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Stock Market & Financial Investment News

News Breaks
March 18, 2013
17:08 EDTENDP, BDSIBioDelivery Sciences reports cash at end of FY12 $63.2M vs. $10.8M
BioDelivery Sciences (BDSI) ,BDSI's, research and development expenditures increased from $20.8M in 2011 to $35.4M in 2012. Revenues recognized in 2012 were $54.5M, including $35.8M from Endo (ENDP) and $17.5M previously deferred revenue associated with the BDSI commercialization agreement with Meda for BDSI's FDA approved product ONSOLIS. At the end of 2012, BDSI had $9.2M in deferred revenue associated with Endo, which will be recognized through 2013 and into early 2014 as clinical trials progress. BDSI reported net income of $1.7M or 5c per share for the twelve months ending December 31. That compares to a net loss of $23.3M or (82c) per share in 2011. At the end of 2012, BDSI had $63.2M in cash compared to $10.8M at December 31, 2011.
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April 16, 2014
10:27 EDTENDPEndo International says AMS unit received FDA warning letter
In a regulatory filing, Endo International disclosed that as previously reported in Endo Health Solutions's Form 10-K filed with the SEC on March 3, in February 2014, the United States FDA conducted an inspection of the Minnetonka, Minnesota facility of American Medical Systems, AMS, a subsidiary of Endo International. Following such inspection, the FDA issued three observations on a Form 483 Notice of Inspectional Observations dated February 24. These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015. On April 14, AMS received a Warning Letter from the FDA, dated April 10. The Warning Letter relates to the same matters as identified in the Form 483 Notice. Specifically, the Warning Letter discusses observations related to process validation, risk analysis and corrective and preventive action procedures. The letter states that the corrective actions which AMS reviewed with the FDA on March 20, 2014 appear to be adequate, but it goes on to state that many of the actions have not yet been completed and will need to be validated in a follow-up inspection. AMS has 15 days to respond to the Warning Letter. AMS expects only limited related impact to its business at this time. The Minnetonka, Minnesota facility will continue to manufacture and ship products while AMS works with the FDA.
10:00 EDTENDPOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: A10 Networks (ATEN) initiated with a Buy at BofA/Merrill... Actavis (ACT) initiated with a Buy at Sterne Agee... Allergan (AGN) initiated with a Buy at Sterne Agee... Autohome (ATHM) initiated with a Neutral at Credit Suisse... BitAuto (BITA) initiated with an Outperform at Credit Suisse... Centene (CNC) initiated with a Neutral at UBS... Endo International (ENDP) initiated with a Buy at Sterne Agee... FS Investment (FSIC) initiated with an Overweight at Evercore... Hertz (HTZ) initiated with a Buy at Gabelli... Hilton (HLT) initiated with a Hold at Jefferies... Hospira (HSP) initiated with a Neutral at Sterne Agee... ImmunoGen (IMGN) initiated with a Buy at Canaccord... Impax (IPXL) initiated with a Neutral at Sterne Agee... Imperva (IMPV) assumed with a Neutral at Wedbush... Ingredion (INGR) initiated with an Outperform at Credit Suisse... Laredo Petroleum (LPI) initiated with an Outperform at RW Baird... Lpath (LPTN) initiated with a Buy at Canaccord... MediWound (MDWD) initiated with an Outperform at Oppenheimer... Medivation (MDVN) initiated with a Hold at Canaccord... NPS Pharmaceuticals (NPSP) assumed with a Buy at Canaccord... Nimble Storage (NMBL) initiated with a Market Perform at Raymond James... Regeneron (REGN) initiated with a Buy at Canaccord... Salix (SLXP) initiated with a Buy at Sterne Agee... Sibanye Gold (SBGL) initiated with an Outperform at Imperial Capital... Teva (TEVA) initiated with a Neutral at Sterne Agee... Wipro (WIT) assumed with a Hold at Jefferies.
07:03 EDTENDPEndo International initiated with a Buy at Sterne Agee
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