Abby Hardy, Author at BioTuesdays

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

Developments

Esperion presents positive Phase 3 NEXLETOL data

Esperion (NASDAQ: ESPR) presented positive pooled results from four Phase 3 NEXLETOL trials at the virtual American Heart Association scientific sessions. NEXLETOL, or bempedoic acid, is a non-statin, low-density...

November 13, 2020

Developments

Albireo Pharma presents positive Phase 3 odevixibat data

Albireo Pharma (NASDAQ:ALBO) presented positive results from two Phase 3 trials of odevixibat at the American Association for the Study of Liver Diseases meeting. Odevixibat is an ileal bile acid transport inhibitor...

November 13, 2020

Developments

Annexon initiates Phase 2 Huntington’s disease trial

Annexon (NASDAQ:ANNX) launched a Phase 2 trial evaluating ANX005 for the treatment of Huntington’s disease. ANX005 is a monoclonal antibody designed to inhibit the complement protein, C1q. “Huntington’s disease is a...

November 13, 2020

Developments

Hepion to present positive CRV431 findings at liver conference

Hepion Pharmaceuticals (NASDAQ:HEPA) will present positive findings from an expanded study of CRV431 at The Liver Meeting Digital Experience 2020 on Nov. 13. The poster presentation will review a study in which...

November 12, 2020

Developments

Surface Oncology gets FDA fast track designation for hepatocellular carcinoma

Surface Oncology’s (NASDAQ:SURF) SRF388 received FDA fast track designation for the treatment of hepatocellular carcinoma in patients who have previously been treated with standard therapies. SRF388 is a fully human...

November 11, 2020

Developments

Lineage Cell Therapeutics completes enrollment in Phase 1/2a dry AMD trial

Lineage Cell Therapeutics (NASDAQ:LCTX) completed enrollment in its Phase 1/2a trial evaluating OpRegen for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy. OpRegen is injected into...

November 11, 2020

Author - Abby Hardy

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

Esperion presents positive Phase 3 NEXLETOL data

Albireo Pharma presents positive Phase 3 odevixibat data

Annexon initiates Phase 2 Huntington’s disease trial

Hepion to present positive CRV431 findings at liver conference

Surface Oncology gets FDA fast track designation for hepatocellular carcinoma

Lineage Cell Therapeutics completes enrollment in Phase 1/2a dry AMD trial

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