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News Breaks | | | | March 18, 2013 | | 09:26 EDT |  | INCY, NVS | Incyte discloses patient treated with ruxolitinib develops PML
Incyte Corporation (INCY) disclosed in a regulatory filing that it was informed last week of a case of progressive multifocal leukoencephalopathy, or PML, in a 75 year old male patient from the United Kingdom with myelofibrosis treated with ruxolitinib. Ruxolitinib is marketed by the company as Jakafi in the United States and by Novartis (NVS) as Jakavi outside the United States, Incyte said. Incyte stated: "It has not been determined whether development of PML in this case was related to the use of ruxolitinib. An independent assessment to confirm the diagnosis and evaluate the causality assessment provided by the investigator is planned. This is the only known case of PML in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product...The Company has informed the U.S. Food and Drug Administration of this case and, as part of its standard procedure for sharing available information in a timely manner, is in the process of informing investigators in its clinical trials." The company added that there are reports in medical literature that "suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML." In pre-market trading, Incyte shares fell over 13% to $21.58. | |
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News For INCY;NVS From The Last 14 Days Check below for free stories on INCY;NVS the last two weeks. |
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| June 18, 2013 | | 11:33 EDT |  | INCY | High option volume stocks: INCY AVT ABC GY EPB
 Subscribe for More Information | | | 09:04 EDT |  | INCY | Wells Faro to host a conference
2013 Healthcare Conference is being held in Boston on June 18-19 with webcasted company presentations to begin at 8:15 am; not all company presentations may be webcasted. Webcast Link | | | 07:28 EDT | | INCY | Wells Faro to host a conference
Subscribe for More Information | | | 07:22 EDT | | NVS | Citigroup to host a conference
Subscribe for More Information | | | June 17, 2013 | | 07:28 EDT | | NVS | Cambridge Healthtech Institute to host a conference
Subscribe for More Information | | | 07:25 EDT | | NVS | Leerink to host a conference
Subscribe for More Information | | | June 16, 2013 | | 14:09 EDT | | INCY, NVS | Jakafi improved overall survival in Phase III trial of patients with myelofibros
Incyte (INCY) announced results from two ongoing clinical trials of Jakafi, ruxolitinib, an oral JAK1 and JAK2 inhibitor that is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis, MF, that were presented at the 18th Congress of the European Hematology Associationm EHA, in Stockholm, Sweden. In a three-year follow-up analysis of the Phase III COMFORT-II study, treatment with Jakafi, which is marketed as Jakavi by Novartis (NVS) outside the United States, was associated with improved overall survival and sustained reductions in spleen size compared to best available therapy. In a separate exploratory analysis of bone marrow fibrosis data from an ongoing Phase I/II single-arm, open-label clinical trial, by 48 months of treatment, Jakafi stabilized or reversed fibrosis of the bone marrow in 56 percent and 22 percent, respectively, of patients with MF, a magnitude of an effect not seen historically with best available therapy. | | | June 13, 2013 | | 07:48 EDT |  | INCY | Incyte Jakafi outlook still positive after label revisions, says Oppenheimer
Subscribe for More Information | | | 07:27 EDT | | INCY | Incyte Jakafi label update expected, says UBS
Subscribe for More Information | | | 06:05 EDT | | INCY | Eli Lilly, Incyte announce efficacy data of baricitinib Phase 2b JADA study
Subscribe for More Information | | | | June 12, 2013 | | 17:28 EDT | | INCY | Incyte says prescribing information for Jakafi updated by U.S. FDA
Subscribe for More Information | | | 08:08 EDT | | INCY | Incyte won't be hurt by patient illness, says Oppenheimer
After a medical publication reported that a patient developed tumor lysis syndrome after discontinuing Incyte's Jakafi, Oppenheimer notes that the patient had previously been very sick. The firm views the data point as a significant outlier and keeps an Outperform rating on Incyte. | | | June 11, 2013 | | 16:21 EDT |  | NVS | On The Fly: Closing Wrap
Stocks on Wall Street were lower after the Bank of Japan's decision to hold off on any further stimulus measures raised investor concern. The averages recovered much of their early losses in the morning, sitting just below the flat line near noon, but the selling intensified during the second half of the session, with the market trending lower into the close. ECONOMIC EVENTS: In the U.S., NFIB's small business optimism index rose to 94.4 in May from a prior 92.1 reading. Wholesale inventories rose 0.2% in April, matching expectations, and wholesale trade rose 0.5% from the prior month, versus expectations for a 0.1% slide. The Job Openings & Labor Turnover report for April showed openings fell 3% to a seasonally adjusted 3.75M, while hiring jumped nearly 5% to 4.4M. In Asia, the Bank of Japan refrained from changing its policies following recent volatility in its stock and bond markets. The dollar weakened considerably against the Yen, losing more than 2% to trade near the Y96 level. COMPANY NEWS: Sprint (S) shares jumped 17c, or 2.37%, to $7.35 after Japan's Softbank (SFTBF) increased its offer to acquire the telecom company in the face of a potential rival bid from DISH Network (DISH). MAJOR MOVERS: Among notable gainers was Questcor (QCOR), up $5.47, or 14.9%, to $42.18 after the company acquired the right to develop