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News Breaks
August 21, 2014
15:37 EDTBAX, NKTRNektar: Baxter announces positive results from Phase 3 study of BAX 855
Nektar Therapeutics (NKTR) reports Baxter International (BAX) announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 - 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study
News For NKTR;BAX From The Last 14 Days
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July 2, 2015
10:00 EDTBAXOn The Fly: Analyst Downgrade Summary
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08:49 EDTBAXBaxter downgraded to Neutral from Buy at BofA/Merrill
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07:05 EDTBAXBaxter now a margin improvement story, says Barclays
Barclays said the new Baxter, following the spinout of Baxalta (BXLT), is now a margin improvement story with EBIT expanding faster than sales and driven by new product launches, cost structure improvements, and portfolio optimizing. The firm sees the biggest catalysts to be Baxter's ability to beat margin guidance. Shares are Overweight rated with a $43 price target.
July 1, 2015
16:28 EDTBAXOn The Fly: Top stock stories for Wednesday
Stocks on Wall Street opened higher amid hopes for a resolution to the Greek debt crisis. The market also received help from positive reports from the ISM on manufacturing and ADP on the labor market. The averages saw their highs shortly after the open and then gradually drifted off those highs, while moving in a fairly narrow range. Investors will now be looking to the release of tomorrow’s nonfarm payrolls report, which will be out a day earlier than normal due to the Independence Day holiday. ECONOMIC EVENTS: In the U.S., ADP reported the private sector added 237,000 jobs in June, versus expectations for 218,000 job additions. Markit's manufacturing purchasing managers' index for June came in at 53.6, narrowly above the 53.4 forecast. ISM's manufacturing index rose to 53.5 in June, topping May's 52.8 reading and the 53.2 consensus forecast. Construction spending rose 0.8% in May, versus the expected growth of 0.5%. In China, manufacturing PMIs came in short of expectations. The HSBC/Markit PMI slipped to a final 49.4 in June from the flash reading of 49.6, while the government's official manufacturing PMI fell to 50.1 in June from 50.9 in May. In Europe, Greece officially missed its $1.7B payment to the International Monetary Fund last night. Reports then indicated that Greece's government was willing to make concessions that get it much closer to creditor demands. The new proposal for budget cuts and policy overhauls from Prime Minister Alexis Tsipras was dismissed by European officials, however, and Eurogroup president Jeroen Dijsselbloem said that he sees no need for further talks on Greece at this point and that he awaits the result of this Sunday's scheduled referendum. COMPANY NEWS: In a blockbuster deal in the insurance industry, ACE Limited (ACE) agreed to acquire Chubb (CB) in a cash and stock transaction valued in excess of $28B that will create the number one global Property and Casualty insurance company by P&C underwriting income and the number two U.S. public P&C insurer by market cap. ACE shares advanced 77c, or 0.76%, to $102.45 following the deal announcement, while Chubb surged $25.63, or 26.94%, to $120.77... U.S. airline stocks dropped after the Associated Press reported that the Justice Department is investigating potential "unlawful coordination" between companies attempting to artificially limit growth to keep fares high. Shares of American Airlines (AAL), Delta Air Lines (DAL), Southwest (LUV), United Continental (UAL) and JetBlue (JBLU) all closed lower by between 1.4% to 3.4% following the report. MAJOR MOVERS: Among the notable gainers was Schnitzer Steel (SCHN), which advanced 13.45% to $19.82 after BofA Merrill Lynch upgraded the shares two notches to Buy from Underperform and raised its price target to $21, saying scrap pricing should be nearing a trough with stability expected ahead. Also higher were shares of Dycom (DY), which gained 7.87% to $63.48 following a fourth quarter guidance hike, an announcement of a $40M repurchase plan and an upgrade to Buy at DA Davidson. Among the noteworthy losers was Baxter (BAX), which fell 44.43% to $38.86 after its spin-off of Baxalta (BXLT), whose shares fell 1.38% to $31.50. Baxter was downgraded to Neutral from Outperform at Credit Suisse after the research firm updated its valuation of Baxter to reflect the split. Also lower was Graham Holdings (GHC), which fell 35.48% to $693.63 after the company completed its spin-off of Cable ONE (CABO), whose shares lost 6.23% to $399. Additionally, shares of General Motors (GM) fell 0.87% to $33.04 after the company halted production at its Russian plant and reported June U.S. sales dropped 3%. INDEXES: The Dow rose 138.40, or 0.79%, to 17,757.91, the Nasdaq gained 26.26, or 0.53%, to 5,013.12, and the S&P 500 advanced 14.31, or 0.69%, to 2,077.42.
