Acadia's Nuplazid Hits A Review Roadblock, But Not A CRL (For Now)

 
• By Jessica Merrill
  
Generate a summary of this article
Listen to this article
Beta

Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.

Wooden roadblock in nature
The road to approval for a Nuplazid sNDA is uncertain • Source: Shutterstock

The outlook for the expansion of ACADIA Pharmaceuticals Inc.'s Nuplazid (pimavanserin) to treat hallucinations and delusions associated with dementia-related psychosis is uncertain after the company received an update from the US Food and Drug Administration. The company warned there could be a delay in approval of a supplemental new drug application (sNDA) for Nuplazid, but management did not have any details so the message was a confusing one for investors to absorb.

After markets closed on 8 March, Acadia provided an update on the status of the review, stating that the FDA...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Neurological

Evidence Growing For GLP-1s To Treat Alzheimer’s And Parkinson’s

 
• By Andrew McConaghie

GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results

As More DLL3 Bispecifics Advance, Doctors Are Adjusting To CRS, ICANS

 
• By Mandy Jackson

Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.

Novo Nordisk’s Semaglutide Shows Promise In Hidradenitis Suppurativa

 
• By Andrew McConaghie

An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.

Biogen Joins Molecular Glue Degrader Club with Neomorph Pact--Test-1

 
• By Saba Afreen

As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.

More from Therapeutic Category

Scrip Data Article Without An Author

"Neque porro quisquam est qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit..."

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.