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News Breaks
November 9, 2012
11:21 EDTVOLC, IFNNY, CBST, AMGN, ARIA, ZLC, PVTB, GILD, CELG, ALXN, WPX, PANW, FRX, BIIB, ABMDOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: ARIAD (ARIA) initiated with a Buy at Guggenheim... Abiomed (ABMD) initiated with a Market Perform at Raymond James... Alexion (ALXN) initiated with a Buy at Guggenheim... Amgen (AMGN) initiated with a Neutral at Guggenheim... Biogen (BIIB) initiated with a Neutral at Guggenheim... Celgene (CELG) initiated with a Buy at Guggenheim... Cubist (CBST) initiated with a Neutral at Mizuho... Forest Labs (FRX) initiated with a Buy at Mizuho... Gilead (GILD) initiated with a Buy at Guggenheim... Infineon (IFNNY) initiated with an Outperform at Bernstein... Palo Alto (PANW) initiated with a Neutral at BofA/Merrill... PrivateBancorp (PVTB) initiated with a Market Perform at Wells Fargo... Volcano (VOLC) initiated with an Outperform at Raymond James... WPX Energy (WPX) initiated with a Hold at Deutsche Bank... Zale (ZLC) initiated with a Buy at Citigroup.
News For ARIA;ABMD;ALXN;AMGN;BIIB;CELG;CBST;FRX;GILD;IFNNY;PANW;PVTB;VOLC;WPX;ZLC From The Last 14 Days
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April 7, 2014
08:31 EDTGILDGilead announecs FDA priority review designation for Ledipasvir/Sofosbuvir
Gilead Sciences announced that the U.S. Food and Drug Administration has granted priority review to the company’s New Drug Application for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, and the FDA has set a target action date under the Prescription Drug User Fee Act of October 10. The FDA has also assigned LDV/SOF a Breakthrough Therapy designation.
07:31 EDTZLCZale, Signet Jewelers announce expiration of HSR Act waiting period
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April 4, 2014
10:45 EDTCELGMylan rises despite Meda rejecting takeover offer
Mylan (MYL) shares are higher this morning following a Financial Times report of its desire to buy Swedish rival Meda. Subsequent to the story being published, Meda confirmed it had been in talks with Mylan but rejected the company's takeover offer. WHAT'S NEW: The Financial Times reported that Mylan was considering buying Meda, a Swedish drugmaker, in a deal that would create a $23B+ pharmaceuticals business. Mylan reportedly hired advisers to put a deal together for Meda, and though the value of a deal was not noted, sources said Mylan was likely to pay a "significant" premium to Meda's market value, which was $4.5B at the end of trading on Thursday. Mylan's market value currently stands at $18.5B. A combination of the drugmakers would create a company with annual revenues of around $9B, the FT said, noting that would be half the size of generic drug rival Teva (TEVA). WHAT'S NOTABLE: Meda's board of directors confirmed that it was contacted by Mylan regarding a proposal to merge the companies, but the board decided to reject the proposal. Meda said all discussions between the company and Mylan have been terminated "without further actions." ANALYST REACTION: Citigroup upgraded Mylan to Buy from Neutral and raised its price target on the stock to $61 from $52 this morning. The firm cited potential operational and tax benefits from an acquisition of Meda, stating that in addition to expanding Mylan's geographic presence, the deal would increase its presence in specialty, OTC and branded generics. OTHER NEWS: Mylan sued Celgene (CELG) to block that company's efforts to keep generic versions of Revlimid and Thalomid off the market, Reuters reported. PRICE ACTION: Mylan shares are up $2.98, or 5.98%, to $52.84 in mid-morning trading.
09:36 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL TSLA MU GNK AMZN FB GILD MA NFLX
09:02 EDTAMGNAmgen announces analysis results of Phase 3 trial of talimogene laherparepvec
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06:49 EDTCELGMylan sues Celgene for blocking Thalomid, Revlimid generics, Reuters says
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April 3, 2014
09:37 EDTAMGNAmgen to pay GlaxoSmithKline $275M to terminate denosumab collaboration pact
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09:37 EDTGILDActive equity options trading on open
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08:27 EDTAMGNLeerink's biotech analyst holds a dinner meeting update
Biotech Analyst Liang holds an update from the AACR's Annual Meeting to discuss some of the presentations including PFE/AMGN's Palbociclib, PBYI/PFE's Neratinib, as well as other new agents for breast cancer from LLY, MDVN and CLDX, in San Diego on April 7 at 9 pm.
06:28 EDTCELGAtopic dermatitis could bring upside to Regeneron, Celgene, says Citigroup
Citigroup believes Regeneron's (REGN) dupilumab and Celgene's (CELG) Otezla for atopic dermatitis are being overlooked by investors and could provide upside for both names. Citi believes both drugs have good efficacy but adds that dupilumab is more advanced. The firm has a Buy rating on both stocks.
April 2, 2014
16:32 EDTGILDGilead Phase 3 sofosbuvir study meets primary efficacy endpoint
Gilead Sciences announced topline results from a Phase 3 clinical trial in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin for the treatment of genotype 2 chronic hepatitis C virus infection. The study met its primary efficacy endpoint of superiority compared to a predefined historical control sustained virologic response rate. In the study, 97% of genotype 2 HCV-infected patients receiving 12 weeks of an all-oral regimen of sofosbuvir plus RBV achieved a sustained virologic response 12 weeks after completing therapy. Based on these trial results, Gilead anticipates submitting a New Drug Application for sofosbuvir to the Japanese Pharmaceutical and Medical Devices Agency by mid-2014
12:33 EDTCELGOn The Fly: Midday Wrap
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11:55 EDTBIIBUniqure rises after Baxter acquires Chatham Therapeutics
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10:12 EDTPANWFortinet advances following Wells Fargo upgrade
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09:35 EDTGILDActive equity options trading on open
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09:29 EDTCELGAcceleron anemia programs get vote of confidence, says Piper Jaffray
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09:18 EDTCELGOn The Fly: Pre-market Movers
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09:00 EDTCELGCelgene to buy 1.1M shares of Acceleron Pharma for $47.15M
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07:35 EDTARIAARIAD appoints Hugh Cole as Chief Business Officer
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06:21 EDTGILDGilead shares attractive at current levels, says Citigroup
Citigroup views shares of Gilead as "cheap" at current levels and keeps a Buy rating on the name with a $96 price target. Citi expects Gilead to generate $117B in free cash flow over the next 10 years and have $100B by 2023.
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