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Stock Market & Financial Investment News

News Breaks
February 11, 2013
06:38 EDTENDP, TEVA, COV, WCRX, VRXFidelity Investments wants an Endo Health Solution's sale, Bloomberg reports
Fidelity Investments, Endo Health Solutions's (ENDP) largest shareholder, wants a sale, sources say, reports Bloomberg. It may be the company's best hope at regaining investor confidence after losing more than $1B in market value, or to undo the acquisitions that built the company. Endo has the lowest valuation in the U.S. specialty pharmaceuticals industry, according to Bloomberg data. On average, analysts see Endo getting at least a 26% premium in a deal. Teva Pharmaceutical Industries (TEVA) or Covidien Plc (COV) could go after parts or all of Endo, according to Stifel Financial Corp. Gabelli & Co. said Endo could break up or sell its pain drugs to Warner Chilcott Plc (WCRX) or Valeant Pharmaceuticals International (VRX). Reference Link
News For ENDP;TEVA;COV;WCRX;VRX From The Last 14 Days
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April 21, 2014
16:58 EDTVRXPershing Square says Valeant intends to propose merger with Allergan
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16:40 EDTVRXValeant expected to make hostile bid for Allergan tomorrow, Faber says
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16:38 EDTVRXAckman, Valeant team up on Allergan bid, WSJ says
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16:26 EDTVRXValeant, Bill Ackman team up on Allergan takeover, DJ says
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09:21 EDTTEVAOn The Fly: Pre-Market Movers
HIGHER: Sarepta (SRPT), up 54% after announcing plans to to submit NDA for Eteplirsen by year end 2014. Shares of Prosnesa (RNA), another drugmaker working on a competing DMD drug, are up more than 12%... AstraZeneca (AZN), up 6% after the Sunday Times says that Pfizer (PFE) is considering a takeover bid for the company. Pfizer is up 1.2% following the report... Newmont Mining (NEM), up 8% after WSJ says the company and Barrick Gold (ABX) could resume merger talks as soon as today... Cbeyond (CBEY), up 39% after agreeing to be acquired for about $323M by Birch Communications... Momenta Pharma (MNTA), up 10.5% after the Supreme Court rejected Teva's (TEVA) bid to delay generic Copaxone... Nu Skin (NUS), up 5% after saying its China division will resume corporate-hosted business meetings... Micron (MU), up 4% after price target raised at Drexel Hamilton... DOWN AFTER EARNINGS: Acacia Research (ACTG), down 6%... athenahealth (ATHN), down 5.6%.
08:18 EDTTEVAMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
April 19, 2014
18:50 EDTTEVAMylan says Teva denied injunction seeking to prevent launch of generic Copaxone
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18:32 EDTTEVASupreme Court denies Teva stay in generic Copaxone case
Teva Pharmaceutical Industries announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808, he denied the company’s application to stay the Federal Circuit's decision due to the potential for the company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis, RRMS, product, Copaxone 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone. Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE patents that expire in May, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition. Any purported generic version of Copaxone would be required to obtain the approval of the FDA prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints in RRMS patients. The company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
April 17, 2014
08:38 EDTTEVATeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
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 EDTTEVA, ENDPOn 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.
08:34 EDTVRXPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
07:19 EDTVRXValeant top pick in specialty pharmaceutical space, says Cantor
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07:03 EDTENDPEndo International initiated with a Buy at Sterne Agee
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07:00 EDTTEVATeva initiated with a Neutral at Sterne Agee
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April 15, 2014
12:26 EDTTEVATeva announces launch of generic Lunesta tablets in U.S.
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09:23 EDTCOVBarclays medical supplies/devices analysts hold analyst/industry conference call
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April 14, 2014
08:05 EDTCOVCovidien announces FDA 510(k) clearance for Kangaroo feeding tube
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April 11, 2014
11:42 EDTCOVCovidien liability from recall appears limited, says Brean Capital
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08:10 EDTCOVCovidien implements voluntary recall of devices
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