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Synta Pharmaceuticals Corp. (SNTA) Message Board

jgmtruth 103 posts  |  Last Activity: Apr 17, 2014 11:39 AM Member since: Feb 21, 2008
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  • Pharmacyclics Inc. of Sunnyvale, Calif., disclosed news that is sure to give a boost to the use of its cancer drug Imbruvica (ibrutinib). Late last year the FDA approved the drug for relapsed/refractory, or R/R, mantle cell lymphoma, but the agency has not yet approved its use in R/R chronic lymphocytic leukemia. However, this week Pharmacyclics said the National Comprehensive Cancer Network endorsed its use in R/R CLL. NCCN guidelines are used to determine reimbursement by Medicare and private health insurers, as they reflect the consensus standard of care practice in oncology. JMP Securities analyst Mike King said he expects the NCCN guidelines will increase off-label use of the drug.

    Sentiment: Strong Buy

  • ZACKS 1hour ago..Pharmacyclics, Inc. (PCYC) has been on the move lately as the stock has risen by 32.5% in the past four weeks, and it is currently trading well above its 20-Day SMA. This is a pretty solid move higher, but the question that has to be on investors’ minds right now is; can this trend continue?

    While there can be no telling for sure, it is certainly encouraging that earnings estimates have risen in the past few weeks on the company, suggesting that sentiment on PCYC is moving in the right direction. In fact, the stock currently has a Zacks Rank #2 (Buy), suggesting that the recent run could certainly continue for this in-focus company.

    Sentiment: Strong Buy

  • jgmtruth jgmtruth Jan 27, 2014 4:41 PM Flag

    Interference Proceedings and Litigation with Idenix Pharmaceuticals, Inc.
    In February 2012, we received notice that the United States Patent and Trademark Office (PTO) had declared an Interference between our U.S. Patent No. 7,429,572 and Idenix Pharmaceuticals, Inc.'s (Idenix) pending patent application no. 12/131868. An Interference is an administrative proceeding before the PTO designed to determine who was the first to invent the subject matter being claimed by both parties. Our patent covers metabolites of GS-7977 and RG7128. Idenix is attempting to claim a class of compounds, including these metabolites, in their pending patent application. In the course of this proceeding, both parties will be called upon to submit evidence of the date they conceived of their respective inventions. The Interference will determine who was first to invent these compounds and therefore who is entitled to the patent claiming these compounds. If the administrative law judge determines Idenix is entitled to these patent claims and it is determined that we have infringed those claims, we may be required to obtain a license from, and pay royalties to, Idenix to commercialize GS-7977 and RG7128. Any determination by the PTO can be challenged by either party in U.S. Federal Court.
    In June 2012, we met with Idenix in mandatory settlement discussions. The parties were unable to settle the Interference due to our widely divergent views on the strength of our respective positions, on whether we need a license to Idenix's patents and on whether Idenix needs a license to Gilead patents to develop and manufacture its pipeline products. We believe the Idenix patent involved in the Interference and similar U.S. and foreign patents claiming the same compounds and metabolites are invalid. As a result, we filed an Impeachment Action in Canadian Federal Court to invalidate the Idenix CA2490191 patent, which is the Canadian patent that corresponds to the Idenix U.S. Patent No. 7608600 and the Idenix patent application that is the subject of the Interference. Idenix has not been awarded patents on these compounds and metabolites in many territories, including Europe, Japan, and China. In the event such patents issue, we expect to challenge them in proceedings similar to the one we invoked in Canada.

