What happened
Shares of the clinical-stage biotech Kezar Life Sciences (KZR -3.55%) are soaring this morning following a positive mid-stage data readout for its lupus nephritis candidate zetomipzomib. Specifically, the drugmaker's shares were up by an eye-catching 71% as of 10:50 a.m. ET Tuesday morning. This potentially deadly autoimmune disorder is characterized by swelling of the kidneys in patients with systemic lupus erythematosus.
What appears to be driving this massive uptick in Kezar's shares today is the drug's 65% overall renal response among patients who reached the end of treatment. Overall renal response in this small phase 2 trial was reportedly defined as a 50% or greater reduction in urine-protein-to-creatinine ratio at end of treatment at week 25.
Image source: Getty Images.
So what
Lupus nephritis is a potential blockbuster indication (greater than $1 billion in annual sales) for zetomipzomib. That's a big deal for a clinical-stage biotech with a $600 million market cap at the time of this writing.
That being said, Kezar is far from alone in pursuing this high-value indication. In fact, there are already two drugs specifically approved by the Food and Drug Administration for lupus nephritis, and several other drugs are currently in trials for this autoimmune disorder.
Now what
Next up, Kezar will have to advance zetomipzomib into a randomized phase 3 trial in order to file for regulatory approval. Pivotal-stage trials for this particular indication tend to take two to three years to complete. So if everything goes according to plan, Kezar's lupus nephritis candidate might be commercially available by 2025.