10:00 EDTBAXOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Autoliv (ALV) downgraded to Underperform from Outperform at Exane BNP Paribas... Baxter (BAX) downgraded to Neutral from Outperform at Credit Suisse... Carter's (CRI) downgraded to Buy from Conviction Buy at Goldman... Fiat Chrysler (FCAU) downgraded to Neutral from Outperform at Exane BNP Paribas... H&E Equipment (HEES) downgraded to Sector Weight from Overweight at KeyBanc... L'Oreal (LRLCY) downgraded to Sell from Neutral at Citi... Marchex (MCHX) downgraded to Equal Weight from Overweight at Stephens... NASDAQ (NDAQ) downgraded to Market Perform from Outperform at Keefe Bruyette... Starbucks (SBUX) downgraded to Buy from Conviction Buy at Goldman... Towers Watson (TW) downgraded to Hold from Buy at Deutsche Bank... Tuesday Morning (TUES) downgraded to Accumulate from Buy at Johnson Rice... United Rentals (URI) downgraded to Sector Weight from Overweight at KeyBanc.
08:08 EDTBAXBaxter downgraded to Neutral from Outperform at Credit Suisse
Credit Suisse downgraded Baxter (BAX) to Neutral with a $39 price target based on valuation following the Baxalta (BXLT) spin-off.
June 25, 2015
07:06 EDTBAXMerrimack's MM-398 NDA granted priority review by FDA
Merrimack (MACK) and Baxalta Incorporated, a wholly-owned subsidiary of Baxter (BAX) announced that the New Drug Application for MM-398 has been accepted for review by the FDA. Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. In addition, the FDA has classified the NDA as having Priority Review status. The FDA has set a goal of October 24 to take action under the Prescription Drug User Fee Act. The European Medicines Agency has also accepted for review a Marketing Authorization Application for MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The acceptance of the MAA marks the beginning of the review process in the European Union for MM-398 in this indication.
June 24, 2015
12:30 EDTNKTROn The Fly: Top stock stories at midday
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June 23, 2015
19:03 EDTNKTROn The Fly: After Hours Movers
UP AFTER PROVIDING GUIDANCE: MeetMe (MEET), up 18.8%. ALSO HIGHER: Nektar Therapeutics (NKTR), up 4.3% after being added to S&P 600... Quidel (QDEL), up 5% after receiving FDA clearance for new Solana molecular system and assay... Vanda Pharmaceuticals (VNDA), up 4.6% after announcing positive results from REPRIEVE study... Netflix (NFLX), up 3.4% after announcing seven-for-one stock split. LOWER: Alcobra (ADHD), down 2.5% after announcing that it will host a conference call and simultaneous webcast presentation to present results from the Phase II clinical trial of MDX... Sysco (SYY), down 2.6% after bid for U.S. foods blocked was blocked by a federal judge... Boeing (BA), down marginally after announcing CEO transition.
