Xenoport (f/k/a XNPT)

[invest2win]

I just sold 50% of my position. I'm riding free shares now!

I'll probably buy more after the dust settles.

[invest2win]

I just bought this yesterday. Talk about good timing. Wee.... indeed. Wee......................

[DADDY FAT SAXX]

Looks like we could open around $11 or higher depending on the morning push. profits will be taken!! Could see a nice mid morning bounce after the profits are taken or it could just run up quick. This was trading at $50ish about a year ago.

[DADDY FAT SAXX]

WEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE

I HAVE ONLY BEEN HERE SINCE LAST WEEK BUT BOUGHT MOST OF MY SHARES BELOW $6. INSTANT PROFITS ARE COMING TOMORROW.

FDA PLAYS POSTED THIS ONE ON THEIR APRIL STOCK LIST.

KABOOOOOOOMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

[Superfly15]

WEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE

[equity2all]

congrats to all longs !!! eom

[moneyonmymind]

APPROVED CONGRADS

[duke1dog]

WEEEEEEEEEEEEE!!!!!!!!!!!

http://finance.yahoo.com/news/GlaxoSmithKline-and-XenoPort-bw-3611956887.html?x=0&.v=1

[duke1dog]

Bears are raiding

[DADDY FAT SAXX]

Me too. I just bought in below $6 but the immediate pps increase has me excited for what is to come.

[buffalo fan]

It would be nice to see approval. I am hoping right along with you.

[duke1dog]

So quite here for having PDUFA date tomorrow.

Heres again hoping for an approval!

[DADDY FAT SAXX]

I am sucking up some shares below $6. New to this stock.

[duke1dog]

It seems 50/50. I went ahead and posted links to the 2 most recent articles I felt were good to read. I have a small position and have learned all about 505(b)(2) applications with the fda in my dd so its more 60/40 imo.

http://www.gekkowire.com/?p=7452

http://seekingalpha.com/article/260919-strategies-and-outlook-for-xenoport-s-upcoming-fda-pdufa-date?source=yahoo

and heres link to read about 505(b)(2) applications with the fda
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079345.pdf

Heres Hoping for an approval!

[rickochey]

whats the overall feeling/belief of the PDUFA approval? And good what price range?

[mlkrborn]

XNPT stopped heart burn drug trial:PPS is $5.92 now!
XenoPort to stop development of heartburn drug


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XenoPort Inc
XNPT.O
$5.89
-0.78-11.69%
12:28pm EST

AstraZeneca PLC
AZN.L
2,853.00p
+25.00+0.88%
12:29pm EST

Glaxosmithkline Plc
GSK.L
1,153.50p
+11.50+1.01%
12:29pm EST

Mon Mar 21, 2011 9:21am EDT

(Reuters) - XenoPort Inc (XNPT.O) will stop development of its experimental drug to treat heartburn after it failed to meet the main goal of a mid-stage trial, sending its shares down 12 percent in pre-market trading.

The company was developing the drug, arbaclofen placarbil, as a combination therapy for people who suffer from gastroesophageal reflux disease (GERD), but do not get complete relief from the medicines that doctors currently prescribe to treat it.

A class of drugs called proton pump inhibitors, or PPIs, such as AstraZeneca's (AZN.L) Nexium and Prilosec are the current standard of care for patients with GERD.

[surf1944]

6:32AM Xenoport reports negative results from a Phase 2b Clinical Trial of arbaclofen placarbil in GERD; none of the AP doses showed statistically significant improvements over placebo in the analysis of the primary endpoint (XNPT) 6.67 : Co announces preliminary top-line results from a Phase 2b clinical trial of arbaclofen placarbil as adjunctive therapy in patients with gastroesophageal reflux disease who do not experience complete relief of GERD symptoms while being treated with proton pump inhibitors. None of the AP doses showed statistically significant improvements over placebo in the analysis of the primary endpoint. Analyses of key secondary endpoints did not yield consistent results when AP doses were compared to placebo. Percent change in weekly heartburn events was analyzed using a repeated measures ANCOVA model. At week six, subjects in the placebo group showed a mean percent reduction in heartburn events of 68%. Although there were trends for improvement over placebo in the AP dose groups, none of the comparisons to placebo reached statistical significance. AP was safe and generally well tolerated at all dose levels. Most reported adverse events were mild or moderate in severity. Co states "We are disappointed that AP failed to demonstrate clear efficacy over placebo in this trial. While we will continue to analyze the data, at this time, we do not believe the efficacy results of this study warrant our investment in further development for AP in GERD. We believe the AP safety profile observed in this study continues to support our planned Phase 3 development program for AP in patients with spasticity."

