Abby Hardy, Author at BioTuesdays

Developments

Lexicon Pharmaceuticals’ reports topline Phase 3 data for Type 2 diabetes drug

Lexicon Pharmaceuticals (NASDAQ:LXRX) reported topline data from its Phase 3 study of sotagliflozin for the treatment of Type 2 diabetes (T2D). Sotagliflozin is an oral dual inhibitor of sodium-glucose co-transporter...

December 20, 2019

Developments

Aravive begins enrollment for Phase 2a kidney fibrosis trial

Aravive (NASDAQ:ARAV) has begun enrolling patients in its Phase 2a clinical trial of AVB-500 in patients with kidney fibrosis, specifically immunoglobulin A nephropathy (IgAN). IgAN occurs when an antibody called...

December 20, 2019

Developments

Arrowhead Pharma doses first patient in Phase 2 alpha-1 liver disease trial

Arrowhead Pharma (NASDAQ:ARWR) dosed the first patient in its Phase 2 clinical study of ARO-AAT for the treatment of alpha-1 antitrypsin deficiency (AATD)-associated liver disease. AATD is a rare genetic disorder where...

December 20, 2019

Developments

Concert Pharmaceuticals completes alopecia areata trial

Concert Pharmaceuticals (NASDAQ:CNCE) completed its open-label trial comparing once-daily versus twice-daily dosing of CTP-543 in alopecia areata patients. Alopecia areata is an autoimmune disease that causes partial or...

December 20, 2019

Developments

Selecta completes enrollment in Phase 2 chronic refractory gout trial

Selecta Biosciences (NASDAQ:SELB) completed enrollment in its Phase 2 COMPARE trial of SEL-212 for the treatment of chronic refractory gout. SEL-212 is designed to sustain control of serum uric acid (SUA) levels in...

December 19, 2019

Developments

Aldeyra enrolls first patient in Phase 3 vitreoretinopathy trial

Aldeyra Therapeutics (NASDAQ:ALDX) enrolled the first patient in its Phase 3 GUARD trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). PVR is an inflammatory disorder of the retina that leads...

December 19, 2019

Developments

MacroGenics submits margetuximab BLA to the FDA

MacroGenics (NASDAQ:MGNX) submitted a biologics license application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer. The submission is based on the safety and efficacy...

December 19, 2019

Developments

Opsens gets FDA clearance to market diastolic pressure algorithm

Opsens (TSX:OPS; OTCQX:OPSSF) received 510(k) clearance from the FDA to market its diastolic pressure ratio (dPR) algorithm. The algorithm is designed to be used with Opsens’ OptoWire, a coronary guide wire used for...

December 19, 2019

Developments

Kane Biotech fulfills first major animal oral care product order from China

Kane Biotech (TSX-V:KNE) fulfilled its first major order, for $125,000 in bluestem pet oral care products, to its exclusive Chinese distribution partner, Eetoys Pet Products. Kane announced the exclusive distribution...

December 17, 2019

Developments

Avadel Pharma completes enrollment in Phase 3 narcolepsy trial

Avadel Pharmaceuticals (NASDAQ:AVDL) completed enrollment in its pivotal trial assessing FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy. The Phase 3 study, called REST-ON, enrolled 212...

December 17, 2019

Author - Abby Hardy

Lexicon Pharmaceuticals’ reports topline Phase 3 data for Type 2 diabetes drug

Aravive begins enrollment for Phase 2a kidney fibrosis trial

Arrowhead Pharma doses first patient in Phase 2 alpha-1 liver disease trial

Concert Pharmaceuticals completes alopecia areata trial

Selecta completes enrollment in Phase 2 chronic refractory gout trial

Aldeyra enrolls first patient in Phase 3 vitreoretinopathy trial

MacroGenics submits margetuximab BLA to the FDA

Opsens gets FDA clearance to market diastolic pressure algorithm

Kane Biotech fulfills first major animal oral care product order from China

Avadel Pharma completes enrollment in Phase 3 narcolepsy trial

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