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Thanks! I am going to steal this and post on my board. May I know where do you get this list? I'd like to bookmark that site.
FDA CALENDAR UPDATE
05/01 DNDN FDA Decision
05/07 CYTX Clinical Trial PLAY OF THE MONTH **
05/12 NICXF FDA Advisory Committee meeting
05/23 PUMD Estimated FDA Decison for 510k device clearance
5/27 THTCF FDA Advisory Committee meeting
05/29 PTXRF Clinical trial
06/04 SNTS FDA Decision
06/04 CLDX Clinical Trial
06/04 OXGN Clinical Trial
06/04 IMMU Clinical Trial
06/04 MYRX Clinical Trial
06/04 PGNX FDA Decision
06/04 CYCC Clinical Trial
06/06 PKNGF FDA Decision
06/06 SNSS Clinical Trial
06/09 MELA FDA Decision
06/11 QCOR Clinical Trial
06/30 ABIO Clinical Trial
06/30 ANTH Clinical Trial
06/30 YMI Clinical Trial
06/30 GENT FDA Filling
06/30 ANDS Clinical Trial
06/30 NBY Clinical Trial
06/30 DARA Clinical Trial
06/30 ATHX Clinical Trial
06/30 SQNM Clinical Trial
06/30 RNN Clinical Trial
06/30 INO Clinical Trial
06/30 CBMX Clinical Trial
06/30 OMER Clinical Trial
06/30 AVNR FDA Filling
06/30 KERX Clinical Trial
06/30 CYTR Clinical Trial
06/30 ACCP Clinical Trial
06/30 BIEL 510K clearance
06/30 SNTA Clinical Trial
06/30 RPRX FDA response
06/30 PVCT Clinical Trial
06/30 ARRY Clinical Trial
06/30 SNGX Clinical Trial
06/30 TTHI Clinical Trial
06/30 ZIOP Clinical Trial
MBHI- Just sold premarket for a nice little profit!
Cytori to Webcast First Quarter Financial Results
SAN DIEGO, Apr 28, 2010 (BUSINESS WIRE) -- Cytori Therapeutics (NASDAQ:CYTX) will host a webcast to discuss their first quarter financial results on Thursday, May 6, 2010 at 10:30 AM Eastern Time. Prior to the webcast at approximately 7:00 AM Eastern Time on May 6, Cytori will post a shareholder letter to its Investor Relations homepage, which will review Cytori's first quarter performance, provide an update on commercialization activities and discuss recent developments.
The webcast will be available both live and by replay two hours after the call on the Company's website, under "Webcasts" on the Investor Relations page (http://ir.cytoritx.com).
About Cytori
Cytori is an emerging leader in regenerative medicine, providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution(R) System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Our StemSource(R) product line is sold globally for cell banking and research applications. www.cytori.com
Sounds like a good plan. I might be doing the same thing :)
Up 32% I'll wait tell the bell for a dip and then I may pick up a position for a quick flip.
Im checking her out now!
CYTX ($5.82) solid article written here!
Joe Feshbach's Highest Conviction Position: A Regenerative Medicine 'Game Changer'
http://seekingalpha.com/article/182039-joe-feshbach-s-highest-conviction-position-a-regenerative-medicine-game-changer
Joseph L. Feshbach has over 25 years of professional investment experience, using both long and short equity strategies. Additionally he has been Chairman and CEO of a publicly traded healthcare services company with a large wound care services business and has served on multiple public and private company boards. Today, he serves as CIO of his family office, Joe Feshbach Partners LLC.
• • •
What is your highest conviction stock position in your fund - long or short?
Our long position in Cytori Therapeutics (Nasdaq: CYTX) is our highest conviction.
Tell us a bit about the company and what it does.
