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Love this play
Sold 50% of my position at $75
Looking to buy them back tomorrow early
Sold 50% of my position here today at $81 even
Looking to get back in here at some point soon
I have my sell order in for $4
I'm loading back up when she hits 531
I have my core position which I hold tight and I flip another 25% from time to time.
This has been very good to me thus far
SNTA on the move
Synta Announces Initiation of Three Multicenter, Randomized Phase II/III Trials of Ganetespib in Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
- Studies Sponsored by Cardiff University and Supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK -
Synta Pharmaceuticals Corp.
5 hours ago
LEXINGTON, Mass.--(BUSINESS WIRE)--
Synta Pharmaceuticals Corp. (SNTA) today announced the initiation of three multicenter, randomized trials supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK, evaluating ganetespib in combination with chemotherapy in first-line treatment of patients with AML and high risk MDS. These trials are conducted under the auspices of the UK National Cancer Institute (NCRI) Haematological Oncology Study Group with investigators in Denmark, France, New Zealand, and the United Kingdom and under the sponsorship of Cardiff University, UK. Ganetespib, Synta’s lead anti-cancer drug candidate, inhibits the heat shock protein 90 (Hsp90) chaperone protein and is being studied in over 25 clinical trials, including an ongoing Phase 3 trial in advanced non-small cell lung cancer.
The biologic heterogeneity of AML, a disease characterized by clonal accumulation and expansion of immature myeloid cells within the bone marrow, represents a major challenge in the advancement of treatment for patients with the disease. Treatment choice and outcome are substantially decided by age. However, with current standard of care, a long term remission is achieved in only 40% of younger patients (age
Preclinical results from Synta and its collaborators, Alan K. Burnett of Cardiff University and Sanjay Bansal of the UT Health Science Center at San Antonio, have shown that ganetespib inhibits a number of cancer-promoting factors believed to contribute to the proliferation of leukemic cells and renders them more vulnerable to treatment with chemotherapy. In total, three randomized, multi-center clinical trials have recently been initiated or are expected to initiate in the coming months designed to evaluate the therapeutic potential of ganetespib in AML and high-risk MDS:
The AML-LI (less intensive)-1 trial, ongoing, evaluates the combination of ganetespib with low dose cytarabine (Ara-C) vs. low dose Ara-C alone in patients who are not eligible for intensive chemotherapy and are traditionally not included in most trials. Up to 50 patients will be enrolled in the ganetespib arm, after which an interim analysis will be conducted to evaluate the potential of proceeding into a potentially registration-enabling extension. This interim analysis is expected to be conducted later in 2014.
The AML-18 trial, expected to begin enrolling patients 1H 2014, will evaluate ganetespib with standard DA (daunorubin and Ara-C) in patients over 60 years old who can tolerate intensive chemotherapy vs. treatment with standard DA alone. Up to 200 patients are expected to be enrolled in the ganetespib arm. Results from a pilot study conducted in the UK under the auspices of the Cardiff Experimental Cancer Medicine Centre in 2012 confirmed the feasibility and safety of combining ganetespib with intensive chemotherapy in older patients with AML.
The AML-19 trial, expected to begin enrolling patients in 2H 2014, will evaluate ganetespib in combination with conventional chemotherapy vs chemotherapy alone in younger patients with AML. The trial is expected to enroll up to 200 patients in the ganetespib arm and will be conducted by the UK NCRI Group, a network of over 100 institutions. Patients will receive ganetespib sequentially to standard intensive therapy, followed by ganetespib maintenance treatment. The objective is to identify if ganetespib reduces the risk of relapse in the overall population or in key subgroups, and as a result, improves overall survival, the primary endpoint.
“There is an urgent need to improve the outcome of patients with AML and high risk MDS, in both the young and the elderly,” said Professor Alan K. Burnett of Cardiff University in the UK, the Principal Investigator in the LI-1 trial. “The comprehensive research program developed by UK NCRI Group, supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK, aims to achieve this goal by using ganetespib to target Hsp90, a chaperone protein critical for malignant growth of AML. This approach is supported by the preclinical findings in AML models as well as clinical results showing that ganetespib has a favorable safety profile and encouraging clinical activity in several other cancer types.”
