Positiv news:
1. NeoPharm Announces LEP-ETU Project Update
Thursday September 29, 2:25 pm ET
LAKE FOREST, Ill.--(BUSINESS WIRE)--Sept. 29, 2005--NeoPharm, Inc. (Nasdaq:NEOL - News):
* Bioequivalency Study Meets Endpoint
* Development For NDA Submission via 505(b)(2) Pathway Planned
NeoPharm, Inc. (Nasdaq:NEOL - News) today announced that, based on the results of its recently completed bioequivalence study, the Company's NeoLipid® drug candidate LEP-ETU (Liposome Entrapped Paclitaxel "Easy to Use") has met the study criteria, established by FDA, for demonstrating bioequivalence. LEP-ETU is NeoPharm's easy-to-use liposomal formulation of paclitaxel (Taxol®), which is a widely-used and approved treatment for advanced cancers, including ovarian, breast, and lung cancer. Based on this initial bioequivalence study, NeoPharm is accelerating the clinical program of LEP-ETU to support submission to FDA of a 505(b)(2) New Drug Application (NDA) for marketing approval.
The Company is currently preparing to submit an abstract in December of the bioequivalence study data to the American Society of Clinical Oncology (ASCO) for consideration for the program of the 2006 ASCO Annual Meeting in Atlanta, Georgia, June 2-6, 2006.
"We are pleased that our LEP-ETU drug candidate has demonstrated bioequivalence to Taxol," said Ronald G. Eidell, NeoPharm's President and Chief Executive Officer. "According to written guidance provided by the FDA, after completion of a 100-patient comparator study, we may be able to file an NDA for LEP-ETU as early as the fourth quarter of 2007."
Under the 505(b)(2) pathway, and guidance from the FDA on LEP-ETU, in addition to the bioequivalence study, the Company will need to initiate a 100-patient comparator study in metastatic breast cancer. The Company estimates the 100-patient comparator study, in which 50 patients would receive LEP-ETU and 50 patients would receive Taxol, will take approximately eight to ten months to enroll with a six-month treatment period. The Company is finalizing preparations for such a study to expedite patient enrollment, and currently expects to commence enrollment in the first quarter of 2006.
The rationale for developing a liposomal formulation of paclitaxel is to attempt to improve the safety profile of paclitaxel by eliminating the drug formulation component polyoxyethylated castor oil (Cremophor® EL), which is associated with toxicities, while maintaining or enhancing efficacy.
In addition to the LEP-ETU comparator study, a Phase II study for another of the Company's NeoLipid drug candidates, LE-SN38 for colorectal cancer, is being planned with the Cancer and Leukemia Group B (CALGB), an NCI funded clinical study group, with protocol submission and acceptance to NCI CTEP and FDA, currently anticipated in the fourth quarter of this year.
2.NeoPharm Posts Positive Study Results
Thursday September 29, 4:29 pm ET
NeoPharm Study Shows Its Redesigned Paclitaxel Drug Is Equivalent to Bristol-Myers' Taxol
LAKE FOREST, Ill. (AP) -- NeoPharm Inc. said Thursday that its redesigned version of the paclitaxel cancer drug, tailored to have fewer side effects, had the same effect as the original therapy in a clinical study.
The company's NeoLipid version of the common chemotherapy drug eliminates the need to mix the active ingredient with castor oil, which can lead to side effects such as hypersensitivity. NeoPharm said the treatment met the standard criteria for "bio-equivalence," a label the Food and Drug Administration applies to drugs that can be prescribed interchangeably. Based on the results, the company said it is accelerating development of the drug and plans to submit an application to the FDA as early as the fourth quarter of 2007.
Paclitaxel is also known by its brand name, Taxol, and is sold by Bristol-Myers Squibb Co. Its common side effects include nausea, vomiting, hair loss, and nerve and muscle pain, NeoPharm said.
