New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
<< 1 | 2 | 3 | 4 | all recent news | >>
January 30, 2015
18:27 EDTSHPGShire announces FDA approval of Vyvanse
Subscribe for More Information
11:37 EDTMRKMerck weekly volatility elevated into Q4 and outlook
Subscribe for More Information
11:11 EDTAMGNAmgen trades lower, levels to watch
Subscribe for More Information
07:35 EDTPFEPfizer issues to Repligen a notice of termination under 2012 license agreement
Subscribe for More Information
06:55 EDTSNYSanofi having hard time finding new CEO, Reuters reports
Subscribe for More Information
06:45 EDTJNJSome suggest doctors could be using stents too often, NY Times reports
Subscribe for More Information
06:34 EDTPFE, AMGN, MRKObama to propose $215M for major medical program, CNBC says
Subscribe for More Information
06:30 EDTPFEEli Lilly FY15 EPS guidance does not include 12c potential charge
Subscribe for More Information
05:14 EDTJNJQuotient, OCD establish exclusive commercial partnership for MosaiQ
Quotient (QTNT) announced that they are entering into a broad strategic collaboration to sell and distribute Quotient's MosaiQ platform within the $2.8B global transfusion diagnostics market. Under the terms of an exclusive Distribution and Supply Agreement, Quotient retains all rights to commercialize MosaiQ in North America, the European Union and certain Asia-Pacific territories, excluding Japan, for the donor testing market, while, Ortho Clinical Diagnostics, or OCD, a full and separate member of the Johnson & Johnson Family of Companies (JNJ), has acquired exclusive rights to sell and distribute MosaiQ for the global patient testing market and the donor testing market in territories not covered by Quotient. Quotient will be responsible for the manufacture of all products associated with MosaiQ and has retained all other commercial rights to MosaiQ with OCD receiving a right of first offer where Quotient decides to commercialize MosaiQ with a third party for an application other than blood grouping. In connection with the transaction, OCD has subscribed for 444,445 new Quotient Ordinary shares at an issue price of $22.50 per new Ordinary share, raising $10M of equity proceeds, and $15M of 7% redeemable preference shares. Following the transaction, OCD will own approximately 2% of Quotient's fully diluted ordinary share capital. Quotient will also be entitled to receive payments totaling $59M upon the achievement of specified regulatory approvals and commercial milestones, which primarily relate to the approval and launch of MosaiQ in the U.S. and the European Union for blood grouping. Quotient and OCD have also agreed to explore opportunities to develop and commercialize MosaiQ in other diagnostics applications outside of blood grouping and serological disease screening, utilizing the combined knowledge and expertise of both parties.
January 29, 2015
11:46 EDTJNJPharmacyclics confirms FDA approval of IMBRUVICA
Subscribe for More Information
10:50 EDTJNJFDA expands use of Imbruvica to rare form of cancer
The FDA expanded the approved use of Imbruvica for previously treated patients with Waldenström’s macroglobulinemia, a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use. The product's new use is being approved more than two months ahead of its prescription drug user fee goal date of April 17, the date the FDA was scheduled to complete review of the drug application. Imbruvica is co-marketed by Pharmacyclics (PCYC) and Johnson & Johnson's (JNJ) Janssen Biotech unit.
09:07 EDTMRKHead researchers of Vertex, Regeneron, Merck invited to White House, CNBC says
Subscribe for More Information
08:45 EDTAMGNAmgen weakness creates buying opportunity, says Argus
After Amgen dropped as investors were disappointed that the company did not raise its guidance, Argus thinks the company is doing a good job of launching its next generation of blockbuster drugs, while its pipeline appears promising. The firm keeps a Buy rating on the stock.
08:15 EDTPFEOPKO Health, Pfizer receive regulatory clearance for global agreement
Subscribe for More Information
07:58 EDTJNJMedivation price target raised to $128 from $112 at Stifel
After surveying 25 urologists, Stifel believes that MEdivation's (MDVN) Xtandi drug has surpassed its main competitor, Johnson & Johnson's (JNJ) Zytiga, as a treatment of prostate cancer prior to chemotherapy. Stifel keeps a Buy rating on Medivation.
