Showing posts with label stock picks. Show all posts
Showing posts with label stock picks. Show all posts

Sunday, May 1, 2011

$SGDH - SGD Holdings, Ltd. - VIDEO: Fundamental and Technical Analysis:

Here is a ten-minute video that shows the Fundamental and Technical Analysis of SGDH - SGD Holdings, Ltd.

http://stockmarketchartanalyst.blogspot.com/



Monday, September 13, 2010

CYCC - Cyclacel reaches Agreement with FDA on a Special Protocol Assessment for Pivotal Phase 3 trial of Sapacitabine in AML:

http://stockmarketchartanalyst.blogspot.com/

(CYCC has been my favorite microcap biotech company this year, mostly because they have a Nobel Prize winning scientist that has been working on an oral form of cancer cures for fourteen years. This would eliminate radiation, chemotherapy, and all of the other toxic anti-cancer drugs in use today. Do your own research on this company. I'm sure you will be pleasantly surprised with what you find.

http://www.cyclacel.com/cyc/investors/news/pressreleases/2010/2010-09-13/

BERKELEY HEIGHTS, NJ – September 13, 2010 – Cyclacel Pharmaceuticals, Inc. (NASDAQ - CYCC), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company’s sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

“The SPA agreement with FDA represents an important milestone for Cyclacel and provides a clear registration pathway for sapacitabine,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “If it reaches the market, sapacitabine would be the first orally-administered drug to be offered to this patient population with the potential to serve as induction, consolidation and maintenance treatment of this life-threatening disease. In addition to progressing to Phase 3 in AML, we look forward to reporting sapacitabine Phase 2 data in myelodysplastic syndromes (MDS) and non-small cell lung cancer (NSCLC).”

The Phase 3, registration-directed, clinical trial of sapacitabine oral capsules to be conducted under the SPA will be a randomized study against an active control drug with the primary objective of demonstrating an improvement in overall survival. Sapacitabine will be administered as an outpatient treatment. Cyclacel plans to begin patient enrollment in this Phase 3 trial before the end of 2010. Additional information on the design of the trial will be provided after initiation of the study.

“We are pleased to receive the SPA Agreement letter from the FDA stating that the design and planned analysis of the pivotal Phase 3 study adequately address the objectives necessary to support the submission of a New Drug Application (NDA),” said Judy Chiao, M.D., Vice President of Clinical Development and Regulatory Affairs of Cyclacel. “AML in the elderly is a life-threatening disease with high unmet medical need. Patients with AML aged 70 years or older have a poor prognosis as the majority of these patients are not candidates for intensive induction chemotherapy because of poor tolerability to such therapy and a high risk of relapse because of the lack of effective consolidation and maintenance therapy. We will now concentrate our efforts on initiating the Phase 3 study in AML in collaboration with our clinical investigators.”

In addition to the Cyclacel-sponsored trials of sapacitabine, the company has been approached by cooperative groups seeking to conduct, largely at their expense, investigator-initiated studies of sapacitabine with alternative study designs.

About Acute Myeloid Leukemia (AML):

AML is a cancer of the blood cells that progresses rapidly and if not treated, could be fatal in a few months. AML is generally a disease of older people and is uncommon before the age of 40. The average age of a patient with AML is about 67 years. There are more than 12,300 new cases of AML, of which about half are elderly, and nearly 9,000 deaths caused by this cancer each year in the United States. A recently published review of The University of Texas M. D. Anderson Cancer Center’s historical experience with front-line intensive induction chemotherapy for elderly AML patients aged 70 years or older demonstrated that while 45% of patients achieved a complete remission, median overall survival was only 4.6 months and 36% of patients died within the first 8 weeks of treatment, underscoring the unmet need in this patient setting. †

About Special Protocol Assessment (SPA):

A Special Protocol Assessment is a binding written agreement with the FDA that the sponsor’s proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. Final marketing approval depends on efficacy results, adverse event profile and an evaluation of the benefit/risk of a treatment as demonstrated in the trial. For further information regarding the SPA process, please visit the FDA website, www.fda.gov.

About Sapacitabine:

Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being evaluated in Phase 2 trials in patients with hematological malignancies and solid tumors. Sapacitabine acts through a dual mechanism, interfering with DNA synthesis by causing single-strand DNA breaks and inducing arrest of cell cycle progression mainly at G2-Phase. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies. Over 200 patients have received sapacitabine in Phase 2 studies in AML, MDS, cutaneous T cell lymphoma (CTCL) and non-small cell lung cancer (NSCLC). Sapacitabine has been administered to approximately 170 patients in five Phase 1 studies with both hematologic malignancies and solid tumors. In December 2009 at the 51st Annual Meeting of the American Society of Hematology (ASH), Cyclacel reported data from a randomized Phase 2 study including promising 1-year survival in elderly patients with AML aged 70 years or older. Sapacitabine is part of Cyclacel’s pipeline of small molecule drugs designed to target and stop uncontrolled cell division.

