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ACADIA Pharmaceuticals Inc. (ACAD)

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18.90-0.30 (-1.56%)
At close: 04:00PM EST
18.70 -0.20 (-1.06%)
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  • L
    Little Jimbo
    Pimavanserin as an adjunct to an antipsychotic showed significant improvements in the negative symptoms of schizophrenia vs. antipsychotic treatment alone. News Out !!
  • l
    Report out: In repurposing study, Pimavanserin demonstrates efficacy against pancreatic cancer in preclinical model. Pima showed significant tumor suppression associated with autophagic programmed cell death:

    Cancers (Basel). 2021 Nov 12;13(22):5661. doi: 10.3390/cancers13225661.

    Pimavanserin: A Novel Autophagy Modulator for Pancreatic Cancer Treatment

    Sharavan Ramachandran 1, Itishree S Kaushik 1, Sanjay K Srivastava 1

    1Department of Immunotherapeutics and Biotechnology, Center for Tumor Immunology and Targeted Cancer Therapy, Texas Tech University Health Sciences Center, Abilene, TX 79601, USA.
    PMID: 34830816 PMCID: PMC8616166 DOI: 10.3390/cancers13225661
    Free PMC article
    Full text linksCite

    Pancreatic tumors exhibit high basal autophagy compared to that of other cancers. Several studies including those from our laboratory reported that enhanced autophagy leads to apoptosis in cancer cells. In this study, we evaluated the autophagy and apoptosis inducing effects of Pimavanserin tartrate (PVT). Autophagic effects of PVT were determined by Acridine Orange assay and Transmission Electron Microscopy analysis. Clinical significance of ULK1 in normal and pancreatic cancer patients was evaluated by R2 and GEPIA cancer genomic databases. Modulation of proteins in autophagy signaling was assessed by Western blotting and Immunofluorescence. Apoptotic effects of PVT was evaluated by Annexin-V/APC assay. Subcutaneous xenograft pancreatic tumor model was used to evaluate the autophagy-mediated apoptotic effects of PVT in vivo. Autophagy was induced upon PVT treatment in pancreatic ducal adenocarcinoma (PDAC) cells. Pancreatic cancer patients exhibit reduced levels of autophagy initiator gene, ULK1, which correlated with reduced patient survival. Interestingly, PVT induced the expression of autophagy markers ULK1, FIP200, Atg101, Beclin-1, Atg5, LC3A/B, and cleavage of caspase-3, an indicator of apoptosis in several PDAC cells. ULK1 agonist LYN-1604 enhanced the autophagic and apoptotic effects of PVT. On the other hand, autophagy inhibitors chloroquine and bafilomycin blocked the autophagic and apoptotic effects of PVT in PDAC cells. Notably, chloroquine abrogated the growth suppressive effects of PVT by 25% in BxPC3 tumor xenografts in nude mice. Collectively, our results indicate that PVT mediated pancreatic tumor growth suppression was associated with induction of autophagy mediated apoptosis.

    Keywords: apoptosis; autophagy; cancer; cell death; drug repurposing.
  • J
    Betting pool on trofinetide/Rett Syndrome results:
    Announcement date - Dec. 8
    Results - positive, with p < 0.01
  • J
    Biogen pulled Aducanumab from EMA's Prime Designation (EU's equivalent to breakthrough designation) also discontinuing its phase 3 trials after last week's negative trend vote. It was granted that designation back in 2016. It has been a mess since approval for both Biogen and the FDA.

    Despite both the agency and company's efforts the optics just look terrible. Head of R&D suddenly retiring, pulling out of Europe, FDA investigations to possible death linked to ARIA, watchdog accusation of unethical meetings, etc. It just never seems to end........
  • A
    Why no positive reaction in Acad after EMA declines Biogen,s Alzheimer’s drug?
  • P
    A Beat: Acadia Pharmaceuticals Reports Third Quarter 2021 Financial Results
    - 3Q21 net sales of $131.6 million, a 9% increase over 3Q20

    - FDA meeting scheduled to discuss next steps towards a resubmission of the pimavanserin sNDA

    SAN DIEGO--(BUSINESS WIRE)--Nov. 8, 2021-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the third quarter ended September 30, 2021.

    “Our third-quarter results reflect volume growth across all channels and our strong relative performance underscores our commercial team’s ability to drive sales of NUPLAZID in a challenging environment,” said Steve Davis, Chief Executive Officer. “As we close out the year, we will meet with the FDA to discuss additional analyses supporting a potential resubmission of our sNDA for pimavanserin focused on specific subgroups of dementia. In addition, we look forward to announcing results from our ongoing Phase 3 LAVENDER study of trofinetide for the treatment of Rett syndrome.”

