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News For ACT;TEVA;ENDP;COV;ABT From The Last 14 Days
Check below for free stories on ACT;TEVA;ENDP;COV;ABT the last two weeks.
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September 17, 2014
16:25 EDTENDPOn The Fly: Closing Wrap
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16:18 EDTACTDepomed says FDA recognizing 7 years orphan-drug exclusivity for Gralise in PHN
Depomed (DEPO) disclosed in a filing that on September 16 the company received a letter from the FDA informing the company that pursuant to the order issued on September 5 by a judge of the U.S. District Court for the District of Columbia, the FDA is recognizing seven years of orphan-drug exclusive approval for the company’s Gralise for the management of postherpetic neuralgia. The letter also confirms the FDA will not approve any abbreviated New Drug Application referencing Gralise during the period of orphan-drug exclusive approval, which began on January 28, 2011. The FDA has 60 days after issuance of the order in Depomed, Inc. v. HHS to file a notice appealing the order to the United States Court of Appeals for the Federal Circuit. The period of orphan drug exclusivity applicable to Gralise for PHN is separate from marketing exclusivity arising from the previously disclosed decision issued on August 19 in the company’s patent litigation lawsuit against Actavis (ACT) related to an ANDA filed by Actavis seeking to market generic versions of Gralise. The decision found that Actavis infringed all seven of the company’s patents asserted in the litigation, upheld the validity of the patents and enjoined FDA approval of the Actavis ANDA until February 26, 2024, the latest expiration date of the infringed patents. On September 15, Actavis filed a notice appealing the decision to the United States Court of Appeals for the Federal Circuit, Depomed stated. Previously disclosed settlement agreements between the Company and two other Gralise ANDA filers permit the sale of generic Gralise beginning on January 1, 2024.
16:01 EDTCOVCovidien raises quarterly dividend to 36c from 32c
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12:22 EDTENDPOn The Fly: Midday Wrap
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12:15 EDTENDPAuxilium climbs, QLT falls after Endo submits takeover bid
Shares of drug maker Auxilium (AUXL) are rallying after another company in the sector, Endo (ENDP), offered to buy Auxilium for $28.10 per share. Endo said that Auxilium's 12 FDA approved products in urology, orthopedic and other areas are "natural complements" to Endo's men's health and pain products, while Auxiium said it would consider the offer. The potential deal, however, jeopardizes Auxiium's prior agreement to acquire another drugmaker, QLT Inc. (QLTI). WHAT'S NEW: Endo announced last night that it had made a cash and stock bid of $28.10, or $2.2B, for Auxilium. The latter company announced this morning that it would "carefully review" the offer. The two companies have "significant synergy opportunities" and the deal is "expected to be immediately accretive" to Endo's EPS, the hopeful buyer added. WHAT'S NOTABLE: On June 26, Auxilium announced that it would merge with Canada's QLT Inc. According to Sterne Agee analyst Shibani Malhotra, Endo said last night that it was not interested in acquiring QLT and Auxilium would have to choose between merging with QLT and being acquired by Endo. ANALYST REACTION: Although Endo's bid represents a 30%+ premium to Auxilium's closing price yesterday, Jefferies analyst Thomas Wei believes that the synergies outlined by Endo justify a higher takeout price. Specifically, the analyst thinks that Auxilium could be acquired for $34 to $45 per share. Wei kept a $34 price target and Buy rating on Auxilium. For his part, Malhotra predicted that Auxilium would approve the Endo deal and reject the QLT merger. The bid appears to be substantially accretive for Endo, added the analyst, who kept a $75 price target and Buy rating on Endo's shares. PRICE ACTION: In early afternoon trading, Auxilium surged over 43% to $30.88 and Endo advanced 6.5% to $69.35, while QLT dropped 12% to $5.46.
11:01 EDTACT, TEVAActavis drops after NY AG seeks to block Alzheimer drug switch
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09:16 EDTACTActavis Namenda sales of $990M could be at risk, says BMO Capital
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09:11 EDTENDPEndo offer likely to be accepted by Auxilium, says Sterne Agee
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09:10 EDTENDPOn The Fly: Pre-market Movers
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09:06 EDTACTNew York AG files antitrust lawsuit against Actavis
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08:44 EDTENDPBioDelivery Sciences remains takeout candidate for Endo, says Summer Street
Summer Street believes a potential takeover of BioDelivery Sciences (BDSI) by partner Endo (ENDP) is no less likely after Endo made a bid to acquire Auxilium (AUXL). The firm believes an Endo buyout of BioDelivery is likely a 2015 event when BioDelivery's Bunavail for opioid dependence is on the market and BEMA Buprenorphine is facing FDA approval. Summer Street says it is a buyer of BioDelivery Sciences on weakness this morning and keeps a Buy rating on the name with a $28 price target.
