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Stock Market & Financial Investment News

News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
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March 3, 2015
12:12 EDTOREXOn The Fly: Midday Wrap
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12:06 EDTPFEPfizer receives orphan status for lung cancer drug
The FDA granted Pfizer orphan status for its treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations, dacomitinib.
11:46 EDTJNJ, AMGN, SNYLeerink biotech analyst holds an analyst/industry conference call
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11:25 EDTOREXOrexigen surges after disclosing weight loss drug data, patent news
Shares of Orexigen (OREX) are surging in morning trading after the company disclosed the data from the 25% interim analysis of the LIGHT cardiovascular study when announcing a method of treatment patent was issued for its weight loss drug, Contrave. In the filing, the company disclosed that Contrave demonstrated a statistically significant benefit over placebo for cardiovascular events, including CV death. ANALYST OPINION: The new patent announced today extends protection for Contrave to 2034, analysts at Piper Jaffray stated. The firm thinks the new data could possibly drive a competitive advantage in the U.S. market for Contrave, and enhance probability of approvals outside the U.S. It kept an Overweight rating on Orexigen and raised its price target on the stock to $26 from $16. Meanwhile, Leerink noted the data show a statistically significant Contrave benefit in the intent-to-treat population on MACE, myocardial infarction, stroke, and cardiovascular death. The firm believes the results "present meaningful upside to expectations" and could have a positive impact on the Contrave launch if they are included on the drug's labels. Leerink reiterates an Outperform rating on Orexigen. OTHERS TO WATCH: Other companies that offer weight loss drugs that compete with Contrave include VIVUS (VVUS) and Arena Pharmaceuticals (ARNA). PRICE ACTION: In morning trading, Orexigen shares surged 44.5% to $8.37, VIVUS shares rose 8% to $2.99 and Arena slid 3.5% to $4.13.
11:01 EDTOREXOrexigen price target raised to $26 from $16 at Piper Jaffray
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10:47 EDTOREXOrexigen Contrave data offer upside to expectations, says Leerink
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10:42 EDTOREXOrexigen discloses patents with data on Contrave effect on CV outcomes
Orexigen disclosed in a regulatory filing that on March 3 the United States Patent and Trademark Office issued U.S. Patent No. 8,969,371 and made publicly available provisional patent applications to which the '371 Patent claims priority. The '371 Patent and the Provisional Patent Applications incorporate data from a pre-planned interim analysis of the large, randomized, placebo-controlled, cardiovascular, or CV, outcomes trial of Contrave, or the Light Study. The '371 Patent, which expires in 2034, is the first in the Light Study family of patent applications Orexigen has prosecuted and covers two subgroups of the larger Light Study patient population. The Provisional Patent Applications are part of the same family of patent applications that were first filed in December 2013. The '371 Patent and the Provisional Patent Applications contain claims related to a positive effect of Contrave on CV outcomes. The observed effects on CV outcomes were unexpected and appear to be unrelated to weight change, the company said. Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater or 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition "Importantly, the U.S. package insert for Contrave states that the effect of Contrave on CV morbidity and mortality has not been established," the company noted. For regulatory approval purposes, the Light Study included a pre-planned interim analysis designed to exclude a doubling of CV risk compared to placebo. This analysis was conducted based on 94 observed and adjudicated major adverse cardiovascular events, which was approximately 25% of the planned MACE for the Light Study. The 25% Interim Analysis was prospectively designed to enable an early and preliminary assessment of safety to support regulatory approval. A larger number of MACE are required to precisely determine the effect of Contrave on CV outcomes, Orexigen said.
08:37 EDTPFEPfizer says EC approves expanded indication for Prevenar 13
Pfizer announced that the European Commission approved an expanded indication for the use of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed -- for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults, which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia, including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.
