Category - Developments

Developments

AVITA enrolls first patient in pivotal vitiligo trial

AVITA Therapeutics (NASDAQ:RCEL) initiated a pivotal study evaluating its RECELL system for the treatment of vitiligo, an autoimmune disease that causes loss of color or pigmentation in the skin. The study will assess...

September 14, 2020

Developments

Hepion CRV431 featured on The Bio Report podcast

The Bio Report podcast featured Hepion Pharmaceuticals’ (NASDAQ:HEPA) CRV431 for the treatment of non-alcoholic steatohepatitis (NASH), and potentially, COVID-19. “We’ve kicked off our Phase 2 trial in NASH...

September 11, 2020

Developments

VBL Therapeutics enrolls first patients in Phase 2 metastatic colorectal cancer trial

VBL Therapeutics (NASDAQ:VBLT) enrolled the first two patients in its Phase 2 trial evaluating VB-111, in combination with nivolumab, for the treatment of metastatic colorectal cancer. VB-111 is an adenovirus that...

September 10, 2020

Developments

Satsuma Pharma STS101 fails Phase 3 migraine trial

Satsuma Pharmaceuticals (NASDAQ:STSA) reported disappointing topline results from its Phase 3 trial of STS101 for the acute treatment of migraine. STS101 is a drug-device combination of dihydroergotamine mesylate (DHE)...

September 10, 2020

Developments

Precision BioSciences gets FDA fast track designation for second allogeneic CAR-T cell therapy

Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR269A, received FDA fast track designation for the treatment of relapsed/refractory multiple myeloma. PBCAR269A...

September 9, 2020

Developments

Spero Therapeutics reports positive topline results from Phase 3 UTI and acute pyelonephritis trial

Spero Therapeutics (NASDAQ:SPRO) reported topline results from its Phase 3 ADAPT-PO trial evaluating tebipenem HBr for the treatment of complicated urinary tract infection (UTI) and acute pyelonephritis. Hospitalized...

September 8, 2020

Developments

Strongbridge Biopharma reports positive topline data from Phase 3 Cushing’s syndrome trial

Strongbridge Biopharma (NASDAQ:SBBP) reported topline data from its Phase 3 LOGICS trial evaluating RECORLEV for the treatment of endogenous Cushing’s syndrome. The study enrolled 44 patients to supplement the long-term...

September 8, 2020

Developments

Hepion completes dosing in Phase 1b multiple ascending dose study of CRV431

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that dosing has now been completed in all subjects enrolled in the Phase 1b multiple ascending dose (MAD) study of CRV431. The open-label MAD study was designed to assess...

September 1, 2020

Developments

Durect presents data from Phase 2a alcoholic hepatitis trial

Durect (NASDAQ:DRRX) reported data from its Phase 2a trial evaluating DUR-928 for the treatment of alcoholic hepatitis at the liver congress. The dose escalation trial evaluated doses of 30 mg, 90 mg, or 150 mg of DUR...

August 27, 2020

Developments

Applied Molecular Transport doses first patient in Phase 2 ulcerative colitis trial

Applied Molecular Transport (NASDAQ:AMTI) initiated its Phase 2a trial evaluating AMT-101 for the treatment of ulcerative colitis. The trial will enrol some 100 patients with moderate-to-severely active ulcerative...

August 27, 2020

Category - Developments

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