Alcobra: How Good Is The Post Hoc Trial Analysis?
Kanak Kanti De
Kanak Kanti De
Alcobra: The Next Big Thing In ADHD
Alcobra: A Speculative Biopharmaceutical Company With An Intriguing ADHD Drug Candidate
The Behavioral Economist
The Behavioral Economist
Mon, May 16, 9:30 AM
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).
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, 8:02 AM
Wed, Feb. 10, 10:40 AM
- The FDA designates Amarantus BioScience Holdings' (OTCQX:AMBS +11.1%) eltoprazine an Orphan Drug for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
- Phase 2-stage eltoprazine, a small molecule neuromodulator, is a 5HT 1A/1B receptor agonist under development for PD-LID and adult attention deficit hyperactivity disorder (NASDAQ:ADHD).
- PD-LID is an involuntary movement disorder that results from prolonged levodopa-based therapy, the standard-of-care for patients with Parkinson's disease. PD-LID occurs in as many as 80% of PD patients. It is difficult to treat and prevents patients from performing routine daily tasks.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
- Previously: First patient dosed in Amarantus Bio's mid-stage study of eltoprazine in movement disorder (July 20, 2015)
Nov. 13, 2015, 5:44 PM
Nov. 13, 2015, 10:54 AM
- Alcobra (ADHD -14.3%) prices its previously announced public offering of 6.175M shares of common stock at $6.50 per share. Underwriters over-allotment is an additional 926,250 shares. Closing date is November 18.
Nov. 12, 2015, 4:50 PM
- Alcobra (NASDAQ:ADHD): Q3 EPS of -$0.20 beats by $0.11.
Sep. 21, 2015, 9:19 AM
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.
Aug. 13, 2015, 10:14 AM
- Alcobra (ADHD +5.1%) Q2 results: Revenues: $0; R&D Expense: $3.7M (-37.3%); SG&A: $1.2M (-7.7%); Net Loss: ($5.1M) (+34.6%); Loss Per Share: ($0.24) (+57.9%); Quick Assets: $41.1M (+89.4%).
- No guidance given.
Aug. 13, 2015, 7:04 AM
- Alcobra (NASDAQ:ADHD): Q2 EPS of -$0.24 beats by $0.05.
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. 23, 2015, 5:34 PM
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
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