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Very much indeed.
GL
mlkrborn
Expediter
Who knows? possible.
mlkrborn
Nice spike :VNDA FDA reviewer recommends approval of Vanda sleep drug for blind
08:42 EDT VNDA Vanda rallies 85% after FDA panel recommends drug for approval
The fly on the wall
"Vanda Pharma climbs as FDA panel review approaches
Vanda nearly doubles in value as date of FDA panel review for sleep disorder drug approaches
1 hour ago
NEW YORK (AP) -- Shares of Vanda Pharmaceuticals nearly doubled in value Tuesday as a group of Food and Drug Administration advisors' prepared to review the company's sleep disorder drug tasimelteon.
THE SPARK: A panel of experts will meet to discuss the drug on Thursday. Briefing documents for the meeting were posted on the agency's website Tuesday, and Wall Street found the briefing documents encouraging. A positive recommendation would improve the chances the drug will be approved.
Tasimelteon is a potential treatment for non-24-hour disorder, a rare malady that affects people who are totally blind. Patients have difficulty synchronizing their bodies with the 24-hour cycle because they can't detect light.
THE BIG PICTURE: The FDA is scheduled to make a decision on tasimelteon by Jan. 31. The drug has met its goals in two late-stage clinical trials.
Vanda Pharmaceuticals Inc. has one approved drug, the schizophrenia treatment Fanapt.
THE ANALYSIS: Piper Jaffray analyst Charles Duncan said he believes the FDA is encouraging approval of tasimelteon, and he thinks the drug will get a positive review and be approved. He rates Vanda shares "Overweight" with a price target of $21.
SHARE ACTION: Shares of Vanda Pharmaceuticals rose $6.46, or 95 percent, to $13.24 in afternoon trading. The stock more than tripled in value between January and June, but shares have slumped in the last two months."
$16 Marrone Bio Innovations approves Marrone Bio Innovations' Zequanox for invasive mussel control (MBII) 15.96 -0.81 : Co announced that the state of California has issued a Certificate of Pesticide Registration for Zequanox to control invasive zebra and quagga mussels (Dreissena species) in pipe systems and infrastructure. Under this registration, Zequanox can now be used as an effective, environmentally responsible alternative to toxic, broad-spectrum chemicals (such as chlorine) to treat irrigation lines and water conveyance structures, as well as cooling and process water systems of industrial and power generation facilities.
Star Scientific announces leadership transition, acceleration of plans for submission of an IND to FDA for pharmaceutical version of anatabine compound (STSI) 1.77 -0.02 : Co announced that it has filed its preliminary proxy statement on Form 14A with the SEC in preparation for its Dec 27 annual shareholder meeting. The proxy statement outlines the co's plan to accelerate the submission of an Investigational New Drug (IND) application to the FDA, with the assistance of a respected global contract research organization (CRO). The co intends to continue the expansion of its dietary supplement business as well, including the addition of a time-release version of its Anatabloc dietary supplement. The proxy statement proposes a shareholder vote for a transition in leadership in connection with this dual-track business plan.
The co believes it has reached a point of inflection following a management and board review of the progress of research on forms of anatabine, for which the co holds several patents and has patents pending. The co's Chairman and the CEO both recommended to the Board that significant leadership changes are needed to better leverage opportunities in pharmaceutical development and FDA approval in the biotechnology space. The co intends, following the leadership transition, to accelerate plans for submission of an IND to the FDA and, with FDA guidance, to undertake appropriate Phase I/II clinical trials.
The proposed transition process centers on the election of five new board members and one current director. Two of the proposed directors would then assume senior leadership positions with the co. As proposed in the proxy, Michael J. Mullan, who currently is CEO of the Roskamp Institute and Archer Pharmaceuticals, would serve as the co's new CEO; it is anticipated that he also would be elected to serve as Chair of the co's new board. Christopher C. Chapman, currently an independent director, would serve as President, and would be a management member of the new board.
