrate a favorable tolerability profile and favorable pharmacokinetic/pharmacodynamic (PK/PD) effects of FT-4202 in patients with SCD.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2020
Details:
FT-4202 is a potent activator of pyruvate kinase-R that, in preclinical studies, demonstrated the potential to beneficially impact both anemia and vaso-occlusive crises for people living with SCD.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2020
Details:
Transaction supports FORMA’s business model transition from early research focus to integrated biopharma company with research, development and commercial capacity.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: NewCo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Divestment March 19, 2020
Details:
FORMA is currently enrolling patients with SCD in a Phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics (PK/PD) of FT-4202.
Lead Product(s): Etavopivat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2020