Category - Developments

Developments

Salarius adds two clinical sites to seclidemstat trial in Ewing Sarcoma

Salarius Pharmaceuticals (NASDAQ:SLRX) added Memorial Sloan Kettering Cancer Center in New York City and Nationwide Children’s Hospital in Columbus, OH as clinical trial sites in its ongoing Phase 1/2 clinical trial of...

October 8, 2019

Developments

Ritter Pharma engages AGP to explore strategic alternatives

Ritter Pharmaceuticals (NASDAQ:RTTR) has engaged Alliance Global Partners as a financial advisor to help the company evaluate strategic alternatives. The company is considering a variety of options, including an...

October 7, 2019

Developments

BriaCell doses first patient in advanced breast cancer combination study

BriaCell Therapeutics (TSXV:BCT; OTCQB:BCTXF)initiated dosing in a Phase 1/2a clinical study of its lead product candidate, Bria-IMT, in combination with Incyte’s INCMGA00012 and epacadostat in patients with advanced...

October 7, 2019

Developments

Ra Pharma doses first patient in pivotal Phase 3 myasthenia gravis study

Ra Pharmaceuticals (NASDAQ:RARX) dosed the first patient in its RAISE study, a pivotal Phase 3 clinical trial evaluating zilucoplan for the treatment of generalized myasthenia gravis (gMG). gMG is a chronic autoimmune...

October 2, 2019

Developments

ArQule doses first patient in registrational trial of miransertib

ArQule (NASDAQ:ARQL) dosed the first patient in its MOSAIC trial evaluating miransertib for the treatment of Proteus syndrome (PS) and phosphoinositide 3 kinase (PIK3CA)-related overgrowth spectrum disorders (PROS). PS...

October 2, 2019

Developments

FDA rejects Savara’s Molgradex for autoimmune pulmonary alveolar proteinosis

Following a Type C FDA meeting, Savara (NASDAQ:SVRA) reported that the agency did not recommend it submit a biologics license application (BLA) for Molgradex for the treatment of autoimmune pulmonary alveolar...

October 2, 2019

Developments

LumiThera enrolls first patient in U.S. multi-center trial in dry AMD

Closely-held LumiThera enrolled the first patient in its multi-center U.S. clinical trial in patients with dry age-related macular degeneration (AMD). The study, called LIGHTSITE III, will evaluate LumiThera’s Valeda...

October 1, 2019

Developments

FDA clears Ziopharm Oncology IND for CAR-T therapy

The FDA has cleared Ziopharm Oncology’s (NASDAQ:ZIOP) IND for CD19-specific CAR-T for the treatment of relapsed CD19+ leukemias and lymphomas. The drug candidate is based on Ziopharm’s non-viral T cell modification...

October 1, 2019

Developments

Catabasis Pharma exceeds target enrollment for global Phase 3 DMD trial

Catabasis Pharmaceuticals (NASDAQ:CATB) completed enrollment for its Phase 3 trial of edasalonexent for the treatment Duchenne muscular dystrophy (DMD). Taking place at 40 clinical sites in eight countries, the trial...

October 1, 2019

Developments

Heron resubmits NDA for postoperative pain drug

Heron Therapeutics (NASDAQ:HRTX) resubmitted its NDA for HTX-011 – a dual-acting combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug, meloxicam – to the FDA. The resubmission was...

October 1, 2019

Category - Developments

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