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8:51AM On The Wires (WIRES) :XenoPort (XNPT) has been awarded a $347,075 grant from The Michael J. Fox Foundation for Parkinson's Research to support preclinical studies to explore XP23829 for its ability to protect against neurodegeneration in experimental preclinical models of Parkinson's disease.
News From www.stockpickr.com:
XenoPort
XenoPort (XNPT) is a biopharmaceutical company focused on developing and commercializing a portfolio of internally for the treatment of neurological disorders. This stock is trading up 10.2% to $5.70 in recent trading.
Today’s Range: $5.28-$5.63
52-Week Range: $3.46-$7.90
Volume: 502,000
Three-Month Average Volume: 416,331
Shares of XNPT are ripping higher today after Wells Fargo initiated the stock with an outperform rating and a price target of $7 to $9. Analyst Brian Abrahams said, “While the opportunity for marketed agent Horizant and phase III candidate arbaclofen placarbil may be more modest, we believe their combined future revenue streams put a floor in valuation near where the shares currently trade.”
Chart looking to get better imo.
http://stockcharts.com/h-sc/ui?s=XNPT&p=D&yr=0&mn=3&dy=0&id=p40000942382
this moved well for traders
thats about it
Credit Suisse places outperform rating with $7.00 price target.
We are Initiating Coverage of XenoPort with an Outperform Rating and
$7 Target Price. Despite a number of fundamental concerns, at its current
valuation ($219mn market cap/$165mn y/e EV) and with low expectations
for its marketed products and pipeline, we think relatively little has to go right
for the stock price to appreciate. Specifically we see 3 main upside
optionality triggers which are not factored into our numbers/valuation (a)
delivery of greater Regnite/Horizant revenues – either via high end-user
sales and/or US re-partnering (b) monetization of clinical assets, in particular
XP23829 or (c) the company seeks strategic alternatives.
6:30AM Xenoport and GlaxoSmithKline (GSK) receive FDA approval for Horizant for postherpetic neuralgia (XNPT) 6.07 : GlaxoSmithKline (GSK) and XenoPort (XNPT) announced that the FDA has approved Horizant (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults. The efficacy and safety of Horizant for the management of PHN was evaluated in a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints. The three clinical studies involved 574 adult patients from the US, Canada and Germany. In association with GSK's first commercial sale of the product after approval for PHN, XenoPort is entitled to a milestone payment of $10 million from GSK.
took a sniff at 5.50
short leash on this
8:31AM Xenoport Submits Investigational new drug application for XP23829 as a potential treatment of RRMS (XNPT) 5.87 : Co announced that it has submitted an Investigational New Drug application to the FDA to begin clinical studies of XP23829 as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). Following clearance of the IND by the FDA, the first Phase 1 clinical trial to be conducted in healthy subjects will commence.
Nope, already sold this one at six.
are we in 5.50 today?
maybe be you meant 5.50 =)
I can see $ 6.50 coming tomorrow...
OK, I just got out at $6, my target. Nice ride, could go even higher but I have to play by my rules.
they are out there
It is a good play for me so far. Just wondering where do I look for the next one?
More than a shorts squeeze. It might go to $6-$6.50 easily over the next few weeks (days?) on the upcoming PDUFA. For the next month or so, it is the only (good) FDA play in town.
XNPT sNDA Sat, June 9, 12am – Sun, June 10, 12am
Calendar
FDA Calendar
8:32AM Xenoport awarded U.S. patent directed to composition and formulations of XP23829, a novel fumarate analog for the potential treatment of relapsing-remitting multiple sclerosis and psoriasis (XNPT) 4.51 : Co announced today that it was awarded U.S. Patent 8,148,414 for "Prodrugs of Methyl Hydrogen Fumarate, Pharmaceutical Compositions Thereof, and Methods of Use." The term of the patent extends until 2029. The patent is directed to the XP23829 compound, analogs thereof and formulations thereof. A related U.S. patent application directed to therapeutic uses of XP23829 is now pending. XP23829 is a prodrug of methyl hydrogen fumarate, also known as monomethyl fumarate (MMF). In cell- and animal-based models, MMF has been shown to exhibit immuno-modulatory properties and inhibit damage from oxidative stress. XenoPort intends to file an Investigational New Drug Application for XP23829 for the treatment of relapsing remitting MS with the FDA in the second quarter of 2012 and expects to initiate human clinical trials later this year.
see here http://phx.corporate-ir.net/phoenix.zhtml?c=187883&p=irol-newsArticle&ID=1625218&highlight=
check the June options and you will see people are interested in it. It is at a very low price right now. read more here http://www.finviz.com/quote.ashx?t=XNPT&ty=c&ta=0&p=m&b=1
Whats the whole story here?
