Orexigen Therapeutics, Inc. (OREX) Stock Drops

By Tim - http://stockstobuy.org

The FDA has denied approval for a diet pill made by Orexigen Therapeutics, Inc. (OREX) on Tuesday. Orexigen Therapeutics, Inc. (OREX) stock fell 72.50% to $2.50.

FDA Issues Complete Response to New Drug Application for Contrave® for the Management of Obesity

Orexigen® Therapeutics, Inc. (Nasdaq:OREX - News) and Takeda Pharmaceutical Company Limited (Takeda) (TSE:4502.to - News) announced today that the United States Food and Drug Administration (FDA) has issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

The FDA noted concern about the cardiovascular safety profile of naltrexone/bupropion when used long-term in a population of overweight and obese subjects. Specifically, the letter stated that "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."

So it looks like Orexigen Therapeutics, Inc. (OREX) will need to complete one more trial before this drug can be approved. All hope is not lost but Orexigen will certainly have it's work cut out for them! Resistance for the stock is located at $2.75

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Orexigen Therapeutics, Inc. (OREX) FDA Approval Denied

By Tim - http://stockstobuy.org

The FDA has denied approval of a diet pill made by Orexigen Therapeutics, Inc. (OREX) this morning. Orexigen Therapeutics, Inc. (OREX) stock is tanking by 74% to $2.35.

FDA Issues Complete Response to New Drug Application for Contrave® for the Management of Obesity

Orexigen® Therapeutics, Inc. (Nasdaq:OREX - News) and Takeda Pharmaceutical Company Limited (Takeda) (TSE:4502.to - News) announced today that the United States Food and Drug Administration (FDA) has issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

The FDA noted concern about the cardiovascular safety profile of naltrexone/bupropion when used long-term in a population of overweight and obese subjects. Specifically, the letter stated that "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."

So it looks like Orexigen Therapeutics, Inc. (OREX) will need to complete one more test before this drug can be approved. All hope is not lost but Orexigen will certainly have it's work cut out for them!

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Savient Pharmaceuticals, Inc. SVNT FDA Approval Gout Drug

Savient Pharmaceuticals, Inc. (SVNT) received FDA Approval last night and the stock is on fire this morning. Savient Pharmaceuticals, Inc. hit $19.10 in pre market but recently slipped into the high $17's. CNBC just announced that Savient Pharmaceuticals is the stock of the day which caused SVNT to jump back to $18.25. This stock will be very active at the open and can be played from both the long and short side.

However, with the latest FDA news below, Savient Pharmaceuticals now becomes a viable takeover candidate. This would have me trading SVNT from the long side versus the short side.

FDA Approves KRYSTEXXA(TM) (pegloticase) for the Treatment of Chronic Gout in Adult Patients Refractory to Conventional Therapy

Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA(TM) (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

"KRYSTEXXA is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals. "The clinical data have demonstrated that many patients treated with KRYSTEXXA 8 mg administered every two weeks can experience within six months of treatment significant positive clinical improvement reversing the course of this severe, crippling and debilitating disease. A statistically significant proportion of patients in our pivotal clinical trials achieved a lowering of their serum uric acid level to a mean of 0.7 mg/dL and achieved a complete response for the resolution of tophi within the first six months of therapy. We believe that the approval of KRYSTEXXA is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering with chronic gout refractory to conventional therapy, as many of them finally have a treatment that gives them hope of reversing this severely debilitating disease." Full Press Release Here

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Cell Therapeutics CTIC FDA Approval Decision Appealed

September 14, 2010 - The CTIC saga continues! Cell Therapeutics Inc. (CTIC) plans to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma.

