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May 15, 2014
05:40 EDTGILD, AMGN, CELG, PCYC, BMRN, INCYASCO abstracts 'surprisingly bland,' says Piper Jaffray
Piper Jaffray calls the ASCO abstracts released last night as "surprisingly bland," saying it does not find much "surprising or even interesting." Piper now believes the cancer field isn't progressing as quickly as it previously thought. The firm says Incyte (INCY) abstracts were "anticlimactic."
News For INCY;PCYC;AMGN;BMRN;CELG;GILD From The Last 14 Days
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November 18, 2015
06:30 EDTBMRNBioMarin assumed with a Buy at Goldman
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06:25 EDTINCYIncyte initiated with a Buy at Goldman
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November 17, 2015
16:10 EDTBMRNBioMarin initiated with a Perform at Oppenheimer
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10:47 EDTGILDBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
08:22 EDTCELGSignificant Celgene overhang removed, says JMP Securities
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November 16, 2015
16:05 EDTAMGNAmgen to present eight IMLYGIC abstracts
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13:11 EDTCELGCelgene jumps 2% after defeating Kyle Bass patent challenge
Shares of Celgene moved higher after the U.S. Patent and Trademark Office declined to review a Revlimid patent expiring in 2019. The USPTO found that that Bass's Coalition for Affordable Drugs was unlikely to succeed, according to Bloomberg. Shares of Celgene are up 2%, or $1.64, to $190.13 in afternoon trading. The agency is reviewing two other patents on the drug.
13:08 EDTCELGCelgene defeats Bass challenege on Revlimid patent, Bloomberg reports
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09:04 EDTGILDGilead says Phase 3 Zydelig study shows 'clinical benefit'
Gilead announced that its Phase 3 Study 115 evaluating Zydelig added to standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology in Orlando, Florida taking place December 5-8. "The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."
07:16 EDTBMRNHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).
07:16 EDTBMRNFDA likely feels compelled to approve at least one DMD drug, says Leerink
Leerink analyst Joseph Schwartz says the FDA likely feels compelled to approve at least one of the exon skipping drugs to treat Duchenne muscular dystrophy in this review cycle. There is so much public attention and vocal demand in the DMD community, Schwartz tells investors in a research note. The FDA advisory panel on BioMarin's (BMRN) drisapersen is on November 24 while the panel on Sarepta's (SRPT) eteplirsen is tentatively scheduled for January 22, 2016. The greatest likelihood is that both drugs are approved, Schwartz contends. Shares of BioMarin have "significant" upside potential on a positive panel vote as many investors still doubt that drisapersen is approvable based on existing data, and approval would "greatly aid" the company's goal to reach profitability, the analyst argues. He reiterates an Outperform rating on BioMarin and a Market Perform rating on Sarepta. Jefferies analyst Eun Yang said on Friday that regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin.
November 15, 2015
20:17 EDTGILDGilead presents results from four Phase 3 studies of sofosbuvir/velpatasvir
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15:47 EDTGILDGilead reports data from multiple studies of Viread, TAF, others
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November 13, 2015
15:32 EDTBMRNSarepta CEO says having BioMarin go first with AdCom is an advantage
Sarepta (SRPT) interim CEO Edward Kaye said BioMarin (BMRN) having to go first with its advisory committee meeting for its own DMD drug will allow Sarepta time to assess the committee's comments and questions on their drug and formulate responses. Kaye is speaking on CNBC.
11:02 EDTCELGCelgene calls active on renewed takeover chatter
Celgene November weekly 111 and 112 calls are active on total call volume of 9K contracts (3K puts) on renewed takeover chatter. November weekly call option implied volatility is at 82, November is at 42, December is at 35; compared to its 52-week range of 23 to 54. Active call volume suggests traders taking positions for large price movement.
10:58 EDTCELGRumor: Celgene moves up on renewed takeover chatter
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10:16 EDTINCYOptions with decreasing implied volatility
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07:57 EDTBMRNExperts see positive FDA panel for BioMarin, says Jefferies
Jefferies analyst Eun Yang says regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin's (BMRN) Kyndrisa, a treatment for Duchenne Muscular Dystrophy. The panel meeting is November 24 and the FDA action date for the drug is December 27. The experts point to a favorable risk/benefit profile for Kyndrisa as well as no current treatment option for DMD as supporting their confidence of FDA approval, Yang tells investors in a research note. The experts see a post-marketing study for Kyndrisa as likely necessary, she adds. On competitor Sarepta's (SRPT) DMD treatment eteplirsen, experts' views are "somewhat mixed," Yang adds. She has a Buy rating on BioMarin with a $166 price target. A positive panel vote could boost shares by 20% and bring increased confidence in BioMarin's three additional candidates targeting additional DMD patients, she contends. The orphan drug developer closed yesterday down $4.35 to $106.80.
November 12, 2015
17:55 EDTGILDGilead announces FDA approval of Harvoni
Gilead Sciences announced that the U.S. FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
08:12 EDTINCYIncyte price target raised to $135 from $130 at Leerink
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