Alcobra Ltd. (ADHD) - NASDAQ
  • Nov. 13, 2015, 5:44 PM
    • Top gainers, as of 5.25 p.m.: SIGM +9.8%. TVIX +2.1%. ITUB +2.0%. AVL +1.9%.
    • Top losers, as of 5.25p.m.: ECA -6.7%. FCAU -5.0%. ADHD -3.2%. OCAT -1.9%.
    | Nov. 13, 2015, 5:44 PM | 10 Comments
  • Sep. 21, 2015, 9:19 AM
    | Sep. 21, 2015, 9:19 AM | 9 Comments
  • Sep. 21, 2015, 9:03 AM
    • The FDA designates Alcobra's (NASDAQ:ADHD) MDX for Fast Track review for the treatment of Fragile X syndrome, an inherited caused by mutations in the FMR1 gene that results in a range of developmental problems such as learning disabilities and cognitive impairment. It affects one in 4,000 males and one in 6,000 females.
    • Orphan Drug-tagged Metadoxine Extended Release (MDX) is a modulator of GABA (gamma-aminobutyric acid), an abundant neurotransmitter in the central nervous system, especially in the cerebral cortex where thinking occurs and sensations are interpreted. It is in Phase 2 development for Fragile X and Phase 3 development for the treatment of adults with attention deficit hyperactivity disorder (ADHD).
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    • Shares are up 14% premarket on increased volume.
    | Sep. 21, 2015, 9:03 AM | 2 Comments
  • Jun. 24, 2015, 9:13 AM
    | Jun. 24, 2015, 9:13 AM
  • Jun. 24, 2015, 7:46 AM
    • Alcobra (NASDAQ:ADHD) slumps 26% in premarket trading on average volume in response to its announcement that a 62-subject Phase 2 clinical trial evaluating its lead product candidate, Orphan Drug-designated MDX (metadoxine extended release), for the treatment of Fragile X syndrome (FXS) failed to achieve its primary endpoint of a statistically significant change from baseline to week 6 of the inattentive subscale of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) compared to placebo (p=0.21). Secondary endpoints such as the total ADHD RS score and Clinical Global Impression (CGI) also failed to reach statistical significance.
    • In the intent-to-treat population, two secondary endpoints did achieve statistical significance: the Vineland Adaptive Behavior Scale (VABS) Daily Living Skills Domain (p=0.017) and the computerized cognitive Test of Attentional Performance for Children (KiTAP) Distractability subscale (p=0.017).
    • Fragile X syndrome, caused by mutations in the FMR1 gene, is characterized by learning disabilities, cognitive impairment (including ADHD) and certain physical characteristics. There are no approved drugs to treat the condition.
    • The company remains undeterred. It plans to discuss the results with the FDA before finalizing the design of the next study of MDX in FXS. A Phase 2 trial of MDX in adolescents with ADHD failed in March as did a Phase 3 in adults with ADHD in October 2014.
    • Previously: Alcobra off on failed Phase 2 MDX trial (March 10)
    | Jun. 24, 2015, 7:46 AM
  • Jun. 23, 2015, 5:34 PM
    | Jun. 23, 2015, 5:34 PM | 1 Comment
  • Mar. 10, 2015, 9:46 AM
    • Thinly-traded micro cap Alcobra (ADHD -13.4%) drops in early trading in response to its announcement of results from a Phase 2 trial assessing MDX (metadoxine extended release) in adolescent patients with attention deficit hyperactivity disorder ((NASDAQ:ADHD)). Although superbly written to give the reader the impression of success, the trial failed to show an efficacy benefit compared to placebo.
    • A total of 83 patients, aged 13 - 17, were enrolled in the multi-center, randomized, double-blind, placebo-controlled, fixed dose study. Subjects received one of three MDX dose options or placebo.
    • Safety and tolerability were fine, but MDX failed to demonstrate statistically significant differences in secondary cognitive measures compared to placebo, although there was an "efficacy signal" on the Test of Variables of Attention (TOVA) assessments Response Time and Errors of Omission.
