According to the law firm press release, Alcobra is a biopharmaceutical company focused on the development and commercialization of proprietary drug candidates, including its most advanced product, MDX, for the treatment of attention deficit hyperactivity disorder (ADHD) and other cognitive dysfunctions. The Complaint alleges that defendants made false and/or misleading statements and failed to disclose material adverse facts about the Company’s operations and financial prospects. Specifically, defendants misrepresented and/or failed to disclose that: (1) MDX did not show a statistical benefit over placebo until patients were removed from the Company’s analysis of the Phase III study; (2) the Company was presenting it analyses inconsistently, including post hoc analysis outside the original protocols; and (3), as a result of the foregoing, defendants’ statements about Alcobra’s business, operations and prospects, including statements about the clinical success of MDX, were false and misleading and or lacked a reasonable basis.
On October 6, 2014, the Company announced topline results from its Phase III study of MDX in Adult ADHD, and declared that MDX demonstrated a statistically significant improvement in ADHD symptoms. Then on October 22, 2014, the Company announced that the MDX Phase III study, in fact, did not demonstrate a statistically significant improvement in patient symptoms, stating in relevant part: “While a complete ITT analysis by ADHD subtypes is still ongoing…the magnitude of symptom improvement appears to be similar in all subtypes, and the Predominantly-Inattentive ADHD (PI-ADHD) subtype alone did not produce a statistically significant outcome."
Then, on November 17, 2014, Alcobra announced that the Company plans to meet with the FDA and launch a second adult Phase III study in 2015. According to the Company, Alcobra is “currently evaluating changes to the design and monitoring of the second trial to control the unusually high placebo response and wide response variability observed in the first Phase III study.” Following this news, Alcobra shares declined 6%, or $0.21 per share, and declined an additional 6% per share the next day, to a closing price of $3.24 per share on November 18, 2014, on unusually heavy volume.
This case was voluntarily dismissed on December 30, 2014.