08:06 EDTENDPAuxilium likely to require higher bid from Endo, says MKM Partners
After Endo (ENDP) made a $28.10 per share bid for Auxilium (AUXL), MKM Partners believes that Endo will probably have to bid at least $32 to buy Auxilium. The firm raised its price target on Auxilium to $32 from $26 and reiterates a Buy rating.
08:05 EDTTEVAEagle Pharm says Teva requests motion to dismiss Bendamustine lawsuit
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07:58 EDTENDPEndo, Auxilium deal can create significant synergies, says Canaccord
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07:39 EDTENDPEndo deal for Auxilium highly complimentary, says UBS
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07:15 EDTENDPEndo bid for Auxilium positive, says Wells Fargo
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07:14 EDTENDPAuxilium to 'carefully review' proposal from Endo for $28.10 per share
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07:12 EDTENDPQLT Inc. provides update on merger with Auxilium
QLT Inc. (QLTI) announces that it has been advised by Auxilium Pharmaceuticals (AUXL) that Auxilium has received an unsolicited offer from Endo International (ENDP) to acquire all of the issued and outstanding shares of Auxilium. Auxilium has further advised QLT that the board of Auxilium is reviewing the Endo Proposal, and has not withdrawn, modified, withheld, changed or qualified its recommendation with respect to the proposed merger with QLT pursuant to the Agreement and Plan of Merger among QLT, Auxilium, QLT Holding, and QLT Acquisition, dated June 25. The Merger Agreement continues in full force and effect. In accordance with the Merger Agreement, QLT has consented to the adoption by Auxilium of a stockholder rights plan in response to the Endo Proposal.
07:11 EDTENDPAnalysts say Auxilium QLT deal could be snarled by Endo bid, Reuters says
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07:04 EDTENDPAuxilium could be worth $34-$45/share in takeout, says Jefferies
Jefferies believes Auxilium (AUXL) could be worth more than the $28.10 per share offer by Endo (ENDP). The firm says it can get to valuations of $34-$45 per share for Auxilium under a takeout scenario. Jefferies thinks proposed acquisition cost "leaves considerable value on the table." It keeps a Buy rating on Auxilium with a $34 price target. In pre-open trading, Auxilium is trading well above Endo's offer price at $30.26 per share, up 41% or $8.74.
06:36 EDTENDPEndo volatility expected to move on Endo acquisition proposal
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06:25 EDTENDPAuxilium volatility expected to move on Endo acquisition proposal
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September 16, 2014
17:29 EDTENDPAuxilium up 42% following Endo acquisition proposal
16:48 EDTENDPEndo delivers proposal to acquire Auxilium for $28.10 per share in cash, stock
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16:48 EDTENDPEndo delivers proposal to acquire Auxilium for $2.2B in cash, stock
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11:51 EDTACT, COV, ABTOECD looks to close tax loopholes with new proposals
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06:06 EDTACTActavis, subsidiary sued by NY attorney general, Reuters says
New York attorney general Eric Schneiderman filed a lawsuit versus Actavis and its subsidiary, Forest Laboratories, to impede the firms from stopping its Alzheimer's medication production, claiming that they were aiming to illegally maintain a monopolistic stance, according to Reuters, citing comments from Schneiderman. Reference Link
September 15, 2014
09:32 EDTABTAbbott initiates ABSORB IV trial
Abbott announced the start of the ABSORB IV clinical trial, which will test whether its Absorb Bioresorbable Vascular Scaffold is more cost-effective and offers a higher quality of life than a permanent, metallic drug eluting stent. Unlike a metallic stent, Absorb completely dissolves over time after doing its job. ABSORB IV is designed to enroll approximately 3K people with coronary artery disease, mostly in the U.S. The ABSORB IV trial is designed to confirm these novel findings that treatment with the Absorb device can help provide people with heart disease a higher quality of life after a heart stent procedure. The data from the ABSORB IV trial will be combined with the data from the ABSORB III trial to create a population of more than 5K people studied in the U.S. This data set, which is the largest of its kind for bioresorbable heart devices, provides an opportunity to evaluate the performance of Absorb compared to the current standard of a metallic drug eluting stent across a number of measures, including the broader health economic impact of this innovative therapy.
