Chardan Capital affirms Rockwell Medical Technologies (Nasdaq: RMTI) at Buy with a price target of $27 following Q3 results.

Analyst Ling Wang noted that RMTI's loss of $0.10 per share was roughly in-line with the firm's $0.11 per share loss estimate.

Wang offered the following commentary:

FDA ODAC panel posted majority vote favoring the approval of Triferic. Last Wednesday, the ODAC panel voted favorably for the approval of RMTI's Triferic as a maintenance therapy for CKD patients in dialysis. Eight members voted yes and 3 voted no to the question, does the efficacy and safety results in the two phase III trials support a positive benefit/risk for the use of Triferic to treat iron loss? We believe the majority favorable vote and the panel discussions underscore the clinical benefit of Triferic and the unmet medical need in iron maintenance therapy.

We expect Triferic approval by the PDUFA date. According to management, the FDA has been provided with all the documents that are required for the approval approval of Triferic. Given the majority favorable vote and the significant unmet medical need, we expect the FDA to follow the ODAC panel’s recommendation and approve Triferic by its PDUFA date on January 24, 2015. We do not expect the ESA-sparing claim to be included in the label indication. Management has not made decisions as to whether or when they would start clinical trials to substantiate the ESA-sparing ability of Triferic.

Calcitriol launch in the near term. The FDA recently approved the manufacturing facility for Calcitriol after a year-long review process. RMTI has started the manufacturing process and plans to start
supplying clients with Calcitriol in 1Q15. With minimal additional SG&A expense to market Calcitriol, we expect the planned market launch of Calcitriol to boost both top and bottom line growth.

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Rockwell Medical Technologies closed at $10.90 yesterday.