Pixantrone NDA transferred to newly created Division of Hematologic Products

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that it intends to appeal the U.S. Food and Drug Administration's (the "FDA") previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its NDA for this patient group for which there are no currently approved drugs. The FDA issued a Complete Response Letter to CTI related to this NDA stating, in part, that CTI should conduct an additional clinical trial prior to approval. CTI is preparing to file an appeal under the FDA's Formal Dispute Resolution process. CTI reached this decision by taking into account that CTI believes there are no approved or effective therapies for patients with relapsed or refractory aggressive NHL beyond second relapse, and that PIX 301 was the first and only randomized trial in this patient group to demonstrate significant improvement in clinically relevant endpoints including complete response rate, overall response rate, and progression free survival while being safe and effective in this indication. Full Press Release

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FDA Approval: BSD Medical Corp. (BSDM) Up 17% Today

Shares of BSD Medical Corp. (BSDM) are surging 17% to $2.45 this morning after the stock sold off significantly during the past 5 trading days. BSD Medical Corp. spiked over 150% last week due to the FDA giving the company 510K clearnace to market their tissue device.

Important levels to Watch: Resistance - $2.88

Support will now be located at $2.00-$2.20

BSD Medical Corp also came out with an 8K today. Form 8-K/A for BSD MEDICAL CORP

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No FDA Approval For CTIC, Yet - FDA Panel Rejects Cell Therapeutics Pixantrone

Shares of Cell Therapeutics Inc (CTIC) have been halted this morning as the FDA Advistory Panel has now come out and rejected their lymphoma drug Pixantrone. When CTIC does reopen, I'd expect the stock to be cut in half atleast. CTIC still has a slight chance of approval when the FDA decision takse place at the end of April. Usually, the FDA will follow their panel ( today's vote ) but not always. With such a huge overwhelming vote, the FDA will likely to reject Pixantrone in April. Cell Therapeutics will probably need to raise more capital if it plans to continue Pixantrone.

US panel rejects Cell Therapeutics lymphoma drug


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HEB: No FDA Approval for Ampligen

December 1, 2009 - The FDA has finally come out and decided on CFS Drug, Ampligen

The Ruling? No

Shares of Hemispherx Biopharma, Inc. (HEB) are trading in the $0.70's tonight in afterhours in the wake of this news.

This doesn't appear over quite yet as Hemispherx Biopharma, Inc. is requesting a meeting with the FDA.


Link


Hemispherx Biopharma Receives Complete Response Letter from FDA on Ampligen® New Drug Application for Chronic Fatigue Syndrome

Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the “Company” or “Hemispherx”), announced that it received a Complete Response Letter from the US Food and Drug Administration (“FDA”) which describes specific additional recommendations related to the Ampligen® NDA. In accordance with its 2008 “Complete Response” procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx is carefully reviewing the Complete Response letter and will seek an expedited meeting with the FDA to discuss its recommendations. Management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen®.


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Discovery Labs DSCO and FDA Meeting Results

September 30, 2009 - Shares of Discovery Laboratories, Inc (DSCO) are spiking in pre market this morning after the company and the FDA have established a path for potential Surfaxin FDA Approval. DSCO stock is indicated to open Up 55% to $1.72 in early trading.

DSCO Forum

Discovery Labs and FDA Establish Path for Potential Surfaxin Approval

Discovery Laboratories, Inc. (Nasdaq:DSCO) held a teleconference on September 29, 2009 with the U.S. Food and Drug Administration (FDA). The meeting established an approach to potentially resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin(R) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The meeting focused on Discovery Labs' plans regarding optimization and final method validation of its fetal rabbit Biological Activity Test (BAT, a quality control and stability release test) and a proposed limited Surfaxin clinical trial design, which would simultaneously employ the newly-optimized BAT. Full Article

Looking at the chart, there is major resistance located at $2 and $2.40. If DSCO stock was to close over $2.40 at any time in the future, the next major resistance level would be $3.02. I will be buying DSCO if it breaks $2.00.

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Generex Biotechnology GNBT FDA Approval

September 10, 2009 - Shares of Generex Biotechnology Corp. (GNBT) are exploding as the company has received FDA Approval on their Buccal Insulin Product. GNBT stock is trading at $0.96 Up 41%.

Generex Announces USFDA Approval of Use of Company's Flagship Buccal Insulin Product, Generex Oral-lyn(TM), Under the USFDA'S Treatment Investigational New Drug (IND) Program

The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing. Full Article

Keep an eye on resistance at $1.14!