PED) 3.24 +0.21 Pacific Energy Development announces initial test results of appraisal well on Kazakhstan asset (PED) 3.24 +0.21 : Co announced the initial results of testing done by Aral Petroleum Capital Limited Partnership ("Aral") on Well #306, which was drilled in 2012, located in western Kazakhstan's East Zhagabulak field located within the North Block of Kazakhstan's Pre-Caspian Basin, which is covered by a production license and included within the 380,000 acre contract area ("Contract Area") covered by an exploration license issued by the Republic of Kazakhstan that is 100% held by Aral. The Company is currently in contract to acquire an indirect 34% interest in Aral, subject to the satisfaction of certain customary closing conditions including the requisite approvals from the Republic of Kazakhstan. According to information received from Aral, the test of the initial target interval of Well #306 was completed on October 28, 2013, the well was tied into the production pipeline on November 4, 2013, and the well is currently producing 79.68 tons of oil equivalent ("TOE") (approximately 579 barrels of oil equivalent ("BOE")) per day. Due to the success of the test of this initial target interval, Aral has decided to defer the test of 2 additional target intervals of Well #306, and instead commence testing (perforation and acidizing) on the previously untested Well #315 and fracturing and acidizing operations on Well #316, each of which were drilled in 2012, and then workover and testing of certain upper objectives of Well #308. As a result of the test on the initial target interval of Well #306, Aral has successfully increased the average daily production of oil from the asset from approximately 290 BOE per day prior to the test, to current average production of approximately 869 BOE per day.
stox sale @ $10 .. Intrinsic value for insiders? Tetraphase Pharmaceuticals prices offering of 4.5 mln shares of its common stock at $10.00 per share (TTPH) 11.31 :
fredy and funny men almost already paid uncle sam.
http://blogs.marketwatch.com/capitolreport/2013/11/07/taxpayers-almost-whole-on-fannie-freddie-bailout/?siteid=bnbh
Java;
xcellent reality check!
GLLs
still holding a core!
Pounding short pricks?
LoL
SBSux;
Good write up!
mlkrborn
Blue;
Kudos!
mlkrborn
SBsSUX; ALIBABA must be a must. Keep us posted.
Interesting!
IsoRay Cancer Fighting cesium-131 seeds, sutures and seeded mesh receive high marks with six abstracts presented during (ASTRO) the american society for radiation oncology conference (ISR) 0.58 : Co announced the presentation of clinical findings by numerous medical centers of the successful treatment of cancers and tumors using IsoRay's patented Cesium-131 seeds, sutured seeds and seed sutured mesh for internal radiation therapy. Note in the following studies, all show Cesium-131's effectiveness in treating tumors compared to other common treatments. Cesium-131 seeds, sutured seeds or mesh were placed within the resected tumor bed at the time of surgery to provide immediate radiation therapy to it and to a margin depth of 5 mm which is dosed to prevent tumor recurrence.
Burlington coat factory and RE MAX did well to my surprise!
Shorties pounded!
Lifevantage will commence its previously announced modified Dutch auction tender offer today, Sept 24, 2013. Co will offer to purchase up to $40 mln of its common stock at a price per share not less than $2.45 and not greater than $2.80 (Stock is halted) (LFVN) 2.23 : Co will commence its previously announced modified Dutch auction tender offer today, September 24, 2013. Through the tender offer, the Co will offer to purchase up to $40,000,000 of its common stock at a price per share not less than $2.45 and not greater than $2.80.
The tender offer will expire at 5:00 p.m., New York City time, on Friday, October 25, 2013, unless extended by the Co. Tenders of shares must be made on or prior to the expiration of the tender offer and may be withdrawn at any time prior to the expiration of the tender offer, in each case, in accordance with the procedures described in the tender offer materials.
The co expects to enter into a new credit facility to fund the share purchases in the tender offer. The tender offer will not be conditioned upon any minimum number of shares being tendered, but will be subject to the completion of the new credit facility and other customary conditions that are described in the tender offer materials.
Regado Biosciences initiated with an Outperform at Cowen
Theflyonthewall.comTheflyonthewall.com – 4 hours ago
RELATED QUOTES
Symbol Price Change
RGDO 6.0231 +1.4231
Cowen believes Regado Biosciences lead program REG1, has the potential to address several indications that collectively could attain blockbuster status. The company owns worldwide rights for all indications. Shares were initiated with an Outperform and $14 price target.