NeoPharm shares rose 19 cents to close at $12.28 on the Nasdaq, while Bristol-Myers shares closed down 3 cents at $24.04 on the NYSE.
insider buying:
Becker Frank (Chairman) bought 28000 shares NEOL
valued at $333480. The trade date was 2005-09-23. The average price of the transaction is 11.91. This was reported by www.insider-monitor.com
TA Link:
http://www.stockta.com/cgi-bin/analysis.pl?symb=NEOL&num1=7&cobrand=&mode=stock
updated chart:
NEOL - Heavy trading on news ;)
UPDATE 1-NeoPharm brain-cancer trial backed; shares soar
http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh10858_2005-12-27_19-13-49_n27327742_newsml
on fire >:D
Quote from: la-onda on December 27, 2005, 04:32:55 PM
on fire >:D
Strong close as well - might gap up tomorrow AM ;)
Update @ 4:59 pm : Wedbush Morgan Keeps Buy on NeoPharm. Price target $19.
http://yahoo.businessweek.com/investor/content/dec2005/pi20051227_7478_pi006.htm
update:
BUYINS.NET: NeoPharm (NEOL) SqueezeTrigger Price Is $10.73. Short Sellers Are Down Approximately $3.5 Million After Late Stage Trial For Brain Cancer Drug To Begin
Wednesday, December 28, 2005 04:29 ET
Dec 28, 2005 (M2 PRESSWIRE via COMTEX) -- BUYINS.NET, www.buyins.net, announced today that the 5.14 million shares declared short on NeoPharm, Inc. (NASDAQ: NEOL) have a SqueezeTrigger Price of $10.73 per share. According to AP, NeoPharm Inc. said Tuesday an independent committee recommended that a planned late-stage trial of NeoPharm's brain cancer drug candidate proceed. The drug candidate, cintredekin besudotox, is being studied to treat glioblastoma multiforme that recurs after surgery. NeoPharm describes GBM as the "most aggressive" form of brain cancer. NeoPharm will conduct an interim efficacy analysis at the first 160 deaths with the final report due at 215 deaths, if necessary. The company said analysis reports are expected late in the second quarter, with the final version due late fourth quarter or early 2007, respectively. As a result of the recommendation, the company said it "remains cautiously optimistic for a positive final outcome" of its clinical trial. Next year, NeoPharm expects to begin a new Phase II study of cintredekin besudotox to treat malignant glioma, another from of brain cancer, as well as a pediatric study. Short sellers are down approximately $3.5 million as the stock is currently trading near $11.40. To access SqueezeTrigger Prices ahead of short squeezes beginning, visit http://www.buyins.net/squeezetrigger.pdf.
From January to November of this year, an aggregate amount of 17,069,053 shares of NEOL have been shorted for a total dollar value of $183 million. The NEOL SqueezeTrigger price of $10.73 is the volume weighted average price that all shorts are short in shares of NEOL. Since crossing above the SqueezeTrigger Price, shares of NEOL are up nearly 6%. There is still approximately $58 million worth of potential short covering in shares of NEOL.
link:
http://www.knobias.com/individual/public/news.htm?eid=3.1.bb1cef74d17311c289c62f7bc709b61e92c1f6cfbd61cec9236711a6ec3ca33f
&
NEOL: JMP Sec Keeps @ Strong Buy; Keeps Tgt @ $19; Analyst Notes
Wednesday, December 28, 2005 09:11 ET
Issuer: NeoPharm, Inc. (NasdaqNM: NEOL)
Analyst Firm: JMP Securities
Ratings Action: REITERATION
Current Rating: Strong Buy
Target Price Action: MAINTAIN
Target Price: $19.00
Analyst Comments: NeoPharm announced an independent data monitoring committee (iDMC) has determined that the PRECISE trial should proceed as designed. The firm believes this is the best of three possible outcomes. Recent underperformance of NEOL shares likely indicates a growing concern regarding the outcome of the iDMC meeting, as well as pressure from the company's balance sheet. In their view, yesterday's news and continued enthusiasm by physicians involved in the development of the drug further enhance their conviction that it could become the first effective treatment for recurrent brain cancer (with an estimated $250-million annual revenue potential in 2009). Near-term news flow on efficacy analyses from PRECISE, and the completion of a planned Phase II study in newly diagnosed patients, could galvanize NEOL shares against the dilutive impact of a possible follow-on in 1H06.
TA feedback is appreciated
chart:
Are you subscribed to buyins.net?
They technology looks interesting. Wonder how many people make money on their suggestions.
So, as I understand, the stock needs to close today >= 10.73 to trigger short squeeze?
no, I am not a subscriber.
We have the same understanding of the article.
Bouncing back from 61,8% fibonacci retracement ???
cheers
O.