    38

    Contract Arbitration
    In March 2012, Jeremy Clark, a former employee of Pharmasset, Inc. (Pharmasset), which we acquired in January 2012, and inventor of U.S. Patent No. 7,429,572, filed a demand for arbitration in his lawsuit against Pharmasset and Dr. Raymond Schinazi. Mr. Clark initially filed the lawsuit against Pharmasset and Dr. Schinazi in Alabama District Court in February 2008 seeking to void the assignment provision in his employment agreement and assert ownership of U.S. Patent No. 7,429,572, which claims metabolites of GS-7977 and RG7128. In December 2008, the court ordered a stay of the litigation pending the outcome of an arbitration proceeding required by Mr. Clark's employment agreement. Instead of proceeding with arbitration, Mr. Clark filed two additional lawsuits in September 2009 and June 2010, both of which were subsequently dismissed by the court. In September 2010, Mr. Clark filed a motion seeking reconsideration of the court's December 2008 order which was denied by the court. In December 2011, Mr. Clark filed a motion to appoint a special prosecutor. In February 2012, the Alabama Court issued an order requiring Mr. Clark to enter arbitration or risk dismissal of his case. Mr. Clark filed a demand for arbitration in March 2012. We cannot predict the outcome of the arbitration. If Mr. Clark's prior assignment of this patent to Pharmasset is voided by the arbitration panel, and he is ultimately found to be the owner of the 7,429,572 patent and it is determined that we have infringed the patent, we may be required to obtain a license from and pay royalties to Mr. Clark to commercialize GS-7977 and RG7128.
    Other Matters
    We are a party to various legal actions that arose in the ordinary course of our business. We do not believe that any of such legal actions will have a material adverse impact on our consolidated business, financial position or results of operations.

    Sentiment: Strong Buy

  • jgmtruth jgmtruth Jan 27, 2014 5:47 PM Flag

    Idenix downgraded to Underperform from Market Perform at JMP Securities
    JMP Securities downgraded Idenix due to valuation and high clinical expectations..
    Today.

  • Reply to

    Short interest

    by olivermhoops Jan 28, 2014 10:04 AM
    jgmtruth jgmtruth Jan 28, 2014 10:14 AM Flag

    Just google nasdaq short interest.But let me tell you that short interest increased in almost all biotech stocks take a look GILD 80 million shares short PCYC and many others..Better for a short squeeze when we get FDA approval..IMO

    Sentiment: Strong Buy

  • jgmtruth jgmtruth Jan 30, 2014 4:08 PM Flag

    'Even a broken clock is right twice a day'

    Sentiment: Strong Buy

  • jgmtruth jgmtruth Jan 31, 2014 10:22 AM Flag

    Jumpy markets may not calm down investor are very fickle.One thing i am sure of and thats Pharmacyclics and ibrutinib .Ask yourself this has Duggan sold any shares yet?You know the answer ..February is here now so it should prove to be a very interesting month.

    Sentiment: Strong Buy

  • jgmtruth jgmtruth Jan 31, 2014 1:16 PM Flag

    Who said anything about earnings next week?I believe they are expected two week from now tentatively that is.

    Sentiment: Strong Buy

  • Noble Financial boosts its price target on Galena Biopharma (Nasdaq: GALE) from $4 up to $6, while maintaining a Buy rating on the the company .

    Analyst Rahul Jasuja said the improved outlook comes following a recent update for GALE-401 and a model update on NeuVax interim data and Abstral sales. The analyst commented, GALE-401 (acquired from Mills Pharmaceuticals) is a controlled release formulation of Anagrelide in the treatment of Essential Thrombocythemia (ET); currently Anagrelide IR (instant release) and hydroxyurea (HU) are the predominant drugs for ET.

    With improved pk metrics GALE-401 may be more effective without the tolerability/safety issues of Anagrelide-IR; could capture larger market share over HU; US sales potential of $150 to $200M; 8K new cases of ET each year and 80-100K prevalence in US ... Company has discussed with FDA, GALE-401 will be developed under 505b2 path for ET with Anagrelide-IR as reference drug; Phase 2 studies to begin shortly; could be on the market late 2017 or early 2018, Jasuja noted.

    Sentiment: Buy

  • jgmtruth by jgmtruth Feb 3, 2014 10:23 AM Flag

    Galena Biopharma. This biotech develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. The company already has an FDA approved product called Abstral. Abstral is a sublingual (under the tongue) fentanyl tablet indicated for the management of breakthrough pain in patients with cancer. Commercially launched in October 2013, Galena hopes to generate significant revenue through this product, which can be used to fund the company’s extremely promising clinical trials.

    The company has built a pipeline that is pursuing treatments for several unmet areas of medical need. The trials in progress include:

    NeuVax — Breast Cancer — Phase 3 Trial Ongoing
    NeuVax + Herceptin Combination — Breast Cancer — Phase 2 Trial Ongoing
    NeuVax — Gastric Cancer — Phase 2 Trial Planned
    Gale-401 — Essential Thrombocythemia — Phase 2 Trial Planned
    Gale-301 — Ovarian and Endometrial Cancer — Phase 2 Trial Ongoing
    Given that pipeline and those major areas of unmet medical need, it shouldn’t come as a surprise that Galena shares have increased by more than 205 percent over the past year. Shares were actually much higher a few weeks ago, but the general market concerns have caused shares to slide. That recent slide represents an excellent opportunity for new investors to get in at an attractive valuation.

