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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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July 29, 2015
12:17 EDTJNJMedivation plummets after Cowen highlights slowing Xtandi trends
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11:23 EDTJNJMedivir says Janssen's Alios BIopharma starts Phase I AL-704 trial
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09:20 EDTMRKMerck recent weakness creates buying opportunity, says Argus
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07:49 EDTAMGNAmgen July weekly volatility elevated into Q2 and outlook
Amgen July weekly call option implied volatility is at 61, August is at 32, September is at 29; compared to its 52-week range of 18 to 34, suggesting large near term price movement into the expected release of Q2 results on July 30.
07:20 EDTSNYSanofi's LixiLan meets Phase 3 primary endpoint for diabetes
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06:50 EDTPFEPfizer CEO: Company has 'sufficient courage' to pursue takeovers, FT says
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05:59 EDTAMGNStocks with implied volatility movement; AMGN CLF
Stocks with implied volatility movement; Amgen (AMGN) 30, Cliffs Natural (CLF) 125 according to iVolatility.
July 28, 2015
16:53 EDTPFE, MRKOn The Fly: Top stock stories for Tuesday
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12:31 EDTMRK, PFEOn The Fly: Top stock stories at midday
Stocks on Wall Street began the session in positive territory but turned mixed a short time after the open. The averages gathered themselves again and began an upward drift about an hour into trading, leaving markets near session highs around noon as stocks try to break their string of five consecutive lower closes. ECONOMIC EVENTS: In the U.S., the Case Shiller 20-city home price index rose 1.1% in May to 179.03, missing a forecast for it to rise 1.7% to 180.2. Markit's services PMI for July rose to 55.2, above the expected 55.0 reading. The Richmond Fed factory index rose to 13.0 in July from an upwardly revised 7 in June. Consumer confidence fell to 90.9 in July, down from a revised 99.8 figure for last month and below the expected reading of 100. In China, the Shanghai composite index closed down 1.7%, but only after a volatile session that saw it down as much as 5.1% and up about 1% at different points in the trading day. In Europe, U.K. GDP growth in the second quarter came in at 0.7%, matching the consensus expectation. COMPANY NEWS: Earnings season continued in earnest with UPS (UPS), Ford (F), Pfizer (PFE) and Merck (MRK) each reporting better than expected quarterly profits. UPS, which said its quarterly results gave it confidence in achieving the upper end of its earnings guidance range for the fiscal year, rose more than 5%. Pfizer and Merck each raised their fiscal year earnings guidance ranges, but Pfizer advanced 1.7% following its report while Merck slid nearly 0.5%. Ford, meanwhile, gained 1.8% after backing its fiscal year pre-tax profit view and repeating that it still expects the second half of the year to be stronger than the first half. MAJOR MOVERS: Among the notable gainers was Supervalu (SVU), which jumped 19% after the company reported better than expected first quarter results and also announced that it is exploring a separation of its Save-A-Lot business into a stand-alone, publicly traded company. Also higher was GrubHub (GRUB), which gained over 5% after reporting better than expect top and bottom line results in its second quarter and issuing 2015 guidance that analysts at Stifel said "appears conservative." Among the noteworthy losers was Immunomedics (IMMU), which tumbled 34% after the company's partner, UCB, announced that two Phase 3 clinical studies for epratuzumab in Systemic Lupus Erythematosus did not meet their primary clinical efficacy endpoints in either dose in both studies. Also lower following its earnings reports was Baidu (BIDU), which fell 16.5% and was downgraded by at least four research firms. INDEXES: Near midday, the Dow was up 136.13, or 0.78%, to 17,576.72, the Nasdaq was up 36.37, or 0.72%, to 5,076.14, and the S&P 500 was up 19.42, or 0.94%, to 2,087.06.
