The scrutiny centers on a February 13, 2026, Complete Response Letter issued by the U.S. Food and Drug Administration. Regulators declined to approve the company’s new drug application for bitopertin, citing unresolved uncertainties that require further evidentiary support. The immediate market reaction erased a significant portion of shareholder value, prompting the New York-based firm to seek out affected investors for a prospective class action suit.
Rosen Law is currently offering legal representation on a contingency fee basis, meaning shareholders may pursue recovery without upfront costs. Investors who held positions during the period leading up to the FDA’s decision are encouraged to contact Phillip Kim to discuss the litigation process and eligibility requirements for joining the suit.
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