CSBio CSBio

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Orforglipron","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Eli Lilly"},{"orgOrder":0,"company":"Crinetics Pharmaceuticals","sponsor":"Adage Capital Partners","pharmaFlowCategory":"D","amount":"$350.0 million","upfrontCash":"Undisclosed","newsHeadline":"Crinetics Pharmaceuticals Announces Oversubscribed $350 Million Private Placement","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Crinetics Pharmaceuticals"}]

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            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.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 21, 2022

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            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 diabetes patients.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 22, 2021

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            Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones.

            Lead Product(s): Sitagliptin Phosphate

            Therapeutic Area: Endocrinology Product Name: Sitagliptin-Generic

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 12, 2021

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            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.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2021

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            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.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 06, 2021

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            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 question.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 27, 2021

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            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 type 1 diabetes.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 27, 2021

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            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.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 08, 2021

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            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-031

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: SVB Leerink

            Deal Size: $100.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering January 13, 2021

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            Details:

            Teplizumab is an anti-CD3 monoclonal antibody (mAb). The BLA has been submitted for Teplizumab for prevention of clinical type one diabetes (T1D) in at-risk individuals with the submission of the chemistry, manufacturing and controls and administrative information modules.

            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 02, 2020

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