Abby Hardy, Author at BioTuesdays

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

Developments

9 Meters doses first patients in Phase 1b/2a short bowel syndrome trial

9 Meters Biopharma (NASDAQ:NMTR) dosed the first patients in its Phase 1b/2a clinical trial evaluating NM-002 for the treatment of short bowel syndrome. Short bowel syndrome is a rare, life-threatening disease caused by...

July 21, 2020

Developments

Cerecor enrolls first patient in COVID-19 trial

Cerecor (NASDAQ:CERC) enrolled the first patient in its a proof-of-concept trial evaluating CERC-002 in patients with COVID-19 cytokine storm-induced acute respiratory distress syndrome (ARDS). CERC-002 is a...

July 21, 2020

Developments

Lexicon sotagliflozin meets primary endpoint in four Phase 3 studies

Lexicon Pharmaceuticals (NASDAQ:LXRX) reported topline data from four Phase 3 studies, each of which demonstrated that sotagliflozin significantly reduced A1C levels in patients with Type 2 diabetes (T2D). Sotagliflozin...

July 21, 2020

Executive Moves

Rhythm Pharma appoints Dr. David Meeker as CEO

David Meeker Rhythm Pharmaceuticals (NASDAQ:RYTM) appointed its chairman, Dr. David Meeker as CEO, effective immediately. Dr. Meeker replaces interim president and CEO, Hunter Smith, who will continue in his role as CFO...

July 20, 2020

Developments

BioXcel BXCL501 meets primary and secondary endpoints in two Phase 3 trials

BioXcel Therapeutics’ (NASDAQ:BTAI) BXCL501, a dexmedetomidine sublingual thin film, met its primary and secondary endpoints in two Phase 3 trials in patients with schizophrenia and bipolar disorders. In the SERENITY I...

July 20, 2020

Developments

Denovo Biopharma DB102 gets FDA fast track designation for glioblastoma

Closely-held Denovo Biopharma’s DB102 received FDA fast track designation for the treatment of patients with newly-diagnosed glioblastoma. DB102, or enzastaurin, is a small molecule, serine/threonine kinase inhibitor...

July 17, 2020

Author - Abby Hardy

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

9 Meters doses first patients in Phase 1b/2a short bowel syndrome trial

Cerecor enrolls first patient in COVID-19 trial

Lexicon sotagliflozin meets primary endpoint in four Phase 3 studies

Rhythm Pharma appoints Dr. David Meeker as CEO

BioXcel BXCL501 meets primary and secondary endpoints in two Phase 3 trials

Denovo Biopharma DB102 gets FDA fast track designation for glioblastoma

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