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Cell Therapeutics CTIC FDA Application Approval

August 24, 2009 - Shares of Cell Therapeutics, Inc. (CTIC) are set to open up premarket at $1.80 in about an hour as the FDA has approved the application for pixantrone for standard review. Fast Track status will be ruled on by 9/4/09. If CTIC can get fast track status, there will be an FDA approval ruling in late December. Check out my CTIC Technical Analysis

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Cell Therapeutics, Inc. (CTIC) FDA Application News

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.

"The FDA's acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL. We look forward to working with the FDA and their final decision on our request for priority review," noted James Bianco, M.D., Chief Executive Officer of CTI.

About Pixantrone

Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although anthracyclines are sufficiently effective to be used as first-line (initial) treatment, anthracyclines cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if the patient's disease returns. Pixantrone also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. The FDA is required to set an action date for review of an application 74 days after the initial submission of the NDA. CTI expects to receive the action date for this drug candidate from the FDA and a final decision on review status on September 4th, 2009. Full Article

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MDRNA MRNA Stock News FDA Approval

MDRNA, Inc. (MRNA) is out today ( June 9, 2009 ) with FDA approval news below. MRNA stock is up 150% now to $3.90. Discuss MRNA

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MDRNA, Inc. Receives Full FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis

Par Pharmaceutical Companies, Inc. Launches Product

Jun 9, 2009 -- MDRNA, Inc. (NasdaqGM:MRNA) announced today that it has obtained full U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis and that Par Pharmaceutical Companies, Inc. (NYSE:PAR) has launched the product.

Calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin® nasal spray, marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin® were approximately $112 million in 2008, according to IMS Health data.

On March 31, 2009, MDRNA and Par entered into an agreement under which Par acquired the Company's Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray and the Company's FDA-approved, cGMP manufacturing facility in Hauppauge, New York, for an upfront cash payment and profit sharing on commercial sales for five years.

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Angiotech (ANPI) FDA 501K Clearance 6/8/09

Angiotech Pharmaceuticals, Inc. (ANPI) is out with FDA Approval news this morning. ANPI stock is soaring to $2.75 in pre market trading!

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ANGIOTECH PHARMACEUTICALS ANNOUNCES FDA 510(K) CLEARANCE OF THE OPTION™ INFERIOR VENA CAVA FILTER

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, for use in both permanent and retrievable indications. Angiotech holds exclusive worldwide rights to market and distribute the Option IVC Filter, which it obtained in a license agreement with privately held Rex Medical, LP (Rex Medical), as previously announced in March 2008.

The Option IVC Filter is used for the prevention of recurrent pulmonary embolism (PE). The device is implanted, typically by interventional radiologists in a minimally invasive procedure, into the body's inferior vena cava to prevent PE. Option is specifically designed for use as both a permanent or temporary implant (in temporary, or retrievable, indications, a physician may later perform a second surgical procedure to remove the Option IVC Filter if necessary or where mandated clinically).

http://www.angiotech.com/news/press-releases/pdf/2009/06-08-2009_OptionFDA_FINAL.pdf

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Hemispherx HEB Stock Rising! 6/2/09

Hemispherx Biopharma, Inc. (HEB) stock is soaring this afternoon ( June 2, 2009 ) on absolutely no news but anticipation for approval of their drug Ampligen. We have been discussing HEB since the stock was in the low $1's and many people are making a lot of money today. The FDA decision could make or break this stock in the next week.

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Below is the latest HEB news as of 6/2/09:

Hemispherx Biopharma Announces Possible Brief Delay in FDA Action On Ampligen(r) New Drug Application

May 26, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) today announced that the U.S. Food and Drug administration ("FDA") has advised the company that it may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen(r) (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome. Reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report. Accordingly the Company's development plan for Ampligen(r) continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.

http://finance.yahoo.com/news/Hemispherx-Biopharma-pz-15344715.html?.v=2


Hemispherx Biopharma Presents Influenza Prevention / Treatment Platform at International Conference in Rome under Auspices of Italian Government

