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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
Check below for free stories on NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE the last two weeks.
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September 17, 2014
09:33 EDTMRKMerck announced positive results from Phase 3 data for omarigliptin
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08:36 EDTJNJJanssen-Cilag announces results from post-hoc canagliflozin analysis
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08:31 EDTMRKMerck, Sun Pharma enter into licensing agreement for Tildrakizumab
Merck and Sun Pharmaceutical Industries, through their respective subsidiaries,announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80M. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.
08:12 EDTJNJJanssen-Cilag announces results from Phase 3 Invokana trial
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08:03 EDTAMGNAmgen price target raised to $151 from $143 at Morgan Stanley
Morgan Stanley raised Amgen's price target to $151 based on increased brodalumab and AMG 416 expectations. Shares are Overweight rated.
07:43 EDTPFE, SHPG, OREXBofA/Merrill to hold a conference
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06:18 EDTSNYSanofi, MyoKardia announce collaboration
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05:51 EDTOREXStocks with implied volatility movement; OREX MNKD
Stocks with implied volatility movement; Orexigen (OREX) 91, MannKind (MNKD) 60 according to iVolatility.
September 16, 2014
11:51 EDTPFE, SHPG, AGNOECD looks to close tax loopholes with new proposals
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07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTMRK, NVO, JNJEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:25 EDTMRKMerck price target raised to $72 from $62 at SunTrust
After meeting with Merck's CEO and head of clinical development, SunTrust increased its price target on the company as the firm thinks that it is ideally positioned across five of the fastest growing therapeutic classes. The firm believes that the company's EPS growth rates from 2015-2020 will be three percentage points above Street estimates, while it has a first-mover advantage in oncology. It keeps a Buy rating on the shares.
07:19 EDTPFECompanies' share buybacks at fasttest clip since 2007, WSJ reports
Companies are buying back their own shares at its fastest pace since the financial crisis to fuel a stock rally, reports the Wall Street Journal. According to Birinyi Associates, companies have bought back $338.3B of stock in 1H14, the most since 2007. Citing an analysis by Barclays, companies with the largest buyback programs by dollar value have outperformed the broader market by 20% since 2008. Reference Link
05:37 EDTAGNValeant, Pershing Square, Allergan settle pending litigation before DE Court
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September 15, 2014
16:40 EDTAMGNAmgen trial finds Prolia treatment enables non-osteoporotic T-scores
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16:05 EDTAMGNAmgen says romosozumab treatment increases bone mineral density
Amgen and UCB announced results from several exploratory analyses of the Phase 2 study evaluating romosozumab in postmenopausal women with low bone mineral density, BMD. Romosozumab is an investigational bone-forming agent that is designed to work by inhibiting the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown. These data were presented at the American Society for Bone and Mineral Research, ASBMR, 2014 Annual Meeting in Houston, Sept. 12-15. "Fractures or broken bones due to osteoporosis are very common and often have a life altering impact on an older woman and her family," said Michael McClung, M.D., director of the Oregon Osteoporosis Center. "It is encouraging to see that treatment with romosozumab for a second year provided additional increases in bone mineral density beyond what was seen during the first 12 months of treatment." "Despite continuing progress in the management and treatment of patients with osteoporosis, there remains a considerable need for new therapeutic approaches for individual patients," said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. "Investigational studies to date suggest that the bone building capacity of romosozumab may show promise as a new treatment option to manage this serious disease. We look forward to reporting the results of the romosozumab Phase 3 program in 2016."
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
11:57 EDTAGNPershing Square submits additional meeting requests
Pershing Square Capital Management announced that on Friday it submitted to Allergan (AGN) additional special meeting requests from shareholders owning approximately 0.6% of Allergan’s shares. With these requests, Pershing Square has delivered requests from 51 institutions representing 35.68% of the outstanding common stock of Allergan. At the special meeting, Allergan shareholders will have the opportunity to voice their support for a number of matters, including the removal of six incumbent members of the Allergan board, the appointment of an independent slate of directors, amendments to Allergan’s bylaws to eliminate onerous restrictions on the calling of a special meeting, a request that Allergan engage in negotiations with Valeant Pharmaceuticals(VRX) and Pershing Square, and certain other actions to improve corporate governance of Allergan.
