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News Breaks
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.
News For ENDP From The Last 14 Days
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September 30, 2014
17:11 EDTENDPEndo reaches master settlement agreements to resolve remaining AMS claims
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September 23, 2014
10:54 EDTENDPStocks, analysts react to Treasury inversion crackdown
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08:00 EDTENDPAuxilium rejection of first Endo offer not surprising, says UBS
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07:02 EDTENDPAuxilium now more likely to be acquired, says RBC Capital
After the U.S. Treasury announced a crackdown on tax inversion deals, RBC Capital thinks that, as a result, Auxilium's (AUXL) proposed takeover of QLT will not occur. The firm believes that instead Auxilium will be acquired by already inverted Endo (ENDP) or another pharmaceutical company. The firm expects Endo to raise its bid for Auxilium to $30-$35, and it keeps an Outperform rating on Auxilium.
September 22, 2014
20:01 EDTENDPEndo management to meet with Sterne Agee
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09:40 EDTENDPEndo says continues to feel Auxilium transaction 'compelling'
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07:11 EDTENDPQLT Inc. says, Auxilium determines Endo proposal not superior
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07:10 EDTENDPQLT Inc. says, Auxilium determines Endo proposal not superior
07:02 EDTENDPAuxilium board determines QLT Inc.'s agreement superior to Endo proposal
Auxilium (AUXL) announced that its board has reviewed the unsolicited, non-binding and conditional proposal from Endo (ENDP) and, after consulting with its independent financial and legal advisors, has unanimously determined it is not a superior proposal under the terms of its existing merger agreement with QLT Inc. (QLTI) and has unanimously reaffirmed its recommendation that Auxilium's stockholders vote in favor of the adoption of such merger agreement. In addition, the board has determined that Endo's proposal significantly undervalues Auxilium. However, under the terms of the merger agreement with QLT, Auxilium maintains the right to engage in discussions with Endo and other third parties, subject to certain conditions in the merger agreement. In unanimously reaffirming its recommendation that Auxilium's stockholders vote in favor of the adoption of the existing merger agreement with QLT, the board confirmed that it is not withdrawing, modifying, withholding, changing or qualifying its recommendation with respect to such merger agreement, or proposing to do so.
September 19, 2014
16:24 EDTENDPStocks rise after Fed keeps pledge for 'considerable time' before rate hike
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September 18, 2014
20:23 EDTENDPAuxilium downgraded to Neutral from Buy at Goldman
Goldman Sachs downgraded Auxilium (AUXL) to Neutral citing a balanced risk/reward following the post-Endo (ENDP) takeover bid rally. The firm raised its price target for shares to $31 from $28.
11:15 EDTENDPRepros sinks after panel backs tests for testosterone therapies
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07:50 EDTENDPEndo Auxilium deal would be disappointing over longer term, says Cantor
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06:10 EDTENDPFDA panel votes 20-1 to study changes to testosterone therapies
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