March 2, 2015
16:49 EDTAMGNAmgen announces presentation of 15 abstracts from cardiovascular pipeline
Amgen announced that it will present 15 abstracts, including data evaluating, an investigational cholesterol-lowering medication, and Corlanor, an investigational drug for chronic heart failure, at the upcoming American College of Cardiology's 64th Annual Scientific Session, being held March 14-16 in San Diego. Repatha is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol, or "bad" cholesterol, from the blood. Corlanor is an oral drug that acts on the body's cardiac pacemaker to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization. Among the abstracts is a Late-Breaking Clinical Trial presentation of LDL-C lowering and major adverse cardiovascular event data after one year of treatment from the OSLER-1 and -2 studies in the Repatha program, and an oral presentation of long-term data from the OSLER-1 trial evaluating the safety and efficacy of Repatha after two years of treatment. Repatha data presentations also include a pooled safety analysis in over 6,000 patients from Phase 2 and 3 short- and long-term clinical trials. The Phase 3 results from the YUKAWA-2 study evaluating Repatha in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol will also be presented. Additionally, two analyses from the Phase 3 SHIFT study evaluating Corlanor will be presented. These data include an oral presentation on the efficacy profile of Corlanor in patients with chronic heart failure and angina, and a poster on whether the addition of Corlanor to optimized background therapy affects beta blocker usage.
16:31 EDTPFEPfizer files automatic mixed securities shelf
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16:26 EDTJNJOn The Fly: Closing Wrap
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16:15 EDTAMGNAmgen announces launch of Neulasta Delivery Kit
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12:13 EDTJNJOn The Fly: Midday Wrap
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11:52 EDTJNJJohnson & Johnson EPS dilution from Cordis deal seems modest, says Wells Fargo
Wells Fargo estimates that Johnson & Johnson's (JNJ) planned sale of Cordis to Cardinal Health (CAH) should dilute J&J yearly EPS by about 3c-4c, assuming all is else equal, and the firm expects the company to be able to absorb at least some of this dilution and possibly offset the rest via share repurchases. Wells maintains its Outperform rating on J&J shares.
09:19 EDTAMGNLigand data should establish superiority of Kyprolis, says Roth Capital
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09:02 EDTPFEAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
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08:53 EDTSNY, NVONon-profit gives lukewarm review to MannKind inhaled insulin, TheStreet says
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08:01 EDTJNJCardinal Health offers to buy Cordis from Johnson & Johnson in $1.99B deal
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07:53 EDTJNJCardinal Health to host conference call
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07:35 EDTJNJCardinal Health to buy Cordis from Johnson & Johnson in $1.99B deal
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07:35 EDTJNJCardinal Health to acquire Cordis for $1.94B in cash
Cardinal Health (CAH) announced plans to acquire Johnson & Johnson's (JNJ) Cordis business, a global manufacturer of cardiology and endovascular devices, for $1.94B in cash, or approximately $1.59B, net of the present value of tax benefits. The acquisition is expected to be financed with a combination of $1B in new senior unsecured notes and the remainder with existing cash. The transaction is expected to close in the United States and key non-U.S. countries towards the end of calendar 2015. Assuming this timing, Cardinal Health expects fiscal 2017 accretion in non-GAAP diluted earnings per share from continuing operations of greater than 20c per share, which includes the cost of an incremental 7c-8c per share of interest expense associated with financing the transaction. The company expects the acquisition to be increasingly accretive thereafter and assumes that synergies will exceed $100M annually by the end of fiscal 2018. Cordis had annual sales in 2014 of approximately $780M, split almost evenly between cardiology and endovascular products. Upon completion of that process, Cardinal Health expects to enter into a definitive purchase and sale agreement in respect of the proposed acquisition. The proposed transaction will also be subject to customary closing conditions, including regulatory approvals, and is expected to close in the approximately 20 principal countries towards the end of calendar year 2015 and in the remaining countries on a rolling basis afterward.
07:20 EDTSHPGCowen to hold a conference
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07:17 EDTAMGNCelimmune announces Anti-IL-15 antibody licensing, option agreements with Amgen
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07:17 EDTSHPGShire submits application to FDA for approval of lifitegrast
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March 1, 2015
19:08 EDTAMGNAmgen ENDEAVOR study demonstrates superiority of Kyprolis over Velcade
Amgen and its subsidiary Onyx Pharmaceuticals announced the results from a planned interim analysis showing that the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis, carfilzomib, for Injection in combination with low-dose dexamethasone versus Velcade, bortezomib and low-dose dexamethasone met the primary endpoint of progression-free survival, PFS. Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade. The Kyprolis combination demonstrated superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study. In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the Velcade arm. There was an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to Velcade and that observed in the ASPIRE study.