About Cyclacel Pharmaceuticals, Inc.:

Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. Three product candidates are in clinical development: Sapacitabine (CYC682), a cell cycle modulating nucleoside analog, completed Phase 2 studies for the treatment of acute myeloid leukemia in the elderly and is in Phase 2 for myelodysplastic syndromes and lung cancer. Seliciclib (CYC202 or R-roscovitine), a CDK (cyclin dependent kinase) inhibitor, is in Phase 2 studies for the treatment of lung cancer and nasopharyngeal cancer and in a Phase 1 trial in combination with sapacitabine. CYC116, an Aurora kinase and VEGFR2 inhibitor, is in a Phase 1 trial in patients with solid tumors. Cyclacel’s ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair® Cream for radiation dermatitis, Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a portfolio of commercial products and a development pipeline of novel drug candidates. For additional information please visit www.cyclacel.com.

Forward-looking Statements:

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety, and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that Cyclacel will not obtain approval to market its products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and current filings that have been filed with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact for Cyclacel Pharmaceuticals, Inc.:

Investors/Media:
Corey Sohmer, (908) 517-7330
csohmer@cyclacel.com

Thursday, July 1, 2010

CYCC - Cyclacel Pharmaceuticals - Announces FDA Orphan Drug Designation for Sapacitabine in Both AML and MDS:

Press Release Source: Cyclacel Pharmaceuticals, Inc. On Thursday July 1, 2010, 7:00 am EDT

BERKELEY HEIGHTS, N.J., July 1, 2010 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's sapacitabine (CYC682) product candidate for the treatment of both acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

"Orphan drug designation for both AML and MDS significantly strengthens the value proposition represented by sapacitabine and enhances our opportunity to advance this promising product candidate to late stage clinical development and commercialization," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.

Sapacitabine, a cell cycle modulating nucleoside analogue, is in Phase 2 studies for the treatment of AML in the elderly, MDS and lung cancer. Cyclacel has reported Phase 2 results from ongoing studies in AML and MDS. The company plans to advance sapacitabine into pivotal Phase 3 development in 2010. During the first quarter of 2010, the company submitted a Special Protocol Assessment (SPA) request to the FDA for a randomized Phase 3 study of sapacitabine in elderly patients with AML.

Orphan drug designation entitles Cyclacel Pharmaceuticals to seven years of marketing exclusivity for sapacitabine upon regulatory approval, as well as the opportunity to apply for grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses and a potential waiver of the FDA's application user fee. Orphan status is granted by the FDA to promote the development of new drug therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States.

http://finance.yahoo.com/news/Cyclacel-Pharmaceuticals-pz-2152455345.html?x=0&.v=1



Sunday, May 2, 2010

VIDEO - Fundamental & Technical Analysis of the S&P 500's Daily & Weekly Charts:


Here is the end of the week Technical Analysis of the S&P 500's daily and weekly charts, plus a look at the important Economic and Earnings Reports due out next week...

Happy Trading this week...
zigzagman



Saturday, May 1, 2010

$POZN Gets FDA Approval for Pozen Inc.'s Pain Drug - Vimovo:


POZN - US FDA OK's AstraZeneca, Pozen Inc.'s Pain Drug:

Fri Apr 30, 2010 5:19pm EDT

http://www.reuters.com/article/idCNN3015546220100430?rpc=44

* Agency clears drug for U.S. market

* Vimovo includes naproxen and Nexium ingredient

* Pozen shares up more than 21 percent after-hours

POZN Conference Call link: http://biz.yahoo.com/cc/5/113585.html

WASHINGTON, April 30 (Reuters) - The U.S. Food and Drug Administration has approved AstraZeneca Plc (AZN.L) and Pozen Inc's (POZN.O) pain drug Vimovo, an agency spokeswoman told Reuters on Friday.

Vimovo is a fixed-dose combination of the anti-inflammatory drug naproxen and an immediate release version of esomeprazole, the active ingredient in AstraZeneca's acid reflux treatment Nexium.

Shares of Pozen were up more than 21 percent, or about $2.30, in after-hours trading on Friday, trading at $13.15, after earlier closing at $10.85. (Reporting by Susan Heavey; additional reporting by Ben Hirschler in London and Vidya Loganathan in Bangalore; editing by Carol Bishopric)

POZN is currently halted...Per the Nasdaq.com website:

http://www.nasdaqtrader.com/Trader.aspx?id=TradeHalts

No time is given for resumption of trading...

There was a huge Bear Raid at 12:37 this afternoon, as the MM's took out all of the stop-loss limit orders people had in place:



POZN After-Hours Chart shows it closed at $13.15 when it was halted for "news pending":