Cytori Therapeutics, Inc. is a leading supplier of regenerative medicine products. The company’s key first mover advantage is its technology platform which can be applied across a broad range of diseases and dysfunctions. Its primary innovation is a family of products designed for the extraction and concentration of stem and regenerative cells from adipose (fat) tissue. The lead product is a system known as Celution® and is sold in many countries around the world and has already been used to improve the lives of hundreds of patients. To bring this and similar products to patients, Cytori has produced complex computerized medical devices, unique cell processing reagents, ground-breaking research and novel clinical therapy approaches.
Cytori is the first regenerative medicine company to successfully apply its technology on a commercial scale in humans with significant clinical success and no adverse side effects. Moreover, it has a broad set of clinical trials, both company-sponsored (heart attack, chronic ischemia and breast reconstruction) and investigator sponsored (wound care, incontinence, renal). Because its technology uses the patient’s own stem cells (autologous) and its system has been designated a device by FDA, EU and other regulatory bodies it avoids the stigma associated with embryonic stem cells and the regulatory hurdles and out-sized expense associated with the approval of a new drug.
Of note, CYTX has attracted important industry partners including Olympus, Green Hospital Supply and GE Healthcare who combined have invested more than $100 million in product and market development of the CYTX technology.
Can you talk a bit about the industry/sector? How much is this an "industry pick" as opposed to a pure bottom-up pick?
Our interest grew out of a company specific focus, which led us to conclude that it had market domination potential in the emerging field of regenerative medicine. Further investigation led us to believe that regenerative medicine is the next big thing in health care and that CYTX has the most important enabling technology platform. Drug development companies such as Geron (GERN) and Osiris (OSIR) face a 13 year, $350 million clinical research pathway to get to FDA approval.
From a company specific perspective, Cytori’s device is already approved in the EU and as a device could be approved in as little as three months (510-k) or as much as two years (PMA), depending on the FDA’s adjudication of its need for clinical trials. Our best bet is that the company will succeed in receiving a 510-k in the next six months with clinical trials required for specific indications such as cardiac and incontinence. In the meanwhile, a device based on the Celution technology is being sold as a research device to plastic surgeons in the US. Some of these plastic surgeons in turn are using the technology commercially for breast reconstruction and augmentation as well for facial enhancement under their authority in their practice of medicine. Our discussions with these surgeons indicate very high patient satisfaction as well as high confidence in the market potential for CYTX’s technology once approved by the FDA.
Moreover, clinical trial results are rolling in and look impressive. Interim results from a European clinical trial, RESTORE 2, demonstrate that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients. These results are based on six-month follow up from the first 32 women enrolled and treated. The results were presented at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (Poster #4123) by Dr. Eva Weiler-Mithoff, M.D., co-principal investigator for the Restore 2 Trial at the Glasgow Royal Infirmary.
The largest near-term upside is in the Company’s Apollo (heart attack) and Precise (chronic myocardial ischemia) trials. Early indications (based on investigator commentary) are very promising and the results of Apollo are likely to be unveiled at an important cardiology meeting in Q1 or early Q2 with Precise following in Q2. We believe these results will be positive enough to give CYTX shares upside potential comparable to Dendreon (DNDN) or Human Genome Sciences (HGSI).
Can you describe the company's competitive environment? How is this company positioned vis a vis its competitors?
As a device company with a platform technology applicable to many different highly valuable therapies, the company has a significant time to market advantage over its drug development competitors - perhaps as much as a decade. There is no meaningful competitor on the device side. Moreover the company has a blocking patent position with over 100 approved or pending patent applications and a stream of new ones on the way. As measured by R&D success, product commercialization, and patient and physician satisfaction the company has no peers.
Can you talk about valuation and how it compares to the competitors?
CYTX’s market cap is $281 million. Perhaps the most relevant valuation metric is in looking at other developers of important medical advances. Now, a mature company with impressive sales and earnings growth, Intuitive Surgical (ISRG) has an $11 billion market cap. Companies that have yet to bring products to market but have very promising medicines and are well along the FDA regulatory pathway include HGSI (market cap $5b), DNDN ($3B) and MDVN ($1.2B), but these are generating little or no product revenues. Stem cell companies like GERN ($590m) and OSIR ($239m) have had no better than equivocal trial results, have no commercial stem cell products, are years away from having one and have inconsequential product revenues.