[Cryptics]

I don't follow how XNPT has anything to do with this. You really think MM's are naked shorting XNPT?

[Pecuniam]

THIS IS THE KICKER ABOUT XNPT AND FINRA TOMORROW!

New FINRA Regulations: should help shorted PINKS and other OTCBB issues starting tomorrow.

Read the following:


There’s 3 new laws gaining attention in the NSS market reform arena: FINRA 4320 goes into effect on 2/28/11. It mandates 13 day buy-ins for open delivery failures FINALLY applying to shares of non-reporting corporations. FINRA 2010-043, also starting on 2/28/11 reinstates the “short sale exempt” (SSE) marking requirements for trade reporting and the OATS system. Those MMs accessing the bona fide MM exemption from executing pre-borrows or “locates” before admittedly naked short sales must now FORMALLY acknowledge the accessing of that universally-abused exemption. Being that these trades are theoretically being made to “inject liquidity” then the excuse to hide the related trade data from the public’s eyes goes out the window. You can’t have it both ways and claim the bona fide MM exemption and later claim that the related trade data needs to be kept secret because it might reveal a “proprietary trading strategy”.

Truly bona fide MMs that are able to legally access that universally-abused exemption cover their naked short position on the next downtick after their short sale when buy side liquidity is in need of being ejected as share prices fall. The 3rd new rule which is in effect now states that the offers and bids that MMs post must be of approximately the same size. No longer can the offers be of 1 million shares and the offsetting bid good for the minimum 5,000 shares.

The verbiage in 4320 is especially well done as it FINALLY puts the clearing firms that aid and abet this crime wave on the spot. With the FFETF, which is made up of 25 different agencies, now on the scene the transparency has increased markedly. You can imagine how critical the lack of transparency is to a crime involving selling nonexistent securities and then refusing to ever deliver that which you sold AFTER being allowed access to the funds of the investor being defrauded.


Here are the links to the rules SR-FINRA-2010-028 and SR-FINRA-2010-043:
Notice the part I marked in bold in the quote above:
"FINRA 4320 goes into effect on 2/28/11. It mandates 13 day buy-ins for open delivery failures FINALLY applying to shares of non-reporting corporations."
--------------------------------------------------------------------------------

GLTA,

PEC!

[Pecuniam]

Buffalo fan it all depends on their share of royalties and percentage. But if I were to make a SWAG (Sophisticated Wild Ass Guess) it would be no less than 25 Million US and additional revenues of 15 Million abroad.

[Pecuniam]

Buffalo fan it all depends on their share of royalties and percentage. But if I were to make a SWAG (Sophisticated Wild Ass Guess) it would be no less than 25 Million US and additional revenues of 15 Million abroad.

[buffalo fan]

If Horizant does get passed by FDA, what is estimated share price potential?

[Pecuniam]

$$$$$XenoPort Reports Q4 EPS of $(0.47) vs. $(0.62)$$$$$$$$$$

XenoPort, Inc. (XNPT) (Nasdaq: XNPT) announced today its financial results for the fourth quarter and year ended December 31, 2010.

Revenues for the quarter were $1.9 million, compared to $5.8 million for the same period in 2009. Net loss for the fourth quarter was $14.8 million, compared to a net loss of $18.3 million for the same period in 2009. At December 31, 2010, XenoPort had cash and cash equivalents and short-term investments of $108.6 million.

[Pecuniam]

Agreed, going to straddle it both ways and see which way it blows. LOL. I am thinking -.55 but if they have updates on IIB trials it should move which is a long shot.

[shankapotamus]

I doubt that's going to be good news.

[Pecuniam]

Back up we go. Parabolic has switched over again.

[Pecuniam]

Adding more at 7.47.

[buffalo fan]

I am still in XNPT. Got in a week ago at $7.68 based on the BioShockers recommendation and looking at the potential. Only have 200shs but would be nice to see this go up with the potentail expected run up to at leat $10.00

Good luck

[Pecuniam]

RU still in this play?

