Acadia Pharmaceuticals Inc. - ACAD STOCK NEWS

Acadia Pharmaceuticals has announced plans to resubmit its supplemental New Drug Application (sNDA) for pimavanserin, aimed at treating hallucinations and delusions associated with Alzheimer's disease psychosis, in the first quarter of 2022. The resubmission will include new analyses from two positive Phase 3 studies, ultimately supporting its clinical benefits without worsening cognitive or motor functions in elderly patients. The company has had constructive discussions with the FDA regarding the resubmission process.

Acadia Pharmaceuticals Inc. has promoted Mark Schneyer to Executive Vice President and Chief Financial Officer (CFO), effective immediately. Schneyer, who served as interim CFO since September 2021, will oversee finance, accounting, investor relations, and business development. CEO Steve Davis expressed confidence in Schneyer’s leadership and experience, highlighting his role in strategic growth initiatives and the acquisition of CerSci Therapeutics. Schneyer joined Acadia in 2020 from Pfizer, bringing extensive experience in corporate finance and strategic transactions.

Acadia Pharmaceuticals announced positive results from its pivotal Phase 3 Lavender study of trofinetide for treating Rett syndrome in 187 girls and young women aged 5-20. The study met co-primary endpoints, showing statistically significant improvements in the Rett Syndrome Behaviour Questionnaire (p=0.0175) and Clinical Global Impression of Improvement (p=0.0030). Additionally, trofinetide improved a key secondary endpoint related to communication (p=0.0064). A pre-NDA meeting with the FDA is planned for Q1 2022, with an NDA submission expected mid-year.

Acadia Pharmaceuticals (ACAD) announced the publication of Phase 2 ADVANCE study results in The Lancet Psychiatry, which evaluated pimavanserin as an adjunctive treatment for schizophrenia's negative symptoms. The study demonstrated a significant improvement in negative symptoms from baseline to week 26 compared to placebo (-10.4 vs. -8.5; p=0.043). Pimavanserin was well-tolerated, with completion rates around 86%, and similar adverse event rates between groups. Acadia plans to continue evaluating pimavanserin in its Phase 3 ADVANCE-2 study.

Acadia Pharmaceuticals has launched Yours, Truly, a storytelling campaign aimed at raising awareness of non-motor symptoms in Parkinson’s disease during National Family Caregivers Awareness Month. This initiative, in collaboration with StoryCorps, enables participants to share personal stories, fostering understanding and reducing stigma. Approximately one million people in the U.S. live with Parkinson's, with around 50% experiencing psychotic symptoms. The campaign seeks to empower patients and caregivers by amplifying their voices and experiences.

Acadia Pharmaceuticals (Nasdaq: ACAD) reported 3Q21 net sales of $131.6 million, a 9% increase from $120.6 million in 3Q20. Net losses narrowed to $14.5 million from $84.7 million year-over-year. Acadia plans an FDA meeting to discuss a potential resubmission of the pimavanserin sNDA for dementia-related psychosis, with top-line results from the Phase 3 LAVENDER study for Rett syndrome expected by year-end. NUPLAZID sales guidance has been narrowed to $480-$500 million, while R&D guidance has been adjusted to $230-$245 million.

Acadia Pharmaceuticals has presented new analyses on Medicare claims data related to dementia-related psychosis (DRP) at Psych Congress 2021. The data shows that over 70% of patients treated with off-label atypical antipsychotics experienced adverse events within a year, with costs averaging $5,565 for hyperlipidemia. Additionally, approximately 38% of patients faced cerebrovascular adverse events, with associated costs soaring to $68,308. Furthermore, nearly two-thirds of patients experienced suboptimal treatment outcomes leading to higher annual costs.

Acadia emphasizes the urgent need for effective treatments for DRP.

Acadia Pharmaceuticals (NASDAQ: ACAD) announced the promotion of Brendan Teehan to Executive Vice President and Chief Operating Officer, effective immediately. Previously the Senior Vice President, Chief Insights and Analytics Officer, Teehan will oversee all sales and marketing functions while continuing to lead commercial strategy and operations. Teehan has over 25 years of experience in healthcare, having worked with companies like Johnson & Johnson and Amgen. Additionally, two senior executives, Charmaine Lykins and Amanda Morgan, will leave the company for new opportunities.

Acadia Pharmaceuticals will report its third quarter 2021 financial results on November 8, 2021, after the market closes. A conference call and webcast will follow at 4:30 p.m. Eastern Time on the same day, providing insights into the company's financials and operations. Participants can access the call via dedicated numbers for U.S. and international callers. The event will also be available for replay until November 22, 2021. Acadia continues to focus on innovative solutions in neuroscience.