February 27, 2015
16:22 EDTSHPGStocks have another winning week after Greek deal, Yellen reassurance
Stocks ended higher this week after the euro zone sealed its deal to extend Greece's bailout and Fed chair Janet Yellen reiterated that the central bank would take a patient approach to raising interest rates. MACRO NEWS: Last Friday afternoon, Greece reached a framework deal with its euro zone partners to extend its bailout by four months, contingent on a reform proposal being accepted. The proposals were accepted by the EU early this week... In testimony before Congress, Janet Yellen reiterated that the Federal Reserve can remain patient in deciding when to hike interest rates... U.S. economic data was mixed, as the Q4 GDP growth revision, durable goods orders for January, and an index of consumer sentiment beat expectations, but weekly jobless claims and existing home sales for January missed expectations... Somewhat positive economic data came out of China, as the flash HSBC/Markit Purchasing Managers' Index was 50.1, representing a four month high. However, China's export orders declined at the fastest rate in 20 months. COMPANY NEWS: Drug maker Valeant (VRX) agreed to buy Salix (SLXP), which develops gastrointestinal products, for $158 per share. In another development on the M&A front, Bloomberg reported that HP (HPQ) is in talks to make its biggest acquisition in several years by potentially acquiring Aruba Networks (ARUN), which provides Wi-Fi products. Additionally, PTC Therapeutics (PTCT) rose after Reuters said the company is working with financial advisers to explore a potential sale after receiving takeover interest from several companies including Shire (SHPG) and BioMarin (BMRN)... Solar energy company SunPower (SPWR) was one of this week's big winners after its quarterly results topped expectations, and the company announced that it's in advanced talks to form a joint YieldCo vehicle with peer First Solar (FSLR). First Solar also rallied after the news... Among the noteworthy losers this week was Lumber Liquidators (LL), after the company reported Q4 earnings per share and revenue that missed consensus expectations. The flooring retailer also warned on its associated call that an upcoming "60 Minutes" piece may cast the company in an unfavorable light and disclosed in its annual report that the Department of Justice indicated in recent communications that it is contemplating seeking criminal charges under the Lacey Act... Companies that rose after reporting their quarterly results included Home Depot (HD) and Gap (GPS), while HP, TASER (TASR), and J.C. Penney (JCP) dropped after reporting their results. INDEXES: For the week, the Dow was down 0.04% to 18,132.70, the Nasdaq was up 0.15% to 4,963.53, and the S&P 500 was down 0.27% to 2,104.50.
14:34 EDTJNJPharmacyclics says Imbruvica combination enhances anti-tumor activity
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09:03 EDTAMGNAmgen receives positive CHMP opinion for use of Vectibix
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix to include combination with FOLFIRI as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer. About half of the patients with mCRC have wild-type RAS tumors.The new indication is based upon the 20060314 study, which evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is already approved in the European Union for the treatment of adult patients with wild-type RAS mCRC.
08:34 EDTAGNAllergan says FDA approves Natrelle Inspira breast implants
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08:15 EDTJNJJohnson & Johnson would benefit from Pharmacyclics deal, says Wells Fargo
After Bloomberg and The Financial Times reported that Johnson & Johnson (JNJ) and Novartis (NVS) are interested in buying Pharmacyclics (PCYC), Wells Fargo thinks the deal would cause a slight acceleration of Johnson & Johnson's revenue growth. The firm believes that the deal could be slightly dilutive to Johnson & Johnson's EPS in the first full year and 1%-4% accretive thereafter. Wells keeps an Outperform rating on Johnson & Johnson.
07:37 EDTAMGNAmgen removed from the short-term buy list at Deutsche Bank
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07:26 EDTAMGNFDA PDUFA Date for Amgen's Ivabradine is February 27, 2015
07:22 EDTSNYSanofi reports positive opinion from CHMP for Toujeo
Sanofi announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion recommending the approval of Toujeo, a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus with low within-individual, within-day blood sugar variability. The European Commission is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the FDA and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units, and it has a maximum single injection dose of 80 IU.
February 26, 2015
18:44 EDTNVONovo Nordisk receives Health Canada approval for Saxenda
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16:35 EDTAMGNAmgen reports EMA acceptance of Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Kyprolis for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA. Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe. Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment. The MAA includes data from the Phase 3 ASPIRE trial as well as other relevant data.
15:20 EDTMRKMerck says GARDASIL 9 recommended by CDC advisory committee
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12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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09:41 EDTJNJ, MRKHospira launches generic Remicade, WSJ says
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08:21 EDTOREXOrexigen Contrave sales encouraging, says RBC Capital
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08:03 EDTJNJJohnson & Johnson forms new health and wellness platform
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07:22 EDTOREXOrexigen Contrave off to strong start, says JMP Securities
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06:52 EDTJNJPharmacyclics downgraded to Hold from Buy at WallachBeth
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05:32 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
Sanofi announced that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations.