10:55 EDTSHPGRegulators to determine AbbVie, Shire deal by next month, Reuters says
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09:26 EDTINFIInfinity Pharmaceuticals management to meet with JMP Securities
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09:25 EDTPFEJPMorgan biotech analysts hold an analyst/industry conference call
Analysts assess Pfizer's M&A options on an Analyst/Industry conference call to be held on September 15 at 10 am.
08:01 EDTSHPGShire announces FDA acceptance for filing of sNDA for Vyvanse
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07:27 EDTPFE, JNJIBC Life Sciences to hold a conference
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07:27 EDTPFEPfizer acquisition could drive shares higher, says JPMorgan
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07:21 EDTAMGNHeart Failure Society of America to hold annual meeting
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05:12 EDTAMGNAmgen presents analyses of Phase 3 ivabradine data for treatment of chronic HF
Amgen announced data from the Phase 3 Systolic Heart failure treatment with the If inhibitor ivabradine Trial, or SHIFT, study evaluating ivabradine in patients with chronic heart failure, or HF, were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America, or HFSA, in Las Vegas. A post-hoc analysis from the SHIFT study confirmed low systolic blood pressure, or SBP, is associated with poor outcomes in chronic HF, and that ivabradine reduced the primary composite endpoint of cardiovascular death or hospitalization for worsening HF in this subgroup with low baseline SBP. Safety was similar across the three SBP groups. Results were published in the July 2014 issue of the European Journal of Heart Failure. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said, "Despite standard of care, chronic heart failure remains a disabling condition with a poor prognosis for patients at risk for hospitalization. Analyses from the pivotal SHIFT study complement the main trial findings that form the basis of our U.S. submission package for ivabradine. We recently received a priority review designation for ivabradine from the FDA and are working with the agency to potentially bring this important treatment option to certain patients with chronic heart failure in the U.S. as soon as possible."
September 14, 2014
13:39 EDTAMGNFurther gains in Amgen could be subdued, Barron's says
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13:32 EDTPFEPfizer shares look cheap, Barron's says
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September 12, 2014
16:44 EDTOREXMarket ends week lower as investors fret over Fed statement
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10:35 EDTOREXOptions with decreasing implied volatility
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10:32 EDTPFEPfizer 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
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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08:02 EDTAGNPershing submits special meeting requests totaling 35% of Allergan shares
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07:14 EDTAMGNAmerican Society for Bone & Mineral Research holds annual meeting
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05:09 EDTAGNAllergan comments on Pershing Square delivery of additional requests
Allergan (AGN) commented on Pershing Square Capital Management delivery of additional requests from stockholders owning 1.5% of Allergan’s shares to call a Special Meeting of Stockholders. Allergan will review these requests in addition to the requests from stockholders owning 2.8% of Allergan’s shares that were delivered on September 3. The company issued the following statement: Notwithstanding Pershing Square and Valeant Pharmaceuticals (VRX) efforts to change the subject, Allergan recognizes that what actually matters is value, and that’s what the company is focusing on delivering to stockholders. In that regard, Allergan’s current strategic plan is expected to deliver a compounded annual growth rate of greater than 20% EPS growth, including estimated 2016 EPS at approximately $10.00. Allergan has already scheduled the Special Meeting for December 18. As such, the delivery of additional requests for the Special Meeting by Pershing Square is not a meaningful development. The lawsuit in California is seeking an order barring Valeant, Pershing Square, Ackman, and entities affiliated with them from voting shares that Allergan believes were acquired in violation of the federal securities laws, including insider trading. If Allergan’s motion for a preliminary injunction is granted, it would prevent Valeant, Pershing Square, and Ackman from voting their shares at any meeting of stockholders.
September 11, 2014
17:12 EDTNVONovo Nordisk Saxenda receives positive 14-1 vote in favor of approval from FDA
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16:21 EDTOREXOn The Fly: Closing Wrap
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12:42 EDTOREXOrexigen falls after FDA requires warnings on Contrave label
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11:08 EDTAGNAllergan shareholders owning 35% to ask for meeting, Reuters says
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11:07 EDTOREXOptions with decreasing implied volatility
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10:59 EDTOREXArena competition picks up after Contrave approval, says Piper Jaffray
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10:49 EDTOREXHigh option volume stocks
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10:29 EDTOREXOrexigen falls, levels to watch
Trading is volatile on very heavy volume nearing three times the daily average. At the current price of $5.41, next support is at $5.30, the low of the day, and then at $4.60 which is the 52-week low. Resistance is at $5.90, the prior session closing price.
