Abby Hardy, Author at BioTuesdays

Developments

Axsome reports positive results from Phase 2 treatment-resistant depression trial

Axsome Therapeutics (NASDAQ:AXSM) reported positive results from its Phase 2 COMET-TRD trial evaluating AXS-05 for the treatment resistant depression (TRD). The trial evaluated 70 patients who had ongoing symptoms of...

December 2, 2020

Developments

Catalyst Biosciences gets FDA fast track designation for hemophilia

Catalyst Biosciences’ (NASDAQ:CBIO) activated marzeptacog alfa, or MarzAA, received FDA fast track designation for the treatment of episodic bleeding in subjects with hemophilia A or B who have developed coagulation...

December 2, 2020

Developments

Hepion reports CRV431 may reduce risk of NASH-associated ischemic stroke

Hepion Pharmaceuticals (NASDAQ:HEPA) reported results from a translational research study in which its lead drug candidate, CRV431, decreased formation of procoagulant platelets. The company noted that patients with...

December 2, 2020

Developments

Aeglea BioTherapeutics gets FDA rare pediatric disease designation for homocystinuria

Aeglea BioTherapeutics’ (NASDAQ:AGLE) ACN00177 received FDA rare pediatric disease designation for the treatment homocystinuria. Homocystinuria is a serious metabolic disorder characterized by elevated plasma...

December 1, 2020

Developments

Bellerophon enrolls first patient in Phase 3 INOpulse study

Bellerophon Therapeutics (NASDAQ:BLPH) enrolled the first patient in its Phase 3 REBUILD study evaluating INOpulse, a pulsed nitric oxide system, for the treatment of fibrotic interstitial lung disease (fILD). The study...

December 1, 2020

Developments

Athira initiates dosing in Phase 2 Alzheimer’s disease study

Athira Pharma (NASDAQ:ATHA) initiated patient dosing in its ACT-AD Phase 2 trial evaluating ATH-1017 in patients with mild-to-moderate Alzheimer’s disease (AD). ATH-1017 is a small molecule designed to regenerate...

December 1, 2020

Developments

Moleculin Biotech gets FDA rare pediatric disease designation for three indications

Moleculin Biotech’s (NASDAQ:MBRX) WP1066 received FDA rare pediatric disease indication for the treatment of diffuse intrinsic pontine glioma (DIPG), medulloblastoma and atypical teratoid rhabdoid tumor. WP1066 is an...

December 1, 2020

Developments

Ovid Therapeutics’ OV101 fails Phase 3 Angelman syndrome trial

Ovid Therapeutics (NASDAQ: OVID) reported that its Phase 3 NEPTUNE trial evaluating OV101 for the treatment of Angelman syndrome failed to meet its primary endpoint. Angelman syndrome is a rare genetic disorder that...

December 1, 2020

Developments

iBio to produce atbtherapeutics’ bioengineered antibody-toxin fusion proteins

iBio (NYSE AMERICAN:IBIO) will use its FastPharming System to produce Belgium-based atbtherapeutics’ bioengineered antibody-toxin fusion proteins. The fusion proteins, called atbodies, are being designed for the...

December 1, 2020

Developments

Profound Medical gets FDA humanitarian device exemption approval for Sonalleve

Profound Medical’s (NASDAQ:PROF; TSX:PRN) Sonalleve received FDA humanitarian device exemption (HDE) approval for the treatment of osteoid osteoma. Osteoid osteoma is a non-cancerous bone tumor that occurs most often in...

November 30, 2020

Author - Abby Hardy

Axsome reports positive results from Phase 2 treatment-resistant depression trial

Catalyst Biosciences gets FDA fast track designation for hemophilia

Hepion reports CRV431 may reduce risk of NASH-associated ischemic stroke

Aeglea BioTherapeutics gets FDA rare pediatric disease designation for homocystinuria

Bellerophon enrolls first patient in Phase 3 INOpulse study

Athira initiates dosing in Phase 2 Alzheimer’s disease study

Moleculin Biotech gets FDA rare pediatric disease designation for three indications

Ovid Therapeutics’ OV101 fails Phase 3 Angelman syndrome trial

iBio to produce atbtherapeutics’ bioengineered antibody-toxin fusion proteins

Profound Medical gets FDA humanitarian device exemption approval for Sonalleve

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