February 25, 2015
20:05 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
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16:50 EDTAMGNAmgen reports positive results from head-To-head Phase 3 study
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14:47 EDTJNJPharmacyclics could fetch as much as $19B in sale, FT says
Pharmacyclics (PCYC) is considering a sale that could fetch as much as $19B, reported Financial Times, citing people familiar with the matter who said Johnson & Johnson (JNJ) is exploring a potential deal for the company. The Fly notes that Bloomberg had a similar report, but its report said Pharmacyclics could fetch $17B-$18B in a sale. Reference Link
14:10 EDTJNJPharmacyclics downgraded to Hold on lack of upside at Deutsche Bank
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12:54 EDTJNJPharmacyclics exploring options including sale, Bloomberg reports
According to sources, Pharmacyclics (PCYC), which develops cancer treatments, is currently exploring options, Bloomberg reports. One option may include a sale of the company, and the sources say Johnson & Johnson (JNJ) and Novartis (NVS) have expressed interest in the company. Pharmacyclics could fetch $17B-$18B in a sale, the sources add. Reference Link
12:53 EDTJNJPharmacyclics weighing sale to U.S. drugmaker, Bloomberg reports
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08:08 EDTMRKMerck to present new data from IMPROVE-IT, TRA 2ºP studies
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06:33 EDTOREXOrexigen reports Q4 EPS 0c, consensus 21c
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06:14 EDTSHPGPTC Therapeutics takeout price likely tops $100/share, said Credit Suisse
Credit Suisse yesterday raised its price target for PTC Therapeutics (PTCT) shares to $100 from $66 after Reuters reported the drug market is starting a sale process with Shire (SHPG) and Biomarin (BMRN) as possible suitors. The firm believes a takeout is a likely outcome before or after data the Phase III data expected to be announced in October. PTC has Translarna Phase III trials ongoing in Duchenne muscular dystrophy and cystic fibrosis to support full approval in the U.S. Credit Suisse said yesterday in a note to investors that a takeout value for the company likely exceeds $100 per share. It believes PTC would be a good fit for Vertex (VRTX), Biogen (BIIB), Roche (RHHBY) and others. The firm kept an Outperform rating on the stock. PTC Therapeutics shares closed yesterday up $6.20 to $71.16.
February 24, 2015
16:04 EDTINFIInfinity Pharmaceuticals reports Q4 EPS (83c), consensus (98c)
Reports Q4 revenue $4.36M, consensus $5.61M. Completion of patient enrollment in DYNAMO and DUO trials expected in 2015, topline data from DYNAMO is anticipated in the second half of 2015 and three new clinical studies of Duvelisib are expected to begin in 2015, the company said. At December 31, 2014, Infinity had total cash, cash equivalents and available-for-sale securities of $333.2M, compared to $214.5M at December 31, 2013.
09:03 EDTOREXUltragenyx adds Orexigen CEO to board
Ultragenyx Pharmaceutical (RARE) announced the appointment of Michael Narachi to the company's board, effective February 20. Narachi, President and CEO and a director of Orexigen Therapeutics (OREX), will serve as an independent director to Ultragenyx.
08:10 EDTOREXOrexigen resumed with an Outperform at Leerink
Target $8.