[Pecuniam]

XenoPort to Release Fourth Quarter and Year-End Financial Results on February 16, 2011

[Pecuniam]

Who else is here playing this stock and why? Let me know and let's get this thing ROLLING!

Cheers,

PEC!

[Pecuniam]

In at 7.4361. On technicals and a little itch that I feel is going to move this up nicely short term.

[lui_gi]

XenoPort: Excellent Run-Up Candidate
Feb 2nd
Posted by BioShockers in Uncategorized
No comments
.XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort is developing its lead product candidate in partnership with Astellas Pharma Inc. and GlaxoSmithKline.

XenoPort’s lead product candidate is Horizant, which is indicated for the treatment of restless legs syndrome (~$800M Market). In Feb. 2010, XenoPort and GSK received a complete response letter (CRL) from FDA for their Horizant 505(b)1 NDA submission. FDA indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at the time.

Fast forward nine months – in Nov. 2010, XenoPort and GSK resubmitted the Horizant NDA, amending it from a 505(b)1 to a 505(b)2 submission. A 505(b)2 NDA submission allows FDA to consider published gabapentin nonclinical data in their assessment of Horizant – which the companies believe will alleviate the FDA concerns raised in the previous CRL.

FDA set a PDUFA date of April 6, 2011 for the Horizant resubmission.

The Horizant PDUFA date is not the only upcoming catalyst for XenoPort. Sometime this quarter, they will be reporting top-line Arbaclofen placarbil (AP) phase 2b GERD trial results.

In our opinion, the upcoming catalysts, along with a solid share structure (~30.58M o/s), and a significant cash position (~$91M – they held a stock offering in Dec. 2010, this cash estimate does not take into account the offering proceeds) make XenoPort an excellent run-up candidate.

[ScovilleUnits]

XenoPort Announces Pricing of Public Offering of Common Stock

Thursday , December 09, 2010 00:37ET

SANTA CLARA, Calif.--(BUSINESS WIRE)-- XenoPort, Inc. (Nasdaq: XNPT) announced today the pricing of an underwritten offering of 4,000,000 shares of its common stock at a price to the public of $7.15 per share. XenoPort has granted to the underwriters a 30-day option to purchase up to an aggregate of 600,000 additional shares of common stock to cover over-allotments, if any. All of the shares in the offering are being offered by XenoPort. Morgan Stanley & Co. Incorporated is acting as bookrunner for the offering. RBC Capital Markets, LLC and Wedbush PacGrow Life Sciences are acting as co-managers.

http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=7284117

[mlkrborn]

SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. (Nasdaq:XNPT - News) announced today that it plans to move arbaclofen placarbil (AP), also known as XP19986, into Phase 3 development as a potential treatment of spasticity in multiple sclerosis (MS) patients. Following discussions with the U.S. Food and Drug Administration (FDA), XenoPort intends to conduct a single placebo-controlled Phase 3 efficacy clinical trial and an open-label, long-term, safety study of AP in patients with MS. Favorable results from these studies could lead to the filing of a new drug application (NDA) with the FDA under Section 505(b)(2) seeking approval of AP for the treatment of spasticity.

Ronald W. Barrett, chief executive officer of XenoPort, stated, “In our previous Phase 2 clinical trial in spinal cord injury patients with spasticity, AP was well tolerated and demonstrated dose-dependent improvement in muscle tone that was maintained throughout the twelve-hour dosing interval. We hope to demonstrate similar results in our Phase 3 trial of AP in MS patients with spasticity.”

Randall Schapiro, M.D., Clinical Professor of Neurology at the University of Minnesota and President of the Schapiro Multiple Sclerosis Advisory Group, stated, “Available treatments do not fully address the needs of MS patients with spasticity. Baclofen is often used in these patients, but its short duration of action and central nervous system side effects can result in sub-optimal therapy. A new oral medicine that could maintain efficacy with limited adverse events would be a welcome addition to the spasticity treatment armamentarium.”

XenoPort intends to initiate this Phase 3 clinical program in the first half of 2011. The pivotal trial would be a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as a treatment for spasticity in MS patients. Patients who complete this study would have the option to enter a long-term study to evaluate the safety of AP in MS patients. Following successful outcomes from these studies, XenoPort would file an NDA with the FDA using the 505(b)(2) application process. The 505(b)(2) application would enable XenoPort to reference published literature and the FDA’s previous finding of safety and effectiveness for baclofen, a drug that has been approved by the FDA for the alleviation of signs and symptoms of spasticity resulting from MS.

