Closely-held PregnanTech is completing a clinical safety study with its Lioness device to prevent preterm birth in non-pregnant women about to undergo a hysterectomy as a steppingstone to a larger proof-of-concept study...
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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...
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...
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...
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...
Maxim starts Monopar Therapeutics at buy; PT $11
Maxim Group launched coverage of Monopar Therapeutics (NASDAQ:MNPR) with a “buy” rating and a 12-month price target of $11. The stock closed at $4.98 on Sept. 24. Monopar is focused on developing therapies for cancer...
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...
BTIG starts MediWound at buy; PT $6
BTIG initiated coverage of MediWound (NASDAQ:MDWD) with a “buy” rating and $6 price target. The stock closed at $3.58 on Sept. 22. MediWound has developed proteolytic enzyme technology targeting severe burns, chronic...
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...
HCW ups OSE Immunotherapeutics PT to €10 from €7
H.C. Wainwright raised its price target for OSE Immunotherapeutics (NXT PA:OSE) to €10 from €7, citing strong results in PD-1 refractory non-small cell lung cancer (NSCLC) from the first 100-patient cohort of the Phase...
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...
WB starts Aravive at OP
William Blair launched coverage of Aravive (NASDAQ:ARAV) with an “outperform” rating, saying that an “appreciable market disconnect exists between lead asset AVB-500’s potential to emerge as a differentiated therapeutic...
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...
Just a few of the companies we’ve highlighted along the way
