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DEPO - by far the most solid upcoming play. Looks like an outstanding 2011 for them....
http://seekingalpha.com/article/235293-depomed-posts-positive-earnings-with-strong-2011-outlook?source=yahoo
DEPO - Gotta love how it's been trading each day.
CLDA ($16.71) DD (gathered from various public sources and articles):
Clinical Data, Inc. (CLDA) $16.93
About: Clinical Data develops first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising molecules in other major therapeutic areas including asthma, diabetes, and neuropathic pain. Our late-stage compounds include: Vilazodone, a potential first-in-class therapeutic for the treatment of depression, is currently under review for marketing approval by the FDA; and Stedivaze™ (apadenoson), a potential best-in-class coronary artery vasodilator for pharmacologic stress testing, which is currently in Phase III trials ( ASPECT-1, Apadenoson Single Photo Emission Computed Tomography).
200 day ma = $16.85
50 day ma = $18.29
Resistance: $17.30 and $17.59
Support: 16.77 and $16.53 (the 200 day has held support since it crossed in early Oct, dipped below a couple times, but came right back)
52 Week High: $22.3899
52 Week Low: $10.87
30 day avg volume: 135,964
Chart: http://stockcharts.com/h-sc/ui?s=CLDA
Website: http://www.clda.com/
Institutional Holders and Mutual Fund Holders (significant): http://www.dailyfinance.com/company/clinical-data-inc-new/clda/nas/institutional-ownership
Financials as of Sept 30: Revs for 6 months = $8,873,00M, Cash/cash equiv $47M, total assets $51.5M, current liabilities $18.4M, long-term liabilities $55.1M
Share Structure: 100M a/s, 29,993,000 o/s
Market Cap: $458.4M
Short Interest (MASSIVE): 2,578,400
Analysts: Clinical Data is currently rated positively by all analysts covering the stock according to Bloomberg. Here’s a run-down of current analyst opinions:
12/13 McNicoll, Lewis & Vlak, buy, price target $37.00
11/30 Roth Capital, buy, price target $28.00
11/30 Piper Jaffray, overweight, price target $23.00
11/29 BMO Capital Markets, outperform, price target $29.00
11/10 Wedbush, outperform, price target $28.00
10/1 Griffin Securities, buy, price target $33.00
Pipeline: http://www.pgxhealth.com/development/pipeline.cfm
Catalyst(s): January 22, 2011 PDUFA for Vilazodone for depression.
Vilazodone has successfully shown statistically significant improvement of depression symptoms over placebo in two phase III trials. In addition, 52-week safety and tolerability studies and a thorough QT study have been performed.
In both Phase III trials, Vilazodone showed statistically significant reduction of depression scores on the Montgomery-Asberg Depression Rating Scale (MADRS) – the study’s primary endpoint. In one of the two trials, Vilazodone showed meaningful reduction of depression as early as week one. Vilazodone also showed statistically significant improvement of scores in the Hamilton Depression Rating Scale (HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), and Clinical Global Impressions - Severity (CGI-S) and Improvement (CGI-I).
The drug was generally well tolerated with most common side effects of diarrhea (28.0% in treatment group versus 9.2% in placebo), nausea (23.4% versus 5.1%), dizziness (8.5% versus 4.6%), insomnia (6.0% versus 2.1%), abnormal dreams (4.1% versus 1.2%), and vomiting (4.6% versus 1.2%). Serious adverse events (SAEs) were rare (2.1% in the vilazodone group versus 1.6% in placebo) and generally did not appear to be treatment related. Additionally, and quite importantly, vilazodone showed no regression in quantitative scores relating to sexual function; a problem common to and often the cause of discontinuation of many other antidepressant drugs.
Thorough QT studies showed no clinically relevant impact on QT intervals and a long-term 52-week safety and tolerability study gave results largely in-line with the shorter 8-week studies.
Risks:
Don’t love the long-term debt.
The company has a less than favorable agreement with Merck KGaA in which Clinical Data must make milestone payments to vilazodone’s original discovered. Acceptance of the NDA will trigger a payment of $13.0 million in stock to Merck KGaA. Merck will also be entitled to certain royalty payments if Clinical Data is successful in commercializing vilazodone.
With such a massive short position, could see a bear raid.
