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NVLX @ Stockcharts
Solid MOMO run with todays news... follow the money..says MFI!
Nuvilex Announces $27 Million Funding Commitment With Institutional Investor to Advance Late Phase Clinical Trials
http://finance.yahoo.com/news/nuvilex-announces-27-million-funding-140000013.html
HRTX @ Stockcharts
Heron Therapeutics Provides Update on Sustol Resubmission
http://finance.yahoo.com/news/heron-therapeutics-provides-sustol-resubmission-130000550.html
Heron Therapeutics (formerly A.P. Pharma, Inc.) is a specialty pharmaceutical company developing products using its proprietary Biochronomerâ„¢ polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks. The Company's lead product, Sustol (formerly known as APF530), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting.
The Company's lead product, Sustolâ„¢ (formerly APF530), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting. Heron Therapeutics received a Complete Response Letter to its Sustol New Drug Application (NDA) and is targeting a resubmission of the NDA to the U.S. Food and Drug Administration late in the first quarter of 2014.
http://www.herontx.com/aboutus-main.html
HZNP @ Stockcharts
While most stocks are getting hammered this one is a winner..+18% and making $$$$
Solid volume at 9M shares and solid news taking this one much higher-bank on it!
7:33 am Horizon Pharma sees Q4 revs of $31.9-32.4 mln vs $27.4 mln CIQ est; provides VIMOVO update (HZNP) : Co provides preliminary revenues for the fourth quarter and fiscal year ended December 31, 2013.
For the fourth quarter of 2013, Horizon expects total net revenues of $31.9-32.4 mln vs $27.4 mln CIQ est.
According to Source Healthcare Analytics, total prescriptions for DUEXIS increased 13% in the fourth quarter of 2013 to 63,947 versus 56,673 in the third quarter of 2013.
Approximately 95% of commercially insured patients taking DUEXIS have a co-pay of twenty dollars or less.
According to SHA, total prescriptions for RAYOS increased 18% in the fourth quarter of 2013 to 2,973 versus 2,530 in the third quarter of 2013.
Approximately 95% of commercially insured patients taking RAYOS have a co-pay of less than twenty dollars.
Preliminary unaudited cash and cash equivalents at December 31, 2013 were ~$80.5 million.
NVLX @ Stockcharts
Nice steady movement today on a down day RSI & MFI move positively!
Nuvilex (NVLX) Partner, Austrianova Chairman and Chief Technical Officer, to Present at Phacilitate International Cell & Gene Therapy Forum 2014, January 27-29 in Washington, D.
http://finance.yahoo.com/news/nuvilex-nvlx-partner-austrianova-chairman-143000548.html
NVLX @ Stockcharts
Nice steady movement on a down day..MFI & RSI heading up..
Nuvilex (NVLX) Partner, Austrianova Chairman and Chief Technical Officer, to Present at Phacilitate International Cell & Gene Therapy Forum 2014, January 27-29 in Washington, D.C.
http://finance.yahoo.com/news/nuvilex-nvlx-partner-austrianova-chairman-143000548.html
FOLD @ Stockcharts
Nice movement upward closing up 3.40% / 398K shares traded.. closing near its high today.
http://finance.yahoo.com/news/amicus-strategy-guidance-215005703.html
Amicus’ strategy is to advance the development of next-generation Enzyme Replacement Therapies (ERTs). Amicus will enter the clinic with lead programs in Fabry, Pompe and mucopolysaccharidosis I (MPS I) in the year 2014, 2015 and 2016 respectively. The proof-of-concept preclinical data for next-generation ERTs for Fabry and Pompe will be presented in the first half of 2014.
Amicus expects cash, cash equivalents and marketable securities of $82.0 million as of Dec 31, 2013. Amicus expects 2014 net cash spend in the range of $54 million to $59 million. The company predicts that the current cash position should fund operations into the second half of 2015.
Amicus and GlaxoSmithKline (NYSE:GSK) are conducting two phase III studies – FACETS Study and ATTRACT Study – to investigate migalastat HCl monotherapy in patients with Fabry’s disease. Data from FACET study is expected in the second quarter this year and the top-line data from the ATTRACT study is expected in the second half of 2014.