“The selection of ganetespib for three major potentially registration-enabling trials in AML is an exciting validation of the clinical potential of ganetespib, and reinforces our strategy of continuing to expand the depth and breadth of the ganetespib program through collaborations with strong groups of investigators,” said Safi R. Bahcall, Ph.D., President and CEO of Synta. “Promising preclinical and early clinical results have been observed with ganetespib and other Hsp90 inhibitors in AML. We are pleased by the decision of the Leukemia & Lymphoma Research Fund, the Cancer Research UK, and the trial investigators to invest in moving ganetespib forward into three large, randomized trials, which we hope will ultimately lead to new options for patients with this devastating disease.”
Synta has established over 100 academic, preclinical collaborations investigating the science and potential applications of ganetespib. Over two dozen clinical trials sponsored by investigators, cooperative groups, or patient foundations are ongoing or planned for 2014.
About AML and MDS
AML is a rapidly progressing hematologic cancer characterized by uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates approximately 14,590 new cases of AML and approximately 10,370 deaths in the U.S. in 2013. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
MDS is a hematopoietic stem cell neoplasm characterized by disordered and ineffective hematopoiesis which results in irreversible decline in the number and quality of blood-forming cells. Patients often develop severe anemia requiring frequent blood transfusions. In most cases progressive bone marrow failure results in neutropenia and thrombocytopenia, and in about one third of patients the disease progresses into AML, usually within a few years.
About Ganetespib
Ganetespib, an investigational drug candidate, is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone which controls the folding and activation of a number of client proteins that drive tumor development and progression. Many solid and hematologic tumors are dependent on Hsp90 client proteins including proteins involved in “oncogene addiction” (ALK, HER2, mutant BRAF and EGFR, androgen receptor, estrogen receptor, and JAK2); proteins involved in resistance to chemotherapy and radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1, survivin, and WEE1); proteins involved in angiogenesis (HIF-1alpha, VEGFR, PDFGR, and VEGF); and proteins involved in metastasis (MET, RAF, AKT, MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of Hsp90 by ganetespib results in the inactivation, destabilization, and eventual degradation of these cancer-promoting proteins. Ganetespib is being evaluated in trials in lung cancer, breast cancer, and other tumor types. The most common adverse event seen to date has been transient, mild or moderate diarrhea, which has been manageable with standard supportive care. Information on these trials can be found at www.clinicaltrials.gov. Ganetespib has received Fast Track designation from FDA for second-line treatment of non-small cell lung adenocarcinoma in combination with docetaxel.
About Synta Pharmaceuticals
Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. Synta has a unique chemical compound library, an integrated discovery engine, and a diverse pipeline of clinical- and preclinical-stage drug candidates with distinct mechanisms of action and novel chemical structures. All Synta drug candidates were invented by Synta scientists using our compound library and discovery capabilities. For more information, please visit www.syntapharma.com.
Safe Harbor Statement
This media release may contain forward-looking statements about Synta Pharmaceuticals Corp. Such forward-looking statements can be identified by the use of forward-looking terminology such as "will", "would", "should", "expects", "anticipates", "intends", "plans", "believes", "may", "estimates", "predicts", "projects", or similar expressions intended to identify forward-looking statements. Such statements, including statements relating to the timing for conduct of the interim analysis in the AML-LI-1 trial and start of enrollment of the AML-18 and AML-19 trials, reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, including those described in "Risk Factors" of our Form 10-K for the year ended December 31, 2012 as filed with the Securities and Exchange Commission. Synta undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.
Contact:
Investors:
Synta Pharmaceuticals Corp.
Mindy Kohl, 781-541-7213
mkohl@syntapharma.com
or
Argot Partners
Andrea Rabney, 212-600-1494
andrea@argotpartners.com
or
Media:
Argot Partners
Eliza Schleifstein, 917-763-8106
eliza@argotpartners.com
indeed
very nice move
Awesome!
Exactly how I felt for the past couple of years!
Glad I kicked the habit
I had to go to NAVBolocis anonymous myself.