What are they trying to get the FDA to approve and how much is it worth? Odds of passing? Is there apanel vote first or straight to FDA decision?
I do not want to wait until a headline hits because it has light volume and moves fast. But hard to ind info on this one.
Bought into XNPT earlier today, DD below from Sheff of Sheffs board....
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=73605663
~ Wednesday! $XNPT ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $XNPT ~ Earnings expected on Wednesday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.
http://stockcharts.com/h-sc/ui?s=XNPT&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=XNPT&p=W&b=3&g=0&id=p54550695994
~ Google Finance: http://www.google.com/finance?q=XNPT
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=XNPT#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=XNPT+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=XNPT
Finviz: http://finviz.com/quote.ashx?t=XNPT
~ BusyStock: http://busystock.com/i.php?s=XNPT&v=2
<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=XNPT >>>>>>
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
UPDATE 1-XenoPort says Glaxo breached Horizant contract
Wed Jan 25, 2012 7:10am EST
* Says GSK failed to maximise horizant sales
* Says it can call off deal if GSK continues to default
Jan 25 (Reuters) - XenoPort Inc said its partner GlaxoSmithKline Plc has breached a contractual obligation to maximise the sales of their drug to treat restless legs syndrome (RLS) and achieve a sales milestone.
Last year, the U.S. Food and Drug Administration approved Horizant, which was co-developed by XenoPort and GSK, to treat RLS -- a neurological disorder characterized by an urge to move the legs, usually caused or accompanied by uncomfortable sensations in the legs.
Under the agreement, GSK has commercial rights to the drug in the United States with XenoPort getting a profit share of 20-50 percent for the first two years.
XenoPort was eligible to receive $312.5 million in milestone payments. It is yet to receive up to $290.0 million upon the achievement of specified sales levels.
On Wednesday XenoPort sent a notice alleging GSK materially breached its contractual obligation, it said in a regulatory filing.
XenoPort said it can terminate the agreement if GSK continues to default its contractual obligation for 90 days after the receipt of the written notice of the breach, which will expire on April 24.
Shares of XenoPort closed at $4.35 on Tuesday on the Nasdaq.
Xenoport announces XP21279 Phase 2 clinical trial results in patients with advanced Parkinson's Disease - improvement with 279/CD was not statistically better than the improvement seen with optimized Sinemet (XNPT) 4.83 : Co announced today preliminary top-line results of a Phase 2, randomized, crossover clinical trial that compared optimized treatment with either Sinemet or XP21279 co-formulated with carbidopa in advanced Parkinson's disease patients with motor fluctuations. 279/CD dosed three times per day reduced mean daily "off time" by 46% compared to baseline when the patients were taking their pre-trial Sinemet dosing regimen. However, in the primary analysis of the trial, the improvement with 279/CD was not statistically better than the improvement seen with optimized Sinemet dosed four or five times per day during the double-blind phase of the trial. All treatment-emergent adverse events were mild to moderate in severity. During the double-blind phase of the trial, dyskinesias were the most common adverse event. The incidence of new or worsening dyskinesias during the double-blind phase of the trial was 11% for Sinemet and 13% for 279/CD. There were no serious adverse events.
4:10PM Xenoport misses by $0.11, misses on revs (XNPT) 6.05 +0.04 : Reports Q3 (Sep) loss of $0.55 per share, $0.11 worse than the Capital IQ Consensus Estimate of ($0.44); revenues were unchanged from the year-ago period at $0.4 mln. GlaxoSmithKline (GSK), XenoPort's collaborator for Horizant(TM) (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary restless legs syndrome (RLS) in adults in the United States, started promoting Horizant in July 2011. GSK filed a supplemental new drug application (sNDA) under Section 505(b)(2) for Horizant in the management of post-herpetic neuralgia (PHN). XenoPort completed enrollment of a Phase 2b trial of XP21279 as a potential treatment of patients with Parkinson's disease and expects top-line results by the end of 2011.