07:45 EDTABTCardiovascular Research Foundation to hold a conference
Transcatheter Cardiovascular Therapeutics: TCT 2014 to be held in Washington, D.C. on September 13-17 with some presentations being webcasted. Webcast Link
07:27 EDTACTPfizer acquisition could drive shares higher, says JPMorgan
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07:04 EDTCOVCovidien announces start of enrollment in two neurovascular trials
Covidien announced the start of enrollment in two clinical trials designed to further underscore the safety and effectiveness of the company’s advanced neurovascular solutions. Baptist Medical Center in Jacksonville, Florida, treated the first patient enrolled in the PREMIER Prospective study, an international Investigational Device Exemption clinical study to evaluate the Pipeline embolization device in smaller unruptured intracranial aneurysms. Separately, Baptist Health Lexington in Kentucky, enrolled the first patient in the STRATIS Registry for Endovascular Stroke Devices, which will evaluate the use of all Covidien market-released stroke devices. The PREMIER study will enroll up to 141 patients in 20 global sites and is designed to assess the safety and effectiveness of the Pipeline device in the treatment of unruptured, small and medium wide-necked intracranial aneurysms. The STRATIS Registry, a prospective, multi-center, non-randomized, observational registry designed to evaluate the use of Covidien endovascular stroke devices in patients diagnosed with an acute ischemic stroke. Covidien’s current endovascular stroke device in the U.S. is the Solitaire™ 2 revascularization device. As many as 60 U.S. sites are expected to participate in the STRATIS Registry, which will enroll up to 1,000 patients to collect clinical outcomes for interventional stroke patients in a real world setting.
September 14, 2014
13:30 EDTABTAbbott announces positive one-year clinical results from ABSORB II
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September 12, 2014
10:32 EDTACTPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
09:01 EDTTEVATeva to present Copaxone gene expression analysis
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08:06 EDTTEVATeva presents new clinical safety data in RRMS patients treated with Laquinimod
Teva (TEVA) and Active Biotech (ACTI) announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis, or RRMS, who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. In the pooled safety analysis, rates of adverse events, or AEs, and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod.
08:03 EDTTEVATeva, Active Biotech present laquinimod follow-up data
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September 11, 2014
13:41 EDTABTAbbott announces new $3B share repurchase program
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09:31 EDTTEVATeva announces new data from Phase IIIb GLACIER study
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03:27 EDTTEVATeva Canada announces launch of generic version of Cipralex
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September 10, 2014
14:25 EDTTEVATeva Canada announces launch of generic version of Cipralex
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09:02 EDTACTActavis won't see serious long-term impact from rejection, says Sterne Agee
After the FDA's Cardiovascular and Renal Drugs Advisory Committee voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension, Sterne Agee does not thinks the vote is very meaningful to the company's longer-term growth and earnings potential. The firm says that removing the product from its revenue outlook causes its 2018 EPS estimate for the company to drop by less than 1%. The firm still thinks the company can easily reach its 2017 EPS target of about $20. Sterne Agee keeps a $272 price target and Buy rating on the shares.
08:56 EDTACTFDA advisors recommend against approval of Actavis' nebivolol/valsartan combo
Actavis last night confirmed that the FDA's Cardiovascular and Renal Drugs Advisory Committee has voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. The committee vote was six to four recommending against approval. The committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014. Actavis' Senior VP, Global Brands Research and Development, David Nicholson, said, "Although we are disappointed in the Committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension. We remain confident in the safety and efficacy of the combination of these two widely used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review." Shares of Actavis are down more than 2% in pre-market trading following yesterday's committee recommendation.
