The regulatory setback occurred when the U.S. Food and Drug Administration issued a Complete Response Letter rejecting the company's new drug application. Federal regulators cited significant uncertainties within the filing that require additional evidence before the treatment can move forward. This move effectively halted the progress of the bitopertin program, leading to a sharp devaluation of shares on the NASDAQ exchange.

The Rosen Law Firm is currently vetting potential claimants for a securities class action, arguing that investors were misled about the company’s business prospects. Shareholders who suffered losses during this period are being encouraged to contact attorney Phillip Kim to discuss legal options, which operate on a contingency fee basis. The firm, known for its history of securities litigation, aims to recover damages for those impacted by the stock's sudden decline.