    • In October, the company reported Phase 3 results for MDX in adults with ADHD that also failed to show statistically significant efficacy versus placebo.
    • Previously: Alcobra's Metadoxine trial fails to show efficacy vs. placebo, share down AH (Oct. 22, 2014)
    | Mar. 10, 2015, 9:46 AM | 1 Comment
  • Mar. 10, 2015, 9:19 AM
    | Mar. 10, 2015, 9:19 AM | 4 Comments
  • Jan. 20, 2015, 1:50 PM
    • Thinly-traded nano cap Alcobra (ADHD +6.2%) continues its clawback from its late September-early October plunge. Shares plummeted 86% from the September intermediate high of $21.53 to the November 18 low of $3.12 but have more than doubled since then on increased volume.
    • Investors stampeded for the exits after the company reported Phase 3 data for Metadoxine Extended Release (MDX) in adults with attention deficit hyperactivity disorder ((NASDAQ:ADHD)) that showed MDX failed to deliver a statistically significant improvement in efficacy versus placebo.
    • Alcobra was not be deterred, however. In a post-hoc analysis, eight patients (five from placebo, three MDX group) who violated entry criteria, based on ICH E9 guidelines, were excluded. This improved the results but still failed to achieve statistical significance.
    • Messaging the data still further, another post-hoc analysis excluded another two patients whose responses were more than three standard deviations away from the average response in the treatment group. The exclusion of the ten "outliers" enabled MDX to demonstrate a statistically significant improvement in efficacy compared to placebo.
    • Investors apparently are warming to the company's approach to data analysis and perceive improved prospects for MDX, buoyed by the recent capital raise.
    • Previously: Alcobra's Metadoxine trial fails to show efficacy vs. placebo, share down AH (Oct. 22, 2014)
    | Jan. 20, 2015, 1:50 PM
  • Jan. 9, 2015, 12:47 PM
    | Jan. 9, 2015, 12:47 PM | 2 Comments
  • Oct. 24, 2014, 12:48 PM
    | Oct. 24, 2014, 12:48 PM
  • Oct. 23, 2014, 12:45 PM
    | Oct. 23, 2014, 12:45 PM | 3 Comments
  • Oct. 23, 2014, 11:22 AM
    • Nano cap Alcobra (ADHD -24.3%) drops on a 3x surge in volume in response to the presentation of Phase 3 trial results for Metadoxine (vitamin B6 + L-PGA) for the treatment of attention deficit/hyperactivity disorder.
    • Based on the market's reaction, investors were expecting more robust results.
    | Oct. 23, 2014, 11:22 AM
  • Oct. 23, 2014, 9:10 AM
    | Oct. 23, 2014, 9:10 AM
  • Oct. 22, 2014, 5:39 PM
    | Oct. 22, 2014, 5:39 PM
  • Oct. 22, 2014, 5:30 PM
    • Lightly-traded nano cap Alcobra (NASDAQ:ADHD) slumps 13% AH on higher-than-average volume in response to a presentation of results from a Phase 2b clinical trial evaluating Metadoxine (vitamin B6 and L-PGA) for the treatment of attention deficit/hyperactivity disorder given by Dr. Lenard Adler at the American Academy of Child & Adolescent Psychiatry Meeting in San Diego.
    • On Slide 26, the graph shows that Metadoxine failed to demonstrate statistically significant efficacy compared to placebo at week six (p=0.136). This was the study's primary endpoint.
    | Oct. 22, 2014, 5:30 PM | 14 Comments
Company Description
Alcobra Ltd. engages in the research, development, and market of pharmaceutical productsfor the treatment of central nervous system disorders and cognitive dysfunctions. Its portfolio includes Metadoxine Extended Release to treat Attention Deficit Hyperactivity Disorder and Fragile X Syndrome.... More
Sector: Healthcare
Industry: Drug Related Products
Country: Israel