Abby Hardy, Author at BioTuesdays

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

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

Kane Biotech launches anti-biofilm shampoo at the Global Pet Expo

Kane Biotech (TSX-V:KNE) launched its silkstem anti-itch shampoo at the Global Pet Expo taking place on February 26-28, 2020 in Orlando, Florida. silkstem is a scientifically formulated anti-itch shampoo for dogs and...

February 26, 2020

Developments

FDA approves Baudax Bio’s ANJESO for pain

The FDA approved Baudax Bio’s (NASDAQ:BXRX) ANJESO for the management of moderate-to-severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once-daily COX-2 preferential NSAID that is...

February 21, 2020

Developments

VBL Therapeutics launches Phase 2 metastatic colorectal cancer trial

VBL Therapeutics (NASDAQ:VBLT) launched a Phase 2 trial evaluating VB-111, in combination with nivolumab, for the treatment of metastatic colorectal cancer. VB-111, an adenovirus that carries a transgene for the Fas...

February 20, 2020

Developments

VistaGen reports positive results from Phase 2a major depressive disorder study

VistaGen Therapeutics (NASDAQ:VTGN) reported positive results from its Phase 2a clinical study of PH10 for treatment of major depressive disorder (MDD). PH10 is a synthetic neurosteroid nasal spray designed to activate...

February 20, 2020

Author - Abby Hardy

Omeros reports updated data from pivotal narsoplimab trial

Stealth gets FDA rare pediatric disease designation for elamipretide

Kura Oncology gets second fast track designation for tipifarnib

Karyopharm’s Phase 3 multiple myeloma trial meets primary endpoint

Ra Medical begins patient enrollment in pivotal atherectomy study

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

Kane Biotech launches anti-biofilm shampoo at the Global Pet Expo

FDA approves Baudax Bio’s ANJESO for pain

VBL Therapeutics launches Phase 2 metastatic colorectal cancer trial

VistaGen reports positive results from Phase 2a major depressive disorder study

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