[{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Announces Investigational New Drug Application Amendment for HST 001","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I"},{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Receives US FDA IND Approval to Initiate Phase 1b\/2a Trial of HST 001 in Androgenic Alopecia","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Publishes Preclinical Data on its HST 004 Spinal Disc Program","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Preclinical"},{"orgOrder":0,"company":"Histogen","sponsor":"Histogen","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Histogen Announces Successful Completion of its Merger with Conatus Pharmaceuticals","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I"},{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Begins Enrollment in Phase 1b\/2a Trial of HST 001 to Treat Androgenic Alopecia","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Histogen","sponsor":"Conatus Pharmaceuticals","pharmaFlowCategory":"D","amount":"$135.1 million","upfrontCash":"Undisclosed","newsHeadline":"Conatus Pharmaceuticals and Histogen Enter into Definitive Merger Agreement","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I"},{"orgOrder":0,"company":"Histogen","sponsor":"U.S. Department of Defense","pharmaFlowCategory":"D","amount":"$2.0 million","upfrontCash":"Undisclosed","newsHeadline":"Histogen Announces $2M Grant Award from the Department of Defense for Clinical Advancement of HST-003 for Cartilage Regeneration in the Knee","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Announces Update for its HST-002 Dermal Filler Program","therapeuticArea":"Dermatology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Completes Patient Dosing in Phase 1b\/2a Trial of HST-001 to Treat Androgenic Alopecia in Men","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I"},{"orgOrder":0,"company":"Histogen","sponsor":"Amerimmune","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Histogen and Amerimmune Enter into a Collaborative Development and Commercialization Agreement for Emricasan in the Treatment of COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling"},{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Reports FDA Clinical Hold for Planned Phase 1\/2 Trial of HST-003 for Knee Cartilage Regeneration","therapeuticArea":"Orthopedics\/Orthopedic Surgery","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Orthopedics\/Orthopedic Surgery","graph2":"IND Enabling"},{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Announces Issuance of US Patent Covering CTS-2090 Methods of Use","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Histogen","sponsor":"Johns Hopkins University","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Histogen Announces Exclusive Intellectual Property License Agreement with Johns Hopkins University","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"}]
Find Clinical Drug Pipeline Developments & Deals by Histogen
Under the agreement, the intellectual property covers the use of emricasan, an orally available pan-caspase inhibitor designed to reduce the activities of human caspases, for the treatment of disease in humans resulting from viral or bacterial infections.
CTS-2090 is a pan-caspase and caspase selective inhibitor that protect the body’s natural process to restore immune function. It has provided protection against inflammation-driven damage to the lining of the GI tract and also protected against loss of body weight.
U.S. FDA has verbally notified the company that it has additional questions about the company’s IND application package for the planned Phase 1/2 clinical trial of HST-003.
Histogen will retain ownership and oversight over emricasan and responsibility for all regulatory filings and maintaining its existing caspase inhibitor patent portfolio. Amerimmune will lead development efforts of emricasan in a phase 1 study in mild-COVID-19 patients.
This blinded, randomized, placebo controlled, single site study has enrolled 36 subjects with male pattern hair loss using a 2:1 randomization of HST-001 to placebo.
Histogen received communications from the Office of Combination Products that HST-002 is a drug-biologic-device combination product. HST-001 1b/2a trial for androgenic alopecia in men on track for top line data results in 4Q20.
The funding supports Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee led by Histogen. The trial is designed to evaluate HST-003 in combination with a microfracture procedure to treat recent focal cartilage defects in the knee caused by injury.
This blinded, randomized, placebo controlled, single site study is designed to assess the safety and tolerability of HST 001, and indicators of efficacy including non-vellus hair count, total hair count, and hair thickness density as measured by Canfield macrophotography.
This merger is transformative for Histogen as it looks to advance its novel regenerative medicine pipeline. The merger provides an opportunity for Histogen to become a leader in the aesthetics and orthopedic medicine markets.
Clinical data from the first three cohorts of the ongoing Phase I dose-escalation trial demonstrating safety of MCY-M11 and feasibility of one-day manufacturing will be shared at the ASCO 2020.
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