January 28, 2015
09:15 EDTAMGNOn The Fly: Pre-market Movers
Subscribe for More Information
07:39 EDTPFEPfizer CEO says company not in need of big M&A deal, FT reports
Subscribe for More Information
January 27, 2015
17:04 EDTSHPGShire granted petitiion by U.S. Supreme Court
Subscribe for More Information
17:00 EDTAMGNAmgen Q4 Enbrel sales grew 19% quarter over quarter
Subscribe for More Information
16:15 EDTAMGNAmgen submits applications in US and Europe for Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced the submission of a supplemental New Drug Application,sNDA to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for Kyprolis for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. In the U.S., the sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. In the European Union, Kyprolis received orphan drug designation and the MAA has been granted accelerated assessment. The sNDA and MAA are based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data. "Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals, Inc. "The U.S. and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma."
16:06 EDTAMGNAmgen trades higher after hours, levels to watch
Subscribe for More Information
16:04 EDTAMGNAmgen backs FY15 EPS view $9.05-$9.40, consensus $9.29
Backs FY15 revenue view $20.8B-$21.3B, consensus $20.87B.
16:03 EDTAMGNAmgen reports Q4 EPS $2.16, consensus $2.05
Subscribe for More Information
15:35 EDTAMGNNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Apple (AAPL), consensus $2.60; AT&T (T), consensus 55c; Amgen (AMGN), consensus $2.05; Yahoo (YHOO), consensus 29c; ACE (ACE), consensus $2.29; Stryker (SYK), consensus $1.45; Western Digital (WDC), consensus $2.10; Electronic Arts (EA), consensus 92c; Juniper (JNPR), consensus 31c; Total System Services (TSS), consensus 53c; Freescale Semiconductor (FSL), consensus 33c; Amdocs (DOX), consensus 81c; VMware (VMW), consensus $1.07; International Game Technology (IGT), consensus 25c; United States Steel (X), consensus 87c; Cytec (CYT), consensus 61c.
12:57 EDTAMGNEarnings Preview: Amgen's Kyprolis, Prolia sales key for Q4 results
Subscribe for More Information
11:29 EDTJNJBayer, Janssen form collaboration to study Xarelto in stroke patients
Subscribe for More Information
07:16 EDTPFEPfizer drops 2.7% after FY15 outlook miss expectations
Subscribe for More Information
07:07 EDTPFEPfizer sees FY15 adjusted EPS $2.00-$2.10, consensus $2.18
Subscribe for More Information
07:01 EDTPFEPfizer reports Q4 adjusted EPS 54c, consensus 53c
Reports Q4 revenue $13.1B, consensus $12.9B.
January 26, 2015
17:34 EDTAGNActavis registration statement for Allergan acquisition declared effective
Subscribe for More Information
16:15 EDTPFEPfizer commits to lower price for Prevenar 13 in developing countries
Subscribe for More Information
15:40 EDTPFENotable companies reporting before tomorrow's open
Subscribe for More Information
13:29 EDTPFEEarnings Preview: Pfizer set to report Q4 results as generics impact Celebrex
Subscribe for More Information
08:52 EDTJNJCourt ruling likely to be positive for Boston Scientific, says Bernstein
Subscribe for More Information
08:31 EDTMRKMerck says CHMP issues positive opinion for Sivextro
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO for the treatment of acute bacterial skin and skin structure infections in adults. Merck acquired SIVEXTRO as a part of its purchase, through a subsidiary, of Cubist Pharmaceuticals, Inc. The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. SIVEXTRO is a once-daily oxazolidinone antibiotic developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria.
08:21 EDTSHPGShire the 'real winner' after NPS gets approval for Natpara, says Janney Capital
Janney Capital said NPS Pharmaceuticals' (NPSP) getting FDA approval for its second marketed product, Natpara, is a positive for NPS, but that the "real winner" is Shire (SHPG), noting that the company had no stipulations dependent on Natpara approval in its deal to buy NPS. The firm expects the acquisition to move forward as planned and maintains its Neutral rating on NPS shares.
