Key Developments: Rockwell Medical Inc (RMTI.OQ)
4.98USD
1 Aug 2013
$-0.07 (-1.39%)
$5.05
$5.08
$5.08
$4.83
119,940
214,509
$9.50
$3.16
Latest Key Developments (Source: Significant Developments)
Rockwell Medical Inc Receives $20 Million in New Financing
Rockwell Medical Inc announced that it has closed a $20 million debt financing with Hercules Technology Growth Capital, Inc. The $20 million straight-debt financing coupled with recent $40 million equity financing provides us with sufficient cash to get SFP to commercial launch. Full Article
Rockwell Medical Inc Announces SFP Phase 3 Efficacy Study CRUISE-1 Completes Patient Dosing
Rockwell Medical Inc announced that CRUISE-1 Phase 3 efficacy study for SFP has completed patient dosing. SFP is the Company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. CRUISE-1 top-line data is expected in July 2013. Completing the CRUISE-1 efficacy study is a achievement for Rockwell, and are excited to be so close to top-line results, stated Robert L. Chioini, Founder, Chairman and CEO of Rockwell Medical. SFP is a promising iron drug that will address the unmet need for correcting functional iron deficiency in CKD-HD patients. The results of the placebo controlled PRIME study, recently reported at the ERA-EDTA Congress in Istanbul, demonstrated that SFP reduced the ESA dose required to maintain hemoglobin by a statistically significant 35% compared to placebo. The CRUISE studies do not allow changes in ESA dosing, so it is confident that in the CRUISE study design, SFP will show a favorable difference in hemoglobin levels compared to placebo. Rockwell is conducting two pivotal Phase 3 efficacy studies called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate, in adult CKD patients requiring hemodialysis. Each study comprises approximately 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months. Full Article
Rockwell Medical Inc Closes $40.3 Million Public Offering Of Common Stock
Rockwell Medical Inc announced that the closing of the sale of 13,196,721 common shares, including 1,721,311 shares of common to cover overallotments, at $3.05 per share in an underwritten public offering for an aggregate offering amount of approximately $40.3 million. The net proceeds from the offering, after commissions and other estimated offering expenses, were approximately $37.7 million. Rockwell Medical plans to use the net proceeds to fund SFP clinical trials and for other general corporate purposes. Chardan Capital Markets, LLC acted as the sole book-running manager for the offering. Summer Street Research Partners acted as lead manager for the offering. C&Co/PrinceRidge LLC acted as co-manager for the offering. Full Article
Rockwell Medical Inc Announces PRIME Study Results At The 50th ERA-EDTA Meeting In Istanbul
Rockwell Medical Inc announced PRIME clinical study results for Soluble Ferric Pyrophosphate (SFP) at the 50th ERA-EDTA congress in Istanbul. SFP is the Company's investigational iron-delivery drug for the treatment of iron deficiency in hemodialysis patients, nearing completion of its Phase 3 clinical studies. This is fully-analyzed data, including atypical data subsequently found in a few study subjects, superseding initial top-line data announced Feb 4, 2013. The PRIME study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study in United States that randomized 108 patients equally to dialysate containing SFP-iron versus conventional dialysate. A total of 103 patients received blinded study drug. In all study patients, ESA doses were titrated to maintain hemoglobin in a target range of 9.5 to 11.5 g/dL according to an algorithm managed by an independent centralized anemia management group. At the end of treatment, the hemoglobin value in the SFP group was 10.5 g/dL and 10.4 g/dL in the placebo group. Intravenous iron was administered according to a protocol to treat iron deficiency. The primary objective of the study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery. The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period). Full Article
Rockwell Medical Inc Announces Exercise Of Over-Allotment Option
Rockwell Medical Inc announced that the underwriters of its recently announced public offering have exercised their over-allotment option to purchase an additional 1,721,311 shares of its common stock at the offering price of $3.05. The Company expects to realize net proceeds of approximately $5 million after deducting underwriter's discounts. The net proceeds of the offering will be used to fund SFP clinical trials and for other general corporate purposes. Chardan Capital Markets, LLC is acting as the sole book-running manager for the offering. Summer Street Research Partners is acting as lead manager for the offering. C&Co/PrinceRidge LLC is acting as co-manager for the offering. Full Article
Rockwell Medical Inc Prices $35.0 Million Public Offering Of Common Stock
Rockwell Medical Inc announced that it has priced an underwritten public offering of 11,475,410 shares of its common stock at a price to the public of $3.05 per share for gross proceeds of $35.0 million. The net proceeds from the sale of the shares, after deducting the underwriters' discounts and other estimated offering expenses payable by Rockwell, will be approximately $32.8 million. Rockwell has also granted the underwriters a 30-day option to purchase up to an additional 1,721,312 shares of common stock offered in the public offering to cover overallotments, if any. The net proceeds of the offering will be used to fund SFP clinical trials and for other general corporate purposes. The offering is expected to close on or about May 20, 2013. Chardan Capital Markets, LLC is acting as the sole book-running manager for the offering. Summer Street Research Partners is acting as lead manager for the offering. C&Co/Prince Ridge LLC is acting as co-manager for the offering. Full Article
Rockwell Medical Inc Announces Proposed Public Offering Of Common Stock
Rockwell Medical Inc announced that its intention to offer shares of its common stock in an underwritten public offering. Rockwell also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering to cover over-allotments, if any. Chardan Capital Markets, LLC is acting as the sole book-running manager for the offering. Full Article
Rockwell Medical Inc Closes $12.9 Million Registered Direct Common Stock Offering
Rockwell Medical Inc announced the closing of the sale of 4,300,000 common shares at $3.00 per share in a registered direct offering for an aggregate offering amount of approximately $12.9 million. The net proceeds from the offering, after commissions and other estimated offering expenses, were approximately $12.0 million. Rockwell Medical plans to use the net proceeds from the offering for general corporate purposes which may include research and development expenses, acquisition of intellectual property relating to complementary drug therapies, funding of clinical trials, and general administrative expenses. Chardan Capital Markets, LLC served as the lead placement agent for the offering and Newbridge Securities, LLC acted as co-placement agent. Full Article
Rockwell Medical Inc To Raise $12.9 Million In Registered Direct Common Stock Offering
Rockwell Medical Inc announced that it has entered into definitive agreements to sell 4,300,000 common shares at $3.00 per share in a registered direct offering for an aggregate offering amount of approximately $12.9 million. The net proceeds from the offering, after commissions and other estimated offering expenses, will be approximately $12.0 million. The closing of the offering is expected to take place on or before March 25, 2013, subject to the satisfaction of customary closing conditions. Rockwell Medical plans to use the net proceeds from the offering for general corporate purposes which may include research and development expenses, acquisition of intellectual property relating to complementary drug therapies, funding of clinical trials, and general administrative expenses. Chardan Capital Markets, LLC served as the lead placement agent for the offering and Newbridge Securities, LLC acted as co-placement agent. Full Article
Rockwell Medical Inc Signs Supply Contract With NxStage Medical
Rockwell Medical Inc announced that it has signed a contract with NxStage Medical, Inc. to manufacture dialysate concentrate for the NxStage System One, the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration. The contract term is for two years. Full Article
Rockwell Medical's iron deficiency drug succeeds in trial
- Rockwell Medical Inc said a late-stage trial of its experimental iron deficiency drug met the main goal of improving hemoglobin levels in patients with chronic kidney disease.

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