Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Kezar KZR-616 gets FDA orphan drug designations for two autoimmune disease

Kezar Life Sciences’ (NASDAQ:KZR) KZR-616 received FDA orphan drug designation for the treatment of polymyositis and dermatomyositis, autoimmune inflammatory myopathies with marked morbidity and mortality. KZR-616 is a...

October 23, 2020

Developments

PhaseBio discontinues Phase 2 COVID-19 trial

PhaseBio Pharmaceuticals (NASDAQ:PHAS) discontinued its Phase 2 trial evaluating PB1046 for the treatment of high-risk, hospitalized COVID-19 patients. PB1046 is a long-acting analog of vasoactive intestinal peptide...

October 23, 2020

Developments

BiondVax universal flu vaccine fails Phase 3 trial

A Phase 3 clinical trial of BiondVax Pharmaceuticals’ (NASDAQ:BVXV) M-001 universal flu vaccine did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu...

October 23, 2020

Developments

TG Therapeutics gets FDA fast track designation for ublituximab plus umbralisib

TG Therapeutics (NASDAQ:TGTX) received the FDA fast track designation for the ublituximab plus umbralisib for the treatment of chronic lymphocytic leukemia (CLL). Ublituximab is a glycoengineered anti-CD20 monoclonal...

October 21, 2020

Developments

Cidara updates Phase 2 rezafungin data

Cidara Therapeutics (NASDAQ:CDTX) reported new data from its Phase 2 STRIVE trial evaluating once-weekly rezafungin for the treatment of candidemia and invasive candidiasis. The trial demonstrated that rezafungin...

October 21, 2020

Developments

IntelGenx grants Tetra Bio-Pharma additional rights to Adversa mucoadhesive delivery technology

IntelGenx (TSXV:IGX; OTCQB:IGXT) granted cannabinoid-derived drug developer Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF) additional exclusive worldwide rights to IntelGenx’s Adversa mucoadhesive delivery technology. Adversa...

October 20, 2020

Developments

Inventiva odiparcil gets FDA fast track designation for mucopolysaccharidosis

Inventiva’s (PSE:IVA; NASDAQ:IVA) odiparcil received FDA fast track designation for the treatment of mucopolysaccharidosis (MPS) Type VI, a rare progressive genetic disorder. MPS is caused by deficient versions of the...

October 20, 2020

Developments

Aclaris doses first patient in Phase 2a atopic dermatitis trial

Aclaris Therapeutics (NASDAQ:ACRS) dosed the first patient in its Phase 2a trial evaluating ATI-1777 for the treatment of moderate-to-severe atopic dermatitis ATI-1777 is a topical Janus kinase (JAK) 1/3 inhibitor...

October 20, 2020

Developments

Evofem Biosciences enrolls first patient in Phase 3 STD prevention trial

Evofem Biosciences (NASDAQ:EVFM) enrolled the first patient in its Phase 3 trial evaluating EVO100 for the prevention of urogenital chlamydia and gonorrhea in women. The trial, called EVOGUARD, will enroll 1,730 women...

October 20, 2020

Developments

Selecta gets FDA rare pediatric disease designation for methylmalonic acidemia gene therapy

Selecta Biosciences’ (NASDAQ:SELB) MMA-101 received FDA rare pediatric disease designation for the treatment of methylmalonic acidemia (MMA). MMA is caused by a mutation in the methylmalonyl-CoA mutase gene, which...

October 20, 2020

Developments

Anavex reports positive results from Phase 2 Parkinson’s disease trial

Anavex Life Sciences (NASDAQ:AVXL) reported positive results from its Phase 2 study evaluating ANAVEX2-73 for the treatment of Parkinson’s disease dementia. The proof-of-concept study enrolled 132 patients who received...

October 15, 2020

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

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

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