09:52 EDTAGNValeant to submit consent from 35% of Allergan holders, CNBC reports
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08:01 EDTOREXOrexigen Contrave could have stronger launch than peers, says Wells Fargo
After the FDA approved Orexigen's (OREX) Contrave as a treatment option for chronic weight management, Wells Fargo does not believe the label included any significant surprises. The firm thinks multiple factors increase the chances that Contrave's launch will be stronger than two other weight loss drugs that were launched in recent years by VIVUS and Arena Pharmaceuticals (ARNA). The firm keeps an Outperform rating on Orexigen.
07:31 EDTNVOFDA Endocrinologic and Metabolic Drugs Advisory Committee to hold a meeting
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07:11 EDTJNJMedivation price target raised to $112 from $89 at Stifel
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07:06 EDTOREXOrexigen's Contrave weight management tablets approved by FDA
Orexigen Therapeutics and Takeda Pharmaceuticals U.S.A. jointly announced that the FDA has approved Contrave extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index indicating obese or overweight, in the presence of at least one weight-related comorbid condition. Takeda is planning to commercially launch Contrave in the fall.
06:49 EDTOREXFDA approves weight management drug Contrave
The U.S. Food and Drug Administration yesterday approved Contrave as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. The effectiveness of Contrave was evaluated in multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. Contrave is distributed by Takeda Pharmaceuticals America (TKPYY) for Orexigen Therapeutics (OREX).
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
18:27 EDTOREXOrexigen trading halted, pending news
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16:00 EDTMRKOptions Update; September 10, 2014
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11:06 EDTNVOHigh option volume stocks
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10:14 EDTJNJJohnson & Johnson says off to 'very good start' this year
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08:37 EDTSHPGMedgenics appoints Scott Applebaum as Chief Legal Officer
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08:21 EDTSGENSeattle Genetics, Genmab enter into new ADC collaboration
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07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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07:06 EDTSHPGSangamo plans to submit IND application for hemophilia B in 2Q15
Sangamo BioSciences (SGMO) plans to submit an Investigational New Drug application for the treatment of hemophilia B in Q2 2015. This program, partnered with Shire (SHPG), is the first therapeutic application of Sangamo's zinc finger nuclease-mediated In Vivo Protein Replacement Platform. Sangamo is developing the IVPRP as a generally applicable strategy to provide a one-time, permanent genetic cure for monogenic diseases that are currently managed by protein replacement therapy, which involves costly repeat infusions over the lifetime of the patient.
September 9, 2014
16:04 EDTAGNPershing Square reports 9.7% stake in Allergan, sends letter to board
Pershing Square Capital Management sent a letter to the board of Allergan that highlights several reasons why Allergan is extremely shareholder unfriendly and why now is the time for Allergan's management team to wake up. In the letter, Pershing Square said: "Since the bid was announced in April, 75% of Allergan’s shareholders have sold all or a portion of their investment including the company’s largest shareholder, which has sold its entire position. These shareholders are sending the board a message. They would not have sold if they believed that Allergan stock was worth more than current values... We note CFO Jeff Edwards recent decision to retire from the company at age 53 for family reasons, and his replacement by an investor relations executive rather than an experienced public company CFO. The notion that Allergan should execute the largest acquisition in its history led by an investor relations executive is a frightening proposition. While we respect an executive’s need to retire from a company for family reasons, Edwards exit also calls into question the company’s forward earnings guidance which shareholders expected him to execute on when the Company presented these projections on July 21st. I had expected that at some point one or more directors would have woken up and smelled the coffee. There is still time for a subset of directors to rescue their reputations by taking over leadership of this process from David Pyott and his handpicked advisors and doing what you are paid $400,000 per year to do on behalf of the company’s owners."
