Acadia Pharmaceuticals Inc Stock Price, News & Analysis

Acadia Pharmaceuticals (Nasdaq: ACAD) will release its first quarter 2021 financial results on May 5, 2021, after U.S. market close. A conference call to discuss these results will take place at 5:00 p.m. ET the same day. Participants can join by phone or via a live webcast on Acadia's website, with a replay available until May 19, 2021. Acadia is focused on advancing neuroscience solutions, including treatments for Parkinson's disease psychosis and dementia-related psychosis, and is engaged in late-stage development for several mental health conditions.

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has received a Complete Response Letter (CRL) from the FDA for its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) aimed at treating hallucinations and delusions in dementia-related psychosis (DRP). The FDA cited insufficient statistical significance in certain dementia subgroups and a lack of substantial evidence for effectiveness. Acadia intends to request a Type A meeting with the FDA to discuss the CRL and potential approval pathways. No safety concerns were raised in the CRL.

Acadia Pharmaceuticals announced on March 3, 2021, that it received an FDA notification identifying deficiencies in its supplemental New Drug Application (sNDA) review, inhibiting discussions on labeling and post-marketing requirements. The notification lacks specific details on the deficiencies, and the company aims to clarify these issues with the FDA. The FDA had previously set a PDUFA action date of April 3, 2021, for the sNDA review.

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) reported strong financial results for Q4 2020, with net sales of NUPLAZID reaching $121 million, a 23% increase from Q4 2019. For the full year, net product sales grew 30% to $441.8 million. However, the company incurred a net loss of $66.8 million for Q4 and $281.6 million for the year. Acadia anticipates net sales of $510-$550 million for NUPLAZID in 2021 but withheld guidance for dementia-related psychosis revenue. Strategic advances include multiple Phase 3 studies and a new FDA label for NUPLAZID.

Acadia Pharmaceuticals has launched MoreThanMemoryLoss.com, an educational website aimed at assisting caregivers and individuals living with dementia. The site offers resources about dementia-related hallucinations and delusions, a common challenge for about 30% of the 8 million people with dementia in the U.S. The initiative was developed with input from caregivers and advocacy groups, featuring guides and personal stories to encourage discussions between caregivers and healthcare providers. This resource aims to address the distressing symptoms of dementia-related psychosis.

Acadia Pharmaceuticals (Nasdaq: ACAD) will participate in two upcoming investor conferences. The 10th Annual SVB Leerink Global Healthcare Conference features a fireside chat on February 26, 2021, at 10:40 a.m. ET. The Cowen 41st Annual Health Care Conference follows with a presentation on March 1, 2021, at 12:20 p.m. ET. Both events will be held virtually, and live webcasts will be available on Acadia's website, followed by archived recordings for about one month. Acadia specializes in neuroscience breakthroughs for conditions like Parkinson’s disease psychosis.

Acadia Pharmaceuticals (Nasdaq: ACAD) will report its fourth quarter and full year 2020 financial results on February 24, 2021, after market close. A conference call to discuss these results will occur the same day at 4:30 p.m. ET, accessible via phone or webcast. Acadia is known for developing the first approved therapy for hallucinations associated with Parkinson’s disease psychosis and is focused on late-stage development for dementia-related psychosis and other CNS disorders. Future projections may be subject to risks inherent in drug development.

Acadia Pharmaceuticals (Nasdaq: ACAD) announced the departure of Michael Yang, Executive VP and Chief Commercial Officer, effective January 29, 2021, as he transitions to a CEO role at another healthcare company. Charmaine Lykins and Amanda Morgan will co-lead the commercial organization post-departure. Lykins has extensive experience in marketing and product launches in CNS disorders, while Morgan brings a strong track record in team development and sales strategies within the healthcare sector.

Acadia Pharmaceuticals (Nasdaq: ACAD) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 2:00 PM ET. The event will occur virtually, featuring a question and answer session following the presentation. A live audio webcast will be available on Acadia's website, with an archived recording accessible until February 12, 2021. Acadia is a leader in neuroscience, known for developing the first approved therapy for hallucinations and delusions related to Parkinson’s disease psychosis.