We note that the Amicus-Glaxo collaboration for migalastat HCl dates back to 2010. This agreement was amended in Nov 2013. As per the agreement, Amicus will have the sole worldwide rights to develop and commercialize migalastat HCl (both as monotherapy and in combination with ERT) for Fabry’s disease.
Amcius currently carries a Zacks Rank #2 (Buy)
BONE @ Stockcharts
News reflects a good start to 2014...market liked the news up 8.81%..closed high of day at .71 with 205k shares traded!
Bacterin Announces Preliminary Fourth Quarter 2013 Revenue
Fourth Quarter Revenue in the range of $8.15 million to $8.28 million, an increase of 4% sequentially, and 1.5% over the same period last year.
Fourth Quarter Biologics Revenue in the range of $8.02 million to $8.07 million, up 5.0% sequentially and 4.5% over the same period last year.
Reorganization of sales force initiated January 1, 2014 to drive top-line growth during 2014
http://finance.yahoo.com/news/bacterin-announces-preliminary-fourth-quarter-211000191.html
Investor 100
BONE @ Stockcharts
News reflects a good start to 2014...market liked the news up 8.81%..going along for the ride!
Bacterin Announces Preliminary Fourth Quarter 2013 Revenue
Fourth Quarter Revenue in the range of $8.15 million to $8.28 million, an increase of 4% sequentially, and 1.5% over the same period last year.
Fourth Quarter Biologics Revenue in the range of $8.02 million to $8.07 million, up 5.0% sequentially and 4.5% over the same period last year.
Reorganization of sales force initiated January 1, 2014 to drive top-line growth during 2014
http://finance.yahoo.com/news/bacterin-announces-preliminary-fourth-quarter-211000191.html
ECTE @ Stockcharts
Nice churing going up finsihing up higher 5%...RSI..MFI curling upward..watching the 50MA & 200MA inch closer together..looking interesting indeed!
http://finance.yahoo.com/news/echo-therapeutics-applies-ce-mark-231504408.html
DARA @ Stockcharts
Churning in the 70's with 1M+ shares traded..awaiting next month updates.
Orphan Drug Status Potentially Huge For DARA Bio
Conclusion
http://seekingalpha.com/article/1035401-orphan-drug-status-potentially-huge-for-dara-bio
In the past we've written that we are Bullish on DARA Bio. KRN5500 is mostly an afterthought in our investment thesis that centers around the company's core commercial assets in Soltamox, Gelclair, and Bionect. Orphan Drug status for KRN5500 changes things - it creates enormous upside coming from the pipeline, as well as partnerships.
DARA's specialty oncology commercial story with a path to profitability and cheap valuation has peaked our interest. At today's price, investors are getting KRN5500 for free. If the FDA grants Orphan Drug status for KRN5500 and the company can secure a partner for phase 2b, this free pipeline asset, largely ignored by investors, could be worth multiples of the company's current market valuation.
KOOL @ Stockcharts
Can you say 111% gainer today - Nice!
http://finance.yahoo.com/news/totipotentrx-corporation-thermogenesis-corp-report-140000031.html
BONE @ Stockcharts
Opportunity to buy the dip.
http://openinsider.com/search?q=bone
FOLD @ Stockcharts
Solid MOMO lift today with a 13%...moving higher
Key Highlights:
Amicus announces "3-in-3" strategy for three next-generation Enzyme Replacement Therapies (ERTs) expected to enter the clinic in next three years with lead programs in Fabry, Pompe and Mucopolysaccharidosis I (MPS I)
Preclinical proof-of-concept data for next-generation ERTs for Fabry and Pompe to be featured at Lysosomal Disease Network WORLD Symposium and American College of Medical Genetics (ACMG) meetings in 1H14
Data from global registration studies of migalastat HCl monotherapy for Fabry disease expected to include complete 12- and 24-month data from Study 011 in 2Q14 and 18-month clinical data from Study 012 in 2H14
Current cash projected to fund operating plan into 2H15
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "As we enter 2014, Amicus is strongly positioned to continue our focus on advancing a pipeline of next-generation enzyme replacement therapies for patients with lysosomal storage diseases. There continues to be significant unmet medical needs in how we treat these diseases today. We believe that our CHART platform together with our Callidus technology provide a unique tool set to enhance enzyme activity, increase enzyme uptake into tissues, and potentially address the tolerability and immunogenicity associated with current ERTs. With the strengthening of our biologics business strategy, we are introducing the Amicus 3-in-3 strategy: advancing three next-generation ERTs into the clinic in the next three years."