[ScovilleUnits]

!!!!.... WOW.....!!!!

[surf1944]

XenoPort Announces Plans for Phase 3 Development of Arbaclofen Placarbil for Spasticity

http://finance.yahoo.com/news/XenoPort-Announces-Plans-for-bw-3875810129.html?x=0&.v=1

[surf1944]

XenoPort president to take CEO role at different company

Read more: XenoPort president to take CEO role at different company - Silicon Valley / San Jose Business Journal


Biopharm XenoPort Inc. said Thursday that William J. Rieflin has resigned as president to take a position as CEO of a private biotech company.

Santa Clara-based XenoPort (NASDAQ:XNPT) said Rieflin will serve on the company's board and also be a consultant during a transition period.

XenoPort also announced that Gianna M. Bosko has been promoted to senior vice president, chief administrative officer, general counsel and secretary.

Bosko joined XenoPort in 2005 and was previously vice president, general counsel and secretary. Prior to that, she was senior corporate counsel from 2005 to 2007.

[mlkrborn]

"A big opportunity?" Source: Motley Fool
"Remember those old Batman TV shows when the Caped Crusader punched out a villain? Pow! Well, that's how XenoPort is undoubtedly feeling after the migraine headache therapy it's developing with GlaxoSmithKline failed to meet study goals last month. Bop! That came after the FDA shot down its restless leg syndrome treatment Horizant earlier this year. Bam!

Still, top-rated CAPS All-Star and biotech guru zzlangerhans said after the Horizant decision that there was still a good chance for a comeback.

The upshot of all this is that Xenoport has a strong chance for a comeback against this FDA concern, and will receive quite a lot of support here. Whether or not they are eventually successful, the magnitude of the destruction indicates a strong likelihood of rebound to at least the 12 level within the next few months. As a back-up plan, the company has several other prodrugs in early development and sufficient funds to progress them into late stage trials, although there is nothing tremendously exciting at this point. "

[mlkrborn]

XenoPort Reports Second Quarter Financial Results
Xenoport (MM) (NASDAQ:XNPT)

Surf ; additional info that came with it quarterly report, which i found significant and makes it a viable reentry candidate with to 105 m cash availability;
Still above $5.00s 52 weeks low price level tho.
from the quarterly report:
"XenoPort also reported today that it has initiated a Phase 2 clinical trial of XP21279 in Parkinson’s disease patients with motor fluctuations. The randomized cross-over trial is designed to compare the efficacy, safety and pharmacokinetics of individual patient-optimized doses of a new bi-layer tablet of XP21279/carbidopa to Sinemet (L-dopa/carbidopa). Earlier this year, XenoPort announced positive results from an open-label Phase 1 trial that compared XP21279/carbidopa to Sinemet in Parkinson’s disease patients. Results from this trial will be presented at the World Parkinson Congress in Glasgow, Scotland, in September.

XenoPort Business Updates

Since the start of the second quarter, XenoPort has:

With its partner, GlaxoSmithKline (GSK), met with the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) for Horizant™ (also known as XP13512) as a treatment for moderate-to-severe primary restless legs syndrome (RLS). GSK plans to file a CRL resubmission later this year.
Announced top-line results from a GSK-conducted Phase 2 clinical trial of Horizant as a prophylactic treatment for migraine headaches that failed to demonstrate a statistically significant improvement over placebo. The failure of the trial may have been a consequence of a high placebo response.
Presented new data from clinical trials of its arbaclofen placarbil (AP) and XP13512 (gabapentin enacarbil) product candidates at the 62nd Annual American Academy of Neurology meeting in Toronto, Ontario and the Associated Professional Sleep Society meeting in San Antonio, TX.
Presented new data from clinical trials of AP at the Digestive Disease Week 2010 annual meeting in New Orleans, LA.
Disclosed the discovery of a prodrug of acamprosate that has the potential to decrease gastrointestinal disturbance, reduce dosing frequency and provide more consistent (and potentially higher) blood levels of acamprosate compared with the currently approved formulation of acamprosate calcium. Published data indicate that acamprosate may be an effective treatment for Fragile X syndrome. Preclinical data on XenoPort’s acamprosate prodrug were presented at the 12th International Fragile X Conference in Detroit, Michigan.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “We are focused on working with GSK to complete its CRL resubmission, which is still planned for later this year. We are also pleased to report that we have initiated our second clinical trial of XP21279 in patients with Parkinson’s disease. We were encouraged by the pharmacokinetic results of our open-label study and the observed reduction in Parkinson’s symptoms when patients were taking XP21279 compared to when they were taking Sinemet. We hope to replicate....."

