Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Teplizumab Vs Placebo Safety and Efficacy In Stage 3 T1DM Participants
Details : Teplizumab is a Antibody drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Diabetes Mellitus, Type 1.
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
July 28, 2025
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Details : Undisclosed
Product Name : Undisclosed
Product Type : Peptide
Upfront Cash : Inapplicable
June 10, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teplizumab, an investigational anti-CD3 mAb developed for delay of clinical type 1 diabetes at-risk individuals, company resubmitted BLA for teplizumab has been considered a complete, class 2 response by USFDA.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
March 21, 2022
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway
Details : FDA approved the Company proceeding to populate the popPK model with data collected from patients receiving therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic substudy of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabe...
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
November 22, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
September 13, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : As part of its ongoing review of the Company's BLA for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
August 04, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : In the pivotal TN-10 Study, a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 T1D compared to placebo.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
June 07, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed BLA under Priority Review by the FDA for the delay of clinical T1D in at-risk individuals. EMDAC of the U.S. Food and Drug Administration (FDA) voted 10 yes and 7 no on the ...
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
May 27, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Provention Bio took part in an informal meeting with the U.S. Food and Drug Administration (FDA) on April 23, 2021, in connection with the FDA's ongoing review of the teplizumab Biologic License Application (BLA) for the delay or prevention of clinical t...
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
April 27, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : SVB Leerink
Deal Size : $100.0 million
Deal Type : Public Offering
Provention Bio Announces Pricing of $100 Million Public Offering of Common Stock
Details : Provention Bio intends to use its net proceeds from the public offering for (i) pre-commercial activities, potential commercial activities, potential milestone or royalty payments, clinical development, and regulatory and manufacturing activities for PRV...
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Undisclosed
January 13, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : SVB Leerink
Deal Size : $100.0 million
Deal Type : Public Offering
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