Vilazodone demonstrates particularly high nausea and diarrhea adverse events and must be titrated up to the 40 mg dose level over a several weeks. In addition, some sources have suggested that the efficacy over placebo is marginal, especially when looking at the HAM-D depression score improvement. Not especially concerned with either of these issues as 1) discontinuation of the study due to diarrhea and nausea were low (1.3% and 1.2% respectively in the one-year safety and tolerability study) and 2) marginal efficacy of antidepressants over placebo is a well documented problem among most marketed antidepressants, and not exclusive to vilazodone. Furthermore, the FDA requires at least two placebo-controlled trials with positive results to authorize a drug indication, regardless of how many trials fail to demonstrate the drug's superiority to placebo - a stipulation satisfied by Clinical Data's two phase III trials. Also read that the 1.8 Hamilton Rating Scale for Depression (HAM-D) secondary endpoint score was a reason not to approve. However, I read that Wellbutrin scored 1.4 and Cymbalta had a 0.4 score, both already approved.
Obviously, if approved, they will need to get the product to market and compete with others. The no sexual side effect result should give them a nice leg up here.
CLDA - investors loading up on January call options....
Bulls taking a dose of Clinical Data
David Russell (david.russell@optionmonster.com), On Thursday December 16, 2010, 12:50 pm
Clinical Data has been drifting lower for almost two months, and now the bulls are stepping in ahead of some key drug developments.
optionMONSTER's Heat Seeker tracking system detected the purchase of more than 2,300 January 25 calls against open interest of just 10 contracts. They priced for $0.19 early in the session and were quickly bid to $0.50--despite the stock barely moving at over the same period. That suggests heavy buying pressure in the calls.
CLDA is down 1.11 percent to $17 in early afternoon trading. The drug developer has lost 11 percent of its value since Oct. 26, when it opened at $21.50 and was immediately pounded lower.
The company is waiting for a Food and Drug Administration ruling on its Vilazodone depression medicine by Jan. 22. It is also expected to begin late-stage trials for its Stedivaze artery treatment in early 2011.
Short interest is significant at about 18 percent of the float, and the stock is apparently finding support around its 200-day moving average (purple line on chart). The 100-day moving average (red line) is also catching up after a big drop in the spring, followed by a rebound in the summer and autumn.
Overall option volume in CLDA is 6 times greater than average so far today, with calls accounting for 87 percent of the activity.
CLDA - have been doing DD and looks like a solid catalyst mover. A couple questions to get answered, but overall looks solid. I'm in this one.
DEPO - yes indeed and doing well. In this one.
OREX - another great catalyst mover with the recent positive panel review. Plan to get in this one.
MNKD - I was thinking the device would be good for children, since they aren't fans of taking pills or getting needles. However, this is for adults only at this point. Takes that out of the equation.
MNKD - the market is massive, no doubt. Word is that the market is growing too, as many more people are becoming diabetic. However, getting people to convert is the challenge, as other biggies have seen (and lost billions trying to do in the past).
MNKD - totally agree with all of your comments here. I've been reading a lot about it...pros and cons. It's a wild one for sure and the volitility will be insane all month. The short position on it is massive, which makes it even more interesting. It will be fun to watch (from afar..lol).
MNKD - 12/29 FDA decision expected.
Major! Too dangerous to trade that one.
DEPO ($5.74) - from a chart perspective, this one is very nice. It's consolidating daily on the way up vs. a big boom with no consolidation.
CYTK - if you're patient, I think this is great entry point. Nice job. The chart is so oversold now, it's down right silly.
CLDA - any thoughts on their use of MADRS vs. HAM-D scales and comparing results to placebo vs. an approved drug in the market? Do you think this could impact the FDA decision?
Upcoming FDA Decision Dates:
Mannkind(MNKD)
Drug/indication: Afrezza for diabetes
Approval decision date: Dec. 29, 2010
This is the second review cycle for Afrezza, a small, inhaled insulin device for diabetes.
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Alimera Sciences(ALIM) and pSivida(PSDV)
Drug/indication: Iluvien for diabetic macular edema
Approval decision date: Dec. 30, 2010
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AztraZeneca(AZN)
Drug/indication: Zictifa for medullary thyroid cancer
Approval decision date: Jan. 7, 2011
An FDA advisory panel on Dec. 2 gave conditional support to the approval of Zictifa, also recommending that a post-approval study be conducted to determine if a lower dose could reduce side effects while maintaining efficacy.
