Category - Developments

Developments

Krystal Biotech initiates Phase 3 dystrophic epidermolysis bullosa trial

Krystal Biotech (NASDAQ:KRYS) initiated a Phase 3 clinical trial evaluating beremagene geperpavec (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB). DEB is a rare and severe monogenic skin disease with...

July 29, 2020

Developments

Regulus gets FDA orphan drug designation for polycystic kidney disease

Regulus Therapeutics’ (NASDAQ:RGLS) RGLS4236 received FDA orphan drug designation for the treatment of autosomal dominant polycystic kidney disease (ADPKD). ADPKD is caused by mutations in the PKD1 or PKD2 genes, and is...

July 29, 2020

Developments

Nabriva XENLETA gets European approval for community-acquired pneumonia

The EMA approved Nabriva Therapeutics’ (NASDAQ:NBRV) XENLETA for the treatment of community-acquired pneumonia. The approval is based on efficacy data from two Phase 3 clinical trials, both of which established XENLETA...

July 28, 2020

Developments

Protara gets FDA rare pediatric disease designation for lymphatic malformation

Protara Therapeutics’ (NASDAQ:TARA) TARA-002 received FDA rare pediatric disease designation for the treatment of lymphatic malformation. Lymphatic malformations are rare, typically congenital and result in the failure...

July 28, 2020

Developments

Celsion randomizes first patients in Phase 1/2 ovarian cancer study

Celsion (NASDAQ:CLSN) randomized the first two patients in the Phase 2 portion of its Phase 1/2 study evaluating GEN-1 for the treatment of advanced ovarian cancer. GEN-1 is an interleukin-12 DNA plasmid vector...

July 27, 2020

Developments

Immunic reports first patients enrolled in Phase 2 COVID-19 trial

The first patients have been enrolled in an investigator-sponsored Phase 2 study evaluating Immunic Therapeutics‘ (NASDAQ:IMUX) IMU-838 for the treatment of COVID-19. IMU-838 is a selective immune modulator that...

July 27, 2020

Developments

PolarityTE reports positive topline data from diabetic foot ulcer trial

PolarityTE (NASDAQ:PTE) reported positive topline results from its trial evaluating SkinTE for the treatment of diabetic foot ulcers. SkinTE is a human cellular and tissue-based product derived from a patient’s own skin...

July 24, 2020

Developments

miRagen cobomarsen gets FDA orphan drug designation for T-cell lymphoma

miRagen Therapeutics’ (NASDAQ:MGEN) cobomarsen was granted FDA orphan drug designation for the treatment of T-cell lymphoma. Cobomarsen, an inhibitor of microRNA-155, is being evaluated in a Phase 1 and Phase 2 trial...

July 24, 2020

Developments

AxoGen completes target enrollment in Phase 3 nerve graft study

AxoGen (NASDAQ:AXGN) completed target enrollment of 220 subjects in its Phase 3 RECON study evaluating its Avance nerve graft in digital nerve injuries. The study will compare AxoGen’s Avance nerve graft with...

July 22, 2020

Developments

FDA accepts Aurinia NDA for voclosporin; agrees to priority review

The FDA accepted for priority review Aurinia Pharmaceuticals’ (NASDAQ:AUPH; TSX:AUP) NDA for voclosporin for the treatment of lupus nephritis (LN). The NDA for voclosporin is based on the Phase 3 AURORA and Phase 2 AURA...

July 22, 2020

Category - Developments

Krystal Biotech initiates Phase 3 dystrophic epidermolysis bullosa trial

Regulus gets FDA orphan drug designation for polycystic kidney disease

Nabriva XENLETA gets European approval for community-acquired pneumonia

Protara gets FDA rare pediatric disease designation for lymphatic malformation

Celsion randomizes first patients in Phase 1/2 ovarian cancer study

Immunic reports first patients enrolled in Phase 2 COVID-19 trial

PolarityTE reports positive topline data from diabetic foot ulcer trial

miRagen cobomarsen gets FDA orphan drug designation for T-cell lymphoma

AxoGen completes target enrollment in Phase 3 nerve graft study

FDA accepts Aurinia NDA for voclosporin; agrees to priority review

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