    There are several reasons why the recent slide presents an attractive value point for new investors:

    Pipeline Market Potential
    Partnerships
    Balance Sheet
    When evaluating a small-cap biotechnology company such as Galena, investors should look at the potential market size of the pipeline, the partnerships that the company has struck, and the balance sheet strength. Galena is excelling at all three of those components.

    Sentiment: Hold

  • jgmtruth by jgmtruth Feb 3, 2014 11:23 AM Flag

    Adam F. is pilling on the bashing wagon.

  • In France , the ibrutinib, which is not yet available on the market, now has a temporary authorization for use (ATU) to try to treat some leukemia patients. © Thinkstock Dominique Maraninchi, managing director of MSNA (French National Security Agency of Medicines and Health Products), said that his institution "has decided to give a favorable opinion on the request for temporary use authorization ( ATU) to ibrutinib. " Hundreds of patients could benefit from this special permission.

    In France , the ibrutinib, which is not yet available on the market, now has a temporary authorization for use (ATU) to try to treat some leukemia patients.
    Dominique Maraninchi, CEO of MSNA (French National Security Agency of Medicines and Health Products), said that his institution "has decided to give a favorable opinion on the request for temporary use authorization (ATU) cohort to ibrutinib. " Hundreds of patients could benefit from this special permission.

    In the context of a cohort ATU, it is only certain types of patients, based on strict criteria, which may be treated with the drug before it is marketed.

    What's this?

    The ibritunib is a drug administered to patients with relapsed or refractory form of chronic lymphocytic leukemia (CLL) and a rare form of lymphoma, lymphoma mantle cell (MCL).

    In trials, the drug has shown good tolerance by patients.

    The overall response rate of patients treated was 50 to 71%, with a durable.Le remission rates were even higher when ibrutinib was given with rituximab, a monoclonal antibody targeting a component of the cancer cell which has proven medication in certain lymphomas and leukemias.

    Why this approach?

    "The cohort ATU allow us to innovative medicines more quickly available to patients," said Mr. Maraninchi. He also said that until the laboratory has the product ANSM grant nominative ATU "compassionate" to patients.

    Indeed, it would have to wait months to have the ibritunib in France . The MSNA was therefore thought it best to make her faster availability.

    The European Medicines Agency (EMA) has received, in turn, demand for the placing on the market (AMM) of ibritunib last October.

  • Reply to

    $5 to $8 Dollars all next week.

    by rick_the_ghetto_man Feb 6, 2014 9:41 PM
    jgmtruth jgmtruth Feb 7, 2014 9:38 AM Flag

    Feb 14 blastoff ..

    Sentiment: Buy

  • Reply to

    Seeking Alpha PURPOSEFULLY

    by ch_a_mp Feb 11, 2014 1:44 PM
    jgmtruth jgmtruth Feb 11, 2014 1:50 PM Flag

    Yes and if you take into consideration he did the same thing in January ..And also this ....This article was co-authored by Nick Zheng and Ted Arhontas.

    Additional disclosure: I am short CHTP using a back ratio put option strategy as described in this article.

    Sentiment: Strong Buy

  • Reply to

    AMAZING how 1 article can just de-rail a stock?

    by maggothound Feb 11, 2014 3:08 PM
    jgmtruth jgmtruth Feb 11, 2014 3:17 PM Flag

    Zheag read his bio he states : Currently, I am working with a group of advanced option traders in a quest to tame volatile biotech stocks. Isn't that like saying he is trying to manipulate the price of a stock?Market manipulation is a deliberate attempt to interfere with the free and fair operation of the market and create artificial, false or misleading appearances with respect to the price of, or market for, a security, commodity or currency. Market manipulation is prohibited in the United States under Section 9(a)(2)[1] of the Securities Exchange Act of 1934,

    Sentiment: Strong Buy

  • Pharmacyclics Inc. (NASDAQ: PCYC) saw the biggest drop in short interest among those biotech companies featured here, 15.4%, to almost 1.39 million shares. That is 2.3% of the company’s float. It would take more than a day to close out all short positions.