09:28 EDTSNYRegeneron buyout talk to renew after collaboration, says Roth Capital
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08:24 EDTAGNTeva deal has solid financial and strategic rationale, says Cowen
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08:22 EDTAGNAllergan price target raised to $400 from $350 at Cowen
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08:19 EDTAGNTeva price target raised to $80 from $69 at Bernstein
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07:40 EDTSNYRegeneron cancer deal could be major value driver, says RBC Capital
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07:34 EDTAMGNJefferies sees entry point for Aegerion, upgrades to Buy
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07:20 EDTMRK, PFEBrookings Institute to hold a public meeting
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07:18 EDTPFEPfizer raises FY15 adjusted EPS view to $2.01-$2.07, consensus $2.04
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07:17 EDTPFEPfizer reports Q2 innovative products revenue $6.63B, up 8%
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07:16 EDTAGNAllergan price target raised to $388 from $354 at Leerink
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07:11 EDTMRKMerck reports Q2 Pharmaceutical sales $8.56B
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07:05 EDTJNJMacroGenics reports MGD011 advances into clinical development
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07:04 EDTMRKMerck narrows FY15 EPS view to $3.45-$3.55, consensus $3.45
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07:03 EDTMRKMerck reports Q2 EPS 86c, consensus 81c
Reports Q2 revenue $9.8B, consensus $9.8B.
07:02 EDTPFEPfizer reports Q2 EPS adjusted 56c, consensus 52c
Reports Q2 revenue $11.9B, consensus $11.42B.
06:49 EDTMRKMerck to acquire cCam Biotherapeutics for $95M
Merck and cCAM Biotherapeutics announced that the companies have signed a definitive agreement under which Merck will acquire cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95M in cash. In addition, cCAM shareholders of record are eligible to receive a total of up to $510M associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions.
06:32 EDTMRKMerck's grazoprevir/elbasvir application accepted by FDA
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06:06 EDTAGNTeva upgraded to Outperform from Market Perform at BMO Capital
BMO Capital analyst David Maris upgraded Teva (TEVA) to Outperform after the company reached a deal to buy Allergan's (AGN) generics business for $40.5B and dropped its proposal to acquire Mylan (MYL). The acquisition looks "very positive" high accretion and significant cost savings, Maris tells investors in a research note. The deal is a "much better option" than Mylan and brings Teva a leading pipeline of generics, Maris writes. He raised his price target for shares of Teva to $80 from $75. The stock closed yesterday up $10.22 to $72.07.
05:39 EDTAGNAllergan price target raised to $366 from $333 at UBS
UBS analyst Marc Goodman raised his price target for Allergan (AGN) to $366 saying he remains bullish on the stock after the company sold its generics business to Teva (TEVA). The sale was a surprise, but you can't blame Allergan management for selling at that price, Goodman told investors yesterday in a research note titled "An Offer They Couldn’t Refuse." He sees "significant upside potential" in shares of Allergan and keeps a Buy rating on the name. The maker of Botox closed yesterday up $18.99 to $327.20.