June 1, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced today an invitation, funded entirely by the government of Italy, to present its technology platform for influenza control, at the upcoming "International Conference on Biotechnologies and Finance" in Rome on July 4-5, 2009, at the Sheraton Parco de Medici. According to the Conference Organizers, leaders of "private and public research centers, intellectual property holders and financial experts from Europe, Australia, Canada, Estonia, Singapore and the USA" will participate. Hemispherx will present in a Round Table Discussion on Pandemic Influenza, moderated by Dr. Elemer Piros, Senior Pharmaceutical Analyst at Rodman and Renshaw, a USA investment bank.

http://finance.yahoo.com/news/Hemispherx-Biopharma-Presents-pz-15398718.html?.v=1

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Hemispherx HEB FDA Delay News May 2009

Hemispherx Biopharma, Inc. (HEB) stock is very active this morning, 5/26/09, as the company has issued the following press release:

HEB Stock News - May 26, 2009

HEMISPHERX BIOPHARMA ANNOUNCES POSSIBLE BRIEF DELAY IN FDA ACTION ON AMPLIGEN® NEW DRUG APPLICATION

Philadelphia, PA, Tuesday, May 26, 2009: Hemispherx Biopharma, Inc. (NYSE/AMEX -HEB) today announced that the U.S. Food and Drug administration (“FDA”) has advised the company that it may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen® (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome. Reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report. Accordingly the Company’s development plan for Ampligen® continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.

http://www.hemispherx.net/content/investor/default.asp?goto=631

Discuss HEB

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Geron GERN Stem Cell Stocks 1/23/09

Geron ( GERN ) is out with Stem Cell news this morning, January 23, 2009 - as this company will be the first company testing a human in the world's first human clinical trial involving Stem Cells. Under the new Obama administration, the FDA has approved this trial in which the Bush administration wasn't allowing Government funding for Stem Cell Research.

GERN stock is exploding higher today, to $6.48 Up 24%. Other Stem Cell stocks are higher such as Stem Cells ( STEM ) and Aastrom Biosciences ( ASTM )

Geron Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.
The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

"The FDA's clearance of our GRNOPC1 IND is one of Geron's most significant accomplishments to date," said Thomas Okarma, Ph.D., M.D., Geron's president and CEO. "This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."

GRNOPC1, Geron's lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005).

"The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. "Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

Full Article - http://www.geron.com/media/pressview.aspx?id=863

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Stem Cells STEM FDA Approval 12/18/08

Expect Stem Cells ( STEM ) to be a big gainer today, 12/18/08, as this company received FDA Approval to initiate a clinical trial of the Company’s proprietary HuCNS-SC product candidate (purified human neural stem cells) to treat Pelizaeus-Merzbacher Disease (PMD), a fatal brain disorder that mainly affects young children. This Phase I trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for PMD. Currently, there are no approved treatments for this disease.

This is the Company’s second FDA-approved clinical trial to evaluate HuCNS-SC cells as a potential treatment for neurodegenerative diseases. The first such study was the Company’s Phase I clinical trial of HuCNS-SC cells to treat neuronal ceroid lipofuscinoses (NCL), or Batten disease. The Phase I NCL trial will be completed in January 2009.

Patients with PMD are born with a gene mutation that results in insufficient myelination of nerve fibers in the brain, neurological impairment and eventually death. Myelin, which is produced by special cells called oligodendrocytes, insulates nerve fibers to allow electrical signals to be conducted normally. Other, more common, myelination diseases include cerebral palsy, transverse myelitis and multiple sclerosis

STEM is up 16% to $1.54 in pre market trading.

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Cardica ( CRDC ) FDA Approval for Surgical System 9/09/09 - CRDC Stock on Fire!

This morning Cardica ( CRDC ) has come out and announced they have received FDA approval for their Pas-Port surgical system:

Surgical systems maker Cardica Inc. said Tuesday the Food and Drug Administration approved its PAS-Port system for use in cardiac bypass surgery.

The system creates a secure connection between the body's main artery and vein grafts. Cardiac bypass surgeries are used to bypass part of a damaged or blocked artery in an attempt to restore blood flow.

The PAS-Port system is fully automated, the company said can complete a connection in about one minute.

CRDC stock is soaring to $10.80 up 35%......Note that ISRG uses some of their devices for surgery