    Company Updates

    Scheduled meeting with the FDA to discuss additional analyses supporting a potential resubmission of the pimavanserin sNDA focused on specific subgroups of dementia. Acadia plans to provide an update following this meeting around year-end.
    Top-line results from the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome are expected in the fourth quarter of 2021.
    Top-line results from the Phase 2 study of ACP-044 for the treatment of postoperative pain following bunionectomy surgery are expected in the first quarter of 2022.
    Three data presentations featuring new analyses of Medicare claims data on dementia-related psychosis outcomes were presented at the Psych Congress 2021 demonstrating the high unmet need in dementia-related psychosis and providing further evidence of the sub-optimal outcomes associated with the use of dopaminergic atypical antipsychotic treatments in managing dementia-related hallucinations and delusions, along with the related cost burdens.
    A scientific presentation on pimavanserin for the treatment of hallucinations and delusions in patients with Parkinson’s disease dementia will be shared at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
    Brendan Teehan has been promoted to Executive Vice President, Chief Operating Officer, Head of Commercial.
    Julie Fisher has been promoted to Senior Vice President, Marketing & Commercial Strategy. Ms. Fisher will report to Mr. Teehan and join the company’s Executive Management Committee.
    Financial Results


    Net sales of NUPLAZID® (pimavanserin) were $131.6 million for the three months ended September 30, 2021, an increase of 9% as compared to $120.6 million reported for the three months ended September 30, 2020. For the nine months ended September 30, 2021 and 2020, Acadia reported net product sales of $353.4 million and $320.7 million, respectively.

    Research and Development

    Research and development expenses for the three months ended September 30, 2021 were $58.6 million, compared to $120.1 million for the same period of 2020. The decrease was largely due to decreased costs associated with the upfront consideration and transaction costs related to the acquisition of CerSci Therapeutics. For the nine months ended September 30, 2021 and 2020, research and development expenses were $172.5 million and $257.0 million. The decrease was largely due to the acquisition of CerSci Therapeutics and reduced development costs for trofinetide and the cessation of development of pimavanserin for major depressive disorder, partially offset by increased costs of our development activities for ACP-044.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended September 30, 2021 were $81.7 million, compared to $81.6 million for the same period of 2020. For the nine months ended September 30, 2021 and 2020, selling, general and administrative expenses were $290.1 million and $267.9 million, respectively. The increase was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.

    Net Loss

    For the three months ended September 30, 2021, Acadia reported a net loss of $14.5 million, or $0.09 per common share, compared to a net loss of $84.7 million, or $0.54 per common share, for the same period
  • J
    Last few sessions a significant portion of the volume has been right at the close or AH. I take it that these are larger blocks of institutional holdings.
  • K
    Wow, 3% increase in price with the volume of 2.2 MM. I think volume spike was in final hour.. is something happening?
  • l
    Report out: Pimavanserin mechanism of action in alleviating neuropsychiatric diseases is elucidated. This is a significant advance in describing the molecular and neural anti-psychotic effects of Pimavanserin:

    Neuropharmacology. 2021 Dec 15;201:108838. doi: 10.1016/j.neuropharm.2021.108838. Epub 2021 Oct 16.

    Pimavanserin, a 5-hydroxytryptamine 2A receptor inverse agonist, reverses prepulse inhibition deficits in the nucleus accumbens and ventral hippocampus

    Mengwen Shi 1, Jiaxin Tang 1, Chengmei Yang 1, Guanlong Guo 1, Huaxing Ou 1, Weihai Chen 2

    PMID: 34666074 DOI: 10.1016/j.neuropharm.2021.108838
    Full text linksCite

    Prepulse inhibition (PPI) is disrupted in many neuropsychiatric diseases. Although the inverse agonist of the 5-hydroxytryptamine 2A (5-HT2A) receptors, pimavanserin, alleviates PPI deficits in rodents, the precise mechanisms and critical brain areas in the reversal effect of 5-HT2A receptor inverse agonists remain unclear. The present study aimed to investigate the critical brain areas responsible for the reversal effect of the 5-HT2A receptor inverse agonist on PPI deficits in male mice. The results showed that intraperitoneal administration of pimavanserin was found to improve normal PPI behavior and reverse PPI deficits elicited by the dopamine D1/D2 receptor nonselective agonist, pergolide. Further, local infusion of pimavanserin into the nucleus accumbens and ventral hippocampus reversed PPI deficits, whereas the same manipulation in the medial prefrontal cortex or ventral tegmental area did not reverse PPI deficits. Overall, the nucleus accumbens and ventral hippocampus are the critical brain areas responsible for the reversal effect of 5-HT2A inverse agonists on PPI deficits. Such findings contribute to the extensive exploration of the accurate molecular and neural mechanisms underlying the antipsychotic effects of 5-HT2A receptor inverse agonists, especially the neural circuits modulated by 5-HT2A receptor activity.