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Clinical Data(CLDA)
Drug/indication: Vilazodone for major depressive disorder
Approval decision date: Jan. 22, 2011
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Orexigen Therapeutics(OREX)
Drug/indication: Contrave for obesity
Approval decision date: Jan. 31, 2011
An FDA advisory panel held Dec. 7 voted 13-7 to recommend Contrave's approval.
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Bristol-Myers Squibb(BMY)
Drug/indication: Yervoy (ipilimumab) for melanoma
FDA advisory panel meeting: Feb. 9, 2011
Approval decision date: March 26, 2011
Both the FDA advisory panel meeting and the FDA's approval decision date for Yervoy were pushed back from December after Bristol submitted additional clinical data. Bristol is seeking initial approval for ipilimumab for patients who have previously received treatment for melanoma.
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Pfizer(PFE) and Protalix Biotherapeutics(PLX)
Drug/indication: Uplyso for Gaucher's disease
Approval decision date: Feb. 25, 2011
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Salix Pharmaceuticals(SLXP)
Drug/indication: Xiafaxan for irritable bowel syndrome
Approval decision date: March 7, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic encephalopathy.
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Human Genome Sciences(HGSI)
Drug/indication: Benlysta for lupus
Approval decision date: March 10, 2011
If approved, Benlysta would be the first new drug for lupus patients in 50 years. GlaxoSmithKline(GSK) will co-market Benlysta. The FDA's approval decision date was pushed back three months from Dec. 9, 2010.
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Dendreon(DNDN)
Drug/indication: Provenge for prostate cancer (manufacturing expansion)
Approval decision date: March 2011
Dendreon is seeking FDA approval to expand Provenge manufacturing capacity at its New Jersey facility. Two additional Provenge plants are under construction outside Atlanta and in Orange Country, Calif. that are expected to come on line in the middle of the year.
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InterMune(ITMN)
Drug/indication: Esbriet for idiopathic pulmonary fibrosis
Approval decision date: First quarter 2011 (estimated)
Intermune is seeking European approval for Esbriet after the FDA rejected the drug in 2010.
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Cell Therapeutics(CTIC)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: First quarter 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April 2010 rejection of pixantrone.
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Forest Laboratories(FRX)
Drug/indication: Daxas for chronic obstructive pulmonary disorder
Approval decision date: First quarter 2011
This is the second FDA review cycle for Daxas.
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Xenoport(XNPT) and GlaxoSmithKline
Drug/indication: Horizant for restless leg syndrome
Approval decision date: April 6, 2011
This is the second FDA review cycle for Horizant. The original new drug application was filed to FDA in January 2009.
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Spectrum Pharmaceuticals(SPPI)
Drug/indication: Fusilev for colon cancer
Approval decision date: April 29, 2011
This is the second review for Fusilev in colon cancer. The drug is already approved as a treatment for a form of bone cancer.
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Adventrx Pharmaceuticals(ANX)
Drug/indication: ANX-530 for non-small cell lung cancer
Approval decision date: May 3, 2011 (estimated, based on Adventrx's Nov. 3, 2010 filing and assuming a six-month FDA review.)
ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The FDA issue a refuse-to-file letter for ANX-530 in 2010.
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Vertex Pharmaceuticals(VRTX)
Drug/indication: Telaprevir for Hepatitis C
Approval decision date: May 23, 2011 (estimated, based on Vertex's filing for approval on Nov. 23, 2010 and assuming six-month FDA review.)
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Delcath Systems(DCTH)
Drug/indication: Hepatic ChemoSat Delivery System for liver metastases in melanoma patients
Approval decision date: June 2011 (estimated, based on expected 2010 year-end filing and a six-month FDA review.)
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Seattle Genetics(SGEN)
Drug/indication: brentuximab vedotin for Hodgkin's lymphoma
Approval decision date: Third quarter 2011 (estimated, based on the company's forecast for a first-quarter 2011 approval filing.)
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MELA Sciences(MELA)
Device/indication: MELAFind for diagnosis of melanoma
Approval decision date: Unknown
FDA rejected MELAFind in March 2010 but an FDA advisory panel in November narrowly recommended the device's approval over the FDA's objection. The FDA has not said when it will issue another approval decision for MELAFind.
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NTWK - nice call!!! +12.3% right now.
Most of us held too long and should have taken profit. Personally, I was hoping for an AMRN type move on CYTK, which was pretty stupid on my part. We can't let prior plays leak into our minds for the current play. Each one is different and needs to be traded/treated that way.