[surf1944]

4:14PM Xenoport misses by $0.03, misses on revs (XNPT) 6.25 -0.04 : Reports Q2 (Jun) loss of $0.64 per share, $0.03 worse than the Thomson Reuters consensus of ($0.61); revenues fell 72.2% year/year to $0.5 mln vs the $2.8 mln consensus. At June 30, 2010, XenoPort had cash, cash equivalents and short-term investments of $105.0 million.

[surf1944]

Hedge Fund Bridger Management Ups XenoPort Stake

http://seekingalpha.com/article/215291-hedge-fund-bridger-management-ups-xenoport-stake?source=yahoo

[mlkrborn]

XNPT: $6.20

[surf1944]

7-Jul-10 Ladenburg Thalmann DowngraddD from Buy to Neutral

[mlkrborn]

Surf; This was their focus programs after restructuring with the failure of Horizant.. "focusing on helping our partners gain approval of Horizant in the U.S. and XP13512 in Japan, completing our ongoing Phase 2b trial of arbaclofen placarbil in gastroesophageal reflux disease patients and initiating a Phase 2 clinical trial of XP21279 in patients with Parkinson's disease."
(gabapentin enacarbil) in setback now wasnt mentioned in their focus programs after recent restructuring?
tia

[Renee]

Insiders had to have known about the poor results yesterday because the selling from $9.50 all the way down to $8.87 was on a 45 degree downward angle all day .

Now the stock is at $6.00-ish on the very poor FDA results .

Someone should be contacting the SEC about the very suspicious selling yesterday . NO co-incidence , IMO .

Renee ( never an XNPT shareholder , FWIW )

[mlkrborn]

XNPT: Dropped to $6.00s now!
GlaxoSmithKline: No Improvement For GSK1838262/XP13512 Vs Placebo
Xenoport (MM) (NASDAQ:XNPT)
Intraday Stock Chart

Today : Wednesday 7 July 2010
Click Here for more Xenoport (MM) Charts.

Pharmaceutical firms GlaxoSmithKline PLC (GSK) and XenoPort, Inc. (XNPT) said Wednesday GSK1838262/XP13512 (gabapentin enacarbil) didn't demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches.

MAIN FACTS:

-This phase 2 billion dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

-The 30-week, double-blind, placebo-controlled study randomized 526 patients to receive 1200, 1800, 2400 or 3000 mg/day of GSK1838262 or placebo, administered twice daily.

-Primary efficacy endpoint was the change from baseline in the number of migraine headache days during the last four weeks of treatment prior to taper.

-Failure of the study may be a consequence of the unexpectedly high placebo response rate observed.

-GlaxoSmithKline shares at 1240 GMT down slightly at 1122.87 pence valuing the company at GBP57.87 billion.

-By Ian Walker, Dow Jones Newswires; 44-20-7842-9296; [e-mail]

[surf1944]

8:33AM Xenoport & GlaxoSmithKline (GSK) report top-line Phase 2b results for GSK1838262/XP13512 as a prophylactic treatment for migraine hyeadache (XNPT) 8.87 : Co's announced that GSK1838262/XP13512 did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache according to the International Headache Society criteria. The most common adverse event was dizziness, which was generally mild or moderate and did not lead to discontinuation in the majority of patients. Eight patients who received GSK1838262 and two who received placebo experienced serious adverse events during the trial. Of these events, two were deaths in patients receiving GSK1838262. One was due to bronchopneumonia and was assessed by the investigator as not related to the study drug. The second death resulted from an accidental overdose involving medications other than GSK1838262, but the relationship of this event to the study drug could not be established.

[surf1944]

GlaxoSmithKline and XenoPort Report Top-Line Phase 2b Results for GSK1838262/XP13512 as a Prophylactic Treatment for Migraine Headache

http://finance.yahoo.com/news/GlaxoSmithKline-and-XenoPort-bw-325303233.html?x=0&.v=1

[mlkrborn]

XNPT; 9.92