Hi,
Good news :
NEOPHARM, Inc. (Nasdaq:NEOL) today announced that, based on long-term follow up data from its Phase I/II clinical studies, CINTREDEKIN BESUDOTOX (IL13-PE38QQR) continues to show evidence of prolonged overall survival in patients with recurrent glioblastoma multiforme (GBM). Specifically, updated survival data for GBM patients treated in the Company's Phase I/II studies and results from a subset analysis of these Phase I/II studies was presented in a scientific symposium on brain tumor treatments at the annual meeting of the European Association of Neuro Oncology (EANO) meeting in Vienna, Austria on Saturday, September 16, 2006.
Insider buying : Chairman John Kapoor bought 20,000 shares at $4.86.
Technical analysis :
a triangle is forming...And negative divergence between price and indicators...
Strategy :
1. Prudent : Buy on triangle breakout or resistance breakout (like Wrangler advice)
2. Buy now
3. Buy on pullback near support at 4.6 - 4.5
Scenario :
Buy now..
Entry price : 4.85
stop-loss : 4.25
target : 7.40
Reward/Risk ratio of 52.5 / 14.11 = 3.72...Good > 3.
Money management protection : sold 1/2 positions at 5.54
Good trade.. :)
nice update sebfr 8)
Analyst update:
1)
NeoPharm "strong buy"
Friday, September 22, 2006 4:15:59 AM ET
JMP Securities
NEW YORK, September 22 (newratings.com) - Analysts at JMP Securities reiterate their "strong buy" rating on NeoPharm Inc (NEOL.NAS).
In a research note published yesterday, the analysts mention that the company has thorough and clear commercial strategies to launch CBtox in the US and EU markets. NeoPharm is focusing immensely on expanding the NeoLipid platform of products, which is currently being undervalued by the market, the analysts say.
http://www.newratings.com/analyst_news/article_1374000.html
2)
NeoPharm "outperform," target price reduced
Thursday, August 10, 2006 3:21:13 AM ET
Robert W. Baird
NEW YORK, August 10 (newratings.com) - In a research note published yesterday, analysts at Robert W Baird reiterate their "outperform" rating on NeoPharm Inc (NEOL.NAS), while reducing their estimates for the company. The 12-month target price has been reduced from $15 to $10.
http://www.newratings.com/analyst_news/article_1342148.html
3)
Moetly Fool quotation:
Newfound optimism at NeoPharm
After years of mistakes, I've come to realize that successful investing is most often a product of unemotionally following a disciplined routine. But that's much easier said than done, especially for a rebellious growth guy like me. So anti-establishment am I that the editors have seen fit to assign me to the Motley Fool Rule Breakers team.
Still, I follow a few rules when picking fast movers for my portfolio. Most important is a committed management team with a big stake in the company I'm researching. Or, in lieu of that, a group of new managers that are buying shares to build a stake. Either one indicates faith that, over the long term, the business case will play out as expected.
Enter NeoPharm. Most days, I'd ignore this biotech (my expertise lies elsewhere). But a combination of already-significant insider ownership coupled with recent buying has me intrigued. Last Thursday, for example, chairman of the board John Kapoor purchased 20,000 stubs. That followed buying from board member Kaveh Safavi in August and CEO Guillermo Herrera in June.
We can only speculate on why this triumvirate of executives has seen fit to buy stock now, but I like the thesis offered by Motley Fool CAPS player Worldfrog:
This is essentially a bet that [NeoPharm] will get approval for its lead drug for brain cancer, currently in phase III trials. I expect some volatility in the meantime, but final results of the trials should be available in early 2007.... There are three other drugs in the pipeline as well, so it's not a one-shot wonder, and the company still has complete marketing rights to those drugs. I'm assuming that the company's lead drug will be approved.
In other words, NeoPharm could very well go to zero if the Feds decide its brain cancer treatment isn't up to snuff. However, substantial insider buying suggests that that outcome is, at best, remote.
http://www.fool.com/news/commentary/2006/commentary06092719.htm?source=eptyholnk303100&logvisit=y&npu=y
cheers
Oliver
nice call sebfr, applaud again
Thank you La-onda...Day-traders, swing traders and long-term investor -> NEOL is for all this kind of strategies
great call thanks guys!!
another 12 %, congrats sebfr
neol having a good day...in at 5.59 last week. making a presentation today...we shall see
still moving higher...news?...we shall see
neol moving up again..no news
can't find any news on this one,but it keeps on climbing..ant thoughts?
wow!! :o -70% as of now!!
