Acadia Will Outperform, Worth $48/Share Says Leerink
Benzinga By Jim Swanson
April 16, 2015 9:39 AM
In a report published Thursday, Leerink analysts initiated coverage of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) with an Outperform rating and a price target of $48. The delay in receiving the pimavanserin NDA and the retirement of CEO Uli Hacksell has provided an attractive entry point for investors, the analysts said.
Acadia's shares are currently trading 19 percent below its previous highs due to the NDA delay and the retirement of its long-standing CEO. The analysts believe that the company's breakthrough drug NUPLAZID (pimavanserin) is likely to receive approval for the treatment of Parkinson's Disease Psychosis by mid-2016.
"Pimavanserin is a 5HT2a receptor inverse agonist with strong efficacy and an exceptionally clean safety profile, rendering it differentiated from other anti-psychotics which are either modestly effective in PDP, poorly tolerated, and/or increase morbidity/mortality in elderly patients," the analysts explained.
Unlike existing drugs for Parkinson's, pimavanserin does not affect with dopamine receptors, which could interfere with the working of other Parkinson's drugs. "Pimavanserin's efficacy was validated in a pivotal PDP study which met its primary endpoint and also showed statistically significant improvements in clinician and caregiver burden," the analysts added.
The drug could also prove effective in the treatment of Alzheimer's Disease Psychosis, for which the analysts expect the company to release clinical data in 1H16.
- Shares of Irish drug developer Prothena surged Friday after the company reported promising results from an early-stage study of a drug designed to treat Parkinson's disease.
Prothena said the study showed the drug, PRX002, was safe, without serious side effects, and that it reduced levels of a protein that is believed it be associated with the disease. The drug was tested on 40 healthy people, which is common in early clinical trials of experimental drugs. Prothena is conducting studies that will involve more people, including patients who suffer from the disease.
Prothena stock was up $8.26, or 28 percent, to $37.49 in afternoon trading. It hit $45 earlier in the day.
PRX002 is designed to reduce levels of free serum alpha-synuclein. When that protein builds up in the brain, it is associated with Parkinson's disease and related conditions.
Wedbush analyst Heather Behanna said the study is an important first step for Prothena, but it's not clear if the drug will work on humans the same way it has worked in preclinical models. Behanna rates Prothena shares "Outperform" with a price target of $46.
Dublin-based Prothena Corp. announced a development deal with Roche in December 2013. The company says it could get as much as $600 million in milestone payments from Roche, as well as a portion of profits and royalty payments on sales of the drug if it is approved. Prothena has received $45 million so far.
One other Company last week declared and were approved for treating the same medical problems ACAD supposed to have a breakthrough in the same diseases. sorry I cannot remember the name - but the stock soared on the approval news.
momoney163 Saturday, 11/24/12 12:24:38 AM
Post # of 1549
ACAD halted today around 1. Big buyout coming!
See why we cannot count on printed 'NEWS:
They are like leeches - and no wonder people have little or no respect for these greedy grabbers!
Personally I believe they are wasting their time - and ours!
No mention of actual physical change to the patients in the trial - notably the outlook favored how the care givers were noticeably less tense and possibly less pressured. Taking the obvious from those statements we are given the message the patients must have been changed enough, maybe easier to control and manage, to remove the strain the everyday care givers have been under for a long time. Congratulations Acadia - the work you are doing is showing definite signs of improvement, leading to success and comfort ahead for the patients who have the horrible disease. - There is a bright light at the end of the tunnel!
Sept. 16th (Cramer's statements - and I personally cannot stand that man or his reporting!)
Something must be happening and we investors deserve to know!
I too have high hopes for ACAD getting regulatory approval and permission to start helping so many people who desperately need a medical break-through.
The uptick in price plus great volume - based on no statements from the Company - means the investors in Acadia have not only confidence in their investments - I believe it also means we can expect an update soon.
Last news item - September 12th. Just business as usual?
I am from England and I found this latest news exciting and very hopeful for a lot of sick people.
Ebola vaccine trials fast-tracked by international consortium
28 August 2014
Unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine
A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of a series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in west Africa.
Human trials of this candidate vaccine, being co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline, are to be accelerated with funding from an international consortium in response to the Ebola epidemic, which the World Health Organization recently declared a public health emergency of international concern.
