Shares of Raptor Pharmaceutical Corp. (NASDAQ:RPTP) slumped modestly Friday, on word that the FDA will need additional time to complete its review of the New Drug Application for RP103 (Procysbi), for the potential treatment of nephropathic cystinosis. Also made known was that the initial Prescription Drug User Fee Act goal date has been extended from January 30th to April 30, 20th, with the three-month extension being the standard period. However, the agency did not ask for additional studies.
Illumina (NASDAQ:ILMN) might be purchased by Roche (RHHBY.PK) at $66 per share, or for an aggregate of $8.1 billion, according to the Swiss newspaper L’Agefi, citing trustworthy information that could not be verified, according to Bloomberg. An arrangement is said to have been reached last week, and might be announced in the first half of January, said L’Agefi.
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Echo Therapeutics (NASDAQ:ECTE) announced the pricing of a previously announced underwritten public offering of 3.2 million shares of its common stock, offered at a price to the public of 95 cents per share, with the gross proceeds to the firm at about $3 million, prior to deducting the underwriting discount and other estimated offering expenses payable by Echo. The company grants the underwriters a 45-day option to buy up to a total of 480,000 additional shares of its common stock to cover any over-allotments. The offering should close on or about December 27th, subject to the usual closing conditions.
On Friday, Chembio Diagnostics (NASDAQ:CEMI) gained FDA approval to market its Dual Path Platform HIV 1/2 assay for the rapid, point-of-care detection of HIV-1/2 antibodies in either oral fluid or blood samples. This decision was subsequent to a review of Chembio’s Premarket Approval application and represents the first FDA approval of a diagnostic assay using the firm’s patented Dual Path Platform tech. Chembio is a leader in point-of-care diagnostic tests for infectious diseases.
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