September 9, 2014
17:06 EDTACTFDA panel votes against Actavis blood pressure pill, Bloomberg says
FDA advisers said that Actavis's experimental pill that combines two existing drugs to lower high blood pressure doesn’t provide a clinically meaningful benefit over the two drugs alone, says Bloomberg. The advisory panel voted 6 to 4 against recommending the treatment, added Bloomberg. Shares of Actavis are trading down almost 1% in after-hours trading. Reference Link
10:18 EDTACTDollar General listed among 5 largest long positions by Jana Partners
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06:42 EDTCOV, ABTLew expects to make decision on combating inversion deals soon, NY Times reports
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September 8, 2014
16:33 EDTENDPEndo reports TOPAS System improves fecal incontinence in women
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12:40 EDTTEVAFTC sues AbbVie over blocking of AndroGel generics
The Federal Trade Commission has filed a complaint in federal district court charging several pharmaceutical companies with "illegally blocking American consumers’ access to lower-cost versions of the blockbuster drug AndroGel." The FTC's complaint alleges that AbbVie (ABBV) and its partner Besins Healthcare filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of the testosterone replacement drug AndroGel. While the lawsuits were pending, AbbVie then entered into an anticompetitive pay-for-delay settlement agreement with Teva Pharmaceuticals (TEVA) to further delay generic drug competition, the FTC claims. Reference Link
11:05 EDTCOVOptions with increasing implied volatility
Options with increasing implied volatility: NPSP GILD VNET AVNR GTAT YHOO RHT VRTX SDRL COV MYL
09:27 EDTTEVALeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
08:02 EDTTEVATeva completes Reslizumab Phase III program
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07:31 EDTENDPEndo announces launch of generic Fortesta gel
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September 5, 2014
11:47 EDTCOVOptions with increasing implied volatility
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10:05 EDTTEVA, ACTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Actavis (ACT) initiated with a Buy at ISI Group... Akamai (AKAM) initiated with a Buy at UBS... Alexion (ALXN) initiated with a Buy at SunTrust... Allegion (ALLE) initiated with a Buy at Buckingham... Allergan (AGN) initiated with a Buy at ISI Group... Aviat Networks (AVNW) initiated with a Neutral at H.C. Wainwright... Celgene (CELG) initiated with a Buy at SunTrust... EZCORP (EZPW) initiated with a Hold at Jefferies... Eaton (ETN) initiated with a Neutral at Buckingham... Emerson (EMR) initiated with a Neutral at Buckingham... HMS Holdings (HMSY) initiated with an Overweight at Stephens... Incyte (INCY) initiated with a Buy at SunTrust... Ingersoll-Rand (IR) initiated with a Neutral at Buckingham... Insmed (INSM) initiated with an Outperform at Cowen... Intercept (ICPT) initiated with an Outperform at Cowen... Johnson & Johnson (JNJ) initiated with an Outperform at BMO Capital... Lennox (LII) initiated with a Neutral at Buckingham... Mylan (MYL) initiated with a Hold at ISI Group... Orion Engineered Carbons (OEC) initiated with a Buy at Goldman... Parker-Hannifin (PH) initiated with a Buy at Buckingham... Pentair (PNR) initiated with a Neutral at Buckingham... Pharmacyclics (PCYC) initiated with a Neutral at SunTrust... Rockwell Automation (ROK) initiated with a Neutral at Buckingham... Sabre (SABR) initiated with an Outperform at Oppenheimer... Santander Consumer (SC) initiated with a Buy at Jefferies... Springleaf (LEAF) initiated with a Buy at Jefferies... Susser Petroleum (SUSP) initiated with a Neutral at Credit Suisse... Teva (TEVA) initiated with a Buy at ISI Group... Valeant (VRX) initiated with a Buy at ISI Group... WESCO (WCC) initiated with a Neutral at Buckingham... Watsco (WSO) initiated with a Neutral at Buckingham... Weyerhaeuser (WY) initiated with a Neutral at JPMorgan... World Acceptance (WRLD) initiated with a Hold at Jefferies.
08:00 EDTACTActavis announces FDA acceptance of the NDA filing for ceftazidine-avibactam
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05:46 EDTABTDexCom competition closer after Abbott approval, says Piper Jaffray
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September 4, 2014
17:16 EDTACTActavis initiated with a Buy at ISI Group
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17:16 EDTTEVATeva initiated with a Buy at ISI Group
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08:02 EDTTEVATeva launches generic Baraclude in U.S.
Teva (TEVA) announces the launch of the generic equivalent to Baraclude tablets in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude is marketed by Bristol-Myers Squibb (BMY).
07:21 EDTTEVAMedidata can obtain major new platform customers, says Stifel
Noting that Medidata (MDSO) partners with Veeva, Stifel believes that a number of Veeva (VEEV) customers could become Medidata platform customers, especially if they already use Medidata for R&D and clinical trial solutions. The firm identifies Merck (MRK), Gilead (GILD), and Teva (TEVA) as companies that may become platform clients for Medidata. Stifel keeps a $55 price target and Buy rating on Medidata.
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