A £2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID) will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, to start safety tests of the vaccine alongside similar trials in the USA run by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).
The phase 1 trials will begin as soon as they receive ethical and regulatory approvals, which will be considered on an expedited basis. If approvals are granted, the UK research teams could start vaccinating volunteers from mid-September.
The consortium’s funding will also enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, so that if the trials are successful stocks could then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities.
The candidate vaccine is against the Zaire species of Ebola, which is the one circulating in west Africa, and uses a single Ebola virus protein to generate an immune response. As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with Ebola. Pre-clinical research by the NIH and Okairos, a biotechnology company acquired last year by GSK, has indicated that it provides promising protection in non-human primates exposed to Ebola without significant adverse effects.
Safety trials with small groups of healthy volunteers are now required to ensure that the vaccine does not cause unforeseen side effects, and that it generates a good immune response to Ebola in humans, before it can be rolled out to larger at-risk populations, even on an experimental basis.
To accelerate these trials, the NIH has generously agreed to provide the NIAID/GSK Ebola vaccine for safety studies led by the Oxford team, which will run in parallel to its own trials. Oxford’s Jenner Institute has extensive experience of clinical trials of similar vaccines, which they have evaluated clinically for six other diseases in Europe and Africa.
If the first volunteers vaccinated in the Oxford study show a good response with no adverse reactions, the trial will, after approval from the relevant authorities, be extended to volunteers at the MRC Unit in The Gambia. A second West African arm of the study, led by Professor Myron M Levine of the Center for Vaccine Development at the University of Maryland School of Medicine, and Professor Samba Sow of the Center for Vaccine Development in Mali (a joint initiative between the University of Maryland School of Medicine and the Ministry of Health of Mali), will then begin in Bamako, Mali.
The Oxford study will involve 60 healthy volunteers, while those in The Gambia and Mali will each involve 40. Each set of volunteers will be split into groups of 20 that will receive different doses of the vaccine so researchers can evaluate the best dose to use in terms of both safety and activity.
NIAID are testing this same vaccine in the USA, in addition to a related vaccine that is designed to protect against two Ebola species (Ebola Zaire and Ebola Sudan).
This collaborative multi-trial approach will help ensure the fastest possible progress to determining the best candidate vaccine approach and delivery. The addition of west African arms will also ensure that the studies take account of differences between European and west African populations that might affect safety or immune response.
It is hoped that the phase 1 trials might be finished by the end of 2014, after which deployment of the vaccine could be fast-tracked should it prove to be safe and immunogenic.
Dr Moncef Slaoui, Chairman of Global R&D and Vaccines at GSK said: “Today’s announcement shows how private and public partners can pull together to respond to this critical public health emergency. Developing a new vaccine is complex with no guarantees of success and it’s still early days for our Ebola vaccine candidate. But we are encouraged by progress so far and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to the control of this or future Ebola outbreaks.”
I believe this to be a big news item.
I am from England and it has just been announced Glaxo Smith Kline who also has an interest in Acadia, has submitted and will senk more of a new 'hopeful' help and/or cure for he horrendous Ebola outbreak. They were already testing a vaccine and it had not fully passed all the required testing with the British Medical Assoc. but as this is a frightening and so dangerous an outbreak - they are going to use the vaccines.
One of the biggest pharmaceutical firms in the British Isles and beyond. I saw this on the BBC news yesterday Less
On July 31, 2014, MannKind Corporation ("MannKind") and Amphastar France Pharmaceuticals S.A.S., a French corporation ("Amphastar"), entered into a Supply Agreement, pursuant to which Amphastar will manufacture for and supply to MannKind certain quantities of recombinant human insulin ("Insulin") for use in MannKind's product AFREZZA�. Under the terms of the Supply Agreement, Amphastar will be responsible for manufacturing the Insulin in accordance with MannKind's specifications and agreed-upon quality standards. MannKind has agreed to purchase annual minimum quantities of Insulin under the Supply Agreement of an aggregate of approximately �120.1 million in calendar years 2015 through 2019. MannKind may request to purchase additional quantities of Insulin over such annual minimum quantities.
Tomorrow should be interesting