Key Developments: Nanosphere Inc (NSPH.W)
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18 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Nanosphere Inc Seals Distribution and Collaboration Deal with Hitachi High-Technologies Corp Reach Distribution Deal- M2 Pharma
M2 Pharma reported that Nanosphere Inc announced that it has inked a distribution and collaboration deal with Hitachi High-Technologies Corp to market its products in Japan. Under the deal, Hitachi High-Technologies will gain exclusive rights to commercialise Nanosphere products in Japan, specifically its molecular diagnostics platform Verigene System. The parties will also collaborate on the development of assays and platforms. Full Article
Nanosphere Inc Reaffirms FY 2013 Revenue Guidance
Nanosphere Inc reaffirmed its fiscal 2013 revenue guidance and expects revenue of $13 million to $15 million. Full Article
Nanosphere Inc Announces Board Changes-DJ
Dow Jones reported that Nanosphere Inc disclosed in a regulatory filing that it terminated without cause President and Chief Executive William Moffitt's employment last week. Mr. Moffitt, as well as three other directors, have resigned from the Board. February 13, 2013, the Company said it has promoted Michael K. McGarrity, most recently its Chief Commercial Officer, to the post of CEO. Mr. McGarrity, as well as Sheli Z. Rosenberg and Michael J. Ward, have been appointed to Nanosphere's Board. Ms. Rosenberg also was appointed to serve as the Board's Chairman. Full Article
Nanosphere Inc Issues FY 2013 Revenue Guidance In Line With Analysts' Estimates
Nanosphere Inc announced that for fiscal 2013, it expects guidance set at $13 million to $15 million in revenue and 200 to 250 customer placements. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $20 million for fiscal 2013. Full Article
Nanosphere Inc Closes Exercise of Over-Allotment and Closing of Common Stock Offering
Nanosphere Inc announced the closing of its previously announced underwritten public offering of 12,075,000 shares of its common stock at a public offering price of $2.40 per share, including 1,575,000 shares of common stock issued pursuant to the underwriters' exercise in full of their over-allotment option, resulting in gross proceeds of approximately $29.0 million. Piper Jaffray & Co. acted as the sole book-running manager and Roth Capital Partners acted as co-manager for the offering. Net proceeds from the sale of the shares after underwriting discounts and commissions and other offering expenses are expected to be approximately $26.9 million. The Company plans to use the net proceeds from the offering for general corporate purposes and working capital. Full Article
Nanosphere Inc Prices $25.2 Million Public Offering of Common Stock
Nanosphere Inc announced the pricing of its previously announced underwritten public offering of 10,500,000 shares of its common stock at a public offering price of $2.40 per share. In connection with the offering, the Company has also granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of common stock to cover over-allotments, if any. Piper Jaffray & Co. is acting as the sole book-running manager and Roth Capital Partners is acting as co-manager for the offering. Net proceeds from the sale of the shares after underwriting discounts and commissions and other offering expenses are expected to be approximately $23.4 million. If the underwriters exercise their over-allotment option in full, net proceeds from the offering will be approximately $26.9 million. The offering is expected to close on July 24, 2012. The Company plans to use the net proceeds from the offering for general corporate purposes and working capital. Full Article
Nanosphere Inc Announces Commencement of Public Offering of Common Stock
Nanosphere Inc announced that it intends to offer shares of its common stock in a public offering. Nanosphere also expects to grant the underwriters a 30-day option to purchase additional shares of common stock to cover overallotments, if any. Piper Jaffray & Co. is acting as the sole book-running manager for the offering. Nanosphere plans to use the net proceeds from the offering for general corporate purposes and working capital. This offering will be made pursuant to a prospectus supplement to the Company's prospectus, dated September 15, 2009, filed as part of the Company's effective $100 million shelf registration statement. Full Article
Nanosphere Inc Receives FDA Authorization To Market Gram-Positive Blood Culture Test
Nanosphere Inc announced the U.S. Food and Drug Administration has granted a de novo petition permitting marketing of its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result Verigene System. The BC-GP test notably expands Nanosphere's infectious disease test capabilities to include fast detection of bacteria that can cause deadly bloodstream infections, an increasingly recognized health threat. With a single automated test, the Verigene BC-GP test provides fast genus and species level detection for a broad panel of clinically gram-positive bacteria. The BC-GP test also detects several crucial markers for antimicrobial resistance, including the mecA, vanA, and vanB genes, which confer resistance to the antibiotics methicillin/oxacillin and vancomycin. Rapid detection of these antimicrobial resistance markers provides vital information for clinicians to determine the treatment for bloodstream infections. Full Article
Nanosphere Inc Enters Into Marketing And Distribution Agreement In Europe With Thermo Fisher Scientific Inc.
Nanosphere Inc announced that it entered into a marketing and distribution agreement with Thermo Fisher Scientific Inc. for markets in Germany. With the commencement of this agreement, Nanosphere will possess distribution agreements in all of the major markets in Europe, a key step in its global expansion strategy. Full Article
Nanosphere Inc Receives FDA Clearance Of Gram-Positive Blood Culture Test For Staphylococcus
Nanosphere Inc announced that it has received 510(k) clearance from the FDA for the Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S). The BC-S test expands Nanosphere's infectious disease test capabilities to include the rapid detection of bacteria that cause deadly bloodstream infections. The Verigene BC-S test was submitted to the FDA as the first phase of a stepwise process to obtain clearance for a larger test panel which will be marketed as the Verigene BC-GP test. The test will be comprised of up to 16 bacterial/resistance marker targets, all on a single test cartridge. A second 510(k), needed to obtain clearance for the full BC-GP test panel, is under FDA review. Nanosphere obtained CE-IVD Mark for regulatory approval of the full BC-GP test as an in vitro diagnostic in Europe. The sample-to-result BC-S test automates the steps of bacterial nucleic acid extraction and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the BC-S test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing. Full Article
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