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News Breaks
June 3, 2014
10:51 EDTINCY, NVSNovartis, Incyte announce results from RESPONSE trial evaluating ruxolitinib
Novartis (NVS) and Incyte (INCY) announced results from the first-ever pivotal Phase III study evaluating a JAK 1/2 inhibitor for the treatment of polycythemia vera. Jakavi, or ruxolitinib, improved hematocrit control without the need for phlebotomy and reduced spleen size in patients with PV who are resistant to or intolerant of hydroxyurea[. Findings are being presented at the 50th Annual Meeting of the American Society of Clinical Oncology. Ruxolitinib was well tolerated and adverse events were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis. Within the first 32 weeks of treatment, Grade 3 or 4 hematologic AEs in the ruxolitinib treatment arm were anemia and thrombocytopenia and fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received best available therapy. The most common non-hematologic AEs were headache, diarrhea and fatigue. Additionally, 3.6% of patients randomized to the ruxolitinib treatment arm discontinued treatment due to AEs compared to 1.8% on the best available therapy arm. Data from the RESPONSE trial will support worldwide regulatory submissions planned this year.
News For NVS;INCY From The Last 14 Days
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February 11, 2016
06:58 EDTINCYIncyte discontinuing studies of ruxolitinib for pancreatic cancer
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05:35 EDTNVSSandoz reports EMA acceptance of MAA for biosimilar pegfilgrastim
Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency, or EMA, has accepted their Marketing Authorization Application, or MAA, for its biosimilar to Amgen's EU-licensed Neulasta - a long-acting recombinant human granulocyte colony-stimulating factor, or G-CSF. Sandoz is seeking approval for the same indication as the reference product.
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 9, 2016
11:18 EDTNVSOptions with increasing call volume; CERS WYN NVS ZIOP PZM PI OC DB MLM
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February 8, 2016
09:38 EDTNVSCigna enters into outcomes-based contract with Novartis
Cigna (CI) has entered into an outcomes-based contract with the pharmaceutical company Novartis (NVS) for the drug Entresto, which was approved by the FDA for the treatment of heart failure with reduced ejection fraction. The pay-for-performance agreement ties the financial terms to how well the drug improves the relative health of Cigna's customers. The primary metric is reduction in the proportion of customers with heart failure hospitalizations. This agreement is effective for Cigna's commercial business. Entresto is a preferred brand subject to prior authorization review. The prior authorization process is part of utilization management to help control prescription drug costs and ensure coverage of the most appropriate drug therapies.
06:28 EDTNVSPharma 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 7, 2016
14:27 EDTNVSNovartis' somatic cell therapy receives orphan designation
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February 4, 2016
07:23 EDTNVSGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 2, 2016
11:14 EDTNVSNovartis management to meet with Jefferies
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07:42 EDTNVSPressure mounts on big pharma names to shrink, sharpen focus, FT says
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January 29, 2016
07:53 EDTNVSNovartis management to meet with JPMorgan
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07:37 EDTNVSRadius Health should be bought aggressively at current prices, says Canaccord
Canaccord said they would be aggressive buyers of Radius Health (RDUS) especially at current share prices. The firm cited its partnership with Novartis (NVS), its drug pipeline, and expectations for an FDA filing of abaloparatide in the first quarter of 2016. Canaccord reiterated its Buy rating and $85 price target on Radius Health shares.
January 28, 2016
12:09 EDTNVSRadius Health to hold a conference call
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11:33 EDTINCYOptions with increasing call volume
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09:38 EDTNVSNovartis downgraded to Neutral from Outperform at Exane BNP Paribas
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08:14 EDTINCYIncyte selloff brings long-term buying opportunity, says Jefferies
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08:08 EDTINCYIncyte selloff a buying opportunity, says Leerink
Leerink analyst Michael Schmidt recommends using today's pullback in shares of Incyte after the company announced its decision to stop one arm of its ongoing Phase II trial of ruxolitinib in metastatic colorectal cancer due to futility as a buying opportunity. The study is one of several ongoing trials to evaluate ruxolitinib in various solid tumor indications, the analyst points out. He says that while the news is disappointing, the stock's current valuation reflects very little if any value for ruxolitinib in solid tumor indications. Schmidt lowered his price target for Incyte shares to $118 from $135 and reiterates an Outperform rating on the name. The stock is down 13%, or $9.98, to $65.01 in pre-market trading.
07:43 EDTINCYIncyte weakness creates buying opportunity, says Oppenheimer
After Incyte announced that it would stop a Phase-2 study of Ruxolitinib plus regorafenib for R/R metastatic colorectal cancer and high-CRP patients due to insufficient efficacy, Oppenheimer says the data makes the drug's anti-inflammatory properties in solid tumors questionable. However, the firm did not previously include revenue from the drug outside of pancreatic cancer in its estimates. The firm keeps a $129 price target and Outperform rating on the shares.
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