If you compare it to its comps then the market cap of CGIX is literally half of what it should be and it has a better revenue and earnings profile. And if It successfully completed an offering at $14 which means institutional investors appetite at that level bodes well for the future of this stock.
Expert Opinion Pharmacother. 2013 Oct;14(14):1969-75.
Pimavanserin for the treatment of Parkinson's disease psychosis.
Movement Disorders Program, Butler Hospital , 345 Blackstone Blvd, Providence, RI 02906 , USA.
Parkinson's disease (PD) is a neurobehavioral disorder defined by its motor features. Its treatment is frequently complicated by the presence of psychotic symptoms, most prominently hallucinations and delusions. These cause major distress and are the primary cause for nursing home placement. Current treatment requires either a reduction in medications for mobility or the addition of atypical antipsychotics, none of which are approved in the United States, and which are associated with major potential drawbacks.
A brief review of the clinical problem and its current state of treatment will be followed by a discussion of pimavanserin and its potential role in treating PD psychosis (PDP). Several observations have implicated serotonin in the physiology of psychotic symptoms. Lysergic acid diethylamide, phencyclidine, and similar drugs that activate 5HT2A serotonin receptors produce psychotic syndromes, and almost all antipsychotic neuroleptics share the property of blocking the 5HT2A receptor as well as the dopamine D2 receptor. The reduced motor side effects of the second-generation antipsychotics have been ascribed to these drugs having greater 5HT2A antagonism than the first generation.
Pimavanserin, a 5HT2A inverse agonist, has no motor side effects, and a remarkable safety profile that is comparable to placebo. Its antipsychotic effects could make it an ideal drug for treating psychotic symptoms in PD, a major unmet need. One Phase III trial in PDP has demonstrated excellent tolerability and significant benefit. The FDA agreed to the filing of a planned new drug approval (NDA) for an indication in the treatment of PDP.
Sentiment: Strong Buy
Thats great that NIH Studies in New England Journal of Medicine came out favoring Chromosomal Microarray Analysis which bodes well for this company. but why wouldnt bigger players get into this. From what i see this company works out of one lab, is short of cash and holds no real patents. $9 mm market cap is tiny but for a one lab operation quite large i would think. Any knowledgeble thoughts? Thanks
I am new to this stock and just started my DD before taking a position and came cross the following article. Any thoughts would be appreciated:
Hemispherx Biopharma (HEB)'s Ampligen Rehash Unlikely to Impress FDA
9/27/2012 8:00:02 AM
Three years after being rejected by U.S. Food and Drug Administration, Hemispherx Biopharma (HEB) is back seeking regulatory approval for Ampligen, its controversial therapy for chronic fatigue syndrome. Everyone loves a comeback story with a happy ending, but Hemispherx's second attempt won't turn out any happier than the first. FDA is likely to reject Ampligen again because Hemispherx ignored the agency's demand to run a new clinical trial in chronic fatigue syndrome. Instead, Hemipsherx has spent the past three years doing essentially nothing but re-analyzing data from the old Ampligen phase III trial completed in 2004. FDA reviewed the original study already, deeming it "lacking credible evidence of efficacy of Ampligen."
For those who truly understand the significance of P3 results, there is every reason to believe that Acadia will be partnering with big pharma to get ready to launch Pimavanserin in the market. Roger Mills the head of development for Acadia was formerly VP development for Pfizer. Its logical and definetly likely that they will be talking.
Thanks daweasel. Will let you know tpharmachick on ARIA
Congratulations Guys hope you did well. I am still holding on to half my shares as i feel this is a such a clear shot to fda approval. Primarily because other than being effective the drug has a fantastic safety profile. This could be a wonder drug for neurology.
Although I would be interested to know what else are you guys looking at. I have begun my DD on ARIA. I think that looks very promising and will probably by some. Look forward to your thoughts.
I have researched it, done my due diligence on management, pimavanserin and the company. for all those who came in at $7, $6 or whatever this will double and go higher. the drug pimavanserin is going for fda approval. this was never a question about the efficacy of the drug itself. but purely about designing the right trial to measure the efficacy. it took them a long time but they did it and the stock has nowhere but to go up from here.
Congratulations all. This stock will go to $12 range in the short term and higher longer term. I am in it for this company future is very bright indeed. At$350 mm market cap this one is a great investment.
That drug works. The real test for P3 in my mind is that if the redesigned trial captures pimavanserins efficacy. Through trial and error,hopefully Acadia has had to figure out the right parameters for the test. Consequently if it clears this hurdle the stock should do very well. There seems to be no question of safety, the trial design would be well formulated, the market need is tremendous, no real competition as of now and the path to FDA approval would be relatively straight forward. If the stock trades at $5 or $6 upon a favorable outcome here, then that would be a better and a safer investment. Tremendous upside and the main challenge for Pimavanserin would have been overcome and it would still only have a market cap in the $300mm range.
Release Date: If one reads the earnings call transcript (2Q not 3Q) they clearly state that results will be announced 3 months after they announce enrollement completion into p3. That announcement was made September 5th or so. That would make the announcement date closer to December 5
Price: If the results are positive then looking at pharmaceuticals devoid of any significant revenue but those who have had successful Phase 3, Pre FDA approval stage for a potential block buster drug trade at a market cap of $400MM to $500MM. Current Price equates to a mkt cap of $120MM. That would point to a price of 3.3x current price on the low end. This brings us to a range of $7.2- $9. Perhaps higher if they announce a partnership.
Of course only if P3 is Positive for which I remain cautiously optimistic.
Thanks. I read the 10K . I think its pretty clear that all on 015 know they are on the drug. Thats good.
You seem knowledgable. One question regarding 90% roll over. Is it for certain that the 90% roll over only are those patients that were on the Pimavanserin arm and not the placebo. Or is there no way to tell.
I visited Teavana store once a month ago and swore never to go back. So expensive and over priced. They need to offer great tea at affordable prices. That will work and hopefully schulz can bring in the scale to do so.
then that would be a complete surprise:
1. That would mean that the management was completely misleading on the earnings CC as there was not a word of caution from them. By November 5 they would clearly have had an indication of how the trial was going as this is a make or break trial for Acadia Pharmaceuticals as we know it.
2. Secondly on all neurology sites, papers clearly Pimavanserin shows efficacy. Trials were mismanaged and poorly designed in the past that is another story but clearly the drug is effective in the right doses
3. Some neurology doctors (overseas) who are in no way connected to the trial mentioned that they are aware of Pimavanserin and that they are waiting for it to come in to regular clinical trials P4 perhaps when the drug is in the open market ( so its not a hoax as some have stated)
4. Acadia is heavily dependent on this Phase III. Clearly if management did not know and were a dead certain of the likely outcome they would not have embarked on this trial. If this fails they are Toast
The post is from april however. It doesnt mention pimavanserin by name but perhaps likely. And there is a side effect of head bobbing that was ommited in the post. but again that could be due to other meds that these patients are on however the caregiver suspects it might be the ¨clincal trial drug¨
Thanks. Although they did mention on the cc that they don't have to pay dividends on preferred to pay div to common. Although that will no longer be valid like you said if the law suit is successful.