18:07 EDTBAXBaxter initiated with a Buy at Goldman
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18:00 EDTNKTRS&P announces changes to the S&P 400, 500, 600 indices
S&P Dow Jones Indices will make the following changes to the S&P 500, S&P MidCap 400 and S&P SmallCap 600 indices: Columbia Pipeline Group (CPGX) will replace Allegheny Technologies (ATI) in the S&P 500, Allegheny Technologies will replace Unit Corp. (UNT) in the S&P MidCap 400, and Unit Corp. will replace PetroQuest Energy (PQ) in the S&P SmallCap 600 after the close of trading on Wednesday, July 1. S&P 500 constituent NiSource (NI) is spinning off Columbia Pipeline Group in a transaction expected to be completed on that date. NiSource will remain in the S&P 500 following the distribution. Allegheny Technologies, Unit and PetroQuest are all ranked near or at the bottom of their current indices. S&P SmallCap 600 constituent Casey’s General Stores (CASY) will replace AOL (AOL) in the S&P MidCap 400, and Nektar Therapeutics (NKTR) will replace Casey’s General Stores in the S&P SmallCap 600 after the close of trading on Thursday, June 25. S&P 100 & 500 constituent Verizon (VZ) acquired AOL in a transaction completed today. TopBuild (BLD) will replace Aéropostale (ARO) in the S&P SmallCap 600 after the close of trading on Tuesday, June 30. S&P 500 constituent Masco (MAS) is spinning off TopBuild in a transaction expected to be completed on that date. Masco will remain in the S&P 500 following the distribution. Aéropostale is ranked near the bottom of the S&P SmallCap 600. “New” Gannett Co. (GCI) will replace Quiksilver (ZQK) in the S&P SmallCap 600 after the close of trading on Friday, June 26. S&P 500 constituent Gannett Co. (GCI) is spinning off “new” Gannett Co. in a transaction expected to be completed on that date. Post spin, the parent company will change its name to TEGNA. and trade under the symbol “TGNA”. It will remain in the S&P 500 following the distribution. Quiksilver is ranked near the bottom of the S&P SmallCap 600. Cable ONE Inc. (CABO) will replace Peabody Energy (BTU) in the S&P MidCap 400 after the close of trading on Tuesday, June 30. S&P MidCap 400 constituent Graham Holdings Company (GHC) is spinning off CableOne in a transaction expected to be completed on that date. Graham Holdings will remain in the S&P MidCap 400 following the distribution. Peabody Energy is ranked near the bottom of the S&P MidCap 400. The Chemours Co. (CC) will replace Semtech Corp. (SMTC) in the S&P MidCap 400, and Semtech will replace Paragon Offshore (PGN) in the S&P SmallCap 600 after the close of trading on Tuesday June 30. S&P 100 & 500 constituent E. I. du Pont de Nemours and Co. (DD) is spinning off Chemours in a transaction expected to be completed on that date. Dupont will remain in the S&P 100 & 500 following the distribution. Semtech and Paragon Offshore are ranked near or at the bottom of their current indices. “New “ Energizer Holdings (ENR) will replace Harsco (HSC) in the S&P MidCap 400, and Harsco will replace FXCM (FXCM) in the SmallCap 600 after the close of trading on Tuesday, June 30. S&P MidCap 400 constituent Energizer (ENR) is spinning off “new” Energizer in a transaction expected to be completed on that date. Post spin, the parent company will change its name to Edgewell Personal Care Co. and trade under the symbol “EPC”. It will remain in the S&P MidCap 400 following the distribution. Harsco and FXCM are ranked near or at the bottom of their current indices.
17:21 EDTNKTRNektar to replace Casey's General Stores in S&P 600 as of 6/25 close
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13:16 EDTNKTRNektar management to meet with William Blair
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June 22, 2015
06:32 EDTBAXKamada collaborates with Baxter on clinical trial with Alpha-1 antitrypsin
Kamada (KMDA) reports that the company has entered into a collaboration with Baxalta International, a wholly-owned subsidiary of Baxter (BAX) on a Phase 1/2 clinical trial of Kamada’s proprietary alpha-1 antitrypsin treatment for the prevention of lung transplant rejection. Under the agreement, Baxalta will collaborate in the development and funding of the study, which will be conducted in Israel. The study is expected to initiate in the first half of 2016, with more details on trial design to be provided at a later date. Kamada’s proprietary, highly-purified, liquid form of human AAT has shown positive interim results in a proof-of-concept Phase II study in Graft-versus-Host-Disease conducted at the Fred Hutchinson Cancer Research Center in cooperation with Baxalta. Based on those results, preclinical data published in Blood, and at the American Society of Hematology meeting, and a similar mechanism of action, the companies now plan to expand the AAT indication to the prevention of lung transplant rejection and may use this data to support clinical development worldwide. Baxalta has distribution rights to intravenous AAT for all indications in the U.S., Canada, Australia and New Zealand, while Kamada has rights in all other territories and all other formulations.

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