What is the current sentiment on the stock? How does your view differ from the consensus?
Sell side coverage (three covering analysts) is evenly divided with a sell, hold and buy. Particularly comforting from a contrarian point of view is the fact that only one analyst has a price target above the current stock price. We believe that all of the covering firms are unwilling to bet on the cardiac results and undervalue the near-term opportunity in plastic and reconstructive surgery. Moreover, the company’s most recent quarters were choppy from a financial perspective.
We differ in believing that in plastic and reconstructive where the company has the most substantive clinical trial and user results that the company is moving through the early adoption stage and will shortly hit an inflection point where it becomes a “pull” marketing effort. We think the sell side and buy side both are slow to grasp the import of the early signs of the cardiac trials. We believe that the Cytori technology is a game changer in the treatment of heart attack and chronic myocardial ischemia and think that the Apollo and Precise results will be eye (and stock) popping. Its therapeutic applications such as cardiac, renal, and urological when fully developed will impact health care and its cost significantly more than ISRG DNDN, HGSI and MDVN. These highly valued analogues do not have the multiple therapeutic applications that the CYTX technology does. As such we expect a radical change in valuation as the perception is updated to the Company’s near-term progress and full potential.
Does the company's management play a role in your position? If so, how?
As an entrepreneurial venture, we consider management a critical determinant in success. We have had many interactions with senior management and find their passion for their company is well complemented by a highly analytical approach to building the business. We also find they are shareholder oriented and aligned by a large personal ownership of CYTX shares including meaningful purchases in the last 12 months.
The depth of management is also impressive. The company’s regulatory, research, sales and marketing leaders have both a depth of experience in the medical device space and a passion for the clinical benefits of the CYTX technology.
What catalysts do you see that could move the stock?
Not necessarily in this sequence, but all over the next three to six months:
1. Cardiac Results (Both Apollo and Precise)
2. Improved financial results Q4 vs Q3
3. One or more strategic partnerships with large non-dilutive capital infusions
4. Breast reconstruction trial results (Restore II)
5. 510-k approval
6. Next gen device Celution One developed by Olympus approved in Europe
What could go wrong with this stock pick?
All early stage med-tech companies have financing risk, speed of adoption risk and poor clinical trial result risk. While we are satisfied, we have appropriately handicapped these risks - caveat emptor.
Thank you very much, Joe
My pleasure.
Disclosure: Joe Feshbach's fund has a long position in CYTX
DRAD- FDA approval news released today. Could be a bagger here!
Thanks, I had a blast. But it's time to start bringing in some cash flow again.
Good morning and welcome back BMZ!
VRAL and ZIPZ reaching their support levels. Accumulate if support holds imo!
AmericanBulls.com confirmed Buy for VRAL!
http://www.americanbulls.com/StockPage.asp?CompanyTicker=VRAL&MarketTicker=OTC&TYP=S
THRA>> watch for a bounce at .002!!
FWTC>> Possible bouncer tomorrow!
CNEX News>> Bottom play on watch!!
Cannon Exploration Releases Assays From 'Queen Alexandra' Gold Property
8:02a ET April 14, 2010 (Market Wire)
Cannon Exploration (PINKSHEETS: CNEX) is pleased to release selected values from the company's recently completed rock sampling program carried out on the Queen Alexandra property, located in the Kenora district of Northern Ontario.
Sample results varied and included values that returned 1.34 Au g/t (#709256), 4.66 Au g/t (#709255) and 14.47 Au g/t (#709258).
"We are making good progress with the Queen Alexandra, and are encouraged with the results achieved up to this point. The sampling confirmed what we thought, that there is gold on the property, so now we have to continue to define the property in terms of its geology and the prospective mineralized zones, by doing more work. We'll look to do more geophysics, possibly some IP surveying of the property, and that will allow us to get a better look at the entire ground from surface and with some depth. After the geophysics, more sampling can be done on a larger scale," stated Edwin Solano, President of Cannon.
