Abby Hardy, Author at BioTuesdays

Developments

Selecta gets FDA rare pediatric disease designation for methylmalonic acidemia gene therapy

Selecta Biosciences’ (NASDAQ:SELB) MMA-101 received FDA orphan drug designation for the treatment of methylmalonic acidemia (MMA). MMA is caused by a mutation in the methylmalonyl-CoA mutase gene, which results in the...

November 19, 2020

Developments

DSMB approves continuation of Hepion’s Phase 2a NASH trial

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that an independent data safety monitoring board (DSMB) approved the continuation of the company’s Phase 2a ‘AMBITION’ clinical trial to the next dose level cohort. After...

November 18, 2020

Developments

Kazia presents positive interim data from Phase 2 glioblastoma trial

At the Society for Neuro-Oncology annual meeting, Kazia Therapeutics (NASDAQ:KZIA) presented positive interim data from its Phase 2 trial evaluating paxalisib for the treatment of diffuse intrinsic pontine glioma...

November 18, 2020

Developments

Milestone Pharma enrolls first patient in Phase 3 etripamil trial

Milestone Pharmaceuticals (NASDAQ:MIST) enrolled the first patient in its Phase 3 RAPID trial evaluating etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). PSVT is characterized by...

November 18, 2020

Developments

Chiasma reports positive topline results from Phase 3 acromegaly trial

Chiasma (NASDAQ:CHMA) reported positive topline results from its Phase 3 trial evaluating MYCAPSSA for the treatment of acromegaly. Designed to support a planned marketing authorization application in the EU, the non...

November 18, 2020

Developments

Synthetic Biologics engages AGP to explore strategic alternatives

Synthetic Biologics (NYSE American:SYN) engaged Alliance Global Partners as an advisor to help the company evaluate strategic alternatives. The company is considering a variety of options, including an acquisition...

November 17, 2020

Developments

BrainStorm NurOwn flunks Phase 3 ALS trial

BrainStorm Cell Therapeutics’ (NASDAQ:BCLI) NurOwn failed to meet its primary and secondary endpoints in a Phase 3 amyotrophic lateral sclerosis (ALS) trial. NurOwn consists of mesenchymal stromal cells (MSCs) that have...

November 17, 2020

Developments

PharmaJet partners with Diomics to detect SARS-CoV-2 immune response

Closely-held PharmaJet’s needle-free injection system will be used to deliver Diomics’ Diocheck SARS-CoV-2 visual immune response indicator. Diomics’ immune response indicator will be injected under the skin using...

November 17, 2020

Developments

Adamis Pharma gets second CRL for ZIMHI

Adamis Pharmaceuticals (NASDAQ:ADMP) received a second complete response letter (CRL) from the FDA regarding its ZIMHI high dose naloxone injection product for the treatment of opioid overdose. The FDA issued its first...

November 16, 2020

Developments

Cytokinetics reports mixed results from Phase 3 heart failure trial

Cytokinetics (NASDAQ:CYTK) reported primary results from its Phase 3 GALACTIC-HF trial evaluating omecamtiv mecarbil for the treatment of heart failure. Omecamtiv mecarbil is a novel selective cardiac myosin activator...

November 13, 2020

Author - Abby Hardy

Selecta gets FDA rare pediatric disease designation for methylmalonic acidemia gene therapy

DSMB approves continuation of Hepion’s Phase 2a NASH trial

Kazia presents positive interim data from Phase 2 glioblastoma trial

Milestone Pharma enrolls first patient in Phase 3 etripamil trial

Chiasma reports positive topline results from Phase 3 acromegaly trial

Synthetic Biologics engages AGP to explore strategic alternatives

BrainStorm NurOwn flunks Phase 3 ALS trial

PharmaJet partners with Diomics to detect SARS-CoV-2 immune response

Adamis Pharma gets second CRL for ZIMHI

Cytokinetics reports mixed results from Phase 3 heart failure trial

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