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News Breaks
May 27, 2014
07:02 EDTINCY, BMYBristol-Myers, Incyte enter collaboration agreement for nivolumab, INCB24360
Bristol-Myers Squibb (BMY) and Incyte (INCY) announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 inhibitor, INCB24360, in a Phase I/II study. Multiple tumor types will be explored in the study, which could potentially include melanoma, non-small cell lung, ovarian, colorectal, squamous cell carcinoma of the head and neck and diffuse large B-cell lymphoma. The study, which is expected to begin in 4Q, will be co-funded by the companies and conducted by Incyte. Additional details of the collaboration were not disclosed.
News For BMY;INCY From The Last 14 Days
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February 11, 2016
09:43 EDTINCYIncyte solid tumor discontinuation mostly expected, says Jefferies
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09:40 EDTINCYJakafi trial ends not Incyte 'thesis killer,' says JPMorgan
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09:21 EDTINCYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Expedia (EXPE), up 8.4%... Tripadvisor (TRIP), up 10.8%... Cisco (CSCO), up 6%... LendingClub (LC), up 8.8%... Tesla (TSLA), up 3.5%... Shire (SHPG), up 3.1%. ALSO HIGHER: 3D Systems (DDD), up 13.4% after reporting preliminary Q4 revenue. DOWN AFTER EARNINGS: Flowers Foods (FLO), down 17.7%... Incyte (INCY), down 14.3%... LivePerson (LPSN), down 16.7%... Twitter (TWTR), down 5.5%... Mylan (MYL), down 12.5%... PepsiCo (PEP), down marginally. ALSO LOWER: Visa (V), down 3% after being downgraded to Neutral from Buy at BofA/Merrill... Mastercard (MA), down 3% after being downgraded to Neutral from Buy at BofA/Merrill.
07:08 EDTINCYIncyte sees epacadostat entering Phase 3 during 1H16
Incyte (INCY) said its position in the field of JAK inhibition is demonstrated by the ongoing commercial success of Jakafi and by the recent submissions, by Eli Lilly and Company (LLY), seeking regulatory approval of baricitinib for the treatment of rheumatoid arthritis. Baricitinib was licensed to Lilly by Incyte, and met the primary endpoint in all four of its global Phase 3 studies. If approved, Lilly expects to launch baricitinib in early 2017. In addition, epacadostat, Incyte's first-in-class IDO1 inhibitor, is expected to enter Phase 3 during the first half of 2016 in first-line advanced or metastatic melanoma in combination with Merck & Co's pembrolizumab. Multiple Phase 2, tumor-specific, expansion cohorts of epacadostat in combination with anti-PD-1 and anti-PD-L1 checkpoint modulators are also underway.
07:07 EDTINCYIncyte sees FY16 Jakafi revenue $800M-$815M
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07:05 EDTINCYIncyte reports Q4 EPS 29c, consensus 9c
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06:58 EDTINCYIncyte discontinuing studies of ruxolitinib for pancreatic cancer
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February 10, 2016
14:32 EDTINCYNotable companies reporting before tomorrow's open
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11:21 EDTINCYIncyte rises after competitor drug put on hold by FDA
Shares of Incyte (INCY) are rising after a competitor's myelofibrosis drug was placed on full clinical hold by the FDA. WHAT'S NEW: CTI BioPharma (CTIC) announced Tuesday night that it received notice from the FDA that its Investigational New Drug Application for pacritinib had been placed on full clinical hold. Under the full clinical hold, all patients currently on pacritinib must discontinue the drug immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment. CTI BioPharma withdrew its New Drug Application until the company has had a chance to review the safety and efficacy data from the PERSIST-2 Phase 3 clinical trial and decide next steps. Previously, on February 8, CTI BioPharma had announced the drug was on partial clinical hold. ANALYST REACTION: Leerink analyst Michael Schmidt said that while he didn't view CTI BioPharma's pacritinib as a significant threat to Incyte's Jakafi franchise in myelofibrosis, he believes the "surprising" setback of a potential competitor should remove a small overhang on Incyte shares. Leerink has an Outperform rating and $118 price target on Incyte shares. Meanwhile, CTI BioPharma was downgraded by analysts at Piper Jaffray, WallachBeth and Ladenburg. Among them, WallachBeth's Bob Ai downgraded CTI to Sell with a 0c price target, saying he sees no reason to hold the stock. PRICE ACTION: Shares of Incyte gained 3.4% to $74.71 in late morning trading, while shares of CTI BioPharma plunged 41% to 29c.
08:20 EDTINCYPacritinib hold an incremental positive for Incyte, says Leerink
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February 8, 2016
07:25 EDTBMYBiotech Industry Organization to hold a conference
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06:28 EDTBMYPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 5, 2016
12:48 EDTBMYBristol-Myers announces expanded use of Daklinza approved by FDA
Bristol-Myers Squibb announced today that Daklinza, an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without ribavirin for 12 weeks.
07:37 EDTBMYBristol-Myers pullback brings buying opportunity, says JPMorgan
JPMorgan analyst Chris Schott sees an attractive opportunity for shares of Bristol-Myers following the recent pullback. He reiterates an Overweight rating on the name with an $80 price target. The analyst sees a number of Immuno-Oncology catalysts for shares of Bristol over the next 12-18 months.
February 2, 2016
13:35 EDTBMYEarnings Watch: Merck down over 5% since last earnings report
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09:46 EDTBMYIntercept rumored to draw interest from many suitors, Daily Mail says
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08:53 EDTBMYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
06:58 EDTBMYPortola Pharma licensed right to andexanet alfa to Bristol-Myers and Pfizer
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06:57 EDTBMYBristol-Myers and Pfizer sign collaboration with Portola Pharmaceuticals
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January 29, 2016
07:49 EDTBMYBristol-Myers, AbbVie receive 'positive' CHMP opinion for Empliciti
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