Protalix BioTherapeutics Announces Proposed $60 Million Offering of Convertible Notes
GlobeNewswirePress Release: Protalix BioTherapeutics, Inc. – 23 hours ago
RELATED QUOTES
Symbol Price Change
PLX.TA 1,863.00 0.00
CARMIEL, Israel, Sept. 11, 2013 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX.TA) announced today that it intends, subject to market conditions, to offer and sell $60 million principal amount of its convertible notes due 2018 (the "notes") through a private offering. The Company expects to grant the initial purchaser an option to purchase up to an additional $9 million principal amount of notes, exercisable for 30 days after the pricing date of the notes offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The notes will be unsecured, unsubordinated obligations of the Company, and interest will be payable semi-annually. The interest rate, initial conversion rate and other terms and conditions of the notes will be determined by the Company and the initial purchaser of the notes at the time of pricing of the notes. The notes may be converted at the option of holders into shares of the Company's common stock at any time prior to the close of business on the business day immediately preceding the stated maturity date of the notes.
The Company intends to use the net proceeds from this offering to fund clinical trials for its product candidates, to fund its research and development activities, to enhance its manufacturing capacity and for working capital and general corporate purposes.
The offering is being made to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale is unlawful. Any offer of the securities will be made only by means of a private offering memorandum. The notes and the shares of common stock issuable upon conversion of the notes, if any, will not be registered under the Securities Act or any state securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state laws.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx(R). Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012, by Israel's Ministry of Health in September 2012, by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in April 2013, and by the regulatory authorities of other countries. Marketing applications for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding Israel and Brazil, where Protalix retains full rights. Protalix's development pipeline also includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-105, a pegylated recombinant human acetylcholinesterase in development for several therapeutic and prophylactic indications, a biodefense program and an organophosphate-based pesticide treatment program; an orally-delivered glucocerebrosidase enzyme that is produced and encapsulated within carrot cells, also for the treatment of Gaucher disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel(R)) for the treatment of certain immune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; PRX-110 for the treatment of Cystic Fibrosis; PRX-107 for the treatment of emphysema due to hereditary alpha1-antitrypsin deficiency; and others.
TG Therapeutics' ublituximab (TG-1101) receives orphan drug designation for the treatment of Nodal Marginal Zone Lymphoma and extranodal marginal zone lymphoma (Mucosa-Associated Lymphatic Tissue, MALT) (TGTX) 6.25 : Co announced that ublituximab (TG-1101), its novel, glycoengineered anti-CD20 monoclonal antibody has received two Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of Nodal Marginal Zone Lymphoma and Extranodal Marginal Zone Lymphoma (Mucosa-Associated Lymphatic Tissue, MALT), both rare subtypes of non-Hodgkin's lymphoma for which there are limited effective treatments.
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S.
The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act filing fees.
BIOD end points met: $5.03 --"Biodel: BIOD-123 achieves primary endpoint in Phase 2 Clinical trial demonstrating glycemic control comparable to Humalog (BIOD) 5.03 : Co announces preliminary results from Study 3-201, a Phase 2 clinical study of BIOD-123, an investigational ultra-rapid-acting mealtime insulin, in patients with type 1 diabetes. BIOD-123 achieved the primary endpoint of non-inferiority for HbA1c relative to insulin lispro, a widely prescribed rapid acting mealtime insulin analog marketed as Humalog.
Highlights
Compared to Humalog, BIOD-123 demonstrated:
Achievement of primary efficacy endpoint; demonstration of non-inferiority in change from baseline HbA1c
Comparable weight gain, mean hypoglycemia event rates and postprandial glucose excursions over the entire treatment period with some notable trends in favor of BIOD-123 in weight gain during the stable dosing period, median hypoglycemia event rates and postprandial glucose excursions to a liquid meal challenge test
Comparable safety and adverse event profiles with the exception of an increased frequency of injection site pain associated with BIOD-123 which appears to be clinically minor, was short-lived and did not result in patient dropouts
PharmAthene's recently acquired Theraclone Sciences announces universal therapeutic antibody for influenza A demonstrates reductions in clinical symptoms score and viral load in a Phase 2a human viral challenge study (PIP) 2.27 : Theraclone Sciences, a therapeutic antibody discovery and development company and recently acquired by PharmAthene, announces results from a Phase 2a viral challenge study of TCN-032 for the universal treatment of influenza A.
