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[{"company":"Genmab","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genmab Announces Positive Topline Results in Phase III ANDROMEDA Study of Daratumumab in Light-chain (AL) Amyloidosis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Genmab"},{"company":"Genmab","sponsor":"Janssen Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Submitts a Type II Variation Application to the EMA for Use Of Subcutaneous DARZALEX\u00ae in Patients with Light-Chain Amyloidosis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Genmab"},{"company":"Orphazyme","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orphazyme Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orphazyme"},{"company":"Orphazyme","sponsor":"CytRx Corporation","pharmaFlowCategory":"D","amount":"$83.7 million","upfrontCash":"Undisclosed","newsHeadline":"CytRx Issues Statement Regarding Orphazyme\u2019s Global Offering","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orphazyme"},{"company":"Zealand Pharma","sponsor":"Oberland Capital Management","pharmaFlowCategory":"D","amount":"$200.0 million","upfrontCash":"$100.0 million","newsHeadline":"Zealand Pharma Announces Seven-Year, $200 Million Financing Agreement with Oberland Capital","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Peptide","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Peptide","graph2":"Zealand Pharma"},{"company":"Zealand Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zealand Pharma Completes Enrollment in Phase 3 Trial of Dasiglucagon in Children with Congenital Hyperinsulinism (CHI)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Peptide","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Zealand Pharma"},{"company":"Zealand Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zealand Pharma Announces Positive Results from Phase 3 Trial of Dasiglucagon in Pediatric Patients with Congenital Hyperinsulinism (CHI)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Peptide","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Zealand Pharma"},{"company":"Novo Nordisk","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novo Nordisk Resumes the Phase 3 Clinical Trials Investigating Concizumab (Anti-Tfpi Mab) In Haemophilia A and B With or without Inhibitors","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Novo Nordisk"},{"company":"Novo Nordisk","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase 3 Data for Concizumab Show 86% Reduction in Treated Bleeds in Haemophilia a or B With Inhibitors","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Novo Nordisk"},{"company":"Novo Nordisk","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mim8 Phase 1 & 2 Data Demonstrates Potential as Once Monthly Treatment for People With Haemophilia A","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Novo Nordisk"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Announces Publication of Results from LUMEVOQ\u00ae RESCUE Pivotal Phase III Trial in AAO journal Ophthalmology\u00ae","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Leo Pharma"}]

Novo Nordisk

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Mim8 Phase 1 & 2 Data Demonstrates Potential as Once Monthly Treatment for People With Haemophilia A

Details:

Mim8 is a next-generation human IgG4 bispecific antibody bridging Factor IXa/X (FIXa/FX) designed to be a potent once weekly or once monthly prophylaxis therapy for people living with haemophilia A.

Lead Product(s): Mim8

Therapeutic Area: Genetic Disease Product Name: Mim8

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 11, 2022

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Novo Nordisk

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Phase 3 Data for Concizumab Show 86% Reduction in Treated Bleeds in Haemophilia a or B With Inhibitors

Details:

Concizumab is an anti-TFPI mAB, designed to block a protein in body that stops blood from clotting, called TFPI. By blocking TFPI, concizumab encourages the production of a blood clotting protein called thrombin, which helps to clot the blood and prevent bleeding.

Lead Product(s): Concizumab

Therapeutic Area: Genetic Disease Product Name: Undisclosed

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 10, 2022

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Zealand Pharma

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Zealand Pharma Announces Positive Results from Phase 3 Trial of Dasiglucagon in Pediatric Patients with Congenital Hyperinsulinism (CHI)

Details:

ZP4207 (dasiglucagon) met the primary endpoint with statistical significance - reducing the requirement for intravenous glucose by 55% compared to placebo in this pediatric patient population (ages 7 days to 12 months) when compared to placebo.

Lead Product(s): Dasiglucagon

Therapeutic Area: Genetic Disease Product Name: ZP4207

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 19, 2022

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Zealand Pharma

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Zealand Pharma Completes Enrollment in Phase 3 Trial of Dasiglucagon in Children with Congenital Hyperinsulinism (CHI)

Details:

Phase 3 trial, 17103 is designed to investigate the potential for chronic ZP4207 (dasiglucagon), a glucagon analog infusion delivered via a pump to prevent hypoglycemia in children with congenital hyperinsulinism in neonates upto 12 month old.

Lead Product(s): Dasiglucagon

Therapeutic Area: Genetic Disease Product Name: ZP4207

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 15, 2022

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Zealand Pharma

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Zealand Pharma Announces Seven-Year, $200 Million Financing Agreement with Oberland Capital

Details:

This new funding from Oberland Capital enables to continue robust clinical-stage pipeline, which includes multiple programs in Phase 3 trials across a range of metabolic and gastrointestinal diseases including ZP4207, as well as in pre-clinical pipeline.

Lead Product(s): Dasiglucagon

Therapeutic Area: Genetic Disease Product Name: ZP4207

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Oberland Capital Management

Deal Size: $200.0 million Upfront Cash: $100.0 million

Deal Type: Financing December 14, 2021

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Leo Pharma

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GenSight Biologics Announces Publication of Results from LUMEVOQ® RESCUE Pivotal Phase III Trial in AAO journal Ophthalmology®

Details:

Journal of the American Academy of Ophthalmology, Ophthalmology®, has published results from the RESCUE pivotal Phase III clinical trial of LUMEVOQ® gene therapy in ND4 Leber Hereditary Optic Neuropathy (LHON) subjects.

Lead Product(s): Lenadogene nolparvovec

Therapeutic Area: Genetic Disease Product Name: Lumevoq

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2021

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Genmab

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Janssen Submitts a Type II Variation Application to the EMA for Use Of Subcutaneous DARZALEX® in Patients with Light-Chain Amyloidosis

Details:

The submission is based on the Phase 3 ANDROMEDA study of daratumumab and hyaluronidase-fihj in combination with VCd as treatment for patients with newly diagnosed AL amyloidosis.

Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide

Therapeutic Area: Genetic Disease Product Name: Darzalex

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Janssen Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 05, 2020

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Orphazyme

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CytRx Issues Statement Regarding Orphazyme’s Global Offering

Details:

CytRx disclosed receipt of a filing communication from the U.S. Food and Drug Administration (“FDA”) relating to the agency’s ordinary course review of its new drug application for arimoclomol in the treatment of Niemann-Pick disease Type C.

Lead Product(s): Arimoclomol

Therapeutic Area: Genetic Disease Product Name: Miplyffa

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: CytRx Corporation

Deal Size: $83.7 million Upfront Cash: Undisclosed

Deal Type: Public Offering September 30, 2020

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Orphazyme

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Orphazyme Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C

Details:

If approved, arimoclomol would become the first approved therapy in the U.S. for people with Niemann-Pick disease Type C (NPC).

Lead Product(s): Arimoclomol

Therapeutic Area: Genetic Disease Product Name: Undisclosed

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 September 16, 2020

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Novo Nordisk

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Novo Nordisk Resumes the Phase 3 Clinical Trials Investigating Concizumab (Anti-Tfpi Mab) In Haemophilia A and B With or without Inhibitors

Details:

Novo Nordisk has together with relevant authorities identified a new path forward for concizumab. New safety measures and guidelines, based on analysis of all available data, have been agreed with the FDA and the clinical hold has been lifted.

Lead Product(s): Concizumab

Therapeutic Area: Genetic Disease Product Name: Undisclosed

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 August 13, 2020

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