05:27 EDTSNYRegeneron, Sanofi launch immuno-oncology collaboration
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July 27, 2015
18:30 EDTAGN, PFEAllergan CEO pursuing 'transformational deals,' FT says
In a Financial Times interview following the sale of its generics unit to Teva (TEVA), Allergan's (AGN) CEO Brent Saunders stated, "We’re going to contemplate transformational deals... We couldn’t before because of our capital structure and debt, but now we can." When asked about the timing of a potential deal, Saunders remarked, "We’re not going to plod along," and when asked about a hypothetical takeover by Pfizer (PFE), the CEO commented, "I spend zero time thinking about Pfizer and I am not doing anything to make us more or less attractive to them." Reference Link
17:36 EDTAGNOn The Fly: Top stock stories for Monday
Stocks began the session deep in negative territory, with weakness attributed to the Chinese market suffering its worst one day loss in over eight years. The U.S. indexes remained in the negatives throughout the day as traders prepare for one of the heaviest weeks for this earnings season. ECONOMIC EVENTS: In the U.S., durable goods orders advanced 3.4% in June versus expectations for a 3.2% increase. Excluding transportation items, the core reading was up 0.8% against estimates for a 0.5% gain. In China, the Shanghai composite index fell 8.5% and the Shenzhen composite dropped 7%, with the moves generally attributed to concerns over growth and fears that the government may pull its market support. Note that Dow Jones quoted the country's top securities regulator this morning as saying China plans to increase stock purchases by the state. COMPANY NEWS: Shares of Teva (TEVA) jumped $10.15, or 16.41%, to $72.07 after the generic drugmaker dropped its pursuit of Mylan (MYL), opting instead to acquire Allergan's (AGN) global generic pharmaceuticals business for $40.5B. Allergan shares rose 6.09% for the session, and Mylan fell 14.51% to $56.37 while reiterating its commitment to pursue Perrigo (PRGO), whose shares gained 3.81% to $193.60. MAJOR MOVERS: Among the notable gainers was Wabtec (WAB), which rose $6.59, or 7.21%, to $97.93 after agreeing to buy Faiveley Transport for roughly $1.8B, noting that it expects EPS accretion in 2016. In other M&A news, Magnetek (MAG) finished the session up $17.27, or 53.55%, to $49.52 after Columbus McKinnon (CMCO) agreed to acquire the company for $50 per share, while Beacon Roofing Supply (BECN) jumped $2.62, or 8.71%%, to $32.70 after agreeing to buy Roofing Supply Group at a transaction value of about $1.1B. Also higher were shares of Xueda Education (XUE), which surged 50.63% after Xiamen Insight Investment announced a deal to purchase the company for $5.50 per American Depository Share. Xueda's positive move came in stark contrast to numerous Chinese stocks traded in New York, with Baidu (BIDU) slipping 4.16% and Alibaba (BABA) losing 2.01% after China's Shanghai composite index plunged overnight. Also lower was McGraw Hill Financial (MHFI), declining $6.01, or 5.69%, to $99.59 after agreeing to acquire SNL Financial for roughly $2.225B in cash. Additionally, GrubHub (GRUB) lost 8.37% to $30.99 following a downgrade from Cowen citing competitive concerns and market saturation. INDEXES: The Dow fell 127.94, or 0.73%, to 17,440.59, the Nasdaq lost 48.85, or 0.96%, to 5,039.78, and the S&P 500 declined 12.01, or 0.58%, to 2,067.64.
16:46 EDTAGNAllergan, KYTHERA announce early termination of HSR waiting period
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16:00 EDTPFEOptions Update; July 27, 2015
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15:03 EDTMRK, PFENotable companies reporting before tomorrow's open
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14:43 EDTMRKEarnings Watch: Merck's Keytruda sales will be focus in Q2 results
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12:36 EDTPFEEarnings Watch: Pfizer shares nearly flat since last earnings report
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12:03 EDTAGNOn The Fly: Top stock stories at midday
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12:01 EDTAGNAllergan to use Teva deal proceeds to pursue other deals, Reuters says
Allergan (AGN) CEO Brent Saunders said it will use the $36B it receives from the sale of its generics business to Teva (TEVA) to pursue further acquisitions, Reuters reports, citing a company conference call. Saunders told investors that proceeds from the Teva deal will be used to increase the size of its existing drug businesses, expand into new therapy areas, and seek out larger deals, the report says. Reference Link
11:07 EDTAGNAllergan removed from Focus List at JPMorgan
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10:40 EDTJNJLeerink major pharma analyst holds an analyst/industry conference call
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09:21 EDTAGNOn The Fly: Pre-market Movers
HIGHER: Magnetek (MAG), up 53.5% after Columbus McKinnon (CMCO) agrees to acquire the company... Xueda Education (XUE), up 40.6% after merging with Xiamen Insight Investment... Box (BOX), up 4.6% after being upgraded to Overweight from Sector Weight at Pacific Crest... Goodrich Petroleum (GDP), up 6.4% after announcing sale of proved reserves and a portion of Eagle Ford leasehold. NOTABLE: Teva Pharmaceutical (TEVA), up 10.7% after acquiring Allergan Generics... Allergan (AGN) is up 6.3%... Mylan (MYL), down 14% after Teva withdraws proposal to acquire the company... Perrigo (PRGO), up 3% after Teva withdraws proposal to acquire Mylan. DOWN AFTER EARNINGS: Sohu.com (SOHU), down 6%... Changyou.com (CYOU), down 10.1%. ALSO LOWER: Bellerophon (BLPH) down 63% after announcing results of BCM clinical trial... Terex (TEX), down 4% after being downgraded to Sell from Neutral at Goldman... Ultragenyx Pharmaceutical (RARE), down 3.5% after being downgraded to Equal Weight from Overweight at Morgan Stanley...
