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 renal disorders, slumped as much as 29% following a downgrade from Brean Capital.
So what: Before the opening bell, Brean Capital downgraded Rockwell Medical to "sell" and placed a $4 price target on the company, implying downside potential of a whopping 70% based on yesterday's closing price. The covering analyst, Jonathan Aschoff, believes the Food and Drug Administration will reject the company's dialysis-induced iron deficiency experimental drug, triferic, because of poor study design and questionable efficacy.
Now what: This is definitely a tale of two worlds, because the data from Rockwell Medical's trial results from September would indicate that triferic has a real chance at becoming the go-to iron deficiency therapy for dialysis patients.
In trials, triferic met both its primary endpoint -- a statistically significant change in hemoglobin levels from baseline to the end of treatment -- as well as its secondary endpoints, which included hemoglobin and reticulocyte maintenance, and an increase in serum iron from the beginning of treatment to the end of treatment without an increase in ferritin. Furthermore, compared with the current standard of treatment, Dexferrum, triferic demonstrated no cases of anaphylaxis, which is a potentially severe adverse event possibility from taking Dexferrum. In other words, it would appear to be deliver a favorable safety profile.
However, it really is up to the FDA and its panel to decide what's best for patients. I would suggest waiting for word from the FDA panel before really diving into Rockwell one way or the other, as that'll give us the best indication of how the FDA may act. With the new drug application accepted in September, we should have a better bearing on its fate by mid-2014.
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