Category - Developments

Developments

Leap Therapeutics DKN-01 gets FDA fast track designation for gastric and gastroesophageal junction cancer

The FDA granted Leap Therapeutics’ (NASDAQ:LPTX) DKN-01 fast track designation for gastric and gastroesophageal junction cancer. Specifically, the designation was granted for patients whose tumors express high Dickkopf...

September 24, 2020

Developments

Mereo setrusumab gets FDA rare pediatric disease designation for osteogenesis imperfecta

The FDA granted Mereo BioPharma’s (NASDAQ:MREO) setrusumab rare pediatric disease designation for the treatment of osteogenesis imperfecta (OI). OI, also known as brittle bone disease, is caused by a genetic mutation in...

September 24, 2020

Developments

Applied Therapeutics AT-007 gets FDA rare pediatric disease and orphan drug designations

The FDA granted Applied Therapeutics’ (NASDAQ:APLT) AT-007 rare pediatric disease and orphan drug designations for the treatment of PMM2-congenital disorder of glycosylation (PMM2-CDG). PMM2-CDG is a rare disease caused...

September 24, 2020

Developments

Calithera treats first patient in Phase 2 non-small cell lung cancer trial

Calithera Biosciences (NASDAQ:CALA) treated the first non-small cell lung cancer (NSCLC) patient in its Phase 2 trial evaluating telaglenastat, a glutaminase inhibitor. The trial will enroll some 120 patients with stage...

September 24, 2020

Developments

AC Immune semorinemab fails Phase 2 Alzheimer’s disease trial

AC Immune (NASDAQ:ACIU) reported disappointing topline results from a Phase 2 trial evaluating semorinemab for the treatment of early Alzheimer’s disease (AD). Semorinemab, an anti-tau antibody, did not meet its primary...

September 23, 2020

Developments

Precipio launches HemeScreen AML

Precipio (NASDAQ:PRPO) launched its HemeScreen acute myeloid leukemia (AML) panel, which tests for the presence of mutations in certain genes to help develop a treatment plan for patients. The company noted that AML...

September 22, 2020

Developments

Crinetics gets FDA rare pediatric disease designation for congenital hyperinsulinism

The FDA granted Crinetics Pharmaceuticals’ (NASDAQ:CRNX) CRN04777 rare pediatric disease designation for the treatment of congenital hyperinsulinism. Congenital hyperinsulinism occurs when infants are born with life...

September 21, 2020

Developments

FDA clears Acutus’ AcQMap catheter

The FDA cleared Acutus Medical’s (NASDAQ:AFIB) AcQMap, a 3D mapping and navigation catheter designed to be inserted into the left and right atrium. In addition to cardiac activation mapping, the AcQMap catheter can...

September 17, 2020

Developments

Zynerba Pharma Zygel gets FDA orphan drug designation for 22q deletion syndrome

Zynerba Pharma’s (NASDAQ:ZYNE) Zygel was granted FDA orphan drug designation for the treatment of 22q11.2 deletion syndrome. Also known as DiGeorge syndrome, 22q11.2 deletion syndrome is caused by a deletion of a small...

September 17, 2020

Developments

Hepion CRV431 shows positive activity against SARS-CoV-2 in NIAID study

Hepion Pharmaceuticals’ (NASDAQ:HEPA) CRV431 demonstrated positive activity against SARS-CoV-2 in a preclinical study conducted at the National Institute of Allergy and Infectious Diseases (NIAID). Conducted under...

September 17, 2020

Category - Developments

Leap Therapeutics DKN-01 gets FDA fast track designation for gastric and gastroesophageal junction cancer

Mereo setrusumab gets FDA rare pediatric disease designation for osteogenesis imperfecta

Applied Therapeutics AT-007 gets FDA rare pediatric disease and orphan drug designations

Calithera treats first patient in Phase 2 non-small cell lung cancer trial

AC Immune semorinemab fails Phase 2 Alzheimer’s disease trial

Precipio launches HemeScreen AML

Crinetics gets FDA rare pediatric disease designation for congenital hyperinsulinism

FDA clears Acutus’ AcQMap catheter

Zynerba Pharma Zygel gets FDA orphan drug designation for 22q deletion syndrome

Hepion CRV431 shows positive activity against SARS-CoV-2 in NIAID study

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