08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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07:05 EDTSHPGShire acquires Meritage Pharma
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05:17 EDTMRKMerck collaborates with Medicines Patent Pool to expand Raltegravir access
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February 23, 2015
16:27 EDTSHPGOn The Fly: Closing Wrap
Stocks on Wall Street began the session in negative territory and remained there for most of the session, with the Nasdaq the lone index to post a small gain. The Dow was weighed down by shares of Boeing (BA), which slid after the stock received a downgrade. There was little in the way of positive economic news, as the most notable report showed existing homes were lower than expected due to a shortage of inventory. The averages drifted for most of the session, as investors may be waiting on the sidelines ahead of tomorrow’s banking panel testimony by Fed Chair Janet Yellen. ECONOMIC EVENTS: In the U.S., the Chicago Fed national activity index rebounded to 0.13 in January, which was nearly in-line with expectations. Existing home sales dropped 4.9% to a 4.82M rate in January, which was much worse than the expected 1.8% drop to a 4.95M unit rate. In Europe, the Ifo Institute’s measure of German business confidence rose to 106.8 in February, which was up a tenth of a percentage point from the previous month but below the 107.7 consensus forecast. Also, the Bank of Israel became the latest central bank to cut rates this year, lowering its main interest rate to 0.1% from 0.25%. COMPANY NEWS: The shares of a number of health insurers rose after the Centers for Medicare and Medicaid Services, or CMS, issued preliminary 2016 Medicare Advantage rates. According to Credit Suisse, the rates were favorable for the insurers. Following the CMS announcement made late Friday, Humana (HUM) climbed $8.40, or 5.38%, to $164.52, UnitedHealth (UNH) rose $3.78, or 3.36%, to $116.40, and WellCare (WCG) gained $4.68, or 5.53%, to $89.30. MAJOR MOVERS: Among the notable gainers was PTC Therapeutics (PTCT), which jumped $9.77, or 17.7%, to $64.96 after Reuters said the company is working with financial advisers to explore a potential sale after receiving takeover interest from several companies including Shire (SHPG) and BioMarin (BMRN). Also higher was Valeant (VRX), which rose $25.49, or 14.71%, to $198.75 after the company agreed to buy Salix (SLXP) for $158 per share and also reported better-than-forecast earnings. Salix shares, however, fell $2.09, or 1.32%, to $155.76, as a report Friday from CNBC's David Faber telegraphed the deal and suggested Valeant could value Salix around $160 per share. Among the noteworthy losers was Spectrum Pharmaceuticals (SPPI), which dropped $1.18, or 15.82%, to $6.28 after a judge ruled that a drug which could compete with the company's Fusilev treatment does not infringe on the company's intellectual property. Also lower were shares of Boeing, which fell $3.57, or 2.26%, to $154.74 after the stock was downgraded to Sell from Neutral at Goldman Sachs. INDEXES: The Dow fell 23.60, or 0.13%, to 18,116.84, the Nasdaq gained 5.01, or 0.1%, to 4,960.97, and the S&P 500 slipped 0.64, or 0.03%, to 2,109.66.
12:53 EDTSHPGAnalysts debate potential for competing Salix takeover bid
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12:29 EDTSHPGPTC Therapeutics exploring potential sale, Reuters reports
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08:27 EDTMRKNGM Biopharmaceuticals to hold a teleconference
NGM Biopharm discusses the strategic collaboration with Merck to discover, develop and commercialize novel biologic therapeutics on a teleconference to be held on February 23 at 9:30 am. Webcast Link
07:55 EDTSHPGJefferies says other bidders may emerge for Salix
Jefferies says it could envision other bidders emerging for Salix (SLXP) and points out recent media reports have suggested Shire (SHPG) and Endo (ENDP) have considered making a bid for the company. It lists AstraZeneca (AZN) and Takeda as others who could have possible interest in Salix. The firm believes Valeant (VRX) could afford to pay more for Salix should other bidders emerge.
07:04 EDTMRKMerck, NGM Biopharmaceuticals announce multi-year collaboration
NGM Biopharmaceuticals and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. This agreement will become effective upon the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The collaboration includes multiple drug candidates currently in preclinical development at NGM, including NP201, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis. NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof of concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved. Under the terms of the agreement, Merck will make an upfront payment to NGM of $94M and will purchase a 15 percent equity stake in NGM for $106M at a price per share that represents a 20% premium to NGM’s most recent financing. Merck will commit up to $250M to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck will have the option to extend the research agreement for two additional two-year terms.
February 22, 2015
18:04 EDTSHPGShire completes acquisition of NPS Pharma
Shire (SHPG) announces the successful completion of the tender offer for all of the outstanding shares of NPS Pharmaceuticals (NPSP) and the subsequent acquisition of NPS Pharma.The tender offer expired at 12:00 midnight, New York City time, at the end of Friday, February 20, and was not extended. As of the expiration of the tender offer, a total of approximately 88,869,118 common shares of NPS Pharma had been validly tendered and not withdrawn pursuant to the tender offer, representing approximately 81.7% of the outstanding common shares of NPS Pharma. All shares that were validly tendered and not withdrawn pursuant to the tender offer were accepted for payment. After the acceptance of shares that were validly tendered and not withdrawn pursuant to the tender offer, Shire completed the acquisition of NPS Pharma today through a merger of one of Shire's subsidiaries with and into NPS Pharma. In connection with the merger, all common shares of NPS Pharma that were not accepted for payment in the tender offer (excluding any shares held by NPS Pharma as treasury stock (other than any shares held in an NPS Pharma benefit plan) and any shares with respect to which the holders have properly demanded appraisal rights in accordance with Delaware law) were converted into the right to receive $46.00 per share in cash, without interest and less any applicable withholding taxes, the same price that will be paid for shares accepted for payment in the tender offer. Following completion of the merger, NPS Pharma became a wholly owned subsidiary of Shire and NPS Pharma's shares ceased to be traded on NASDAQ.