Regulatory Update: GSK and XenoPort Submit Supplemental New Drug Application to FDA for Horizant™ in Postherpetic Neuralgia
Follow these stocks
Press Release Source: XenoPort, Inc. On Tuesday August 9, 2011, 4:05 pm EDT
LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(BUSINESS WIRE)-- GlaxoSmithKline (NYSE:GSK - News)(LSE:GSK.l - News) and XenoPort, Inc. (Nasdaq:XNPT - News) announced today that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults. The sNDA has been submitted to the FDA by GSK.
Notes to Editors
Horizant is not approved or licensed anywhere in the world for PHN. For information about the current licensed indication for Horizant, which is in the United States only, please visit http://www.gsk.com/products/prescription-medicines/horizant.htm for full Prescribing Information and Medication Guide.
XenoPort to Present at Upcoming Healthcare Conferences
Press Release Source: XenoPort, Inc. On Wednesday September 7, 2011, 10:00 am EDT
SANTA CLARA, Calif.--(BUSINESS WIRE)-- XenoPort, Inc. (Nasdaq:XNPT - News) announced today that it will provide access via the World Wide Web to its presentations at the Morgan Stanley Global Healthcare Conference and the UBS Global Life Sciences Conference. The live presentations will occur as follows:
Morgan Stanley Global Healthcare Conference 1:00 pm EST, September 13, 2011
UBS Global Life Sciences Conference 1:00 pm EST, September 20, 2011
To access the live presentations via the Web, please go to www.XenoPort.com. Please connect to the Web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the Webcast.
A replay of the Webcasts can be accessed for a minimum of one week and will be available approximately 24 hours after each live presentation.
http://finance.yahoo.com/news/XenoPort-to-Present-at-bw-2159588302.html?x=0&.v=1
Wonder if Xenoport has a presence
A tweet from @FierceBiotech
Some bio-bigwigs (ie Biogen CEO George Scangos) already mingling here at partnering mtg #BPA11 I'll be live tweeting here all day - RM $BIIB
8/16/11 Wedbush Conference Notes by mcbio
#msg-66250032
Xenoport: Favorable Risk/Reward Ratio
http://seekingalpha.com/article/269243-xenoport-favorable-risk-reward-ratio
Biomavin who posts here and on SI penned this nice write up on the company. Its one of the better written pieces on SA and a good read for those who own or are considering a position in XNPT.
Well Acorda just made a small deal for a Phase 1 drug so it appears they are open to compounds not yet approved. Though licensing the Xenoport compound would cost significantly more.
Acorda Therapeutics Licenses Rights to Investigational Treatment for Spinal Cord Injury and Traumatic Brain Injury
http://finance.yahoo.com/news/Acorda-Therapeutics-Licenses-bw-4144382498.html?x=0&.v=1
Cohen is thinking of other ways to boost sales short term -- specifically, with a drug acquisition. Acorda had $225 million in cash and marketable securities at the end of March. Cohen would like to use some of that cash to buy another company’s already approved drug to give his sales people another product to market to doctors.Cohen is thinking of other ways to boost sales short term -- specifically, with a drug acquisition. Acorda had $225 million in cash and marketable securities at the end of March. Cohen would like to use some of that cash to buy another company’s already approved drug to give his sales people another product to market to doctors.
Xenoport: Favorable Risk/Reward Ratio
http://seekingalpha.com/article/269243-xenoport-favorable-risk-reward-ratio
Biomavin who posts here and on SI penned this nice write up on the company. Its one of the better written pieces on SA and a good read for those who own or are considering a position in XNPT.
Team, I am selling XNPT and buying PSPW. If anyone wants to run the board, please drop me a line. XNPT was good for that FDA approval but it cannot hold its gains and the pipeline is a little dry near term. I will be back to play this again.
