Abby Hardy, Author at BioTuesdays

Developments

FDA clears Pluristem IND for PLX-PAD in COVID-19-related ARDS

Pluristem Therapeutics (NASDAQ:PSTI) received FDA clearance for an IND application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with intramuscular injections of PLX-PAD. ...

May 8, 2020

Developments

Cytokinetics gets FDA fast track designation for chronic heart failure drug candidate

Cytokinetics (NASDAQ:CYTK) omecamtiv mecarbil received FDA fast track designation for the treatment of chronic heart failure with reduced ejection fraction (HFrEF). Omecamtiv mecarbil is a novel selective cardiac myosin...

May 8, 2020

Developments

Ovid Therapeutics reports positive topline results from Phase 2 Fragile X syndrome study

Ovid Therapeutics (NASDAQ:OVID) reported positive topline results from its Phase 2 trial of OV101 in males with Fragile X syndrome. A total of 23 participants were randomized to receive either 5 mg of OV101 either...

May 7, 2020

Developments

Puma Biotech anti-HER2 breast cancer drug approved in China

Puma Biotech (NASDAQ:PBYI) received approval to market neratinib in China via its licensing partner, CANbridge Pharmaceuticals. Neratinib, marketed as NERLYNX, is an extended adjuvant treatment for early stage HER2...

May 7, 2020

Developments

SetPoint Medical gets FDA investigational device exemption for bioelectronic platform

Closely-held SetPoint Medical received the FDA’s investigational device exemption approval to study the company’s bioelectronic platform in a pivotal trial in patients with rheumatoid arthritis (RA). The company’s...

May 6, 2020

Developments

TG Therapeutics umbralisib and ublituximab meet primary endpoint in Phase 3 leukemia trial

TG Therapeutics (NASDAQ:TGTX) reported positive topline results from its Phase 3 trial in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The trial met its primary endpoint...

May 6, 2020

Developments

Mateon gets FDA rare pediatric disease designation for melanoma drug candidate

Mateon Therapeutics’ (NASDAQ:MATN) CA4P received FDA pediatric disease designation for the treatment of stage 2b-to-4 melanoma due to genetic mutations that disproportionately affect pediatric patients. As a single...

May 6, 2020

Developments

Akebia reports positive topline data from Phase 3 vadadustat studies

Akebia Therapeutics (NASDAQ:AKBA) reported positive topline data from two Phase 3 studies of vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. The first study...

May 6, 2020

Feature

Eyenovia micro-array print therapeutics targeting various ophthalmic indications

Eyenovia (NASDAQ:EYEN) is using its unique microdose drug delivery technology, Optejet, to build a late-stage pipeline of ophthalmic therapeutics. “We have three late-stage programs for three major indications that we...

May 5, 2020

Developments

Aridis Pharma enrolls first COVID-19 patient in ongoing Phase 3 trial

Aridis Pharmaceuticals (NASDAQ:ARDS) enrolled the first COVID-19 patient in its ongoing Phase 3 trial of AR-301 for ventilator-associated pneumonia. Initiated in the first quarter of 2019, the Phase 3 study will assess...

May 4, 2020

Author - Abby Hardy

FDA clears Pluristem IND for PLX-PAD in COVID-19-related ARDS

Cytokinetics gets FDA fast track designation for chronic heart failure drug candidate

Ovid Therapeutics reports positive topline results from Phase 2 Fragile X syndrome study

Puma Biotech anti-HER2 breast cancer drug approved in China

SetPoint Medical gets FDA investigational device exemption for bioelectronic platform

TG Therapeutics umbralisib and ublituximab meet primary endpoint in Phase 3 leukemia trial

Mateon gets FDA rare pediatric disease designation for melanoma drug candidate

Akebia reports positive topline data from Phase 3 vadadustat studies

Eyenovia micro-array print therapeutics targeting various ophthalmic indications

Aridis Pharma enrolls first COVID-19 patient in ongoing Phase 3 trial

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