Market Overview

What Investors Should Expect From Rockwell Medical's Next FDA Decision


On Wednesday, Rockwell Medical Inc (NASDAQ: RMTI) announced it will be presenting two Triferic abstracts at the Annual Dialysis Conference on February 2 in New Orleans. Triferic is the company's iron-replacement drug used for iron deficiency in chronic kidney disease patients receiving hemodialysis.

Rockwell also has a PDUFA approval decision with the FDA on January 24 for Triferic. On November 6, the company met with the Oncologic Drugs Advisory Committee (ODAC). ODAC recommended that the Phase 3 Triferic efficacy and safety results support approval.

The Committee voted in favor of approval eight to three.

The Rockwell CEO recently stated: "We welcome the committee's recommendation supporting a positive benefit/risk of Triferic. We look forward to working with the FDA to complete its review of Triferic. We remain committed to addressing the unmet needs in managing patients with chronic kidney disease."

In November, Rockwell raised about $58 million from a secondary offering.

Related Link: What Investors Should Be Watching In The Antibiotic Space

A month later on December 12, Jim Cramer mentioned he thought Rockwell was a "battleground" stock between longs and shorts. However, he stated he would rather be a speculative buyer than a seller, because Baxter International Inc. (NYSE: BAX) is invested in Rockwell.

On Wednesday, Oppenheimer initiated coverage on Rockwell and set a price target of $24. On the other hand, Brean Capital's Jonathan Aschoff rates Rockwell as a sell and gives the stock a $4 price target.

Other companies with FDA decisions at the end of January are NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), Zogenix, Inc. (NASDAQ: ZGNX) and The Medicines Company (NASDAQ: MDCO).


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