Cheers,
PEC!
MLKR not sure why it did not make more difference but the chart looks very nice.
6:30AM Xenoport announces FDA agreement on a special protocol assessment for a pivotal phase 3 clinical trial of arbaclofen placarbil for spasticity in MS patients (XNPT) 8.08 : Co announces that it had reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for a pivotal Phase 3 clinical trial of arbaclofen placarbil, previously known as XP19986, as a potential treatment of spasticity in multiple sclerosis patients. An SPA is a written agreement with the FDA on the design, including the scope and size of the patient population, the efficacy endpoints and safety assessments, the duration of treatment and the statistical analysis plan, of a pivotal Phase 3 trial to support an efficacy claim in a New Drug Application.
Hello everybody
I'va published a technical analysis of XenoPort on my blog
http://boursicoteur-belge.blogspot.com/
Have a good day
A Belgian investor
Great Day!
Learned new things about different fda filings with this one and reaped the rewards. Took my profits and depending on how Friday and Monday trade may get back in at anytime.
GLTA
Well done......!
sdh
XenoPort Rises After Winning Approval From U.S. FDA for Its First Medicine
By Catherine Larkin and Rob Waters - Apr 7, 2011 9:43 AM ET
XenoPort Inc. (XNPT) had its biggest gain in Nasdaq trading after U.S. regulators approved its first product following more than a year of delays.
The Santa Clara, California-based company surged 70 percent, to $10.86 at 9:31 a.m. New York time in Nasdaq Stock Market composite trading, the most intraday since the shares were listed in June 2005.
XenoPort and partner GlaxoSmithKline Plc (GSK) said late yesterday that the Food and Drug Administration cleared their Horizant medicine as a treatment for moderate-to-severe restless legs syndrome. The FDA asked in February 2010 for more information about tumors in rats that were seen in early drug studies. The delay led XenoPort to fire half its employees.
“We think it’s a great example of a company able to work with the FDA to clear up misconceptions, suggesting the agency indeed can still work rationally with biotech companies,” said Michael Yee, an analyst with RBC Capital Markets in San Francisco, in an e-mail.
Horizant may bring in at least $100 million a year in U.S. sales, Yee said. The drug was developed by XenoPort and licensed to London-based Glaxo. It will compete with Glaxo’s Requip and closely held Boehringer Ingelheim GmbH’s Mirapex.
Millions of Patients
People with restless legs syndrome have uncontrollable urges to move their legs to relieve uncomfortable sensations, according to the National Institute of Neurological Disorders and Stroke. The condition affects 2 percent to 3 percent of the U.S. population, according to XenoPort.
In two studies of more than 400 patients, about 75 percent of those taking Horizant for 12 weeks said their symptoms were much or very much improved, compared with about 45 percent of those taking placebos.
“This significant milestone represents the culmination of XenoPort’s efforts,” said Ronald W. Barrett, XenoPort’s chief executive officer. “XenoPort is honored to have contributed to the efforts to find new treatments for restless legs syndrome.”
Horizant is a modified-release form of Neurontin, a Pfizer Inc. (PFE) drug for epilepsy that is now sold as a generic. Astellas Pharma Inc. (4503), of Tokyo, has licensed rights to the product in Japan.
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
FDA Approves XenoPort, Glaxo Drug For Restless Leg Syndrome
Date : 04/06/2011 @ 8:55PM
Source : Dow Jones News
Stock : XenoPort Inc. (XNPT)
Quote : 6.38 0.0 (0.00%) @ 7:22AM
FDA Approves XenoPort, Glaxo Drug For Restless Leg Syndrome
Xenoport, Inc. (MM) (NASDAQ:XNPT)
Intraday Stock Chart
Today : Thursday 7 April 2011
Click Here for more Xenoport, Inc. (MM) Charts.
The Food and Drug Administration has approved Horizant, a drug for restless legs syndrome that XenoPort Inc. (XNPT) and GlaxoSmithKline PLC (GSK, GSK.LN) developed together, the companies said in a release.
XenoPort shares surged 57%, to $10 in after-hours trading, on the news of its first U.S. drug approval.
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8/16/11 Wedbush Conference Notes by mcbio
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