15:59 EDTSHPGValeant to buy Salix for $10.1B, FT says
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12:51 EDTJNJJ&J considers Cordis sale with Cardinal the leading suitor, Bloomberg says
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February 20, 2015
17:31 EDTJNJJ&J considering sale of Cordis with Cardinal the leading suitor, Bloomberg says
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16:03 EDTJNJOptions Update; February 20, 2015
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12:02 EDTNVOEmisphere says Novo Nordisk completes Phase 2 OG217SC trial
Emisphere Technologies (EMIS) highlighted positive Phase 2 data from Eligen licensee Novo Nordisk (NVO) pertaining to OG217SC, the oral formulation of semaglutide, a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. OG217SC is provided in a tablet formulation with an absorption-enhancing excipient, SNAC. SNAC is included in the Eligen Carrier Concept. Novo Nordisk announced that it has successfully completed the phase 2 trial for OG217SC, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks. Results of the study are available on Novo Nordisk's website. Based on these results, Novo Nordisk announced that it will initiate consultations with regulatory authorities subsequent to which a decision of whether to progress OG217SC into phase 3 development will be made. Under its GLP-1 License Agreement, Novo Nordisk is working to develop and commercialize oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere carriers. Under the GLP-1 License Agreement, Emisphere could receive additional contingent product development and sales milestone payments and would also be entitled to receive royalties in the event Novo Nordisk commercializes products developed under such Agreement. Under the GLP-1 License Agreement, Novo Nordisk is responsible for the development and commercialization of the products.
10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
09:38 EDTJNJActive equity options trading on open
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07:23 EDTPFE, JNJAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTSHPG, SNY, MRK, AGNAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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16:50 EDTSNYSanofi appoints Olivier Brandicourt CEO
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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09:59 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Altisource Residential (RESI) upgraded to Neutral from Sell at Compass Point... Angie's List (ANGI) upgraded to Overweight from Equal-Weight at First Analysis... Barrick Gold (ABX) upgraded to Buy from Hold at TD Securities... British Land (BTLCY) upgraded to Buy from Hold at Societe Generale... Coach (COH) upgraded to Buy from Hold at Topeka... Fiat Chrysler (FCAU) upgraded to Outperform from Neutral at Exane BNP Paribas... Garmin (GRMN) upgraded at BofA/Merrill... Hologic (HOLX) upgraded to Buy from Hold at Canaccord... Iberdrola (IBDRY) upgraded to Neutral from Underweight at HSBC... KPN (KKPNY) upgraded to Neutral from Underperform at Exane BNP Paribas... Monster Worldwide (MWW) upgraded at Evercore ISI... Pharmacyclics (PCYC) upgraded to Buy from Neutral at Nomura... RPC, Inc. (RES) upgraded to Equal Weight from Underweight at Morgan Stanley... Sanofi (SNY) upgraded to Buy from Neutral at BofA/Merrill... Sasol (SSL) upgraded to Neutral from Underweight at HSBC... Tractor Supply (TSCO) upgraded at Oppenheimer... Valero (VLO) upgraded to Buy from Hold at Deutsche Bank... Weingarten Realty (WRI) upgraded to Neutral from Sell at UBS... Werner (WERN) upgraded on improving freight fundamentals at RBC Capital... diaDexus (DDXS) upgraded to Buy from Neutral at Ladenburg,
08:38 EDTMRKNewLink reports clinical development milestone achieved with Merck for rVSV-EBOV
NewLink Genetics (NLNK) announced that it had received notification from Merck (MRK) that the milestone event specified in the license and collaboration agreement between the two companies relating to the further development of the rVSV-EBOV, Ebola, vaccine candidate had been achieved. Under the terms of the agreement, NewLink Genetics will receive a payment of $20M in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.