NeoPharm drug misses goal in brain-cancer trial
NEW YORK, Dec 11 (Reuters) - NeoPharm Inc. (NEOL.O: Quote, Profile , Research) said on Monday that its experimental drug, cintredekin besudotox, failed to meet the efficacy goal in a late-stage study for brain cancer.
The company said it would work with its scientific advisers and regulators to determine the next steps.
NeoPharm upgraded to "hold"
Monday, December 11, 2006 3:21:54 PM ET
Brean Murray, Carret & Co
NEW YORK, December 11 (newratings.com) - Analysts at Brean Murray upgrade NeoPharm Inc (NEOL.NAS) from "sell" to "hold."
christmas update incl MACD crossing, bottom fishing in 2007 ?
1)
NeoPharm downgraded to "market outperform" - update
Tuesday, December 12, 2006 1:30:21 PM ET
JMP Securities
NEW YORK, December 12 (newratings.com) - Analysts at JMP Securities downgrade NeoPharm Inc (NEOL.NAS) from "strong buy" to "market outperform," while raising their estimates for the company. The target price has been reduced from $19 to $6.
In a research note published yesterday, the analysts mention that the company's Phase III PRECISE trial has failed to meet its primary endpoint. The downgrade in the rating reflects the undervalued NeoLipid programme and the recent sell-off in NeoPharm's stock, the analysts add. The EPS estimate for 2007 has been raised from -$1.32 to -$0.72.
2)
NeoPharm downgraded to "neutral"
Tuesday, December 12, 2006 3:34:47 AM ET
First Albany
NEW YORK, December 12 (newratings.com) - In a research note published yesterday, analysts at First Albany downgrade NeoPharm (NEOL.NAS) from "buy" to "neutral."
3)
NeoPharm "neutral," target price reduced
Tuesday, December 12, 2006 7:46:37 AM ET
Robert W. Baird
NEW YORK, December 12 (newratings.com) - Analysts at Robert W Baird reiterate their "neutral" rating on NeoPharm Inc (NEOL.NAS), while reducing their estimates for the company.
The target price has been reduced from $8 to $2.
In a research note published yesterday, the analysts mention that the company has announced that its Phase 3 PRECISE trial for cintredekin besudotox (IL-13) has failed to show better efficacy than Gliadel. NeoPharm is now left with few value drivers in its pipeline, with the Neolipid development programme having put on the backburner, the analysts say. The EPS estimates for 2007, 2008 and 2009 have been reduced from -$1.45 to -$0.82, from -$0.63 to -$0.82 and from $0.50 to -$0.81, respectively.
4)
NeoPharm downgraded to "reduce"
Tuesday, December 12, 2006 8:34:13 AM ET
UBS
NEW YORK, December 12 (newratings.com) - Analysts at UBS downgrade NeoPharm Inc (NEOL.NAS) from "neutral" to "reduce."
5)
NeoPharm cuts 20 percent of work force
Fri Dec 22, 2006 5:16 PM ET
LOS ANGELES, Dec 22 (Reuters) - Drug developer NeoPharm Inc. <NEOL.O> said on Friday that it has completed a restructuring which reduced its work force by 14 jobs, or about 20 percent.
The company estimated costs associated with termination benefits at about $300,000 and said the cuts will yield 2007 cost savings of about $1.5 million over 2006.
This is what happen when you buy shitty company. Welcome to Vega.....
Volume coming in out of nowhere, no news, in at 2.05 for a trade.
While reading the latest issue of Journal of Clinical Oncology (most prestigious oncology journal) published today, I stumbled upon a report describing the effect of Cintredekin Besudotox (IL13-PE38QQR) on Recurrent Malignant Glioma published by UCSF group. This happens to be the drug being developed by NEOL. They conclude that Cintredekin appears to have a favorable effect on patients with relapsed glioblastoma..
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17327604&query_hl=3&itool=pubmed_docsum
I think it explains recent increased activity in this stock and together with todays news that NEOL will discuss its 2006 results and update on Cintredekin on March the 14th it could cause a nice speculative rise >:D. I bought this morning. Let's see what happens :-).
I posted the same message on NEOL yahoo board and on Investorshub.com... A little private pump action >:D
better link for the paper: http://www.jco.org/cgi/content/abstract/25/7/837 . I could get fulltext version if anybody would be interested in :-).