07:27 EDTSHPGShire price target raised to $263 from $247 at Jefferies
Subscribe for More Information
05:26 EDTSHPGShire SHP609 receives FDA fast track designation
Subscribe for More Information
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 25, 2015
12:30 EDTSHPGShire comments on press release from NPS Pharma on Natpara approval
Subscribe for More Information
January 23, 2015
16:55 EDTJNJMarket ends week higher after ECB announces bond purchase plan
Stocks finished higher for the week after the European Central Bank unveiled a larger than expected bond buying plan and earnings season in the U.S. picked up steam. MACRO NEWS: The European Central Bank announced that it would buy EUR 60B of government and private bonds per month through September 2016. Reports before the ECB's official announcement had suggested that the central bank would buy EUR 50B of bonds per month... On a negative note, the International Monetary Fund cut its 2015 global growth outlook to 3.5% from 3.8%... U.S. economic data was mixed, as weekly jobless claims and sales of existing homes in December were worse than expected, but the index of leading economic indicators and new housing permits for December came in above the consensus outlook. COMPANY NEWS: Netflix (NFLX), Starbucks (SBUX), firearm maker Smith & Wesson (SWHC), and Southwest Airlines (LUV) were among the companies whose stocks rose following their results and guidance. On the other side of the ledger, Johnson & Johnson (JNJ), IT management solution provider CA Technologies (CA), UPS (UPS), and application delivery networking products maker F5 Networks (FFIV) were among the companies that fell after they reported their earnings or updated their financial outlooks... M&A reports moved a number of stocks this week. The Financial Post reported that Samsung (SSNLF) had hired investment bank Evercore (EVR) to evaluate a purchase of the troubled Canadian company. Samsung is still considering purchasing BlackBerry (BBRY), the newspaper added. However, Canada's BNN reported that Evercore said that Samsung has not been a recent client of theirs and that they prepare ideas "routinely" on their "own accord." Avon (AVP) has held talks about a potential sale to private equity firm TPG Capital, dealReporter stated. Bloomberg reported that online travel agency Orbitz Worldwide (OWW) is working with an adviser to contact potential buyers and has drawn interest from private-equity funds and other Internet companies... DreamWorks Animation (DWA) tumbled after announcing a new strategic plan that will see it cut its feature production from three films per year down to two and axe about 500 jobs. INDEXES: For the week, the Dow dipped 0.37% to 17,672.60, the Nasdaq rose 1.14% to 4,757.88, and the S&P gained 0.34% to 2,051.82.
16:08 EDTPFETeva volatility elevated, Pfizer approached late last year, Bloomberg says
Teva (TEVA) overall option implied volatility of 25 compares to its 26-week average of 23 according to Track Data, suggesting large price movement into Pfizer (PFE) approach late last year, Bloomberg says.
16:04 EDTPFETeva rebuffed Pfizer approach late last year, Bloomberg says
Subscribe for More Information
10:02 EDTOREXOn the Fly: Analyst Initiation Summary
Subscribe for More Information
06:39 EDTJNJ, MRKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
Subscribe for More Information
January 22, 2015
16:15 EDTOREXOrexigen initiated with an Outperform at RBC Capital
Subscribe for More Information
14:33 EDTNVONovo Nordisk receives positive opinion from CHMP for Saxenda
Subscribe for More Information
11:23 EDTPFEPfizer says CHMP adopted positive opinion on Prevenar 13 expansion
Subscribe for More Information
10:05 EDTINFIHigh option volume stocks
Subscribe for More Information
09:43 EDTINFIActive equity options trading
Active equity options trading according to Track Data: AAPL DG ABX AMZN FXCM LVS FFIV INFI SD
07:31 EDTJNJBoston Scientific damages in case likely to be manageable, says Wells Fargo
Subscribe for More Information
05:27 EDTSHPGShire reports positive response from European DCP for Elvanse Adult
Subscribe for More Information
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
Subscribe for More Information
January 21, 2015
16:35 EDTJNJMinerva reports positive Phase 1 data with MIN-202
Minerva Neurosciences (NERV) announced that preliminary results from a Phase 1 clinical study showed that treatment with MIN-202, a selective orexin-2 antagonist, resulted in significant improvements in sleep onset and sleep duration in patients with comorbid insomnia related to major depressive disorder, or MDD. Preliminary results from two additional Phase 1 studies also suggest that MIN-202 is well tolerated and possesses advantageous pharmacokinetic and pharmacodynamic features. The three Phase 1 studies were conducted by Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), as part of a collaboration to develop MIN-202 with Minerva that was facilitated by Johnson & Johnson Innovation Ltd in London.
