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Stock Market & Financial Investment News

News Breaks
February 13, 2013
07:55 EDTQSII, QSII, RPTP, RPTP, HTWR, HTWR, CVD, CVD, MDVN, MDVN, IDIX, IDIX, ACHN, ACHN, NVS, NVS, ALR, ALR, SNTA, SNTALeerink to host a conference
Global Healthcare Conference 2013 is being held in New York on February 13-14 with webcasted company presentations to begin on February 13 at 8 am; not all company presentations may be webcasted. Webcast Link
News For QSII;ALR;NVS;ACHN;IDIX;MDVN;CVD;HTWR;RPTP;SNTA From The Last 14 Days
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July 29, 2014
05:19 EDTNVSNovartis sees high uptake in meningitis B vaccination program
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July 28, 2014
05:30 EDTNVSAlcon announces Simbrinza approved in EU
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July 25, 2014
15:24 EDTCVDCovance management to meet with Sterne Agee
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July 24, 2014
05:52 EDTQSIIQuality Systems reports Q1 EPS 13c, consensus 14c
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05:41 EDTNVSNovartis announces FDA acceptance of Sandoz application for filgrastim
Sandoz, a Novartis Group company, announced that the FDA has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.
July 23, 2014
06:41 EDTNVSArray BioPharma shares attractive at current levels, says Piper Jaffray
Piper Jaffray says shares of Array BioPharma are attractive at current levels ahead of Phase III data readouts for binimetinib in melanoma, selumetinib in Kras-mutant lung, thyroid and uveal melanoma, and filanesib in multiple myeloma. Piper sees the biggest overhang on Array shares as being the financing requirement and it notes that binimetinib could be returned to the company from current partner Novartis (NVS). Nonetheless, it feels investors should take a "serious look" at Array and keeps an Overweight rating on the stock with a $9 price target.
July 22, 2014
10:01 EDTSNTASynta Pharmaceuticals strength a selling opportunity, says Stifel
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10:00 EDTQSIIOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Abengoa Yield (ABY) initiated with an Equal Weight at Morgan Stanley... Actinium Pharmaceuticals (ATNM) initiated with a Buy at Canaccord... Axys Technologies (AXYS) initiated with a Buy at Dougherty... Chambers Street Properties (CSG) initiated with a Neutral at SunTrust... Enphase Energy (ENPH) initiated with a Buy at Dougherty... Minerals Technologies (MTX) initiated with an Outperform at Wedbush... NextEra Energy Partners (NEP) initiated with a Buy at BofA/Merrill... PTC Therapeutics (PTCT) initiated with a Buy at BofA/Merrill... QIWI (QIWI) initiated with a Positive at Susquehanna... Quality Systems (QSII) initiated with a Buy at Topeka... Sarepta (SRPT) initiated with a Neutral at BofA/Merrill... Trinseo S.A. (TSE) initiated with a Buy at BofA/Merrill... Washington Prime Group (WPG) initiated with a Neutral at SunTrust... Zhaopin (ZPIN) initiated with a Buy at UBS.
09:07 EDTSNTASynta Pharmaceuticals data positive, says JMP Securities
JMP Securities believes that early top-line data indicates Synta's ganetespib plus current standard of care, low-dose Ara-C provide clinical benefit in high-risk elderly patients with newly diagnosed AML and MDS. The firm says the results increase its confidence in a positive GALAXY-2 outcome in NSCLC and broad applicability of ganetespib across a variety of tumor types. It keeps an Outperform rating on the stock.
July 21, 2014
19:21 EDTQSIIQuality Systems initiated with a Buy at Topeka
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16:32 EDTSNTASynta Pharmaceuticals advances ganetespib into Phase 3 extension of AML LI-1
Synta Pharmaceuticals announced the advancement of ganetespib into the Phase 3 extension of the AML LI-1 trial. AML LI-1 is a multicenter, randomized Phase 2/3 clinical study evaluating several novel treatment regimens, including the combination of ganetespib with low dose cytarabine, in newly diagnosed elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who are not eligible for intensive chemotherapy. Ganetespib is a next-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 1000 patients to date. Advancement into the Phase 3 extension follows an interim analysis of results from 50 patients who received the ganetespib-cytarabine combination in the Phase 2 portion of the trial. The primary efficacy outcome in Phase 2 was rate of complete response. Per protocol, the Phase 3 extension will include an interim futility analysis and enroll approximately 200 patients in the ganetespib-cytarabine and the cytarabine alone arms, for a total of approximately 400 patients. The primary efficacy endpoint for the Phase 3 extension will include overall survival. The Company is currently in discussion with study investigators, and anticipates providing additional details, including the timing of study milestones, as they become formalized. The AML LI-1 trial is the first of three multicenter, randomized studies supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK to include a ganetespib treatment arm. AML LI-1 is being conducted under the auspices of the UKís National Cancer Research Institute Haematological Oncology Study Group, with investigators in Denmark, France, New Zealand, and the UK, and under the sponsorship of Cardiff University, UK. The other two studies, to be initiated later this year, are the AML-18 trial, evaluating ganetespib with standard DA in patients over 60 years old who can tolerate intensive chemotherapy, and the AML-19 trial, evaluating ganetespib in combination with conventional chemotherapy in younger patients with AML.
07:38 EDTNVSNovartis management to meet with JPMorgan
Meetings to be held in Los Angeles/Pasadena on July 24 and in San Francisco on July 25 hosted by JPMorgan.
07:11 EDTNVSInternational Society of DNA Vaccines to hold a conference
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07:03 EDTNVSAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
July 17, 2014
11:12 EDTIDIXOptions with decreasing implied volatility
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08:34 EDTNVSVanda requests award of $539M in proceedings with Novartis
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05:32 EDTNVSNovartis reconfirms FY14 revenue guidance up at low to mid single digit rate
The company stated, "We are reconfirming our outlook for FY14. Group net sales in 2014 are expected to grow at a low to mid-single digit rate. Group core operating income is expected to grow ahead of sales in 2014, and now refined to mid to high-single digit. This outlook recognizes the entry of generic competition for Diovan monotherapy in the U.S. on July 7, including an authorized generic from Sandoz on the same date. If June average exchange rates prevail for the remainder of the year, the currency impact for the year would be -1% on sales and -3% to -4% on core operating income."
05:29 EDTNVSNovartis reports Q2 Core EPS $1.34, consensus $1.42
Reports Q2 revenue $14.6B, consensus $14.81B. Reports continued pipeline progress with positive regulatory decisions and significant clinical trial data released in Q2.
July 15, 2014
05:44 EDTNVSNovartis to license Google 'smart lens' technology
Novartis (NVS) announced that its eye care division Alcon has entered into an agreement with a division of Google (GOOG) to in-license its "smart lens" technology for all ocular medical uses. The agreement with Google[x], a team within Google that is devoted to finding new solutions to big global problems, provides Alcon with the opportunity to develop and commercialize Google's "smart lens" technology with the potential to transform eye care and further enhance Alcon's pipeline and global leadership in contact lenses and intraocular lenses. The transaction remains subject to anti-trust approvals. The agreement between Google and Alcon represents an important step for Novartis, across all of its divisions, to leverage technology to manage human diseases and conditions. Google's key advances in the miniaturization of electronics complement Novartis's deep pharmaceuticals and medical device expertise. Novartis aims to enhance the ways in which diseases are mapped within the body and ultimately prevented.
05:35 EDTNVSNovartis collaborates with Banner Alzheimer's Institute on study
Novartis announced a collaboration with Banner Alzheimer's Institute, or BAI, on a pioneering clinical study in Alzheimer's disease, or AD, prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease. Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.
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