Mr. Crowley continued, "We are well-capitalized to move these programs forward and expect our current cash position to fund our operating plan through many value-creating inflection points, including our Fabry next-generation ERT into the clinic this year and our Pompe next-generation ERT into the clinic in 2015. Both of these programs have the potential to markedly improve outcomes for patients."
http://finance.yahoo.com/news/amicus-therapeutics-provides-full-2014-123000037.html
Took a starter position at .67
Investor 100
Alexza Pharmaceuticals Announces Ferrer's Launch of ADASUVE® (Staccato® Loxapine) in Spain Triggering a $1 Million Milestone Payment
MOUNTAIN VIEW, Calif., Jan. 21, 2014 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (ALXA) today announced that ADASUVE® inhalation powder, pre-dispensed (Staccato® loxapine) is now available in Spain through Grupo Ferrer Internacional, S.A. (Ferrer). Ferrer is Alexza's commercial partner for ADASUVE in the European Union (EU), Latin America, Russia and the CIS countries. In conjunction with this commercial introduction of ADASUVE in Spain by Ferrer, Alexza will receive a milestone payment of $1 million.
(Logo: http://photos.prnewswire.com/prnh/20140121/SF49110LOGO)
"Given that Ferrer is one of the largest Spanish pharmaceutical companies, launching ADASUVE in our home market is an important milestone," said Antoni Villaro, Chief Operating Officer of Ferrer. "We expect to demonstrate Ferrer's commitment to commercial excellence and hope to serve as a reference for all other markets."
"Ferrer has consistently demonstrated a high degree of focus, commitment and collaboration in introducing ADASUVE to physicians who are seeking new therapeutic options for the treatment of agitation associated with bipolar disorder or schizophrenia," said Thomas B. King, President and CEO of Alexza. "With the launch of ADASUVE in Spain, we are pleased with how Ferrer is continuing to execute on its planned commercial launch across Europe."
Alexza received marketing authorization for ADASUVE from the European Commission in February 2013. ADASUVE is the first inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder authorized for marketing in the EU. Alexza and Ferrer estimate that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder1. Agitation is a common symptom for these patients2, characterized by feelings of distress, anxiety and loss of control. The marketing authorization for ADASUVE requires that patients receive regular treatment immediately after control of acute agitation symptoms. It also requires that ADASUVE be administered only in a hospital setting under the supervision of a healthcare professional and that short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects, such as bronchospasm.
Alexza and Ferrer established a collaboration agreement in October 2011. Under the terms of this agreement, Alexza is the exclusive supplier of ADASUVE and is responsible for all aspects of manufacture of the product. Ferrer is responsible for commercial activities and is expected to launch ADASUVE in additional EU countries throughout 2014.
About ADASUVE (Staccato loxapine)
ADASUVE combines Alexza's proprietary Staccato system with loxapine, an antipsychotic medicinal product. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in intravenous-like pharmacokinetics and rapid systemic effects.
ADASUVE has been approved for marketing in the United States by the U.S. Food and Drug Administration and in the EU by the European Commission. The authorization for ADASUVE in the EU differs from that in the U.S., with respect to the indication statement, dose regimen, available dose strengths, and risk mitigation and management plans.
For more information about ADASUVE, including the Summary of Product Characteristics and Patient Information Leaflet approved in the EU, please visit: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002400/human_med_001618.jsp&mid=WC0b01ac058001d124. For the full prescribing information including boxed warnings for the U.S., please visit www.adasuve.com.
About Ferrer
Founded in 1959, Ferrer is a privately-held European R&D-based pharmaceutical company headquartered in Barcelona. It is active in the pharmaceutical, health, fine chemicals and food sectors in Europe, Latin America, Africa, the Middle East, Asia and the United States. In total, Ferrer's human healthcare products are commercialized in more than 90 countries, through 27 international affiliates (including joint ventures) and 70 partners and distributors.