12:30 EDTPFE, AGNGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
Subscribe for More Information
10:16 EDTSNY, MRK, AMGN, JNJLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
08:02 EDTMRKMerck completes tender offer to acquire Cubist
Merck (MRK) announced the successful completion of the tender offer for all of the outstanding shares of common stock of Cubist Pharmaceuticals (CBST) at a purchase price of $102.00 per share. As of the tender offer expiration yesterday, 58,039,667 shares of common stock of Cubist were validly tendered and not properly withdrawn from the tender offer, representing approximately 75.7% of the outstanding common stock of Cubist on a fully diluted basis. All of such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for all such shares. Following consummation of the tender offer, Merck expects to complete the acquisition of Cubist later today through a merger of Merck’s wholly owned subsidiary with and into Cubist without stockholder approval. Upon completion of the merger, all outstanding shares of common stock of Cubist, other than shares held by Cubist in treasury or shares held by Cubist’s stockholders who are entitled to and properly exercise appraisal rights under Delaware law, will be canceled and converted into the right to receive cash equal to the $102.00 offer price per share without interest, less any applicable withholding taxes. In addition, upon completion of the merger, Cubist will become a wholly owned subsidiary of Merck and the common stock of Cubist will cease to be traded on the NASDAQ Stock Market.
07:22 EDTAGNActavis price target raised to $330 from $280 at Deutsche Bank
Subscribe for More Information
January 20, 2015
17:18 EDTMRKDana Holding to replace Cubist in S&P 400 as of 1/22 close
Subscribe for More Information
16:23 EDTJNJOn The Fly: Closing Wrap
Stocks began the session in positive territory, but the major averages were unable to hold their early gains. Lackluster earnings reports, the falling price of oil, and lowered global growth expectations appeared to be too much to overcome after a three day holiday weekend. The Dow led the way lower and had losses of more than 100 points before reversing and slowly paring its losses. Late in the day the averages made it back to positive ground, as investors await the next round of earnings due out after the close. ECONOMIC EVENTS: In the U.S., the NAHB homebuilder sentiment index fell to 57 in January, missing expectations for it to hold steady at 58. In China, Q4 GDP growth of 7.3% came in slightly better than expected, though that puts the nation's 2014 GDP growth at 7.4%, which was the lowest reported in 24 years. Of note, the International Monetary Fund cut its forecast for global growth in 2015 to 3.5% and in 2016 to 3.7%, which were both revised down by 0.3% relative to the organization's October 2014 outlook. COMPANY NEWS: Shares of Johnson & Johnson (JNJ) led all decliners on the Dow Jones Industrial Average with a drop of $2.75, or 2.64%, to $101.29 after its Q4 earnings were nearly in-line and its FY15 outlook failed to spur buying of the stock... Morgan Stanley (MS) declined 14c, or 0.4%, to $34.75 after the firm became the latest in the financial space to report headline earnings that missed expectations. MAJOR MOVERS: Among the notable gainers was Smith & Wesson (SWHC), which rose $1.65, or 16.47%, to $11.67 after the gunmaker increased its financial guidance and said it has seen recent, positive trends in the primary indicators it uses to assess its business and the consumer firearm market. Also higher was Orbitz Worldwide (OWW), which jumped 79c, or 8.62%, to $9.95 after Bloomberg reported that the online travel agency is working with an adviser to contact potential buyers and has drawn interest from private-equity funds and "other Internet companies." Among the noteworthy losers was FXCM (FXCM), which plunged $11.03, or 87.33%, to $1.60 after the stock reopened following the company struck a $300M rescue agreement with Leucadia (LUK) and gave further details on that deal over the weekend. Also lower were shares of Redbox owner Outerwall (OUTR), which fell $15.72, or 20.21%, to $62.05 after the company announced that its CEO had stepped down. INDEXES: The Dow rose 3.66, or 0.02%, to 17,515.23, the Nasdaq gained 20.46, or 0.44%, to 4,654.85, and the S&P 500 advanced 3.13, or 0.15%, to 2,022.55.
