Key Takeaways
Pomerantz LLP announced an investigation into Grace Therapeutics Inc. (NASDAQ: GRCE) after the company’s stock price fell 45.48% following the rejection of its new drug candidate by the U.S. Food and Drug Administration.
"The investigation concerns whether Grace and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices," Pomerantz LLP said in a statement released on May 14, 2026.
The law firm's action follows an April 23 press release from Grace Therapeutics, which disclosed the FDA had issued a Complete Response Letter (CRL) for its New Drug Application for GTx-104. The FDA cited deficiencies related to product packaging, non-clinical toxicology assessments, and issues at a contract manufacturer. On the news, the company's stock fell $1.96 per share to close at $2.35.
The investigation opens Grace Therapeutics to potential class-action litigation, adding legal and financial uncertainty on top of its clinical setbacks. For investors, the probe seeks to determine if there were disclosure failures or misleading statements made by the company regarding its drug application.
Pomerantz, a firm known for pioneering securities class actions, is advising investors who lost money to contact them. The outcome of the investigation could lead to significant legal claims against the company, further pressuring its valuation and ability to fund future operations. Grace Therapeutics has not yet publicly responded to the investigation.
This article is for informational purposes only and does not constitute investment advice.
