vista's key points
- Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation and high costs to health care systems. In the U.S. alone, kidney diseases affect an estimated 37 million people and account for over $120 billion in annual costs.
- The FDA recently pivoted and is now recognizing surrogate markers such as proteinuria as a registration endpoint for accelerated approval in primary glomerular diseases. Chinook has 3 programs with validated mechanisms - 2 for glomerular diseases, 1 for primary hyperoxaluria.
- Well-funded development programs with participation in a $115 million private placement financing concurrent with the close of a merger with Aduro Biotech in Q4 2020 from top-tier healthcare investors including, EcoR1 Capital, OrbiMed Advisors, funds managed by Rock Springs Capital, Fidelity Management and Research Company LLC, Avidity Partners, Surveyor Capital (a Citadel company), Ally Bridge Group, Monashee Investment Management LLC, Northleaf Capital Partners, Janus Henderson Investors, Sphera Biotech and others.
- Chinook plans to initiate a Phase 3 trial (ALIGN) of atrasentan, an endothelin receptor antagonist (ERA), for IgA Nephropathy in early 2021, as well as a Phase 2 basket trial (AFFINITY) for primary glomerular diseases during the first half of 2021.
- Chinook will have several data presentations at major nephrology conferences throughout 2021, including data readouts from the ongoing Phase 1b study of BION-1301, an anti-APRIL monoclonal antibody, in development for IgA Nephropathy.
- With Chinook’s debut on NASDAQ as KDNY in October 2020, Wall Street is beginning to discover Chinook as it now has coverage from 7 research analysts with BUY Recommendations and price targets ranging from $25 - $38.
- The U.S. Food and Drug Administration (FDA) (Feb. 2021) granted rare pediatric disease designation for KDNY's CHK-336, an investigational oral small molecule inhibitor of lactate dehydrogenase A (LDHA) for primary hyperoxaluria (PH). PH is a group (PH1, PH2 and PH3) of ultra-rare genetic diseases caused by enzyme mutations that result in excess oxalate production in the liver, and in its most severe forms, can lead to end-stage kidney disease at a young age. Inhibition of LDHA with CHK-336 allows for the potential to treat all forms of PH and other disorders arising from excess oxalate, while its liver-targeted tissue distribution profile enables maximal inhibition of liver oxalate production with minimal systemic exposure.
Chronic kidney disease, also called chronic kidney failure, describes the gradual loss of kidney function. Your kidneys filter wastes and excess fluids from your blood, which are then excreted in your urine. When chronic kidney disease reaches an advanced stage, dangerous levels of fluid, electrolytes and wastes can build up...Read More
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