Ferrer carries out activities throughout the full pharmaceutical value chain, from R&D to international marketing, including fine chemical development and the manufacturing of both raw materials and finished pharmaceuticals. Its research centers in Spain and Germany, and manufacturing sites in Europe and Latin America cover the pharmaceutical, diagnostics, vaccine, fine chemical, food and feed sectors.
Ferrer is Alexza's commercial partner for ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.
For more information, visit www.ferrergrupo.com
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's products are based on the Staccato system, a hand-held inhaler designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.
ADASUVE (Staccato loxapine) is Alexza's first commercial product, which was approved by the U.S. Food and Drug Administration in December 2012 and by the European Commission in February 2013. Teva Pharmaceuticals USA, Inc. is Alexza's commercial partner for ADASUVE in the U.S. Grupo Ferrer Internacional, S.A. is Alexza's commercial partner for ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.
http://finance.yahoo.com/news/alexza-pharmaceuticals-announces-ferrers-launch-140500661.html
SNGX @ Stockcharts
Nice solid start to 2014!
PRINCETON, N.J., Jan. 16, 2014 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well a developing several biodefense vaccines and therapeutics, announced today that it has recently received approximately $750,000, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program (the Program).
http://finance.yahoo.com/news/soligenix-receives-750-000-non-121500114.html
http://finance.yahoo.com/news/soligenix-announces-positive-one-high-121500959.html
ECTE @ The Street
Chart Analysis:
http://www.thestreet.com/story/12243851/2/4-under-10-health-care-stocks-moving-higher.html
From a technical perspective, ECTE bounced modestly higher here right off its 200-day moving average of $3.52 with lighter-than-average volume. This move is starting to push shares of ECTE within range of triggering a near-term breakout trade. That trade will hit if ECTE manages to take out Thursday's high of $3.85 to some more near-term overhead resistance at $4.13 with high volume.
Traders should now look for long-biased trades in ECTE as long as its trending above some near-term support at $3.22 or above its 50-day at $3.04 and then once it sustains a move or close above those breakout levels with volume that hits near or above 563,173 shares. If that breakout hits soon, then ECTE will set up to re-test or possibly take out its next major overhead resistance levels at $4.91 to $6.
Bone@Stockcharts
Solid MOMO day passing the 200MA with a 16.92% gainer!
About Bacterin International Holdings
Bacterin International Holdings, Inc. (NYSE MKT: BONE) develops, manufactures and markets biologics products to domestic and international markets. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.
Bacterin's Medical Device division develops, employs, and licenses coatings for various medical device applications. For further information, please visit www.bacterin.com.
Recent PR:http://finance.yahoo.com/news/bacterin-present-noble-financial-tenth-123000803.html
Website:http://bacterin.com/
SEC Filings:http://investor.bacterin.com/phoenix.zhtml?c=234008&p=irol-sec
MSTX @ Stockcharts
Nice upward movement / rebound...Accum/Distribution upward...took a starter position on the dip!
http://finance.yahoo.com/news/mast-therapeutics-announces-positive-data-130000374.html
ECTE @ Stockcharts
Nice movement today with a 11% gain..MFI curling up with pending presentation..nice storyline for 2014
Recent PR:
Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference
http://finance.yahoo.com/news/echo-therapeutics-present-noble-financial-125000618.html
Echo Therapeutics Hires Product Development Management Executive
http://finance.yahoo.com/news/echo-therapeutics-hires-product-development-125000761.html
Hi fam401
I would be pleased with double digits $10.00+
http://finance.yahoo.com/q/ao?s=HZNP+Analyst+Opinion
Investor 100
DARA @ Stockcharts
Solid MOMO movement today..MFI -MACD moving upward with a 19.3% gainer!
Insiders Buying: http://openinsider.com/search?q=dara
DARA is focused on expanding its portfolio of oncology supportive care products in the United States, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a Fast Track Drug, and DARA is seeking orphan status for the treatment of CCIPN.
http://finance.yahoo.com/news/dara-biosciences-completes-breast-cancer-133000249.html