Developments – Page 2

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

Developments

Synthetic Biologics discontinues Phase 2b irritable bowel syndrome trial

Synthetic Biologics (NYSE American:SYN) reported disappointing results from an interim futility analysis of its Phase 2b clinical study of SYN-010 for the treatment of irritable bowel syndrome with constipation. While...

October 2, 2020

Developments

Otonomy completes enrollment in Phase 3 Meniere’s disease trial

Otonomy (NASDAQ:OTIC) completed enrollment in its Phase 3 study evaluating OTIVIDEX for the treatment of Meniere’s disease, a disorder of the inner ear that can lead to vertigo and hearing loss. The trial enrolled 149...

October 2, 2020

Developments

iBio inks agreement with Safi Biosolutions to develop blood cell therapy products

iBio (NYSE AMERICAN:IBIO) entered into an agreement with Safi Biosolutions to develop growth factors and cytokines using iBio’s FastPharming system. Safi is the cell therapy commercialization partner for a five-year U.S...

October 2, 2020

Developments

Windtree doses first patient in Phase 2 cardiogenic shock study

Windtree Therapeutics (NASDAQCM:WINT) dosed the first patient in its Phase 2 study evaluating istaroxime in patients with early cardiogenic shock due to heart failure. Cardiogenic shock is a condition where the heart...

October 1, 2020

Developments

Athira initiates dosing in Phase 2/3 Alzheimer’s disease study

Athira Pharma (NASDAQ:ATHA) initiated patient dosing in its Phase 2/3 trial evaluating ATH-1017 for the treatment of mild-to-moderate Alzheimer’s disease. ATH-1017 is a small molecule designed to regenerate brain...

October 1, 2020

Developments

Enlivex posts positive COVID-19 results in severe/critical patients

Enlivex Therapeutics (NASDAQ:ENLV) reported positive topline results of an investigator-initiated clinical trial of Allocetra in five COVID-19 patients, three of which were in severe condition and two in critical...

October 1, 2020

Developments

Clarigent Health launches Clairity suicide risk identification app

Closely-held Clarigent Health launched Clairity, an app-based listening tool designed to provide clinical decision support to mental health professionals. Clairity uses AI to analyze speech and identify vocal...

October 1, 2020

Developments

Soleno Therapeutics updates topline data from Phase 3 Prader-Willi Syndrome trial

Soleno Therapeutics (NASDAQ:SLNO) updated topline results from its Phase 3 trial evaluating diazoxide choline controlled-release (DCCR) tablets for the treatment of Prader-Willi Syndrome (PWS). The randomized, double...

September 30, 2020

Developments

Ocular Therapeutix doses first patients in Phase 2 dry eye disease trial

Ocular Therapeutix (NASDAQ:OCUL) dosed the first patients in its Phase 2 trial evaluating OTX-CSI for the treatment of dry eye disease. The trial will enroll some 105 patients who will receive either one of two...

September 29, 2020

Developments

Forte Biosciences doses first patient in Phase 2 atopic dermatitis trial

Forte Biosciences (NASDAQ:FBRX) dosed the first patient in its Phase 2 trial evaluating FB-401 for the treatment of atopic dermatitis. FB-401 is a topical mixture comprised primarily of three strains of the commensal...

September 29, 2020

Developments

Concert completes enrollment in Phase 2 schizophrenia trial

Concert Pharmaceuticals (NASDAQ:CNCE) completed enrollment in its Phase 2 study evaluating CTP-692 as an adjunctive treatment in patients with schizophrenia. The trial enrolled 325 patients already on a stable course...

September 29, 2020

Developments

Field Trip Psychedelics completes GLP synthesis of FT-104

Closely-held Field Trip Psychedelics successfully completed GLP synthesis of its psychedelic molecule, FT-104. FT-104 is a new chemical substance designed to be a commercially viable alternative to naturally derived...

September 29, 2020

Developments

Imagin Medical to host KOL webcast on Oct. 29

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) will host a virtual investor event with key opinion leaders on Oct. 29 at 12:00 pm ET to highlight the potential of the company’s i/Blue...

September 29, 2020

Developments

Soricimed receives $500,000 in Government of Canada funding

Closely-held Soricimed Biopharma received $500,000 in funding from the Government of Canada to support the company’s continued research and development work. The Government of Canada provided the repayable contribution...

September 29, 2020

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

Synthetic Biologics discontinues Phase 2b irritable bowel syndrome trial

Otonomy completes enrollment in Phase 3 Meniere’s disease trial

iBio inks agreement with Safi Biosolutions to develop blood cell therapy products

Windtree doses first patient in Phase 2 cardiogenic shock study

Athira initiates dosing in Phase 2/3 Alzheimer’s disease study

Enlivex posts positive COVID-19 results in severe/critical patients

Clarigent Health launches Clairity suicide risk identification app

Soleno Therapeutics updates topline data from Phase 3 Prader-Willi Syndrome trial

Ocular Therapeutix doses first patients in Phase 2 dry eye disease trial

Forte Biosciences doses first patient in Phase 2 atopic dermatitis trial

Concert completes enrollment in Phase 2 schizophrenia trial

Field Trip Psychedelics completes GLP synthesis of FT-104

Imagin Medical to host KOL webcast on Oct. 29

Soricimed receives $500,000 in Government of Canada funding

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