Cannon has also begun the process of interviewing candidates to act as the "Qualified Person" (QP), under National Instrument 43 101 (NI 43 101), to assume the management of the next phase of exploration for the Queen Alexandra. The role of the QP will be to guide the next phase of exploration on the property. The QP will be responsible for the accuracy and reporting of all information and direction regarding the property.
The QP designation will ensure that the company and all information released will be compliant with the standards of exploration and development as set by the NI 43 101 program, the industry standard.
About Cannon: Cannon Exploration is positioning itself to emerge as a quality mineral resource Exploration Company in the North American mining industry, focusing primarily on properties located in preferred mining districts in Canada.
Forward-Looking Statements: The statements which are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including but not limited to, the effect of economic conditions, the impact of competition, the results of financing efforts, changes in consumers' preferences and trends. The words "estimate," "possible," and "seeking" and similar expressions identify forward-looking statements, which speak only to the date the statement was made. The Company undertakes no obligation to publicly update or revise any forward-looking statements, because of new information, future events, or otherwise. Future events and actual results may differ materially from those set forth herein, contemplated by, or underlying the forward-looking statements.
Contact:
Investor Relations:
1-866-365-4724
Website: http://www.cannon-exploration.com
SOURCE: Cannon Exploration Inc.
http://www.cannon-exploration.com/
Radient Pharmaceuticals Corporation (RPC)
(NYSE Amex: RPC) announced today it continues to grow its partnership with
GenWay Biotech Inc. and has signed an exclusive 5-year marketing, sales and
distribution agreement with the company for the commercialization of RPC's
Onko-Sure(TM) in vitro diagnostic cancer (IVD) test in Greece.
Under the terms of the agreement GenWay Biotech is responsible for the marketing
and product sales in this new market. Radient Pharmaceuticals signed a similar
agreement with GenWay Biotech earlier this year which gave GenWay Biotech the
exclusive rights to market, sell and distribute Onko-Sure in seven other
international markets.
RPC is on an aggressive path in executing an international commercialization
strategy for Onko-Sure in key international markets with strong demand for
cancer screening, diagnostic and monitoring tests. According to Douglas
MacLellan, Chairman and CEO of Radient Pharmaceuticals, "RPC is making strong
headway in its 2010 Onko-Sure commercialization plan. Today's announcement and
expansion to Greece demonstrates significant progress particularly in the
European Union where RPC holds the CE mark from the European Union for Onko-Sure
product sales in Europe as a general cancer screen. As a strong partner to RPC,
GenWay has already initiated product sales in this market through an extensive
sales network." GenWay is penetrating the EU through the support of a dedicated
sales and marketing organization for Onko-Sure.
According to Sergey Sikora, Vice President of Business Development for GenWay
Biotech Inc., "Our relationship with Radient Pharmaceuticals continues to grow
and we remain extremely pleased with the addition of Greece as the newest
international market we are representing. Product sales are already underway and
we expect this market to be among the strongest in our growing network of
countries where GenWay is selling Onko-Sure."
Onko-Sure is a simple, non-invasive, patent-pending and regulatory-approved in
vitro test for use as an aid in early detection of cancer that enables
physicians and their patients to effectively monitor and/or detect certain types
of cancers by measuring the accumulation of specific breakdown products in the
blood called Fibrin and Fibrinogen Degradation Products (FDP). FDP levels rise
dramatically with the progression of cancer. Onko-Sure is approved by the US FDA
for the monitoring of colorectal cancer and by Health Canada as a lung cancer
screen and cancer monitoring tool.
Javelin (JAV-$2.16) Gets Higher $141 Million Takeover Offer From Hospira
DOW JONES NEWSWIRES
Javelin Pharmaceuticals Inc. (JAV) announced plans to junk its $81 million takeover deal with rival drug developer Myriad Pharmaceuticals Inc. (MYRX) after getting a $141 million offer from Hospira Inc. (HSP), which Javelin's board has deemed as superior.