07:40 EDTAGNActavis price target raised to $352 from $300 at Canaccord
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07:12 EDTPFEWharton Health Care Club to hold a conference
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06:21 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
05:31 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
February 18, 2015
16:46 EDTAGN, JNJOn The Fly: Closing Wrap
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12:36 EDTJNJAnalysts applaud cheaper than expected Boston Scientific settlement
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12:31 EDTJNJ, AGNOn The Fly: Midday Wrap
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09:48 EDTAGNActavis Q4 'exceptional,' taking Allergan name 'wise,' says BMO Capital
BMO Capital says Actavis (ACT) is "firing on all cylinders" after reporting "exceptional" Q4 earnings on the strength of the company's North American Generics and International segment. BMO views the decision to adopt the Allergan (AGN) name as "wise" given the Botox maker's strong reputation. The firm keeps an Outperform rating on Actavis.
09:05 EDTSGENSeattle Genetics submits supplemental BLA to FDA for Phase 3 Aethera trial
Seattle Genetics announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration based on data from the phase 3 AETHERA trial of ADCETRIS as consolidation therapy immediately following an autologous stem cell transplant in Hodgkin lymphoma patients at high risk of relapse. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma. ADCETRIS is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT. The supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA that were presented at the 56th American Society of Hematology Annual Meeting in December 2014. Results from the AETHERA trial in 329 HL patients at high risk of relapse included: The trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate was 63 percent in the ADCETRIS arm compared to 51 percent in the placebo arm. The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease.
07:50 EDTAGNActavis CEO says company gave appropriate guidance to analysts
Actavis (ACT) CEO Saunders said he believes that the company did provide appropriate guidance to analysts ahead of its earnings beat. Saunders sees the Allergan (AGN) deal closing by the end of this quarter or early next quarter. Saunders says tying R&D to a percentage of revenue "makes no sense to me," noting that Actavis will spend about $1.7B on R&D next year. Saunders says will do acquisition if opportunity arises, but not planning for M&A right now. Actavis CEO Brent Saunders is speaking on CNBC.
07:41 EDTJNJSettlement 'a big win' for Boston Scientific, says Bernstein
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07:12 EDTJNJBoston Scientific settlement should remove overhang, says Stifel
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07:09 EDTJNJBoston Scientific payment to J&J well below expectations, says Piper Jaffray
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07:01 EDTAGNActavis announces intention to adopt 'Allergan' corporate name
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06:34 EDTAGNActavis sees Allergan transaction completed in late Q1 or early Q2
February 17, 2015
18:17 EDTAMGNJANA Partners gives quarterly update on stakes
NEW STAKES: NCR (NCR), Liberty Ventures (LVNTA), Solarcity (SCTY), Computer Sciences Corp (CSC), Salix (SLXP), and Applied Materials (AMAT). INCREASED STAKES: Hertz (HTZ), Valeant (VRX), Walgreens Boots Alliance (WBA), Rackspace (RAX), and HD Supply (HDS). DECREASED STAKES: AIG (AIG), Actavis (ACT), Charter (CHTR), AerCap (AER), and Energy Transfer Equity (ETE). LIQUIDATED STAKES: Equinix (EQIX), Cameron International (CAM), Dollar General (DG), QEP Resources (QEP), and Amgen (AMGN).
18:06 EDTSHPG, AGNPaulson & Co gives quarterly update on stakes
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17:18 EDTAGNPershing Square gives quarterly update on stakes
NEW STAKES: Restaurant Brands International (QSR). INCREASED STAKES: Zoetis (ZTS), and Platform Specialty Products (PAH). DECREASED STAKES: Allergan (AGN). LIQUIDATED STAKES: None.
17:02 EDTAGNSoros Fund Management gives quarterly update on stakes
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16:29 EDTJNJ Boston Scientific announces settltement of merger agreement lawsuit
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15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
13:52 EDTAGNEarnings Preview: Actavis near 52-week high ahead of Q4 earnings report
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11:38 EDTSNYGenzyme reports publication of ENGAGE registration study results
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10:01 EDTPFE, AMGNCVS says PCSK9 inhibitors could cost system $150B annually
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09:12 EDTSHPGShire multiple poised to expand, says SunTrust
SunTrust believes that Shire's rare disease unit will account for 40% of its 2020 sales, versus the company's estimate of about 35%. As a result, the firm expects the company's multiple to "re-rate." The firm thinks that the company's long-term growth outlook is underappreciated, and it keeps a $262 price target and Buy rating on the shares.
07:04 EDTJNJGTx names Robert Wills as executive chairman
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