Key Developments: Xenoport Inc (XNPT.OQ)
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Latest Key Developments (Source: Significant Developments)
XenoPort Inc Announces Top-Line Results of Phase 3 Trial of Arbaclofen Placarbil for Spasticity in Multiple Sclerosis Patients
XenoPort Inc announced top-line results from its pivotal Phase 3 clinical trial of arbaclofen placarbil (AP) for the treatment of patients with spasticity due to multiple sclerosis (MS). The trial was unsuccessful in demonstrating that AP provided statistically significant improvement relative to placebo in the co-primary endpoints of the study. The trial was a 13-week, multicenter, randomized, double-blind, placebo-controlled study that enrolled 228 subjects in 30 sites in the United States. There was a one-week placebo run-in period, two weeks of up-titration, eight weeks at the maintenance dose and two weeks of down-titration. Eligible subjects were randomized to one of four arms: 15 mg, 30 mg or 45 mg of AP or placebo dosed twice a day (BID) with food. The first of the co-primary endpoints for the study was the time-matched change from baseline in Maximum Ashworth score (six hours post-dose time point) at the end of the maintenance dose period. The muscle group in the lower limbs with the highest Ashworth score at baseline was followed throughout the trial. Subjects entering the trial were required to have a Maximum Ashworth score of two or greater prior to entering the study and at the end of the placebo run-in period, which served as baseline. The second co-primary endpoint was the score on the 7-point Patient Global Impression of Change scale at the end of the maintenance period. Full Article
XenoPort, Inc. Announces Pricing of Public Offering of Common Stock
XenoPort, Inc. announced the pricing of an underwritten offering of 6,153,846 shares of its common stock at a price to the public of $6.50 per share. XenoPort has granted to the underwriters a 30-day option to purchase up to an additional 923,076 shares of its common stock. All of the shares in the offering are being offered by XenoPort. The offering is expected to close on or about July 30, 2012. Credit Suisse Securities (USA) LLC is acting as sole book-running manager for the offering. RBC Capital Markets, LLC is acting as co-manager for the offering. A registration statement relating to the shares described above was previously filed with, and has been declared effective by, the Securities and Exchange Commission (SEC). Full Article
XenoPort, Inc. Announces Proposed Public Offering of Common Stock
XenoPort, Inc. announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. All of the shares in the proposed public offering are to be sold by XenoPort. Credit Suisse Securities (USA) LLC is acting as sole book-running manager for the offering. RBC Capital Markets, LLC is acting as co-manager for the offering. Full Article
XenoPort, Inc. Announces Initiation of Phase 1 Clinical Trial of XP23829
XenoPort, Inc. announced that the first subjects have been dosed in a Phase 1, randomized, double-blind, two-period crossover, food effect comparison study of XP23829 in healthy adults. The trial is designed to assess the pharmacokinetics, safety and tolerability of a single dose of XP23829 administered in both fasted and fed conditions. Approximately 60 subjects will be assigned to one of five cohorts with each cohort receiving one of four different formulations of XP23829 or placebo. Subjects will receive a single dose of XP23829 or placebo in both a fasted and fed state in randomized order. The trial will assess the blood levels of XP23829, its active metabolite, monomethyl fumarate (MMF), and other potential metabolites. The four XP23829 formulations will include one immediate-release formulation and three extended-release formulations that are designed for possible once-a-day dosing of XP23829. Full Article
Glaxosmithkline Plc And XenoPort, Inc. Receive FDA Approval For Horizant For Postherpetic Neuralgia
Glaxosmithkline Plc (GSK) and XenoPort, Inc. announced that the United States (US) Food and Drug Administration (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. The recommended dosage for the management of PHN in adults is 600 mg twice daily. Treatment should be initiated at a dose of 600 mg in the morning for three days followed by 600 mg twice daily (1,200 mg/day) beginning on day four. Doses must be adjusted in patients with impaired renal function. In the 12-week, controlled study in patients with PHN, somnolence and dizziness were the most frequently reported side effects. Somnolence was reported in 10% of patients treated with 1,200 mg of Horizant per day compared with 8% of patients receiving placebo. Dizziness was reported in 17% of patients receiving 1,200 mg of Horizant per day compared with 15% of patients receiving placebo. In association with GSK’s first commercial sale of the product after approval for PHN, XenoPort is entitled to a payment of $10 million from GSK. Full Article
XenoPort, Inc. Announces XP21279 Phase 2 Clinical Trial Results in Patients With Advanced Parkinson`s Disease
XenoPort, Inc. announced preliminary top-line results of a Phase 2, randomized, crossover clinical trial that compared optimized treatment with either Sinemet (immediate-release levodopa/carbidopa) or XP21279 co-formulated with carbidopa (279/CD) 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. Full Article
XenoPort to drop multiple sclerosis drug, shares fall
- XenoPort Inc said it would stop development of an experimental multiple sclerosis treatment it planned to launch in 2015 after a late-stage trial failed to show significant improvement over a placebo.

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