    Keywords: 5-Hydroxytryptamine 2A receptor; Inverse agonist; Pimavanserin; Prepulse inhibition.
  • M
    we have to wait by end of year , so 31 december 2021 is on a friday.
    last day of the trading week
    last day of the year 2021
    are they picking this day for some announcement(good/bad) , would they dare ???? ;-)
    going in to the new year with ... news !
  • H
    WSJ this AM reporting Biogens ALZ drug is under investigation for a fatal brain swelling. WHICH was a WELL KNOWN side effect coupled with other questionable items. jury’s not in yet but sure not looking good for FDA. And my fear is given just what we heard on the call with ACAD if the are looking for ALZ approval will the FDA be totally spooked and swing to the other end of the spectrum. I just shake my head.
  • J
    A new poster here, and long time ACAD holder, about 5 years +/-. I couldn't look at the ticker since first week of July and after all that time, my alert notifications tell me that we are at 20 and above. So, I am cautiously optimistic after the CC today. I did, BTW, buy about 30% more after the CRL news in the summer.
  • J
    Clear that they are adjusting the ask with FDA to ADP. If they can get the blessing on this, it's going to be "good enough". Gigi is amazing, by the way. Overall, all better than I expected, with the exception of lowered range for guidance.
  • K
    Very promising pipeline along with sustainable growth in sales!
    Before the end of 2021, a lot of good results will be released and some in the first quarter of 2022!
    Very impressed with the outcomes!
  • S
    Adding another 2000 to my 5500 position. Very few biotechs have rev coming in. We are talking 1/2 billion rev to backupbthr billions $ pipeline. 20-30% gain tomorrow.
  • K
    10% increase in price along with 3-month average volume..
    I think some individuals who recently bought at $ 15-16 might have taken profit today. Rest of the holders plan to keep it longer after hearing yesterday earning call. Longs will certainly be rewarded in next six-month period. It is my own guess.
  • J
    Up trend shall resume! Been a long time coming, may be past it’s moody teenage stock price and gap to low/mid 20s
  • l
    Report out: Pimavanserin treatment of PD-related psychosis reduces falls/fractures by more than 50% compared to atypical antipsychotics:

    Drugs Real World Outcomes. 2021 Oct 30. doi: 10.1007/s40801-021-00284-1. Online ahead of print.

    Falls and Fractures in Patients with Parkinson's Disease-Related Psychosis Treated with Pimavanserin vs Atypical Antipsychotics: A Cohort Study

    J Bradley Layton 1, Joan Forns 2, Mary Ellen Turner 3, Colleen Dempsey 3, Jennifer L Bartsch 4, Mary S Anthony 4, Heather E Danysh 5, Mary E Ritchey 4 6, George Demos 7
    Affiliations expand

    PMID: 34718963 DOI: 10.1007/s40801-021-00284-1

    Background: Parkinson's disease-related psychosis increases patients' risk of falls. Pimavanserin is an atypical antipsychotic approved in the USA in 2016 for the treatment of hallucinations and delusions associated with Parkinson's disease-related psychosis.

    Objective: We aimed to compare the risk of falls/fractures among patients with Parkinson's disease-related psychosis treated with pimavanserin vs other atypical antipsychotics.

    Patients and methods: We identified a cohort of patients with Parkinson's disease-related psychosis aged ≥ 40 years initiating either pimavanserin or a comparator antipsychotic (clozapine, quetiapine, risperidone, olanzapine, aripiprazole, brexpiprazole) in US commercial insurance and supplementary Medicare claims (2015-2019). Comparators were propensity score matched 2:1 with pimavanserin initiators; incidence rates of falls/fractures were compared using incidence rate ratios (IRRs) and 95% confidence intervals (CIs).

    Results: We identified 112 eligible pimavanserin initiators and 982 comparators. Pimavanserin initiators were younger and had fewer severe comorbidities, indicators of impairment, and healthcare encounters, though they had higher Parkinson's disease medication use. The crude incidence rates [cases/100 person-years] (95% CI) for composite falls/fractures were 17.8 (7.7-35.0) for pimavanserin and 40.8 (35.0-47.4) for comparators. Matching retained 108 pimavanserin initiators and 216 comparators-all characteristics were well balanced after matching-with a matched IRR (pimavanserin vs comparator) of 0.71 (95% CI 0.27-1.67). Sensitivity analysis IRR estimates were consistently below 1.00, with a sensitivity analysis not requiring a diagnosis of psychosis resulting in an IRR estimate of 0.55 (95% CI 0.34-0.86).

    Conclusions: The results of this study do not suggest an increase in the risk of falls or fractures associated with pimavanserin compared with other antipsychotics in patients with Parkinson's disease-related psychosis. Sensitivity analyses suggest a decreased risk.
  • P
    Overall Q results & CC grades from my perspective:

    Revenue Grade: B
    Business Development Issues Grade: C+ (up from D- in Q2)
    Participant Performance Grade: A- (up from D in Q2 CC)
    Overall Q & CC Grade: B-

    Bottom Line: Good improvement from last CC, but the key issues, although more in focus, are yet to be resolved throughout all aspects of the business. There remains, however, a very positive potential.
  • j
    Average BIO's are down 1% + today. ACAD stepped out of the norm. Can't help but think that might be a good thing or maybe just wishful thinking.