The filed complaint alleges that defendants made false statements and/or concealed that: (i) the Company concealed the true nature of the LUNAR study data, including that the study relied on a relatively small percentage of study participants that had been receiving standard of care therapy; (ii) as a result, the data was materially less reliable in terms of demonstrating clinical efficacy; (iii) the foregoing, once revealed, was reasonably likely to have a material negative impact on the Company’s regulatory prospects and operations; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.