Category - Developments

Developments

FDA clears Neuronetics TouchStar protocol for major depressive disorder

The FDA cleared Neuronetics’ (NASDQ:STIM) TouchStar protocol for the treatment of major depressive disorder. TouchStar is a three-minute intermittent theta burst protocol administered using the company’s NeuroStar...

November 24, 2020

Developments

Capricor initiates dosing in Phase 2 COVID-19 trial

Capricor Therapeutics (NASDAQ:CAPR) dosed the first two patients in its Phase 2 trial evaluating CAP-1002 for the treatment of severe COVID-19. CAP-1002 is an intravenously delivered allogeneic cardiac cell therapy...

November 24, 2020

Developments

Oramed initiates Phase 3 oral insulin trials

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) began screening patients for its two Phase 3 trials evaluating ORMD-0801 for the treatment of Type 2 diabetes. The trials will enroll a total of 1,125 Type 2 diabetes patients...

November 24, 2020

Developments

PolyPid D-PLEX100 gets FDA breakthrough therapy designation

The FDA granted PolyPid’s (NASDAQ:PYPD) D-PLEX100 breakthrough therapy designation for the prevention of surgical site infections in patients undergoing colorectal surgery. D-PLEX100 is designed to provide prolonged...

November 24, 2020

Developments

FDA clears Orchard Therapeutics IND for OTL-200

The FDA cleared Orchard Therapeutics’ (NASDAQ:ORTX) IND for OTL-200, a stem cell-based gene therapy for the treatment of metachromatic leukodystrophy (MLD). MLD is caused by a mutation in the arylsulfatase-A gene, which...

November 23, 2020

Developments

FDA approves Eiger’s Zokinvy for progeria

The FDA approved Eiger BioPharmaceuticals’ (NASDAQ:EIGR) Zokinvy for the treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies. Progeria is an extremely rare and fatal disease caused by a...

November 23, 2020

Developments

Seelos Therapeutics SLS-005 gets FDA orphan drug designation for ALS

Seelos Therapeutics’ (NASDAQ:SEEL) SLS-005 (trehalose) received FDA orphan drug designation for the treatment of amyotrophic lateral sclerosis (ALS). Trehalose is a low molecular weight disaccharide that crosses the...

November 19, 2020

Developments

Kintara Therapeutics reports interim data from two Phase 2 trials of VAL-083

Kintara Therapeutics (NASDAQ:KTRA) reported interim data from two Phase 2 trials evaluating VAL-083 for the treatment of glioblastoma multiforme (GBM). In the first Phase 2 study, newly diagnosed patients receiving VAL...

November 19, 2020

Developments

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

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

November 19, 2020

Developments

DSMB approves continuation of Hepion’s Phase 2a NASH trial

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that an independent data safety monitoring board (DSMB) approved the continuation of the company’s Phase 2a ‘AMBITION’ clinical trial to the next dose level cohort. After...

November 18, 2020

Category - Developments

FDA clears Neuronetics TouchStar protocol for major depressive disorder

Capricor initiates dosing in Phase 2 COVID-19 trial

Oramed initiates Phase 3 oral insulin trials

PolyPid D-PLEX100 gets FDA breakthrough therapy designation

FDA clears Orchard Therapeutics IND for OTL-200

FDA approves Eiger’s Zokinvy for progeria

Seelos Therapeutics SLS-005 gets FDA orphan drug designation for ALS

Kintara Therapeutics reports interim data from two Phase 2 trials of VAL-083

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

DSMB approves continuation of Hepion’s Phase 2a NASH trial

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