The law firm of Wohl & Fruchter LLP announces that it is investigating possible violations of federal securities laws by officers and directors of Vanda Pharmaceuticals, Inc. (Vanda) (NASDAQ: VNDA).
Vanda is a biopharmaceutical company that engages in the development and commercialization of products for the treatment of central nervous system disorders. One of its drugs in clinical development, Tasimelteon, has completed two Phase III clinical trials for the treatment of circadian rhythm sleep disorders.
On May 31, 2013, Vanda announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Tasimelteon. The NDA seeks FDA approval of Tasimelteon for the treatment of Non-24-Hour Disorder (Non-24), a sleep disorder that affects the totally blind, based on the results of Vanda’s Phase III trials of the drug.
On June 19, 2013, an article appeared on theStreet.com claiming that a detailed analysis of Vanda’s Phase III trials reveals a large number of irregularities and red flags. Among other issues, the article cites multiple changes in the primary endpoint over the course of the trials, including a change just one month before study results were announced to a new primary endpoint that has allegedly never been used before in sleep-drug clinical trials, and that was not endorsed by the FDA. The article also states that Vanda was forced to cut patient enrollment in the clinical trials in half because an insufficient number of totally blind patients with Non-24 could not be identified, and that ultimately less than 5% of the patients enrolled in the trials suffered from Non-24 according to the "textbook definition" of the disease.
Following publication of the Street.com article, VNDA dropped over 24% from a close of $10.92/share on June 18, 2013, to $8.28/share shortly after noon during trading on June 18, 2013.
Additional information is available on our website at:
Persons with relevant information, and VNDA shareholders with questions about this investigation, are invited to contact the attorney below, or our Firm by calling 866.582.8140.