Category - Developments

Developments

Neuronetics gets FDA breakthrough device designation for NeuroStar

Neuronetics (NASDQ:STIM) received FDA breakthrough device designation for its NeuroStar Advanced Therapy System for the treatment of bipolar depression. Neurostar is a transcranial magnetic stimulation device that...

March 6, 2020

Developments

FDA clears Stereotaxis Genesis robotic magnetic navigation system

Stereotaxis (NYSE:STXS) received FDA 510(k) clearance of the Genesis RMN System for the robotic navigation of magnetic ablation catheters to treat heart rhythm disorders. “Genesis is a leap forward in robotic magnetic...

March 6, 2020

Developments

Omeros reports updated data from pivotal narsoplimab trial

Omeros (NASDAQ:OMER) reported updated data from its pivotal clinical trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. All 28 patients have completed...

March 3, 2020

Developments

Stealth gets FDA rare pediatric disease designation for elamipretide

Stealth BioTherapeutics’ (NASDAQ:MITO) elamipretide received FDA rare pediatric disease designation for the treatment of Barth syndrome. Barth syndrome is a very rare genetic condition characterized by cardiac...

March 3, 2020

Developments

Kura Oncology gets second fast track designation for tipifarnib

The FDA granted fast track designation to Kura Oncology’s (NASDAQ:KURA) tipifarnib for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma and nodal...

March 3, 2020

Developments

Ocugen genetic modifier for retinitis pigmentosa published in Nature Gene Therapy

Peer-reviewed, Nature Gene Therapy, published Ocugen’s (NASDAQ:OCGN) preclinical data of nuclear hormone receptor gene, NR2E3, as a genetic modifier and therapeutic agent to treat multiple retinal degenerative diseases...

March 3, 2020

Developments

Karyopharm’s Phase 3 multiple myeloma trial meets primary endpoint

Karyopharm Therapeutics (NASDAQ:KPTI) reported positive topline results from its Phase 3 BOSTON study in patients with multiple myeloma who have received one-to-three prior lines of therapy. The study evaluated once...

March 2, 2020

Developments

Ra Medical begins patient enrollment in pivotal atherectomy study

Ra Medical Systems (NASDAQ:RMED) enrolled the first patient in its pivotal study of the DABRA excimer laser system for the treatment of peripheral vascular stenoses. DABRA is an atherectomy device that uses...

February 27, 2020

Developments

SELLAS reports positive follow-up data from Phase 1/2 acute myeloid leukemia trial

SELLAS Life Sciences (NASDAQ:SLS) reported final follow-up data from its Phase 1/2 study of galinpepimut-S in patients with acute myeloid leukemia (AML) in second complete remission. The data demonstrate a median...

February 26, 2020

Developments

Oramed posts positive results in final cohort of Phase 2b oral insulin trial

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) reported positive topline data from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, at lower...

February 26, 2020

Category - Developments

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