16:00 EDTJNJOptions Update; January 20, 2015
iPath S&P 500 VIX Short-Term Futures down 36c to 35.12 Option volume leaders: AAPL TSLA TWTR GILD NFLX MGM ABX AMAT JNJ C according to Track Data.
14:06 EDTSHPGCitizens, Keysight identified as long positions by Einhorn
Subscribe for More Information
13:08 EDTJNJOn The Fly: Midday Wrap
Subscribe for More Information
10:33 EDTJNJJohnson & Johnson falls post-earnings, levels to watch
Subscribe for More Information
09:48 EDTJNJJohnson & Johnson says eyeing options in orthopedics, surgical, vision care
Subscribe for More Information
09:21 EDTJNJJ&J says negative impact of currency to be 'more significant' than expected
Says currency impact will be more significant in 1H than in 2H.
09:20 EDTJNJJ&J says 'comfortable' with models reflecting midpoint of FY EPS view
Subscribe for More Information
09:18 EDTJNJJohnson & Johnson sees FY15 reported sales $75B-$76B
Subscribe for More Information
09:18 EDTJNJJohnson & Johnson CEO says core businesses 'strong'
Johnson & Johnson (JNJ) providing sustainable, high quality healthcare "one of society's greatest challenges." Says core businesses "strong," positioned to continue expanding their leadership positions. CEO Alex Gorsky says company is changing the way it interacts with customers, evolving to be more "effective," "efficient." Says U.S. OTC consent decree requirements completed. Says in the process of developing a China lung center. Says still plans to take $1B out of P&L in next three years. Says aims to bring Ebola vaccine to market "as fast as possible." Says "well-positioned" for long-term. Says currency headwinds have increased "quite substantially," negatively impacting sales, earnings to greater extent than company had anticipated. Sees Depomed (DEPO) transaction closing in Q2. Expects R&D tax credit will be renewed in 2015. If R&D tax credit is approved, sees effective tax rate for 2015 of approx. 20%-21%. Sees operational sales growth for 2015 approx. 6%. Says Wall Street forecasts may not adequately reflect likely negative impact in 2015 of foreign exchange. Sees FY15 operational sales growth 1%-2% in constant currency. Comments made on the Q4 earnings conference call.
08:18 EDTJNJJohnson & Johnson sees 10 major Pharmaceuticals filings from 2013-2017
Sees 10 major filings, 25 line extensions in Pharmaceuticals expected between 2013-2017. Sees about 100 ongoing discovery projects, 50 novel compounds in early development, 5 breakthrough designations. Sees 30 major Medical Devices filings expected from 2014-2016, 20 key Consumer product launches expected global in 2015. Says near-term priorities include: Accelerating growth in Medical Devices through innovation, expanding market leadership in key consumer segments like OTC, Oral Care, Baby and Beauty. Comments from slides that will be presented on the Q4 earnings conference call.
08:10 EDTSHPGShire price target raised to $247 from $228 at Jefferies
Subscribe for More Information
07:52 EDTJNJJohnson & Johnson reports Q4 Pharmaceutical sales $8B
Subscribe for More Information
07:48 EDTJNJJohnson & Johnson sees FY15 adjusted EPS $6.12-$6.27, consensus $6.13
Subscribe for More Information
07:46 EDTJNJJohnson & Johnson reports Q4 EPS ex-items $1.27, consensus $1.26
Subscribe for More Information
07:23 EDTMRKMerck funding testing of lower dosages of Zilmax, Reuters reports
Subscribe for More Information
<< 1 | 2 | 3 | 4 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use