15:27 EDTOREXOrexigen volatility elevated
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12:46 EDTNVO, OREXNovo Nordisk weight loss drug helped people get thinner, Bloomberg reports
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06:42 EDTAGNLew expects to make decision on combating inversion deals soon, NY Times reports
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September 8, 2014
17:22 EDTOREXOrexigen, Takeda Pharmaceutical in services agreement
Orexigen disclosed in a regulatory filing that in preparation for the potential launch of NB32, Orexigen Therapeutics (OREX) and Takeda Pharmaceutical Company (TKPYY) entered into a Manufacturing Services Agreement, dated September 2, in accordance with the Collaboration Agreement between the company and Takeda, effective as of September 1, 2010, as amended by Amendment Number 1 to Collaboration Agreement effective as of September 26, 2013. Pursuant to the Agreement, among other things, the company will supply to Takeda, and Takeda will, subject to certain exceptions as set forth in the Agreement and Collaboration Agreement, exclusively purchase from the Company, all of Takeda’s requirements of NB32 for commercialization in the United States, Canada and Mexico during the term of the Collaboration Agreement. The Agreement will continue in full force and effect until the expiration or termination of the Collaboration Agreement.
16:00 EDTMRKOptions Update; September 8, 2014
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14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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07:21 EDTAGNJazz looks more attractive for Allergan than Salix, says Wells Fargo
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07:15 EDTPFE, AMGNIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
06:49 EDTAMGNAmgen shares to trend higher, price target to $150 at RBC Capital
RBC expects shares of Amgen to trend higher due to evolving sentiment around the 2015 pipeline and low multiple. Some investors want a break-up of the company to increase shareholder value but the analyst does not expect it to occur given the concentrated portfolio, tax reasons, and a commercial infrastructure that can not be split off. Shares are Outperform rated with a $150 price target, raised from $135.
September 5, 2014
16:45 EDTMRKMarket ends week little changed after mixed economic data
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11:17 EDTMRKBristol-Myers files patent infringement suit against Merck
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10:05 EDTJNJ, AGNOn 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.
08:41 EDTJNJJohnson & Johnson initiated with an Outperform at BMO Capital
Target $118.
08:39 EDTMRKMerck Keytruda sales to reach $5B in 2018, says BMO Capital
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September 4, 2014
19:12 EDTAGNAllergan provides update on requests from Pershing regarding special meeting
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17:17 EDTAGNAllergan initiated with a Buy at ISI Group
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16:05 EDTPFEPfizer granted orphan status for sickle cell disease drug
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15:16 EDTMRKMerck receives accelerated approval of Keytruda
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11:05 EDTJNJJ&J unit Janssen receives orphan status for whipworm treatment
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10:29 EDTINFIOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: AeroVironment (AVAV) upgraded to Buy from Hold at Benchmark Co... D.R. Horton (DHI) upgraded to Buy from Neutral at UBS... IAC (IACI) upgraded to Overweight from Equal Weight at Barclays... Imperial Tobacco (ITYBY) upgraded to Outperform from Underperform at Exane BNP Paribas... Infinity Pharmaceuticals (INFI) upgraded at JMP Securities.
09:44 EDTAGNValeant, Ackman deliver another 2.8% consent vote to Allergan, CNBC reports
Valeant (VRX) and Bill Ackman delivered another 2.8% consent vote to Allergan, bringing its total vote to call a special meeting to 33.8%, CNBC's David Faber reports, citing sources. A special meeting has been set for December 18, Faber added.
09:02 EDTMRKMerck's relebactam granted QIDP, fast track designations by FDA
Merck announced that the U.S. Food and Drug Administration has designated relebactam -- previously known as MK-7655 -- the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product with designated Fast Track status. The QIDP and Fast Track designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Relebactam is an investigational, class A and C, beta-lactamase inhibitor that is being evaluated in combination with imipenem/cilastatin in ongoing Phase 2 clinical trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. In preclinical studies, relebactam administered in combination with imipenem/cilastatin demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens. Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.
08:52 EDTINFIInfinity Pharmaceuticals upgraded at JMP Securities
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07:38 EDTINFIInfinity Pharmaceuticals price target raised to $21-$25 from $17-$20 at Wells Fargo
Wells Fargo increased its price target on Infinity (INFY) after the company announced a global development and commercialization oncology agreement with AbbVie (ABBV) for duvelisib. The firm thinks the financial terms of the deal are favorably for Infinity, and significantly lower the risk presented by Infinity's stock. It raised its estimate of the drug's chances of success to 75% from 65% and keeps an Outperform rating on Infinity.
