Category - Developments

Developments

Catalyst Biosciences reports positive Phase 2b data from hemophilia trial

Catalyst Biosciences (NASDAQ:CBIO) reported positive results from its Phase 2b trial of DalcA, a subcutaneously administered Factor IX (FIX) therapy for the treatment of hemophilia B. The study was designed to evaluate...

February 7, 2020

Developments

Soricimed reports first cohort completion in Phase 1b trial of SOR-C13

Closely-held Soricimed Biopharma reported that the MD Anderson Cancer Center completed the first cohort in its investigator-initiated trial of Soricimed’s SOR-C13. The trial, launched in September 2019, is building on...

February 7, 2020

Developments

FDA clears Kleo Pharma IND for multiple myeloma study

Closely-held Kleo Pharmaceuticals received FDA clearance of its IND to initiate a safety and tolerability clinical study, combining its KP1237, a CD38-targeting antibody recruiting molecule, with patients’ own...

February 6, 2020

Developments

Profound Medical retires bank debt ahead of schedule

Profound Medical (TSX:PRN; NASDAQ:PROF) retired its $12.5-million in principal amount loan with Canadian Imperial Bank of Commerce, maturing July 29, 2022. “We are pleased to have repaid the CIBC loan almost 30 months...

February 5, 2020

Developments

Hepion elucidates CRV431’s mechanism of action in NASH

Hepion Pharmaceuticals (NASDAQ:HEPA) released a video illustrating CRV431’s mechanism of action in non-alcoholic steatohepatitis (NASH). CRV431 inhibits multiple forms of cyclophilins to impact multiple stages of NASH...

February 4, 2020

Developments

Anavex gets fast track designation for Rett Syndrome drug candidate

The FDA granted fast track designation to Anavex Life Sciences’ (NASDAQ:AVXL) ANAVEX2-73 for the treatment of Rett syndrome. Rett syndrome is a genetic neurodevelopmental disorder characterized by severe physical and...

February 3, 2020

Developments

Mesoblast submits completed BLA for Ryoncil to FDA

Mesoblast (NASDAQ:MESO; ASX:MSB) submitted its completed biologics license application (BLA) to the FDA for Ryoncil, its lead allogeneic cell therapy for the treatment of children with steroid-refractory acute graft...

February 3, 2020

Developments

Histogen and Allergan expand cell conditioned media skin care partnership

Allergan (NYSE:AGN) expanded its partnership with closely-held Histogen to include exclusive rights to incorporate and commercialize Histogen’s cell conditioned media (CCM) in microdermabrasion therapies along...

January 31, 2020

Developments

Aprea Therapeutics gets breakthrough therapy designation for myelodysplastic syndrome treatment

Aprea Therapeutics (NASDAQ:APRE) received FDA breakthrough designation for APR-246, in combination with azacytidine, for the treatment of myelodysplastic syndromes (MDS) with a susceptible tumor suppressor protein p53...

January 30, 2020

Developments

Pulmatrix gets fast track designation for Pulmazole

Pulmatrix (NASDAQ:PULM) received FDA fast track designation for Pulmazole, an inhaled itraconazole antifungal for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The safety...

January 30, 2020

Category - Developments

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