08:41 EDTAGNTeva says main markets of overlap with Allergan are U.S., U.K.
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08:32 EDTMRKMerck receives 'positive' CHMP opinion for Zerbaxa
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08:23 EDTAGNTeva sees capacity to continue executing deals in 2015 and 2016
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08:22 EDTSNYNews reports on Regeneron Praluent label inaccurate, says RBC Capital
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08:05 EDTSNYAlnylam initiates Phase 1/2 clinical trial for ALN-AAT
Alnylam Pharmaceuticals (ALNY) has initiated a Phase 1/2 clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin for the treatment of AAT deficiency-associated liver disease. The Phase 1/2 trial will be conducted initially in normal healthy volunteers, and, then, in patients with alpha-1 liver disease. Initiation of this trial is based on encouraging pre-clinical data presented at the Digestive Disease Week meeting May 16 – 19, 2015. The company expects to present initial clinical data from this trial in early 2016. ALN-AAT is a subcutaneously administered investigational RNAi therapeutic that utilizes Alnylam’s proprietary ESC-GalNAc-siRNA conjugate delivery technology. ESC-GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor, and enable subcutaneous dosing with increased potency and durability and a wide therapeutic index. As per the filed CTA, the Phase 1/2 trial of ALN-AAT is a randomized, single-blind, placebo-controlled study being conducted in three parts. Parts A and B are single-dose and multi-dose, dose-escalation studies, designed to enroll up to a total of 48 healthy adult volunteers. Part C will be a multi-dose study designed to enroll up to a total of 24 adults with alpha-1 liver disease and mild-to-moderate liver fibrosis. The primary objective of the study is to evaluate safety and tolerability of single and multiple subcutaneous doses of ALN-AAT. Secondary objectives include evaluation of pharmacokinetics and clinical activity for ALN-AAT as measured by knockdown of serum AAT. In addition, biopsies will be obtained from subjects with alpha-1 liver disease to quantify the effects of treatment on levels of periodic acid-Schiff-stained globules, a measure of misfolded AAT accumulation observed in the livers of alpha-1 liver disease patients. In January 2014, Alnylam and Genzyme, a Sanofi (SNY) company, formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in North America and Western Europe, while Genzyme obtained the right to access certain programs in Alnylam's current and future Genetic Medicines pipeline, including ALN-AAT, in the rest of the world. In certain defined instances, Genzyme has co-development/co-commercialization and/or global product rights. Genzyme's rights are structured as an opt-in that is triggered upon achievement of human proof-of-principle.
07:51 EDTAGNAllergan generics divestiture adds capital for deals, says Cowen
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07:43 EDTAGNAllergan to hold a conference call
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07:40 EDTSNYEsperion price target lowered to $120 from $130 at Citi
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07:40 EDTAGNTeva to hold a conference call
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07:37 EDTMRKAeterna Zentaris starts promoting Saizen for injection in 25 U.S. territories
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07:32 EDTAGNTeva weekly volatility elevated into acquiring Allergan generics unit
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07:24 EDTAGNAllergan's volatility flat into Teva acquiring generic unit
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07:18 EDTAGNMylan volatility flat into Teva canceling proposal to acquire
Mylan (MYL) July weekly call option implied volatility is at 32, August and September is at 37; compared to its 52-week range of 23 to 53, suggesting non-directional price movement into Teva (TEVA) withdrawing its proposal to acquire and entering a definite agreement to purchase Allergan's (AGN) generics unit.
