Alcobra Ltd., a biopharmaceutical company, focuses on the development and commercialization of oral drug candidates. The company is primarily developing MDX (metadoxine), an onset/extended release formulation of the chemical pyridoxine pyroglutamate, which is in Phase III clinical trial for adults with attention deficit hyperactivity disorder (ADHD); in Phase II clinical trial for pediatric with ADHD; and in Phase II clinical trial in adolescents and adults with Fragile X Syndrome. Alcobra Ltd. was founded in 2008 and is headquartered in Tel Aviv, Israel.
Amot Investment Building
2 Weizman Street
Tel Aviv, 6423902
Founded in 2008
U.S. Food and Drug Administration Grants Fast Track Designation to Alcobra's MDX for Fragile X Syndrome
Sep 21 15
Alcobra Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Metadoxine Extended Release (MDX) for the treatment of Fragile X Syndrome. Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening diseases or conditions. Companies that receive Fast Track designation can have more frequent interactions with the FDA review team to facilitate product development. In addition, based on clinical data, the New Drug Applications (NDA) for these products could be eligible for priority and/or rolling review.
Alcobra Ltd. Reporta Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015
Aug 13 15
Alcobra Ltd. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported net loss attributable to holders of ordinary shares of $5,123,000 or $0.24 per basic and diluted per share against $7,780,000 or $0.57 per basic and diluted per share a year ago. Loss before taxes on income was $5,109,000 against $7,774,000 reported last year. Net cash used in operating activities was $3,891,000 against $5,468,000 a year ago. Purchase of property and equipment was $24,000 against $20,000 last year.
For the six months, the company reported net loss attributable to holders of ordinary shares of $10,300,000 or $0.50 per basic and diluted per share against $15,546,000 or $1.14 per basic and diluted per share a year ago. Loss before taxes on income was at $10,273,000 against $15,531,000 reported last year. Net cash used in operating activities was $8,486,000 against $11,096,000 a year ago. Purchase of property and equipment was $36,000 against $70,000 last year.
Alcobra Ltd. to Report Q2, 2015 Results on Aug 13, 2015
Aug 3 15
Alcobra Ltd. announced that they will report Q2, 2015 results at 8:30 AM, US Eastern Standard Time on Aug 13, 2015