Category - Developments

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

Developments

ImmunoGen IMGN632 gets FDA breakthrough therapy designation

The FDA granted ImmunoGen’s (NASDAQ:IMGN) IMGN632 breakthrough therapy designation for the treatment of relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). BPDCN is a rare and aggressive form of...

October 5, 2020

Developments

Hepion launches AI-POWR platform, forms clinical pharmacology analytics team

Hepion Pharmaceuticals (NASDAQ:HEPA) launched AI-POWR, a proprietary AI machine learning platform, which is designed to select novel drug targets, biomarkers, and appropriate patient populations for clinical trials...

October 5, 2020

Developments

FDA approves Chembio’s dual path platform HIV-syphilis testing system

The FDA approved Chembio Diagnostics’ (NASDAQ:CEMI) dual path platform (DPP) HIV-syphilis system, a 15-minute test designed to detect HIV Type 1 and 2 antibodies and the bacteria that causes syphilis. The system...

October 2, 2020

Category - Developments

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

ImmunoGen IMGN632 gets FDA breakthrough therapy designation

Hepion launches AI-POWR platform, forms clinical pharmacology analytics team

FDA approves Chembio’s dual path platform HIV-syphilis testing system

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