ADHD
Alcobra Ltd.NASDAQ
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  • Tue, Nov. 15, 7:35 AM
    | Tue, Nov. 15, 7:35 AM
  • Fri, Oct. 7, 9:52 AM
    • Alcobra (ADHD) reports that it has received the written full clinical hold notice from the FDA regarding Metadoxine Extended Release (MDX) in adult patients with attention-deficit/hyperactivity disorder [ADHD]. Shares plummeted almost 60% on September 29 when the company first announced the FDA's action, conveyed verbally.
    • In the letter, the agency stated that it instituted the clinical hold on the basis of electrophysiological neurologic findings in previously submitted long-term animal studies with Metadoxine. The next step will be a meeting to discuss a plan to collect additional human safety data in its development program, which the company says will be a top priority. The letter did not mention any clinical safety issues related to the Phase 3 MEASURE trial or previous human studies with MDX.
    • 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 also being developed for Fragile X syndrome.
    • Shares are unchanged in early trading.
    • Previously: FDA places Alcobra's MDX program on clinical hold due to adverse effects; shares down 57% (Sept. 29)
    | Fri, Oct. 7, 9:52 AM | 7 Comments
  • Fri, Sep. 30, 9:15 AM
    | Fri, Sep. 30, 9:15 AM
  • Thu, Sep. 29, 12:46 PM
    | Thu, Sep. 29, 12:46 PM
  • Thu, Sep. 29, 11:00 AM
    | Thu, Sep. 29, 11:00 AM | 2 Comments
  • Thu, Sep. 29, 10:16 AM
    • Thinly traded nano cap Alcobra (ADHD -56.8%) plummets on a 23x surge in volume in response to its announcement that it has received verbal notice from the FDA that its Metadoxine Extended Release (MDX) program has been placed on full clinical hold due to adverse neurological findings in a preclinical study. The action suspends recruitment and dosing in its Phase 3 MEASURE study in adults with attention deficit hyperactivity disorder despite the absence of questionable safety data. There have also been no safety issues in previous MDX clinical trials.
    • The company intends to work closely with the agency to remove the clinical hold.
    • 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 also being developed for Fragile X syndrome.
    | Thu, Sep. 29, 10:16 AM
  • Thu, Sep. 29, 9:15 AM
    | Thu, Sep. 29, 9:15 AM
  • Mon, Sep. 12, 11:00 AM
    | Mon, Sep. 12, 11:00 AM
  • Tue, Aug. 30, 12:47 PM
    | Tue, Aug. 30, 12:47 PM
  • Tue, Aug. 30, 11:01 AM
    | Tue, Aug. 30, 11:01 AM | 1 Comment
  • Tue, Aug. 30, 7:53 AM
    • Alcobra (ADHD) Q2 results: Revenues: $0; R&D Expense: $4.2M (+13.5%); SG&A: $1.4M (+16.7%); Net Loss: ($5.8M) (-13.7%); Loss Per Share: ($0.21) (+12.5%); Quick Assets: $53.1M (+4.7%); CF Ops: ($4.1M) (-5.1%).
    • No guidance given.
    • Shares are down 14% on a 5x surge in volume.
    | Tue, Aug. 30, 7:53 AM
  • Tue, Aug. 30, 7:04 AM
    • Alcobra (NASDAQ:ADHD): Q2 EPS of -$0.21 beats by $0.01.
    • Cash and cash equivalents of $15.1M
    • Press Release
    | Tue, Aug. 30, 7:04 AM
  • Mon, May 16, 9:30 AM
    • Alcobra (ADHD) Q1 results: Revenues: $0; R&D Expense: $3.4M (-5.6%); SG&A: $1.5M (+15.4%); Net Loss: ($5.1M) (+1.9%); Loss Per Share: ($0.18) (+30.8%); Quick Assets: $53.2M (+4.9%); CF Ops: ($4.4M) (+4.3%).
    • No guidance given.
    | Mon, May 16, 9:30 AM
  • Mon, May 16, 8:04 AM
    • Alcobra (NASDAQ:ADHD): Q1 EPS of -$0.18 beats by $0.04.
    • Cash and cash equivalents of $13.5M
    | Mon, May 16, 8:04 AM
  • Fri, Feb. 19, 8:22 AM
    • MacroGenics (NASDAQ:MGNX) initiated with Buy rating and $36 (110% upside) price target by Janney Capital.
    • Alcobra (NASDAQ:ADHD) initiated with Buy rating with a $10 (95% upside) price target by Jefferies.
    • Valeant Pharmaceuticals (NYSE:VRX) initiated with Buy rating and $150 (60% upside) price target by Rodman & Renshaw.
    • Ocular Therapeutix (NASDAQ:OCUL) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target maintained at $15 (81% upside).
    • HealthStream (NASDAQ:HSTM) upgraded to Buy from Hold with a price target of $25 (16% upside) by Needham.
    • Juno Therapeutics (NASDAQ:JUNO) upgraded to Buy from Neutral by Guggenheim.
    • Regeneron Pharmaceuticals (NASDAQ:REGN) upgraded to Neutral from Sell by Chardan Capital. Price target lowered to $375 (3% downside risk) from $400.
    • Community Health Systems (NYSE:CYH) downgraded to Market Perform from Outperform by Avondale. Price target lowered to $18 (20% upside).
    | Fri, Feb. 19, 8:22 AM | 7 Comments
  • Wed, Feb. 17, 10:03 AM
    • Alcobra (ADHD +2.2%) Q4 results: Revenues: $0; R&D Expense: $3.3M (-32.7%); SG&A: $1.3M (-7.1%); Net Loss: ($4.9M) (+27.9%); Loss Per Share: ($0.20) (+60.0%).
    • FY2015 results: Revenues: $0; R&D Expense: $13.5M (-46.2%); SG&A: $5M (-13.8%); Net Loss: ($19.4M) (+40.9%); Loss Per Share: ($0.90) (+62.5%); Quick Assets: $40.7M (+87.6%).
    • No guidance given.
    | Wed, Feb. 17, 10:03 AM