Synacthen from Novartis (NVS). Also higher was Catamaran (CTRX), up $5.33, or 10.95%, to $53.99 after the company struck a ten-year strategic pharmacy benefits agreement with Cigna (CI) and its stock received upgrades from at least three firms. Among noteworthy losers was lululemon (LULU), down $14.43, or 17.54%, to $67.85 after its CEO announced plans to step down and the stock was downgraded at Sterne Agee and UBS. Also lower was GenMark Diagnostics (GNMK) which lost $1.96, or 12.95%, to $13.17, after Natural Molecular Testing launched a cardiac testing panel using technology from GenMark's competitor Luminex (LMNX). INDICES: The Dow was down 116.57, or 0.76%, to 15,122.02; the Nasdaq was down 36.82, or 1.06%, to 3,436.95; and the S&P 500 was down 16.68, or 1.02%, to 1,626.13. | | | 16:07 EDT |  | NVS | PDL BioPharma sees Q2 royalty revenue $143M
Subscribe for More Information | | | 13:18 EDT | | INCY | Incyte Jakafi side effects raises some concerns, says Morgan Stanley
Subscribe for More Information | | | 13:11 EDT | | INCY | Incyte mentioned cautiously at Morgan Stanley
Subscribe for More Information | | | 12:32 EDT | | NVS | On The Fly: Midday Wrap
Stocks on Wall Street were lower at midday but well off their lows after the Bank of Japan held off from implementing any additional stimulus measures. The U.S. market followed Japan's benchmark stock index lower at the open, though the averages climbed back fairly steadily during the morning and stood near session highs just a bit below the flat line near noon. ECONOMIC EVENTS: In the U.S., NFIB's small business optimism index rose to 94.4 in May from a prior 92.1 reading. Wholesale inventories rose 0.2% in April, matching expectations, and wholesale trade rose 0.5% from the prior month, versus expectations for a 0.1% slide. The Job Openings & Labor Turnover report for April showed openings fell 3% to a seasonally adjusted 3.75M, while hiring jumped nearly 5% to 4.4M. In Asia, the Bank of Japan refrained from changing its policies following recent volatility in its stock and bond markets. The benchmark Nikkei fell about 1.5% as the decision disappointed investors who may have expected some action. COMPANY NEWS: Sprint (S) shares rose over 2% after Japan's Softbank (SFTBF) increased its offer to acquire the telecom company in the face of a potential rival bid from DISH Network (DISH). MAJOR MOVERS: Among the notable gainers was Catamaran (CTRX), which was upgraded by at least three Street firms and rose 11% after announcing a ten-year strategic pharmacy benefits deal with Cigna (CI). Also higher were shares of Questcor (QCOR), which jumped 19% after buying the rights to develop Synacthen from Novartis (NVS). Among the noteworthy losers was GenMark Diagnostics (GNMK), which fell 24% after Natural Molecular Testing launched a cardiac testing panel using technology from GenMark's competitor Luminex (LMNX). Also lower were shares of yoga apparel maker lululemon (LULU), which fell 17% after its CEO announced plans to step down and the stock was downgraded at Sterne Agee and UBS. INDICES: Near noon, the Dow was down 6.68, or 0.04%, to 15,231.91; the Nasdaq was down 11.21, or 0.32%, to 3,462.56; and the S&P 500 was down 4.89, or 0.30%, to 1,637.92. | | | 09:16 EDT | | NVS | On The Fly: Pre-market Movers
HIGHER: Dole Food (DOLE), up 21.9% after CEO offers buyout at $12 per share... Questcor (QCOR), up 32% after buying rights to develop Synacthen and Synacthen Depot in the U.S. from Novartis (NVS), upgrade to Buy at CRT Capital... CardioNet (BEAT), up 44% after announcing a three-year national provider agreement with UnitedHealthcare Insurance (UNH)... Catamaran (CTRX), up 13.2% after announcing a ten-year strategic pharmacy benefits deal with Cigna (CI)... Sprint (S), up 2% after Softbank (SFTBF) increases buyout offer terms. Clearwire (CLWR) up 1.2%. LOWER: lululemon (LULU), down 14.9% after reporting earnings, CEO announces plans to step down, stock downgraded at Sterne Agee and UBS... Texas Instruments (TXN), down 2% after narrowing second quarter revenue, earnings forecast ranges... Corinthian Colleges (COCO), down 15.4% after disclosing the receipt of a subpoena from the SEC. Corinthian peer Career Education (CECO) 5.5%... Kinross Gold (KGC), down 5.5% after canceling development project in Ecuador, taking $720M charge, stock downgraded at Canaccord. DOWN AFTER EARNINGS: LDK Solar (LDK), down 8.5%. | | | 07:02 EDT | | NVS | Questcor acquires rights to develop Synacthen from Novartis
Subscribe for More Information | | | June 5, 2013 | | 05:49 EDT | | NVS | New data shows Novartis drug Gilenya benefited MS patients
New data will be presented at the 23rd meeting of the European Neurological Society, or ENS, that show how Novartis' Gilenya positively impacted the key measures for multiple sclerosis, or MS, -relapse rates, brain volume loss, lesions and disability progression. Improving these key measures led to favorable clinical outcomes. New findings from the TRANSFORMS study showed that a greater proportion of patients were disease free after one year on Gilenya treatment compared to interferon. For patients on interferon during the first year, the proportion who were disease free during the second year increased after they were switched from interferon to Gilenya treatment. These findings suggest that switching from interferon to Gilenya is beneficial for patients with RMS to achieve and maintain long-term disease-free status. In a separate analysis, patients with high disease activity who were switched toGilenya from interferon experienced improved disease measures, regardless of previous treatment. | | |
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