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Stock Market & Financial Investment News

News Breaks
May 15, 2014
10:01 EDTPBCT, ICPT, GSK, CHKE, SUSQ, MPET, ITW, FCF, CAMP, RAX, LEJU, GLRI, EBS, ACAD, BDSIOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: ACADIA (ACAD) initiated with an Overweight at JPMorgan... BioDelivery Sciences (BDSI) initiated with a Buy at Summer Street... CalAmp (CAMP) initiated with an Overweight at Stephens... Cherokee (CHKE) initiated with a Buy at B. Riley... Emergent BioSolutions (EBS) initiated with a Buy at Summer Street... First Commonwealth (FCF) initiated with a Neutral at SunTrust... GlaxoSmithKline (GSK) initiated with an Overweight at JPMorgan... Glori Energy (GLRI) initiated with a Buy at Maxim... Illinois Tool Works (ITW) reinstated with a Neutral at Credit Suisse... Intercept (ICPT) initiated with a Buy at Summer Street... Leju (LEJU) initiated with an Outperform at Macquarie... Magellan Petroleum (MPET) initiated with a Buy at B. Riley... People's United (PBCT) initiated with a Neutral at SunTrust... Rackspace (RAX) assumed with an Overweight at JPMorgan... Susquehanna (SUSQ) initiated with a Neutral at SunTrust.
News For ACAD;BDSI;CAMP;CHKE;EBS;FCF;GSK;GLRI;ITW;ICPT;LEJU;MPET;PBCT;RAX;SUSQ From The Last 14 Days
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January 23, 2015
08:10 EDTGSKArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:44 EDTGSKGlaxo says now in position to deliver 'tens of thousands' of Ebola vaccine doses
Witty expects to start seeing data from trials of Ebola vaccines in next four to five months. GlaxoSmithKline CEO Andrew Witty speaking on CNBC.
06:39 EDTGSKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 22, 2015
07:17 EDTICPTIntercept price target lowered to $300 from $500 at Deutsche Bank
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January 21, 2015
16:31 EDTSUSQSusquehanna reports Q4 EPS 17c, consensus 18c
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12:30 EDTGSKGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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09:00 EDTCHKECherokee announces license agreement with Argos for U.K., Ireland
Cherokee Global Brands announced that it has entered into a new license agreement with Argos, a subsidiary of Home Retail Group plc, to launch a broad family-assortment of Cherokee lifestyle products online, in catalog and in more than 750 Argos stores across the United Kingdom and Ireland in Fall 2015.
January 20, 2015
09:40 EDTRAXFollow-up: Rackspace upgraded at CLSA
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09:17 EDTRAX, RAXRackspace upgraded to Buy from Outperform at CLSA
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January 16, 2015
13:16 EDTGLRIGlori Energy management to meet with FBR Capital
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08:31 EDTGSKGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
16:06 EDTPBCTPeople's United reports Q4 EPS 22c, consensus 21c
Provision for loan losses totaled $9.9M. Net loan charge-offs totaled $8.5M. At December 31, People's United Financial's tier 1 common and total risk-based capital ratios were 9.8% and 12.2%, respectively, and the tangible equity ratio stood at 7.5%.
15:14 EDTPBCTNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Intel (INTC), consensus 66c; Schlumberger (SLB), consensus $1.46; Bank of the Ozarks (OZRK), consensus 41c; People's United (PBCT), consensus 21c; Wintrust Financial (WTFC), consensus 77c.
14:31 EDTGSKMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
08:36 EDTGSKOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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January 13, 2015
14:44 EDTACADACADIA says Nuplazid NDA submission planned for 1Q15
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January 12, 2015
12:04 EDTGSKNovartis sees closing GSK transactions in 1H15
Novartis (NVS) says portfolio transformation is progressing "on track." Sees closing GlaxoSmithKline (GSK) transactions in 1H. In 2015, plans to execute integration of GSK oncology business, execute separation of Vaccines, ensure successful start-up of Consumer Health JV with GSK. Sees NBS to continue to deliver synergies. Comments from slides that are being presented at the JP Morgan Healthcare Conference.
08:37 EDTGSKShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. 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).
08:13 EDTICPTIntercept plans to initiate PSC Program Biliary Atresia Phase in 2H15
Intercept provided a clinical update on obeticholic acid, or OCA, a novel bile acid analog and first-in-class agonist of the farnesoid X receptor, or FXR, as well as planned 2015 milestones and other general business updates. OCA is currently being developed for the treatment of several chronic liver diseases, including primary biliary cirrhosis, or PBC, nonalcoholic steatohepatitis, or NASH, and primary sclerosing cholangitis, or PSC. The completion of PBC Program NDA and MAA filings planned in 1H15. The NASH Program Phase 3 program initiation planned in 1H15 and Japan Phase 2 trial data expected at the end of 2015. The PSC Program Biliary Atresia: Phase 2 initiation planned in 2H15 and INT-767: Phase 1 initiation planned for the end of 2015. Intercept ended 2014 with approximately $240M in cash and investments. For FY15, the company projects adjusted operating expenses in the range of $180M-$200M, which excludes stock-based compensation and other non-cash items. These expenses will support the clinical development program for OCA in PBC, NASH and PSC, expansion of our clinical, regulatory, medical affairs and commercial infrastructure in the United States and Europe, expansion of OCA manufacturing activities, as well as advancement of INT-767 and other preclinical pipeline programs. Adjusted operating expense, as presented above, is a non-GAAP financial measure. The company anticipates that stock-based compensation expense will represent the most significant non-cash item that is excluded in adjusted operating expenses as compared to operating expenses under GAAP.
06:22 EDTGSKWHO approves 2 ebola vaccines to enter West Africa trials, Financial Times says
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