06:46 EDTAGNMylan comments on Teva agreement to acquire Allergan Generic Drug Unit
Mylan N.V. (MYL) issued the following statement regarding Teva's (TEVA) announcement of its entry into an agreement to acquire Allergan's (AGN) Generic Drug Unit and its withdrawal of its unsolicited expression of interest to acquire Mylan. Mylan Executive Chairman Robert Coury stated: "We congratulate Teva on their agreement to acquire Allergan's generics business and welcome their continued, and potentially enhanced, commitment to the generics industry. As Teva continues to move forward with their strategy, Mylan's strategic focus remains unchanged. Mylan's board and leadership team remains steadfast in its commitment to our mission, vision and strategy to provide access to quality medicine to the world's 7B people and deliver value and sustainable growth for our shareholders and other stakeholders. Our offer to acquire Perrigo continues to be the next natural step in this strategy. Combining Mylan and Perrigo will create a unique infrastructure that is able to maximize on evolving industry dynamics and capitalize on key trends. Further, the complementary cultures and strategies of these two businesses will enable us to redefine how healthcare is delivered and position our company for the future."
06:28 EDTAGNTeva to acquire Allergan Generics in transaction valued at $40.5B
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05:44 EDTAGNAllergan confirms divestiture of global generic pharma business for $40.5.B
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05:43 EDTAGNTeva says Allergan Generics transaction to bolster pipeline, commercial reach
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05:43 EDTAGNTeva says Allergan Generics transaction to provide 'substantial' benefits
The transaction is expected to provide substantial financial benefits for Teva including highly diversified revenues and profits, and substantial cost synergies and tax savings. Teva expects Allergan Generics to contribute approximately $2.7B in EBITDA in 2016, excluding synergies. Following the completion of the acquisition, Teva is expected to have pro forma sales of approximately $26B and EBITDA of approximately $9.5B in 2016, including an estimated $11B in sales outside of the United States. Teva also believes the acquisition will be significantly accretive to non-GAAP EPS, including expected double digit non-GAAP EPS accretion in 2016 and more than 20% accretion in year two and year three following the close of the transaction. Teva expects to achieve cost synergies and tax savings of approximately $1.4 billion annually, largely achievable by the third anniversary of the closing of the transaction. Teva expects the savings to come from efficiencies in operations, G&A, manufacturing, and sales and marketing. Teva expects the acquisition to generate strong free cash flow of approximately $6.5B in 2016 and expects increasing free cash flow in subsequent years. Teva’s free cash flow will allow for rapid deleveraging and the ability to continue to pursue future acquisitions to expand Teva’s portfolio in both specialty pharmaceuticals and generics, in line with Teva’s stated strategy to grow through value-enhancing and complementary acquisitions. Teva will continue to evaluate opportunities to deliver attractive total stockholder returns on an ongoing basis.
05:40 EDTAGNTeva to acquire Allergan Generics for transaction valued at $40.5B
05:28 EDTAGNTeva withdraws proposal to acquire Mylan
Teva (TEVA) announced that it has withdrawn its cash and stock proposal to acquire all of the outstanding ordinary shares of Mylan (MYL) and Teva does not intend to continue to pursue a transaction with Mylan at this time. Teva’s decision to terminate the proposal to acquire Mylan follows announcement that Teva has entered into a definitive agreement with Allergan (AGN) to acquire Allergan Generics. Teva CEO Erez Vigodman commented, “We continue to believe that a combination of Teva and Mylan would have made sense for our companies, our respective stockholders and the healthcare industry as a whole. However, despite our clear commitment to consummating a transaction, and our conviction that we ultimately would have succeeded in acquiring Mylan, we believe we have an even greater opportunity to create compelling, sustainable value for Teva’s stockholders through our transaction with Allergan – and we acted quickly to seize the opportunity. Our agreement with Allergan will reinforce Teva’s strategy to create an even stronger business model in the industry and will position us well to grow the business and better serve our customers and patients.” Teva intends to review its options with respect to its ownership of approximately 4.6% of the outstanding ordinary shares of common stock of Mylan.