07:23 EDTPFEAstraZeneca called for inversion clamp down as part of defense, WSJ says
Amid its defense against an unsolicited takeover bid from rival Pfizer (PFE), AstraZeneca (AZN) hired advisers with close ties to the Obama administration, who made calls to senior administration officials urging a clamp down on tax inversions, said The Wall Street Journal, citing people familiar with the previously undisclosed calls. Reference Link
07:21 EDTMRKMedidata 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.
07:17 EDTINFIInfinity deal terms suggest intention to stay independent, says Jefferies
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06:13 EDTINFIInfinity upgraded to Outperform from Market Perform at JMP Securities
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05:23 EDTJNJJohnson & Johnson to fast-track development of Ebola combination vaccine regimen
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September 3, 2014
17:25 EDTMRKMerck management to meet with SunTrust
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16:20 EDTINFIOn The Fly: Closing Wrap
Stocks on Wall Street began the session in positive territory after Russian President Vladimir Putin said he had an outline for a cease-fire plan for eastern Ukraine and was closing in an agreement. The averages hit their highs shortly after the open and the Nasdaq was the first index to cross into negative territory as it was weighed down by Apple's (AAPL) decline. The market moved in a narrow range as investors anticipated the Fed’s Beige Book report, scheduled for release mid-afternoon. The report was fairly benign and the market limped into the close, with volume remaining light. ECONOMIC EVENTS: U.S. factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book stated that the pace of growth did not change significantly in any of the central bank's 12 regions during a six week period ended in August compared with the previous six week period. COMPANY NEWS: Shares of Apple retreated $4.36, or 4.22%, to $98.94 after research firm Pacific Crest advised investors to take some profits in the stock. Analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which surged $4.81, or 44.05%, to $15.73 after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which jumped $3.94, or 9.16%, to $46.97 ahead of its second quarter earnings report, which is due tomorrow morning. Among the noteworthy losers was Repros Therapeutics (RPRX), which fell $4.11, or 18.55%, to $18.05 after FDA briefing documents ahead of a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower after its earnings report was apparel company Vince Holding (VNCE), which fell $4.47, or 11.54%, to $34.27. Analysts at Piper Jaffray attributed the post-earnings weakness to investor concerns over heightened inventory levels, but the firm said it still sees Vince as one of the best small cap growth names in its space and would be "aggressive buyers" on the weakness. INDEXES: The Dow edged up 10.72, or 0.06%, to 17,078.28, the Nasdaq fell 25.62, or 0.56%, to 4,572.56, and the S&P 500 slipped 1.56, or 0.08%, to 2,000.72.
12:49 EDTSNYSanofi reports Dengue vaccine candidate achieves its phase 3 primary endpoint
Sanofi Pasteur, the vaccines division of Sanofi, announced that the final landmark phase 3 efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8% of dengue disease cases in children and adolescents 9-16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes. Additional observations of the results showed a clinically important reduction by 80.3% in the risk of hospitalization due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever, the severe form of dengue, which is consistent with the results released from Sanofi’s phase 3 dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue.
12:33 EDTINFIOn The Fly: Midday Wrap
Stocks on Wall Street were higher to begin the day, as reports spurred optimism that a ceasefire agreement between Russia and the Ukraine may soon be reached. The move was short lived, as the averages turned mixed during the second hour of trading. Shares of Apple (AAPL) are weighing down the Nasdaq after an analyst recommended investors take some profits in the stock. ECONOMIC EVENTS: In the U.S., factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book is scheduled to be released at 2:00 pm ET. In Europe, the final reading of Eurozone services PMI was knocked down to 53.1 from a preliminary 53.5 reading, mirroring the lowering of the Eurozone manufacturing PMI reading yesterday. COMPANY NEWS: Shares of Apple retreated 4% after research firm Pacific Crest advised investors to take some profits in the stock. Pacific Crest analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event... Carmakers reported on August vehicle sales in the U.S., with Chrysler (FIATY) reporting a 20% increase, Ford stating that sales rose slightly compared to the prior year and General Motors (GM) posting a 1.2% decline in sales. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which jumped 46% after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which gained nearly 10% after Morgan Stanley wrote that the stock could rise "towards $100" if the company maintains its current market, gross margins and earnings position. Mobileye is scheduled to report on its second quarter results tomorrow morning, which will be its first quarterly report since its August IPO. Among the noteworthy losers was Repros Therapeutics (RPRX), which dropped 15% after newly posted FDA briefing documents regarding a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower following its earnings report was apparel company Vince Holding (VNCE), which fell 11%. INDEXES: Near midday, the Dow was up 33.71, or 0.2%, to 17,101.27, the Nasdaq was down 23.24, or 0.51%, to 4,574.95, and the S&P 500 was down 0.64, or 0.03%, to 2,001.64.
