Category - Developments

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

Developments

IntelGenx, Exeltis expand RIZAPORT commercialization pact to include the EU

IntelGenx (TSXV:IGX; OTCQB:IGXT) granted its partner, Exeltis Healthcare, an exclusive license to manufacture and commercialize RIZAPORT in the EU. Under the accord, Exeltis will pay IntelGenx royalties on net RIZAPORT...

August 27, 2020

Developments

Hepion to present CRV431 preclinical data at liver congress

Hepion Pharmaceuticals (NASDAQ:HEPA) will present a poster on CRV431’s antifibrotic activity at the Digital International Liver Congress 2020, taking place from Aug. 27-29. Dr. Joseph Kuo will present a preclinical...

August 27, 2020

Developments

Outlook Therapeutics reports topline results from Phase 2 wet AMD trial

Outlook Therapeutics (NASDAQ:OTLK) reported topline results from its Phase 2 NORSE 1 trial evaluating ONS-5010 for the treatment of wet age-related macular degeneration (AMD). The study, whose primary endpoint is the...

August 26, 2020

Developments

Ovid Therapeutics soticlestat meets primary endpoint in Phase 2 epilepsy trial

Ovid Therapeutics (NASDAQ:OVID) reported positive topline results from its Phase 2 study evaluating soticlestat in children with Dravet syndrome or Lennox-Gastaut syndrome, two highly refractory epilepsy syndromes...

August 25, 2020

Category - Developments

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

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

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

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

Durect presents data from Phase 2a alcoholic hepatitis trial

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

IntelGenx, Exeltis expand RIZAPORT commercialization pact to include the EU

Hepion to present CRV431 preclinical data at liver congress

Outlook Therapeutics reports topline results from Phase 2 wet AMD trial

Ovid Therapeutics soticlestat meets primary endpoint in Phase 2 epilepsy trial

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