Javelin shares soared 63.4% at $2.19 in recent trading, while Hospira was down three cents at $56.22 and Myriad was inactive after closing on Friday at $4.53.
Hospira is offering $2.20 for each Javelin share as well as financing help and the $4.4 million termination fee due Myriad if its deal isn't completed. Myriad had made a minimum offer of 0.282 share for each share of Javelin, which valued Javelin's stock at $1.27 based on Friday close.
Javelin said it notified Myriad on Friday that it plans to terminate its agreement, and is required to negotiate with them for five business days, giving them a chance to meet the Hospira offer.
Myriad President and Chief Executive Adrian Hobden said as the company weighs its response this week, "our foremost priority will be to use our substantial financial resources prudently, including to develop our promising portfolio of drug candidates." He also called Myriad's deal with Javelin "fair" to both companies' holders.
Javelin's post-operative pain treatment Dyloject is pending U.S. Food and Drug Administration approval. Studies are ongoing and Javelin submitted a new drug application in December to the FDA.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com;
Interesting one to look at. There waiting on FDA approval.
BOMSF
[img]http://www.profitspi.com/stock-chart-str.aspx?id=BOMSF&ca=468228368/img]
Possible Merger Play
TMR
Meridian Announces Increase in Offer From Alta Mesa and Date of Reconvened Special Meeting of Shareholders
10:45a ET April 8, 2010 (GlobeNewswire)
As previously announced, on April 6, 2010, The Meridian Resource Corporation (NYSE:TMR) adjourned its special meeting of shareholders regarding the adoption of the definitive merger agreement with Alta Mesa Holdings, LP. Following the adjournment, Meridian's Board of Directors approved an amendment to the merger agreement whereby Alta Mesa has agreed to increase its offer price for the outstanding common stock of Meridian to $0.33 per share from $0.29 per share in cash, a 14% increase over its prior offer price and a 23% premium over the closing price of Meridian stock on April 7, 2010. The merger agreement was not amended in any other respect.
Accordingly, the special meeting of shareholders will be reconvened on Wednesday, April 28, 2010, at 3:00 p.m. Central Time in the auditorium in Fulbright Tower, 1301 McKinney, Houston, Texas. The record date for shareholders entitled to vote at the meeting remains February 8, 2010. Only holders of record of our common stock on that date are entitled to vote at the reconvened special meeting.
Meridian also announced that it has hired bankruptcy counsel to prepare for a possible bankruptcy filing in the event the merger with Alta Mesa is not consummated. Our lenders have agreed in principle to extend the date by which shareholder approval must be received under the forbearance agreement to a date after April 28, 2010. We anticipate that this extension will be formally documented in the next few days. If the forbearance agreement terminates because of the failure to receive shareholder approval or for any other reason, the lenders could then take action to enforce their rights, including foreclosing on substantially all of Meridian's assets. Therefore, if the merger is not completed, Meridian may be forced to liquidate or to otherwise seek protection under federal bankruptcy laws, and there is no assurance that in a bankruptcy proceeding the Meridian shareholders would receive any value for their shares.
Meridian will be delivering another proxy card to each shareholder of record. If you have already voted, you have the right to change or revoke your proxy at any time before the vote is taken at the reconvened special meeting by taking any of the steps below:
-- if you have instructed a broker, bank or other nominee to vote your
shares, by following the directions received from your broker, bank or
other nominee to change those instructions;
-- if you voted by telephone or the Internet, by voting a later time by
telephone or Internet;
-- by submitting a later-dated proxy card;
-- by attending the special meeting and voting in person (your attendance
at the meeting will not, by itself, revoke your proxy - you must vote in
person at the meeting to revoke a prior proxy); or
-- by delivering to our Corporate Secretary, Lloyd V. DeLano, at The
Meridian Resource Corporation, 1401 Enclave Parkway, Suite 300, Houston,
Texas 77077 a signed written notice of revocation, bearing a date later
than the date of the proxy, stating that the proxy is revoked.
If you do not want to change your vote, no action is required.
Meridian's board of directors unanimously recommends that our shareholders vote "FOR" adoption of the merger agreement, as amended.
Shareholders are encouraged to read Meridian's definitive proxy materials in their entirety as they provide, among other things, a detailed discussion of the process that led to the proposed merger and the reasons behind the Board of Directors' unanimous recommendation that shareholders vote "FOR" the proposal to adopt the merger agreement.
The adoption of the merger agreement, as amended, requires the affirmative vote of the holders of at least two-thirds of the outstanding shares of common stock entitled to vote. A failure to vote will have the same effect as a vote "AGAINST" the adoption of the merger agreement, as amended.
Additional Information Regarding the Merger and Where to Find It
The proposed merger is being submitted to Meridian's shareholders for their consideration, and Meridian has filed a proxy statement to solicit shareholder approval of the proposal to adopt the merger agreement, as amended, as well as other relevant documents concerning the proposed merger, with the SEC. Meridian's shareholders are urged to read the proxy statement regarding the proposed merger and any other relevant documents filed with the SEC, as well as any amendments or supplements to those documents, because they contain important information. You can obtain a free copy of the proxy statement, as well as other filings with the SEC containing information about Meridian, at the SEC's website at www.sec.gov. Copies of the proxy statement can also be obtained, without charge, by directing a request to The Meridian Resource Corporation, Investor Relations, 1401 Enclave Parkway, Suite 300, Houston, Texas 77077 or at Meridian's Investor Relations page on its corporate website at www.tmrx.com.
If you have additional questions about the merger, need assistance in submitting your proxy or voting your shares of common stock, or need additional copies of the proxy statement or the enclosed proxy card, you can also contact The Altman Group, Inc., our proxy solicitor, toll-free at (877) 864-5052 or call (201) 806-7300 or e-mail questions to TMRinfo@altmangroup.com.
Forward-Looking Statements
Statements identified by the words "expects," "plans," and certain of the other foregoing statements may be deemed "forward-looking statements." Although Meridian believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties regarding the transactions described that may cause actual future activities and results to be materially different from those suggested or described in this press release. Risks and uncertainties regarding the transactions include the possibility that the closing of the merger does not occur, either due to the failure of closing conditions, including the approval of the shareholders of Meridian, rights of the parties to terminate the merger agreement, as amended, or other reasons, risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger, the outcome of legal proceedings that have been, or may be, initiated against Meridian related to the merger and the amount of the costs, fees, expenses and charges related to the merger. Other risks relating to Meridian are described in Meridian's documents and reports, available from the U.S. Securities and Exchange Commission, including the report filed on Form 10-K, as amended, for the year ended December 31, 2008 and any updates to those factors set forth in our subsequent Quarterly Reports on Form 10-Q, including risks associated with our default under our credit facility and other lending arrangements.
About Meridian
The Meridian Resource Corporation is an independent oil and natural gas company that explores for, acquires and develops oil and natural gas properties. Through its wholly owned subsidiaries, Meridian holds interests primarily in the onshore oil and natural gas regions of south Louisiana and Texas and offshore in the Gulf of Mexico.
Click here to join our email alert list: http://www.b2i.us/irpass.asp?BzID=1440&to=ea&s=0
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: The Meridian Resource Corporation
CONTACT: The Meridian Resource Corporation
Lance L. Weaver
(281) 597-7125
lweaver@tmrx.com
www.tmrc.com
Kaboom called at 0.70! 1.80 Now!!
0.34's printing!!!!!!
Could be a daytraders dream right here! I'm calling a nice dip right after market opens.
THRA>> Time for a reversal imo! A lot of volume poured in at the EOD yesterday. Possible gapper!