Replies to post #233767 on Biotech Values

[DewDiligence]

ACAD -37%/AH on “regulatory update” re Nuplazid sNDA for dementia-related psychosis:

https://finance.yahoo.com/news/acadia-pharmaceuticals-provides-regulatory-supplemental-210500999.html

Acadia Pharmaceuticals today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company’s supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them. In July 2020, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2021 for completion of its review of the sNDA.

ACAD held a CC this evening, but (judging from the comments about it I’ve read) nothing of consequence was disclosed.