Shares of Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) have been diving -36% in pre-market trading today. The decline came continuing the fall the stock has begun in the last session dropping -6.53% to $45.78. The decline was all because of a notification received by the company from FDA highlighting several deficiencies in its application for a new drug.
What the notification says?
Advances in neuroscience at Acadia have elevated life to new heights. The company, which has been delivering vital healthcare solutions to people for more than 25 years, keeps at the forefront of healthcare research. The first and the only approved therapy to treat an individual with hallucinations or delusions linked to Parkinson’s disease psychosis has been developed by ACAD.
Development efforts in the late stages of the Company’s project are geared toward negative symptoms of Rett syndrome, schizophrenia, and dementia-related psychosis. The ACAD is advancing clinical research in early-stage clinical trials, to better understand the mechanisms of pain management and the cognitive and neuropsychiatric symptoms associated with disorders of the central nervous system.
Acadia yesterday unveiled that the U.S. Food and Drug Administration (FDA) had notified the company on March 3, 2021.
- The notification sent to the Company states that FDA has identified deficiencies that prevent it from discussing labeling or post-marketing requirements/commitments at this time as part of its ongoing review of the Company’s supplemental New Drug Application (sNDA).
- In the notification, the FDA stated that the information being reviewed did not reflect a final decision.
- There has been no clarification from the FDA on the deficiencies mentioned in the notification, and no further behavior has been reported by the FDA at this time.
- To resolve any shortcomings, the Company intends to work with FDA.
- In July 2020, the FDA assigned an April 3, 2021 action date under the Prescription Drug User Fee Act (PDUFA) for completion of its review of the FDA.