BBY - thanks for the heads up. +$1188 trading it today several times.
Rough going here this week, but we need to learn from it! Time to regroup, continue to do excellent DD, and find the next slam dunk (e.g. AVNR).
PSDV ($5.76) New Gekkowire out. Any thoughts regarding the data the FDA might use from the Phase 3 studies?
http://www.gekkowire.com/?p=6213
Thanks!
oldberkeley: very well said!
CYTK - Expensive, yet valuable lesson learned with regards to non-PDUFA plays. Need to think about the Phase of the trial, the type of disease the drug is related too, etc.
I sold for a big loss today. I didn't like how it was trading, as there seemed to be an endless amount of shares on the ask, regardless of buying pressure. I'm also not a fan of holding too long. I'd rather use my $ towards the next one.
It was a nice play, just played incorrectly on my part. For those holding, I hope you get a nice pop at some point. I also hope CYTK continues down this positive path to help people live better.
Time to find the next winner and play it right!!!!!
CYTK - seems to be an endless supply of shares.
PSDV ($5.524) - was advised by Gekkowire that he confirmed with the company this morning that the 12/29/10 FDA date is not a lock (i.e. confirmed), even though that date is out there in some places. He said he would be putting out an update on it soon.
Exactly, very odd.
CYTK - I'm baffled at the trading on this today. Trying to figure out what's going on with these HUGE blocks.
CYTK - yes, I see that on the chart and the next day it was back up to $2.60's-$2.70's.
CYTK - and the shorts certainly don't want this to go up. CYTK, in conjuction with Amgen, are going to initiate a Phase II trial for of their CK-357 drug in patients with myasthenia gravis too. So this is another pending event coming soon.
CYTK - excellent observation. CYTK looking better and better. That's why Wedbush has a $9 target and Canaccord has a $6 target.
CPIX - not a peep all weekend. Should see something in the morning.
CYTK - This is part is pretty huge for the patients, company, and investors....
"This is a disease for which there is absolutely no effective therapy," Dr. Shefner said. "To show that you had nearly 45 percent of patients feeling better on a drug after a single dose is quite an amazing finding."
Repligen Corporation (RGEN) DD $3.93
About: Repligen Corporation is comprised of a therapeutics and a bioprocessing division committed to advancing the development and commercialization of pharmaceutical products. The focus of the therapeutics business is on the development of innovative therapies which deliver value to patients and clinicians in neurology, gastroenterology and orphan diseases. The bioprocessing division focuses on the development and commercialization of products that are used for the production of biopharmaceuticals. Repligen's corporate headquarters are located at 41 Seyon Street, Waltham, Massachusetts 02453.
200 day ma = $3.50
50 day ma = 3.68
Resistance $4.01 and $4.08
Support $3.89 and $3.84
52 Week High: $4.22
52 Week Low: $3.00
30 day avg volume: 41,036
Chart: http://stockcharts.com/h-sc/ui?s=RGEN
Website: www.repligen.com
Institutional Holders and Mutual Fund Holders: http://www.dailyfinance.com/company/repligen-corporation/rgen/nas/institutional-ownership
Financials as of Sept 30th: $15.163M in cash, $64.297M in assets, $4.365M in liabilities (very little long-term). Revs and Gross Profits increasing quarterly. $7.307M in revs last Quarter.
Share Structure: 40M authorized, 30,787,307 issued and outstanding
Market Cap: $120.99M
Short Interest: 256,800
Analysts: Only 1 on it recently Merriman with a Buy and $9.00 target, initiated June 30, 2010
Pipeline:
• RG1068, synthetic human secretin, in Phase 3 development to improve magnetic resonance imaging of the pancreas
• RG2417, an oral formulation of uridine, in Phase 2b development for treatment of acute depression in bipolar disorder
• RG2833, HDAC-3 inhibitors in preclinical development for Friedreich's ataxia
• RG3039, promoters of SMN2 gene expression for spinal muscular atrophy
More about the Protein A Business:
For over 20 years, Repligen has also made a difference in patients' lives through its commitment to quality in its bioprocessing business. Through the sale of its Protein A products, Repligen provides the biopharmaceutical industry with tools used in the manufacturing of therapeutic and diagnostic monoclonal antibodies. Monoclonal antibodies are the largest class of biological drugs and include important new therapies for rheumatoid arthritis and cancer, and the class continues to grow. Sales of Repligen's recombinant Protein A products have resulted in a steady revenue stream for the company, allowing Repligen to continue to invest in its bioprocessing product line in order to capture this growing market, while at the same time funding development of its therapeutic pipeline.
