Why Rockwell Medical Shares Soared

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Rockwell Medical (NASDAQ: RMTI  ) , a biopharmaceutical company focused on developing therapies to treat various kidney diseases and disorders, jumped as much as 16% after reporting positive late-stage study results for soluble ferric pyrophosphate, or SFP, an iron replacement therapy for chronic kidney disease patients on dialysis.

So what: Following positive data from its first study (results were released in July), Rockwell's second late-stage study showed that SFP met the primary endpoint of a statistically significant change in hemoglobin levels from the beginning of treatment to the end relative to the current standard of treatment. SFP also met its secondary endpoints, which included the "maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin."

Now what: Now shareholders simply watch and wait for Rockwell Medical to file for a new drug application. SFP's safety profile was very similar to that of the placebo, so I don't foresee any holdups in the potential approval process there from the Food and Drug Administration. Given its form of delivery -- being administered within the dialysate -- SFP has a good shot at slowly but surely becoming the go-to iron replacement option for dialysis patients since it doesn't come with the nasty allergic reaction potential of the current standard of treatment. With peak sales estimates ranging between $150 million and $225 million, and Rockwell valued just under $250 million, there may still be a little room for the company to head higher, assuming the FDA rules in its favor and the launch of the drug is successful.

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