Category - Developments

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

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

Kane Biotech signs first U.S. distribution agreement with King Wholesale

Kane Biotech (TSXV:KNE) signed an agreement with King Wholesale, a California-based distributor of wholesale pet supplies. Under the accord, King will distribute Kane’s bluestem oral care and silkstem anti-itch shampoo...

February 25, 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

Category - Developments

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