05:25 EDTSNYGenzyme acquires Caprelsa from AstraZeneca for $300M
Genzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.
July 26, 2015
18:22 EDTAGNMedia reports say Teva to buy Allergan unit as it looks beyond Mylan
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12:39 EDTAGNAllergan to acquire Naurex, plans research collaboration with Naurex spinoff
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12:30 EDTAGNTeva nears deal to buy Allergan generics unit for $40.5B, Bloomberg says
Teva (TEVA) is nearing a deal to buy Allergan's (AGN) generic drug unit for roughly $40.5B and an agreement could be announced as early as Monday, reports Bloomberg, citing people familiar with the matter. Sources said Teva also plans to withdraw its bid for Mylan (MYL) as soon as Monday. Reference Link
12:17 EDTAGNTeva to cancel Mylan bid, plans offer for Allergan generics unit, Bloomberg says
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July 24, 2015
18:36 EDTAGNAllergan considers split into two businesses, Bloomberg reports
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18:25 EDTAGNAllergan considering breakup of company, Bloomberg reports
Allergan is reportedly working with advisors and leaning towards a sale or spinoff of generics, Bloomberg added.
16:00 EDTSNYRegeneron, Sanofi say the U.S. WAC price of Praluent is $40 per day
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15:27 EDTSNYEsperion likely to stay pressured until path for ETC-1002 clearer, says Barclays
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15:25 EDTSNYRegeneron, Sanofi's cholesterol treatment Praluent gets FDA approval
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration approved Praluent Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Praluent is the first and only PCSK9 inhibitor approved in the U.S. and is available in two different doses- 75 mg and 150 mg. Both doses of Praluent are available in a single 1 milliliter injection delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks. The companies carefully considered the potential medical value that Praluent offers patients in determining the Wholesale Acquisition Cost. The U.S. WAC price of Praluent is $40 per day, $1,120 every 28 days, for both the 75 mg and 150 mg doses, making Praluent the lowest priced patient-administered monoclonal antibody therapy on an annualized basis. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.
15:00 EDTAMGNBroader label for PCSK9 drug positive for Regeneron, Amgen, says Deutsche Bank
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14:44 EDTSNYEsperion slides after FDA assigns indication for rival cholesterol drug
Shares of Esperion Therapeutics (ESPR), a drug company focused on LDL-cholesterol lowering therapies, are sharply lower in afternoon trading after the FDA granted approval for the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. WHAT'S NEW: This afternoon, the FDA announced the approval of Praluent injection, which is a PCSK9 drug marketed by Sanofi (SNY) and Regeneron (REGN). Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol, the FDA indicated. The drug, like Esperion's ETC-1002, seeks to lower patients' cholesterol. PRICE ACTION: In afternoon trading, Esperion shares are down 12% to $84.21. The stock spiked as low as $81.50 immediately after the FDA made its announcement regarding Praulent. Meanwhile, Sanofi shares are fractionally higher and Regeneron shares are halted.
14:20 EDTSNYSanofi drops 0.4% to $53.32 after FDA makes announcement on Praluent
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14:20 EDTSNYFDA approves Regeneron, Sanofi cholesterol-lowering treatment
The announced the approval of Praluent injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Praluent is marketed by Sanofi-Aventis (SNY) and Regeneron (REGN). Shares of Regeneron remain halted.
12:44 EDTAMGNAmgen announces FDA approval of expanded Kyprolis indication
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12:27 EDTAMGNFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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July 23, 2015
17:51 EDTJNJJanssen submits sNDA to update label for Olysio
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14:01 EDTSHPGShire receives 'positive opinion' on Intuniv from CHMP
Shire announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv, or guanfacine hydrochloride extended release, for the treatment of attention deficit/hyperactivity disorder in children and adolescents. The positive opinion is based on results from three Phase 3 pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents. The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe, said Shire.