    Read more: Short Sellers Shy Away From Biotechs - Amgen, Inc. (NASDAQ:AMGN) - 24/7 Wall St. http://247wallst.com/healthcare-business/2014/02/12/short-sellers-shy-away-from-biotechs/#ixzz2t7Qdp9XU
    Follow us: @247wallst on Twitter | 247wallst on Facebook

    Sentiment: Strong Buy

  • jgmtruth jgmtruth Feb 12, 2014 10:55 AM Flag

    When its so quiet you could hear a pin drop that is when this company with Mr.R. Duggan at the helm is at its best..Silence is golden..

    Sentiment: Strong Buy

  • Reply to

    SA's Credibility

    by delhidada1 Feb 12, 2014 11:27 AM
    jgmtruth jgmtruth Feb 12, 2014 11:34 AM Flag

    Correct..Seeking Alpha removed five articles from its web site Sunday, all of which included an identical paragraph about Galena and its experimental breast cancer vaccine Neuvax. The articles, published over the past two months, appeared to have been written by three different people all under the cloak of anonymity using the aliases Elegant Trader, Momentum Trading and Thomas Option Hunter.After looking into the matter, Seeking Alpha discovered that a single individual wrote all five articles."We investigated this situation and have identified an individual who is responsible for these articles. As this person has operated contrary to our editorial and ethical principles, we have shut down their access to the site," said Seeking Alpha Managing Editor George Moriarty, in an email response to questions regarding the articles. [Disclosure: Moriarty is a former managing editor at TheStreet, where he supervised my work.]

    Seeking Alpha allows contributors to publish investment articles under pseudonyms -- a practice the web site says is necessary because some of its most talented contributors work for companies or firms which forbid employees from being quoted in the media or publish under their own name.

    Still, anonymously penned investment articles are controversial and risky. By removing a layer of accountability, readers are less able to judge the credibility or motives of the author. Seeking Alpha says it tries to minimize the risks by holding anonymous authors to the same compliance and biographical standards as contributors who write under their own name. Seeking Alpha also insists on knowing the real identity of anonymous authors even as that information is withheld publicly.

    In this case, Seeking Alpha's safeguards broke down. One article written by Momentum Trading and two each by Elegant Trading and Thomas Option Hunter all touted the prospects of Galena Biopharma. Each of the articles was slightly different except they all included an identical paragraph starting with the sentence: "On Friday, December 7th, Galena presented the results of a Phase II trial for its flagship product, Neuvax. The results were well received by analysts even though the stock fell off a little bit."

    Sentiment: Strong Buy

  • jgmtruth by jgmtruth Feb 12, 2014 1:01 PM Flag

    FDA NEWS RELEASE

    For Immediate Release: Feb. 12, 2014
    Media Inquiries: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA
    FDA approves Imbruvica to treat chronic lymphocytic leukemia

    The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.

    CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013.

    Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.

    “Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”

    Under the agency’s accelerated approval process, the FDA may approve a drug based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Drugs receiving accelerated approval are usually subject to an agreement to conduct confirmatory trials verifying and describing clinical benefit. Imbruvica for CLL also received priority review and orphan-product designation because the drug demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease, respectively.

    The FDA’s accelerated approval of Imbruvica for CLL is based on a clinical study of 48 previously treated participants. On average, participants were diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All study participants received a 420 milligram orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed. Results showed nearly 58 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 5.6 to 24.2 months. An improvement in survival or disease-related symptoms has not been established.

    The most common side effects observed in the clinical study include low levels of platelets in the blood (thrombocytopenia), diarrhea, bruising, a decrease in infection-fighting white blood cells (neutropenia), low red blood cells (anemia), upper respiratory tract infection, fatigue, pain in the muscles and bones (musculoskeletal pain), rash, fever (pyrexia), constipation, swelling of tissues (peripheral edema), joint pain (arthralgia), nausea, mouth sores (stomatitis), sinus infection (sinusitis) and dizziness.

    Imbruvica is manufactured by Sunnyvale, Calif.-based Pharmacyclics.

    Sentiment: Strong Buy

  • Reply to

    FDA NEWS RELEASE

    by jgmtruth Feb 12, 2014 1:01 PM
    jgmtruth jgmtruth Feb 12, 2014 1:03 PM Flag

    FDA approves Imbruvica to treat chronic lymphocytic leukemia

    Sentiment: Strong Buy

SNTA
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