Catalysts:
2 big ones in Q1 of 2011
RG1068 – Phase III data (pancreatic imaging agent) release and NDA submission – potential $100M market in U.S. and Europe. Repligen has completed a Phase 3 study of RG1068 to evaluate the safety and efficacy of RG1068 to improve MRI imaging of the pancreas in patients with a history of pancreatitis. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved our proposal to re-analyze the images from our Phase 3 study based on the numerous deficiencies with the analysis of the radiographic images by the contract research organization hired to oversee the analysis of the Phase 3 data. A successful re-read of the Phase 3 data may support registration of RG1068 for MRI imaging of the pancreas. There are more than 300,000 MRI procedures conducted in the U.S. and Europe each year that could benefit from the addition of RG1068.
RE2417 – Phase 2b data (bipolar drug) release – potential $2B market. Phase 2a results demonstrated a statistical significant reduction in the symptoms of depression. Was safe and well tolerated and no serious adverse events. Phase 2b enrollment of patients completed Sept 30, 2010 for the 8 week trial. Based on this timing, the trial is close or already complete; therefore, data could be released soon.
PSDV - yes, this is a concern. I was reading that although a concern, there is a surgical fix (filtering surgery) to the issue. I hear it's not uncommon and happens with other eye implants also (but less for PSDV). Given the benefit of not going blind and better vision, this likely outweighs the concern.
"Patients that received Retisert, a similar type of implant only in a different region of the eye, also exhibited increased occular pressure in the eye when given the implant, in fact approximately 37% of patients that received the Retisert implant required the same filtering surgery, this compares to the 5% seen with Iluvien (data here)."
Source: http://www.gekkowire.com/?p=4731&page=4
NEOP - nice report, thx.
CYTK - yep would be nice to something come out of that meeting this evening.
Agreed - when looking at these catalysts, a key factor is the potential market and how easy will it be for the company to penetrate. This is why we see the FDA sometimes approve and a stock going down. We want to find stocks with a huge or even untapped market.
MNKD - so it looks like approval really means nothing here, since it's impossible to market. Wonder why they are trying to defeat the odds that some of the biggies couldn't overcome in the past.
CYTK Dial-In Info For Tomorrow Morning @ 7:00 a.m.:
Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that the company is scheduled to host an Investor Event entitled "Perspectives on the Phase IIa Clinical Trial Data of CK-2017357 in Patients with ALS" on Monday, December 13, 2010 from 7:00 a.m. - 8:00 a.m. Eastern Standard Time in the Del Lago 4 Room at the JW Marriott Grande Lakes Hotel in Orlando, Florida.
At this meeting, Robert Blum, Cytokinetics' President and Chief Executive Officer, is scheduled to be joined by members of Cytokinetics' management team and key opinion leaders in the ALS field, including Robert G. Miller, M.D., Clinical Professor of Neurology and Neurological Sciences at Stanford University, and Director of the Forbes Norris ALS Research Center at the California Pacific Medical Center, and Jeremy M. Shefner, M.D., Ph.D., Professor and Chair of the Department of Neurology at the Upstate Medical University at the State University of New York, who served as the Principal Investigator in this clinical trial.
The presentation and accompanying slides will be simultaneously webcast beginning at 7:00 a.m. Eastern Standard Time and can be accessed through the Investor Relations section of the Cytokinetics' website at www.cytokinetics.com. The live audio of the forum will also be accessible via telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 28990049. Those wishing to attend this event in person should RSVP to investor@cytokinetics.com by the morning of Friday, December 10, 2010.
An archived replay of the webcast will be available on the Presentations page in the Investors Center section of Cytokinetics' website until January 14, 2011. The replay will also be available via telephone from December 13, 2010 at 10:00 a.m. Eastern Standard Time until December 20, 2010 by dialing (800) 642-1687 (United States and Canada) or (706) 645-9291 (international) and typing in the passcode 28990049.
