3 Upcoming FDA Decisions We're Most Excited About
Here's how Acadia, Intercept, and Clovis Oncology could win big in 2016.
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Interested in what biotechs might soon bag an important new drug approval? