Ovid Therapeutics Announces OV101 Granted Fast Track Designation by U.S. FDA for Treatment of Fragile X Syndrome

Ovid Therapeutics (NASDAQ:OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OV101 for the treatment of Fragile X syndrome.

As quoted in the press release:

“Fragile X syndrome continues to have a high unmet medical need and has no FDA-approved therapies available. Fast Track designation enables us to work closely with the FDA to accelerate our efforts to potentially provide an impactful therapy to people with Fragile X syndrome,” said Amit Rakhit, M.D., MBA, chief medical and portfolio management officer of Ovid Therapeutics. “This important designation by the FDA comes on the heels of several other clinical and regulatory milestones for our OV101 program in recent months, including positive Phase 1 data, orphan drug designation for Fragile X syndrome, and Fast Track designation for Angelman syndrome. We are committed to exploring the potential of OV101 to become a transformative medicine and we look forward to announcing further progress this year.”

Click here to read the full press release.