NEOP.OB DD For Review/Discussion
Neoprobe Corp. (NEOP.OB) $1.96
About: Neoprobe Corporation (OTCBB:NEOP.ob - News) is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions
200 day ma = $1.83
50 day ma = $1.80
Resistance $2.02 and $2.09
Support $1.90 and $1.85
52 Week High: $2.30
52 Week Low: $1.03
30 day avg volume: 425,824
Chart: http://stockcharts.com/h-sc/ui?s=NEOP
Website: www.neoprobe.com
Institutional Holders and Mutual Fund Holders (not many): http://www.dailyfinance.com/company/neoprobe-corporation/neop/nab/institutional-ownership
Financials as of Sept 30, 2010: Revs $2.1M last Q ($7.5M for 9 months). Cash $2.6M, Liabilities ~$5.87M, Net loss $2.38M vs $25M 1 year ago. Assets $6.98M.
Share Structure: A/S 200M, OS 82,573,372 as of 11/8/10
Market Cap: $161.84M
Short Interest: 5,263,900 (pretty good size, plus they are on the REGSHO list)
Analysts: n/a
Catalyst(s):
1) Company has requested and been granted a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding its RIGS® technology Biologic License Application (BLA). The pre-IND meeting request is another step in Neoprobe’s efforts to develop and commercialize the RIGS technology designed to enhance the surgical treatment of patients with solid tumor cancers.
“The pre-IND meeting request is one of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology program,” said Rodger Brown, Neoprobe’s Vice President of Regulatory Affairs and Quality Assurance. “The FDA has confirmed a meeting date in the first quarter of 2011 and we are in the process of completing the briefing documents in preparation for this meeting. Once FDA has agreed with our RIGS development plans, and has assigned a new IND, we anticipate more extensively restarting our clinical, non-clinical and CMC efforts including pursuing the possibility of obtaining a Special Protocol Assessment (SPA) for the clinical evaluation of the RIGS technology.”
About RIGS®
Neoprobe’s RIGS technology involves the use of a radiolabeled tumor-specific targeting agent to alert surgeons to the existence of cancerous tissue, undetectable by traditional diagnostic and intraoperative techniques. The RIGS procedure may enable more effective colorectal cancer surgeries leading to improved patient treatment.
2) http://seekingalpha.com/article/239104-5-biotechs-investors-should-be-watching?source=yahoo
Neoprobe Corporation (NEOP.OB) is another company to keep your eyes on. After the recent mention by Uri Landesman, President of Platinum Partners, about Neoprobe being an interesting acquisition by Covidien (COV) or Cardinal Health (CAH) sometime in 2011, assuming Lymphoseek Phase 3 trials are successful. They recently raised $6M in cash. Notably, insiders have been buying very recently. On 11/15, insiders collectively purchased 70K shares (about $120K) on the open market. Last week they gave several Lymphoseek presentations at the International Sentinel Node Society (ISNS) Bi-Annual Meeting 2010.
“Lymphoseek presentations at ISNS 2010 signal an important step in the international clinical community’s interest in the technology’s potential to improve lymph node mapping and patient treatment and care, and the growing importance of accurate intra-operative identification of sentinel lymph nodes in surgical oncology,” said Dr. Frederick O. Cope, Senior Vice President of Pharmaceutical Research and Clinical Development of Neoprobe. Neoprobe has plans to investigate Lymphoseek’s clinical potential to help improve diagnosis in melanoma, breast, head and neck cancer and other solid tumor cancers.
The NEO3-05 Phase 3 study was an open label trial of node-negative subjects with either breast cancer or melanoma. It was designed to evaluate the safety and the accuracy of Lymphoseek while identifying lymph nodes draining from the subject’s tumor site. To demonstrate the accuracy of Lymphoseek, each subject consenting to participate in the study was injected in proximity to the tumor with Lymphoseek and one of the vital blue dyes that are commonly used in lymphatic mapping procedures. The primary efficacy objective of the study was to identify lymph nodes that contained the vital blue dye and to demonstrate a statistically acceptable concordance rate between the identification of lymph nodes with the vital blue dye and Lymphoseek. To be successful, the study needed to achieve a statistical p-value of at least 0.05. The protocol compliant clinical sites that participated in the NEO3-05 study contributed 136 Intent-To-Treat (ITT) subjects who provided 215 lymph nodes that contained the vital blue dye. 210 of the vital blue dye positive lymph nodes contained
Lymphoseek for an overall concordance rate of 98%, achieving a highly significant statistical p-value of 0.0001. In addition to the nodes identified by vital blue dye and Lymphoseek, Lymphoseek was able to identify 85 additional lymph nodes that did not contain the vital blue dye, and 18% of these nodes were found by pathology to contain cancer, pointing to the agent’s ability to identify lymph nodes containing occult tumors that can be missed by conventional diagnostic methods.