12:31 EDTINFIInfinity Pharmaceuticals upgraded to Neutral from Underperform at Wedbush
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12:19 EDTSHPGOptions with increasing implied volatility
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11:30 EDTPFEPfizer has conference call hosted by Bernstein
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10:46 EDTINFIHigh option volume stocks
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09:15 EDTINFIOn The Fly: Pre-market Movers
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07:59 EDTINFIInfinity Pharmaceuticals to host conference call
Conference call to discuss the strategic collaboration with AbbVie Inc to develop and commercialize duvelisib will be held on September 3 at 8:30 am. Webcast Link
06:48 EDTINFIInfinity, AbbVie announce global strategic collaboration to develop duvelisib
Infinity Pharmaceuticals (INFI) and AbbVie (ABBV) announced that they have entered into a global collaboration to develop and commercialize duvelisib, Infinity’s oral inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, for the treatment of patients with cancer. Duvelisib has shown clinical activity across a broad range of blood cancers, including indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia. Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMOTM, a Phase 2 study in patients with iNHL, and DUOTM, a Phase 3 study in patients with CLL. Under the terms of the agreement, Infinity will receive an upfront payment of $275M and is eligible to receive up to $530M in additional payments for the achievement of development, regulatory and commercial milestones, including up to $405M for the achievement of milestones through the first commercial sale of duvelisib. In the U.S., the companies will jointly commercialize duvelisib and will share equally in any potential profits. Outside the U.S., AbbVie will be responsible for the conduct and funding of commercialization of duvelisib, and Infinity is eligible to receive tiered double-digit royalties on net product sales. Development and commercialization activities under the collaboration will be managed through a shared governance structure. In the U.S., Infinity and AbbVie will jointly commercialize duvelisib, assuming regulatory approval, with Infinity booking sales, and will share equally in any potential profits or losses. Outside the U.S., AbbVie will be responsible for conducting and funding of any commercialization of duvelisib, and Infinity is eligible to receive tiered royalties on net product sales, with percentages ranging from 23.5%-30.5%. For sales of duvelisib in the U.S., AbbVie and Infinity will share equally the existing royalty obligations to Mundipharma International Corporation Limited/Purdue Pharmaceutical Products L.P., and Infinity will be responsible for these royalty obligations outside of the U.S. Infinity will also be responsible for the existing royalty obligations to Millennium: The Takeda Oncology Company for sales of duvelisib worldwide. As part of the strategic collaboration, the companies will share responsibility for the conduct of specific trials specified within an agreed-upon global development plan, with each company leading the development of certain trials within the plan. For the initial global development plan agreed to by the companies, Infinity will fund the trials it conducts and the companies will share equally the funding of trials conducted by AbbVie. The agreement includes plans to launch multiple Phase 2 and Phase 3 studies of duvelisib in hematologic malignancies over the next several years.
06:48 EDTINFIInfinity Pharmaceuticals, AbbVie announce global strategic collaboration
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06:48 EDTINFIInfinity Pharmaceuticals partners with Roche for blood cancer clinical studies
Infinity Pharmaceuticals (INFI) has entered into a master clinical supply agreement with Roche (RHHBY) under which Roche will supply Gazyva to Infinity for use in planned clinical studies to evaluate the combination of Gazyva and duvelisib, Infinity’s oral inhibitor of phosphoinositide-3-kinase -delta and PI3K-gamma, in patients with hematologic malignancies, or blood cancers. The companies have also entered into a material transfer agreement under which Infinity is supplying Roche with duvelisib for use in Roche’s preclinical and translational research to evaluate the combination of duvelisib and Gazyva.
06:33 EDTINFIInfinity Pharmaceuticals partners with Roche for blood cancer clinical studies
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