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RMTI

Rockwell Medical

08:34
09/13/17
09/13
08:34
09/13/17
08:34

Rockwell Medical updates progress on Calcitriol commercial launch

Rockwell Medical provided an update on the commercial launch of Calcitriol, stating that product stability data for manufacturing approval is suitable for submission to the FDA. The company plans to submit its chemistry, manufacturing and controls, or CMC, post-approval drug manufacturing supplement to the FDA at the end of September 2017, as guided. As a result, the company anticipates Calcitriol to be commercially available in the U.S. approximately 30 days after the CMC submission, provided the FDA has no further requests. Calcitriol is Rockwell's FDA approved active Vitamin D injection for the management of hypocalcemia in patients undergoing chronic renal dialysis.

  • 13

    Sep

RMTI Rockwell Medical

11/08/16
11/08/16
DOWNGRADE
Target $5

Underperform
Rockwell Medical downgraded on lack of Triferic sales at BofA/Merrill
As previously reported, BofA/Merrill downgraded Rockwell Medical to Underperform from Neutral and lowered its price target to $5 from $9. Analyst Tazeen Ahmad said Q3 results proved little visibility into when Triferic may launch, and as a result, removed his 2016 sales forecasts and ramp rate. Ahmad now assumes peak Triferic sales of $104M in 2024, versus $153M previously and notes Calcitriol manufacturing issues have resulted in a delayed launch of that product.
11/08/16
MSCO
11/08/16
NO CHANGE
Target $2
MSCO
Underweight
Rockwell Medical price target cut to $2 from $3 at Morgan Stanley
08/14/17
IFSG
08/14/17
INITIATION
Target $11
IFSG
Strong Buy
Rockwell Medical initiated with a Strong Buy at IFS Securities
IFS Securities analyst David Bouchey started Rockwell Medical with a Strong Buy and $11 price target. The analyst believes the company is "headed for a massive surge in revenues" due to Triferic and Calcitriol.
08/29/17
08/29/17
NO CHANGE

Richmond Brothers says Rockwell Medical CEO should be replaced immediately
Richmond Brothers, owner of 10.8% of Rockwell Medical's outstanding shares, disclosed last night in a regulatory filing that it has concluded the company "continues to blatantly disregard the will" of its shareholders. Richmond added that it has "lost all confidence" in Chairman and CEO Robert Chioini's ability to effectively oversee the company and drive shareholder value. The fund stated, "Given the Issuer's significant financial and stock price underperformance and inability to monetize promising drugs Triferic and Calcitriol under Mr. Chioini's leadership, the Reporting Persons do not believe Mr. Chioini has proven himself capable of successfully leading the Company forward and are convinced that he should be replaced as Chairman and CEO immediately. To the extent this does not happen , the Reporting Persons note that Mr. Chioini, along with long-standing director Patrick J. Bagley, will be up for election at the 2018 annual meeting of shareholders, at which the Reporting Persons intend to nominate a competing slate of director candidates. Separate and apart from the Ravich Parties, the Richmond Parties intend to engage in discussions with shareholders of the Issuer, private equity firms, potential sources of financing and other interested parties regarding the Issuer's capital allocation, corporate governance and other means to enhance shareholder value, including a possible sale of the Issuer. While the Richmond Parties are not advocating for a sale of the Issuer at this time, the Richmond Parties believe there are multiple paths to value creation and that all paths should be evaluated. To the extent there is strategic interest in the Issuer, the Richmond Parties invite potential strategic acquirers to contact the Richmond Parties."

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