• Shares of Aldeyra Therapeutics Inc. plummeted 61.9% after FDA finds issues with NDA for dry-eye disease treatment
  • FDA identified “substantive review issues” with the new drug application
  • Trading volume ballooned to 12.3 million shares
  • FDA stated that additional clinical trials were needed to satisfy efficacy requirements
  • Aldeyra’s stock has plunged 73.6% over the past three months

Shares of Aldeyra Therapeutics Inc. plunged 61.9% after the U.S. Food and Drug Administration (FDA) found “substantive review issues” with the new drug application (NDA) for their dry-eye disease treatment. The FDA stated that additional clinical trials were needed to support the clinical relevance of the ocular signs for the dry eye indication. Aldeyra submitted responses to the FDA, but it is uncertain if the NDA will be approved by the FDA before the NDA review cycle ends on November 23. The stock has seen a significant decline of 73.6% over the past three months.