11:54 EDTOREXOptions with increasing call volume
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11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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09:10 EDTAMGNAmgen submits NDA for Kyprolis in relapsed multiple myeloma
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial in which relapsed multiple myeloma patients treated with Kyprolis and dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade.
07:25 EDTSHPGShire raises FY15 EPADS growth view to mid-to-high single digit percentage
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07:22 EDTSHPGShire reports Q2 EPS $2.63, consensus $2.81
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July 22, 2015
10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
12:47 EDTSNY, AMGNPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
11:49 EDTAMGNNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
07:12 EDTAMGNAmgen's Repatha granted marketing authorization by EC
Amgen announced that the European Commission, or EC, has granted marketing authorization for Repatha, or evolocumab, the first proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.
July 20, 2015
07:05 EDTAGNAllergan Q2 to alleviate competitive concerns, says JPMorgan
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July 17, 2015
10:05 EDTAGNOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Accretive Health (ACHI) downgraded to Market Perform from Outperform at Cowen... Allergan (AGN) downgraded to Outperform from Top Pick at RBC Capital... Best Buy (BBY) downgraded to Underperform from Buy at BofA/Merrill... Cablevision (CVC) downgraded to Hold from Buy at Jefferies... Credit Suisse (CS) downgraded to Hold from Buy at Deutsche Bank... Domino's Pizza (DPZ) downgraded to Sector Weight from Overweight at KeyBanc... First Quantum Minerals (FQVLF) downgraded to Neutral from Outperform at Credit Suisse... First Republic (FRC) downgraded to Market Perform from Outperform at FBR Capital... Fresenius SE (FSNUY) downgraded to Neutral from Buy at Goldman... Golden Minerals (AUMN) downgraded to Neutral from Buy at Roth Capital... JD Wetherspoon (JDWPY) downgraded to Reduce from Neutral at Nomura... NV5 Holdings (NVEE) downgraded to Neutral from Accumulate at Global Hunter... National Oilwell (NOV) downgraded to Sell from Neutral at UBS... Natural Gas Services (NGS) downgraded to Neutral from Buy at Global Hunter... Primoris (PRIM) downgraded to Neutral from Accumulate at Global Hunter... Receptos (RCPT) downgraded to Hold from Buy at Evercore ISI... SKF AB (SKFRY) downgraded to Hold from Buy at Deutsche Bank... STAG Industrial (STAG) downgraded to Sell from Neutral at UBS... SolarWinds (SWI) downgraded to Hold from Buy at Deutsche Bank... Syntel (SYNT) downgraded to Market Perform from Outperform at William Blair... TECO Energy (TE) downgraded to Neutral from Buy at UBS... Tangoe (TNGO) downgraded to Underweight from Equal Weight at Barclays... Tegna (TGNA) downgraded to Hold from Buy at Evercore ISI.
06:39 EDTAGNAllergan downgraded to Outperform from Top Pick at RBC Capital
RBC Capital downgraded Allergan to Outperform and maintained its $361 price target. The firm sees few catalysts and is less confident near-term in P&L upside, but has left estimates unchanged. RBC Capital said there are several important products subject to competitive threats that could pressure sentiment but said valuation remains attractive against solid mid-teens multi-year earnings growth.
July 16, 2015
16:05 EDTAMGNAmgen announces Phase 2 trial results evaluating Blincyto
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16:00 EDTPFEOptions Update; July 16, 2015
iPath S&P 500 VIX Short-Term Futures down 1.17 to 16.52 Option volume leaders: NFLX AAPL BAC FB F INTC C EBAY AMZN GM JPM MU PFE BABA JD X
11:57 EDTNVONovo Nordisk receives FDA approval for FlexPro PenMate
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07:25 EDTINFIInfinity Pharmaceuticals management to meet with Deutsche Bank
Meeting to be held in Boston on July 16 hosted by Deutsche Bank.
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