I feel your pain
I bought more today at 2.82 after cashing out of NAVB today.
It was a very nice day indeed.
maybe he's just ready to cash in and go to the beach?
I am very familiar with this drug and it's a game changer for us who treat these kinds of patients.
I bought the dip today and still hold a large core position as well.
GLTU
i finally sold out of the remainder of my large position here today. I just got tired of waiting for it to hit.
I took the proceeds and bought 70,000 shares of FNMA at 2.82 (it closed at 3.07) and made over $17,000 back in one day.
of course, I'm still way under water here still, but it felt good to get some of it back in just one day.
I should have sold out of NAVB a long time ago.
Moral: Never get too attached to your equities.
Taking profits is always a good idea, but I think we are headed over $5 fairly easily.
Good luck to you
Thanks for the heads up.
Bought some .154's
Plenty of cash on hand now.
Ready to rock!
Awesome news for HALO:
Halozyme Secures Additional $20 Million Term Loan
47 minutes ago - DJNF
SAN DIEGO, Jan. 6, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced it secured an additional $20 million loan from Oxford Finance and Silicon Valley Bank. On December 27, 2013, Halozyme entered into an Amended and Restated Loan and Security Agreement, extending the original $30 million term loan and providing for an additional $20 million term loan, bringing the total loan balance to $50 million. The term loan was fully drawn at close on December 27, 2013 and has a maturity date of January 1, 2018. The proceeds will be used for working capital and other near-term growth initiatives. Additional details of the credit facility are outlined in the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on January 3, 2014. As of December 31, 2013, Halozyme had approximately $71 million in cash and cash equivalents.
(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the absorption and dispersion of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex(R) recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com and follow us on Twitter @HALOTherapeutic.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the use of cash from its additional term loan) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2013.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Nurha Hindi
Hill + Knowlton Strategies
310-633-9434
Nurha.Hindi@hkstrategies.com
SOURCE Halozyme Therapeutics, Inc.
/Web site: http://www.halozyme.com
(END) Dow Jones Newswires
January 06, 2014 09:00 ET (14:00 GMT)
I'm doing my DD here.
It looks intriguing to say the least.
Yes
And the worst part is the time value of our money.
My other stocks have done well so it's even more frustrating knowing that I could have put this money to work elsewhere.
Dead money here for a long time now.
Very frustrated here.
I averaged down to 2.40 per share but still way under water.
I think you are correct, but I don't think this is the bottom yet.
I think she goes below $530. That's where I'm reloading.
Nice move yesterday.
I sold 25% at 2.44 then bought them all back at 2.30
Raised my average price to $2.03
Ready for another run.
IMO, this coming year will be very good to all of us longs here.
The eventual news of re-submission will get us back to the .80's then the PDUFA date announcement will see us get close to $1 as that date approaches.
All good here this year!
I agree
And where else can you triple your money in 4 Q's?
Climb should continue as we approach PDUFA date.
Very high odds for approval, IMO
IMO,
There are many,many less risky equities to short.
I would not want to get in front of the FnF train.
I'm long from 1.23 buy in thanks to DT.
I agree
I've been holding for a long time.
Doubled down at .33
Looking forward to the eventual news of re-submission.
Very nice!
It will take some time to get used to all the incoming data, but once you have a good handle on it, there is no other way to trade.
Congrats!
Looks like we are breaking out!!
Same to you.
Gal 4:4 Behold, when the fullness of time had come, God sent his Son into the world.
Merry Christmas to you and yours and
God Bless
Looks like we start the day at $5.05
Looking good for a breakout here.
Yes; the earnings statement will be a huge catalyst here.
$5 is not far off IMO.
IMO, these are still very cheap shares. I continue to accumulate here.
I'm not sure how long we will continue in this consolidation pattern, but once she breaks north, we should see blue sky for a while.
We have consolidated in low $3's.
IMO we are ready for the next leg up.
Awesome news
AAPL should pull up most of the tech and the XLK too
Loving it!
IMO
This will be a bullish week for us here.
The word is getting out on ETRM.
It's going to get ugly real quick here
More bad news
I'm increasing my position here