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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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February 26, 2015
07:33 EDTENDPQLT Inc. reports Q4 EPS 31c, consensus 14c
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February 24, 2015
14:31 EDTENDPBoston Scientific deal for Endo unit would be favorably received, says Needham
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12:40 EDTENDPBoston Scientific may strike deal for Endo AMS unit within weeks, Reuters says
Boston Scientific (BSX) is reportedly close to buying Endo International's (ENDP) AMS medical device unit which could be valued at roughly $2B, reports Reuters, citing people familiar with the matter. The sources said the companies want to finalize a deal "within a matter of weeks" but cautioned that talks are continuing and could still fail. Reference Link
12:14 EDTENDPEndo near deal to sell AMS device unit to Boston Scientific, Reuters says
February 23, 2015
12:53 EDTENDPAnalysts debate potential for competing Salix takeover bid
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09:02 EDTENDPAcceptance of NDA for Belbuca triggers $10M milestone payment to BDSI
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07:31 EDTENDPEndo, BioDelivery Sciences announce acceptance of NDA for Belbuca
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February 22, 2015
15:59 EDTENDPValeant to buy Salix for $10.1B, FT says
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February 20, 2015
09:17 EDTENDPEndo price target raised to $101 from $86 at Goldman
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08:21 EDTENDPSummer Street still feels Endo could acquire BioDelivery Sciences
Summer Street reiterated its belief that Endo (ENDP) could acquire BioDelivery Sciences (BDSI), its partner on multiple products. The firm says scripts for BioDelivery's Bunavail continue to trend in the right direction. It reiterates a Buy rating on the stock with a $25 price target.
February 19, 2015
16:34 EDTENDPAmerican Medical Systems enrolls 1,000th patient in PROPPER registry
American Medical Systems, or AMS, a subsidiary of Endo International, announced the enrollment of the 1,000th patient in the largest prospective, multi-year, global registry study of penile prosthetic outcomes in the world. The study, entitled PROPPER, or Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration, is sponsored by AMS and is being conducted by a team of experienced urologists at 11 North American sites. It aims to better characterize real-world patient satisfaction and other outcomes among men who are receiving prosthetic implants to treat their erectile dysfunction. All patients enrolled in the registry will be implanted with penile implants manufactured by AMS, the majority of whom will receive the three piece inflatable penile prosthesis, the AMS 700.
06:13 EDTENDPEndo resumed with a Buy at Citigroup
Price target raised to $98 from $87.
February 17, 2015
17:02 EDTENDPSoros Fund Management gives quarterly update on stakes
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February 13, 2015
18:09 EDTENDPEndo interested in buying Salix, Reuters reports
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17:57 EDTENDPEndo interested in buying Salix, Reuters reports
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