Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology.
Mineralys Therapeutics Inc., a Philadelphia-based company developing an aldosterone synthase inhibitor in-licensed from Mitsubishi Tanabe Pharma Corp. (MTPC), has raised $40 million in series A funding to complete a phase II proof-of-concept study in hypertension for the candidate, known as MLS-101.
Inflarx NV has submitted a special protocol assessment (SPA) to the FDA for the phase III trial with vilobelimab against the skin disorder hidradenitis suppurativa (HS), pleasing investors with clarity regarding the path forward for the drug, which is in the works for antineutrophil cytoplasmic antibody-associated vasculitis (AAV) as well – and faces competition on both fronts.
Barely five and a half years since the company was founded, Kiniksa Pharmaceuticals Ltd. has moved its first drug over the finish line, winning FDA approval for interleukin-1 blocker (IL-1) rilonacept to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 and older.
Regeneron Pharmaceuticals Inc.’s angiopoietin-like 3 (ANGPTL3)-targeting antibody, Evkeeza (evinacumab), won FDA approval for use in reducing LDL cholesterol in patients with homozygous familial hypercholesterolemia.
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
Sekar Kathiresan is building Verve Therapeutics Inc. around the concept of a one-and-done treatment for cardiovascular disease because only half of patients are disciplined enough to take a statin every day. “That’s a huge issue for durable cholesterol lowering after a heart attack,” Verve’s CEO and co-founder told BioWorld.
LONDON – A remodeled Rexgenero Ltd. has launched as an integrated cell and gene therapy specialist, following integration of a French biotech acquired last year and a commitment from the company’s two shareholders to invest £40 million (US$54 million).
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.