![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-desktop-headergif-72716.gif)
![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-mob-headergif-95876.gif)
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
0
Listed 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:
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC. CONTESSA met the primary endpoint of improved PFS as assessed by the IRC.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
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 11, 2020
Details:
Cohorts 2 and 3 of CONTESSA TRIO will expand on results from TOB203, a Phase 2 study that evaluated tesetaxel monotherapy in 38 patients with hormone receptor-positive, HER2-negative MBC.
Lead Product(s): Tesetaxel
Therapeutic Area: Oncology Product Name: Undisclosed
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 07, 2020
Details:
CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 got each each 21-day cycle plus a reduced dose of capecitabine to the approved dose of capecitabine alone in patients with HER2 (-), HR (+) MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
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 05, 2020
Details:
Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development, regulatory and commercial preparation activities relating to tesetaxel, as well as for working capital and general corporate purposes.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $80.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 27, 2020
Details:
CONTESSA met the primary endpoint of improved PFS as assessed by the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for the approved dose of capecitabine alone, an improvement of 2.9 months.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
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 24, 2020