Category - Developments

Developments

Titan Pharma to focus on ProNeura-based product development

Titan Pharmaceuticals (NASDAQ:TTNP) reported that it will discontinue U.S. Probuphine sales and wind down commercialization activities as it restructures to focus on ProNeura-based product development. “Marketing of...

October 15, 2020

Developments

Taysha gets FDA rare pediatric and orphan drug designations for Rett syndrome

Taysha Gene Therapies (NASDAQ:TSHA) received FDA rare pediatric and orphan drug designations for TSHA-102 for the treatment of Rett syndrome. Rett syndrome is a genetic neurodevelopmental disorder characterized by...

October 14, 2020

Developments

Evelo doses first patient in Phase 2 psoriasis study

Evelo Biosciences (NASDAQ:EVLO) dosed the first patient in its Phase 2 study evaluating EDP1815 for the treatment of mild-to-moderate psoriasis. The placebo-controlled study will enroll 225 patients to evaluate three...

October 13, 2020

Developments

AnaptysBio reports positive topline data from Phase 2 pustular psoriasis trial

AnaptysBio (NASDAQ:ANAB) reported positive topline data from an interim analysis of its Phase 2 trial evaluating imsidolimab or the treatment of generalized pustular psoriasis (GPP). GPP is a rare, chronic, life...

October 13, 2020

Developments

Axovant gets FDA rare pediatric designation for gangliosidosis gene therapy

Axovant Gene Therapies (NASDAQ:AXGT) received FDA orphan drug designation for AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a progressive and fatal disease where mutations in the GLB1 gene...

October 9, 2020

Developments

Rigel Pharma enrolls first patients in Phase 2 COVID-19 trial

Rigel Pharmaceuticals (NASDAQ:RIGL) enrolled the first patients in its Phase 2 trial evaluating fostamatinib for the treatment of hospitalized COVID-19 patients. The study is sponsored by the NIH’s National Heart, Lung...

October 9, 2020

Developments

X4 Pharma’s mavorixafor gets FDA fast track designation for WHIM syndrome

The FDA granted X4 Pharmaceuticals’ (NASDAQ:XFOR) mavorixafor fast track designation for WHIM syndrome. WHIM stands for warts; hypogammaglobulinemia, or low antibody levels; infections; and myelokathexis, or low white...

October 8, 2020

Developments

Imagin Medical selects Lighthouse Imaging as i/Blue contract manufacturer

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) selected Lighthouse Imaging as the contract manufacturer for the i/Blue Imaging System. Lighthouse is an FDA registered and ISO 13485:2016...

October 7, 2020

Developments

Oncternal gets FDA rare pediatric disease designation for Ewing sarcoma

The FDA granted Oncternal Therapeutics’ (NASDAQ:ONCT) TK216 rare pediatric disease designation for the treatment of Ewing sarcoma. Ewing sarcoma is the second most common bone tumor among children and adolescents, with...

October 6, 2020

Developments

Corbus Pharma lenabasum flunks Phase 2b cystic fibrosis study

Corbus Pharmaceuticals (NASDAQ:CRBP) reported disappointing topline results from its Phase 2b trial of lenabasum for the treatment of cystic fibrosis. Patients were randomized to receive either 5 mg or 20 mg of...

October 6, 2020

Category - Developments

Titan Pharma to focus on ProNeura-based product development

Taysha gets FDA rare pediatric and orphan drug designations for Rett syndrome

Evelo doses first patient in Phase 2 psoriasis study

AnaptysBio reports positive topline data from Phase 2 pustular psoriasis trial

Axovant gets FDA rare pediatric designation for gangliosidosis gene therapy

Rigel Pharma enrolls first patients in Phase 2 COVID-19 trial

X4 Pharma’s mavorixafor gets FDA fast track designation for WHIM syndrome

Imagin Medical selects Lighthouse Imaging as i/Blue contract manufacturer

Oncternal gets FDA rare pediatric disease designation for Ewing sarcoma

Corbus Pharma lenabasum flunks Phase 2b cystic fibrosis study

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