The data further show that in all the Phase 1 through Phase 3 studies, there were no significant safety events in any study related to Lymphoseek. In all studies, Lymphoseek fulfilled its performance objective relative to its prospective bio-targeting design toward discerning lymphatic tissue in intra-operative lymphatic mapping.
3) A potential buyout in 2011 could be #3, but impossible to time that one.
Other: In 2010, received notice of grant awards totaling over $1.2 million to support Lymphoseek development through non-dilutive funding.
PSDV - Need to dig further into the clinical data to determine the chance of approval on 12/29/10, but this will get our DD started....
pSivida Corp PSDV $5.62
About pSivida Corp.
pSivida is a world leader in the development of tiny drug delivery products that are administered by implantation, injection or insertion and provide sustained release of drugs on a controlled and level basis for months or years. The Company uses these systems to develop treatments for serious, unmet, medical needs. The Company's most advanced product candidate, Iluvien(R), delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME). DME is a leading cause of vision loss, affecting more than a million people in the US alone, for which there is currently no FDA-approved drug therapy. Iluvien is licensed to Alimera Sciences, Inc., which is completing fully-recruited Phase III clinical trials and submitted a New Drug Application (NDA) with the Food and Drug Administration (FDA) in June 2010. In August 2010, the FDA granted Priority Review status for the NDA. pSivida has two products approved by the FDA for sustained release delivery of drug to treat chronic back-of-the-eye diseases: Retisert(R) for the treatment of posterior uveitis and Vitrasert(R) for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida also has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products using certain of the Company's technologies. pSivida's intellectual property portfolio consists of over 50 patent families, more than 100 granted patents, including patents accepted for issuance, and more than 150 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
200 day ma = $4.26
50 day ma = $5.42
Resistance $5.76 and $5.89
Support $5.37 and $5.11
Chart: http://stockcharts.com/h-sc/ui?s=PSDV
Website: http://www.psivida.com/
Institutional Holders and Mutual Fund Holders: http://www.dailyfinance.com/company/psivida-corp/psdv/nas/institutional-ownership
Financials: Revs last Q $476,000, Cash and cash equivs $15,514,000, Assets $19,034,000, Liabilities $9,973,000 ($7.039M long-term)
Share Structure: 60M A/S 18,531,392 O/S as of Sept 30, 2010
Market Cap: $104.14M
52 Week High: $6.13
52 Week Low: $3.06
30 day avg volume: 108,987
Short Interest: 233,300
Analysts: 2 on it - Ladenburg Thalmann 11/17/09 Buy $9.00 target; Rodman & Renshaw Market Outperform 10/12/10 No target.
Pipeline: http://www.psivida.com/products.html
Catalyst(s):
The NDA for Iluvien for DME, pSivida's most advanced product candidate, is presently undergoing Priority Review by the FDA, and the Company anticipates a decision by the end of the year (12/29/10). If approved, pSivida will be entitled to a $25.0 million milestone payment from our licensee Alimera Sciences and 20% of profits (as defined) on sales of Iluvien by Alimera, which it has indicated could commence as early as the first calendar quarter of 2011. pSivida is also developing other ophthalmic products, some in partnership with Pfizer, pSivida's largest shareholder, and some internally, as well as working to adapt its drug delivery platforms to deliver therapeutics outside ophthalmology.
FDA Priority Review status is given to therapies that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This status reduces the review time goal from 10 months to six months.
The fact that Bausch & Lomb already has gained approval for Retisert, a retinal insert using the same steroidal treatment in the same dose as Ilubien for a related condition, uveitis, provides additional comfort that Iluvien could gain approval from the FDA.
Last month, the call open interest was at 1,094 contracts vs. put open interest at 81 contracts. Need to get current data.
Potential Market looks to be about $3B in the U.S. alone.( 250,000 - 300,000 possible patients at $6,000 per eye).
Really good article: http://seekingalpha.com/article/225205-2-year-end-fda-run-up-stock-plays?source=qp_article
Other: 10/20/10 pSivida Ranked 15th on 2010 Technology Fast 500™, Deloitte’s Ranking of Fastest Growing Companies in North America
Going to do some DD this weekend on PSDV, RGEN, NEOP, and MNKD. No idea if they are + or -, but will find out and share.