The results of this study represent the first demonstration that a non-neutralizing antibody can provide immediate immunity and potential therapeutic benefit in influenza. TCN-032 is a recombinant, fully human monoclonal antibody that has the potential to treat patients who are hospitalized with serious influenza, as well as during pandemic outbreaks.
In the Phase 2a study, TCN-032 treatment resulted in significant reductions in clinical symptoms score as well as viral load as compared to placebo-treated subjects. While the Phase 2a study did not meet its pre-specified primary endpoint, the overall data support an anti-influenza effect, providing the impetus to proceed to clinical studies in patients with natural infection. TCN-032 was well-tolerated with no serious adverse events or immunogenicity observed. Pharmacokinetic parameters were consistent with a human antibody as previously confirmed in the Phase 1 study.
Good sign!
Siebert Financial Corp. announces death of Muriel F. Siebert, Founder, Chairwoman and Chief Executive Officer (SIEB) 1.55 : Ms. Siebert died of complications from cancer at Memorial Sloan-Kettering in Manhattan on Saturday, August 24. Joseph M. Ramos, the Company's Chief Operating Officer, as principal executive officer, will continue performing a similar function to those performed by Ms. Siebert.
OGEN $3.05 Oragenics collaboration demonstrates initial success in the second phase of lantibiotics project (OGEN) 3.05 : Co announced that through its Exclusive Channel Collaboration with Intrexon (XON), a synthetic biology company, preliminary experiments demonstrate that a genetically-modified (GM) host can be engineered to produce improved titers of OGEN's lead compound MU1140, progressing towards the commercial production of lantibiotics, a novel-class of broad-spectrum antibiotics. The collaboration has also uncovered two new methods of purifying its lead compound resulting in higher purity and yields of MU1140. The next step will be to use the GM host to produce analogs of MU1140 that are expected to demonstrate improved antimicrobial, chemical and pharmacological properties, with the objective of building a comprehensive antibiotic pipeline against various life-threatening indications.
Affymetrix Rise on Turnaround 2Q Earnings - Analyst Blog
Date : 08/07/2013 @ 12:25PM
Source : Zacks
Stock : Affymetrix, Inc. (MM) (AFFX)
Quote : 5.28 0.19 (3.73%) @ 4:38PM
Affymetrix Rise on Turnaround 2Q Earnings - Analyst Blog
Print
Alert
Shares of Affymetrix Inc.’s (AFFX) rose 6.4% to $5.00 yesterday following the release of its promising 2013-second quarter results on Jul 31. The company reported its first earnings since the first quarter of 2011. The stock price is very close to the 52-week high of $5.26 on Jul 12.
Affymetrix posted adjusted earnings per share of 4 cents in the quarter in sharp contrast to the year-ago adjusted loss of 13 cents. This reflected a whopping 500% earnings surprise compared with the Zacks Consensus Estimate of a loss of a penny.
Thanks to AFFX’s strategic restructuring plans and its acquisition of eBioscience in Jun 2012 that has opened new avenues for the company and turned its focus away from the beleaguered Gene Expression business.
Revenues increased 19.7% year over year to $79.5 million (including the eBioscience acquisition), almost in line with the Zacks Consensus Estimate. eBioscience revenues increased manifold to $18.8 million from $1.4 million in the year-ago period.
During the quarter, Affymetrix launched a new product, Axiom 384HT Genotyping Format, a high-throughput platform capable of genotyping 384 samples simultaneously and run on the GeneTitan Instrument.
We are impressed with Affymetrix’s strong second-quarter results, following a dismal first quarter. We believe that AFFX is ready for a turnaround due to management's strategy to transform it into a company with a broad reach in the high-growth markets for translational medicine, molecular diagnostics and applied markets. Despite a tight U.S. academic funding environment, AFFX’s new products and strategic agreements should propel growth in the company.
Currently, AFFX has a Zacks Rank #1 (Strong Buy). Other companies like Biogen Idec (BIIB), Gilead Sciences (GILD) and Actelion (ALIOF), all carrying a Zacks Rank #1 (Strong Buy), are also expected to do well in the Medical-Biomed/Gene industry.
ZACKS
MACK $3.46 British journal..."Merrimack Pharma: Study of Novel nanoliposomal irinotecan in late stage pancreatic cancer published in British Journal of Cancer; Phase 2 Study laid the groundwork for ongoing phase 3 NAPOLI-1 study in gemcitabine-refractory pancreatic cancer (MACK) 3.29 : Co announced that the FDA for Orphan Products Development has granted two separate orphan drug designations for its bispecific antibody, MM-111, for the treatment of esophageal cancer and for the treatment of gastric as well as gastroesophageal junction cancers.
MM-111 is designed to inhibit ErbB3 (HER3) receptor signaling in cancers that overexpress ErbB2 (HER2). Overexpression of the ErbB2 cell surface receptor has been reported in 7-34 percent of gastric cancers according to various scientific articles. Research has shown that ErbB3 expression is associated with poor prognosis in gastric cancer and may contribute to resistance to some current standard treatments. Currently, MM-111 is being tested in a Phase 2 study in advanced gastric, esophageal and gastroesophageal junction cancers. "
Mid-stage trial promising: Up almost $9 http://www.reuters.com/article/2013/08/21/us-incyte-study-cancer-idUSBRE97K0HY20130821?feedType=RSS&feedName=globalMarketsNews&rpc=43
Blue;
Why gradual decline to $4s?
tia
GL
mlkborn
Looking convincing one? Are you in?
Apricus Biosciences receives national phase approvals for Vitaros in Ireland and the Netherlands (APRI) 2.22 : Co announced that the Irish Medicines Board and the Netherlands' Medicines Evaluations Board have each granted national phase approvals to Vitaros, indicated for the treatment of patients with erectile dysfunction. The Company has now received a total of four national phase approvals for Vitaros including Ireland, the Netherlands, Sweden and the United Kingdom.
Concord Medical Services (thinly traded) announces acquisition of its shares by CEO and COO from other shareholders for an aggregate purchase price of ~ $103.8 mln (CCM) 4.80 +0.60 : Co announced that it has been informed that Mr. Jianyu Yang, the co's Chairman and CEO, Mr. Zheng Cheng, the co's director, President and COO, and certain other shareholders have entered into certain share purchase agreements. The co understands that pursuant to the Share Purchase Agreements, Mr. Yang and Mr. Cheng have agreed to establish a co under the laws of the British Virgin Islands as the purchaser and cause the purchaser to acquire an aggregate of 37,064,808 ordinary shares and 4,660,976 American Depository Shares, each representing three ordinary shares of the co, from certain other shareholders for a purchase price of $6.10 per ADS, with an aggregate purchase price of $103,797,063.21. It is currently expected that, upon the closing of such acquisition, the aggregate beneficial ownership of Mr. Yang and Mr. Cheng in the Company will increase to ~ 48.0%.
Dividend news : up 0.66 to $1.86..
BIOLASE Declares Stock Dividend for 2013 Third Quarter
MarketwiredPress Release: BIOLASE, Inc. – 11 hours ago
RELATED QUOTES
Symbol Price Change
BIOL 1.86 +0.66
IRVINE, CA--(Marketwired - Aug 15, 2013) - BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that its Board of Directors has declared a one-half percent stock dividend payable on September 13, 2013, to stockholders of record on August 30, 2013.
About BIOLASE, Inc.
BIOLASE, Inc. is a biomedical company that develops, manufactures, and markets innovative lasers in dentistry and medicine and also markets and distributes high-end 2D and 3D digital imaging equipment and CAD/CAM intraoral scanners; products that are focused on technologies that advance the practice of dentistry and medicine. The Company's proprietary laser products incorporate approximately 340 patented and patent-pending technologies designed to provide biologically clinically superior performance with less pain and faster recovery times. Its innovative products provide cutting-edge technology at competitive prices to deliver the best results for dentists and patients. BIOLASE's principal products are revolutionary dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications, and a full line of dental imaging equipment. BIOLASE has sold more than 23,000 lasers. Other laser products under development address ophthalmology and other medical and consumer markets.
For updates and information on WaterLase® and laser dentistry, find BIOLASE® online at www.biolase.com, Facebook at www.facebook.com/biolaseinc, Twitter at www.twitter.com/biolaseinc, Pinterest at www.pinterest.com/biolase, LinkedIn at www.linkedin.com/company/biolase, Instagram at www.instagram.com/biolaseinc and YouTube at www.youtube.com/biolasevideos.
Oversold. Time to add ,to start new positions! Short pricks will get punished again!
GL longs!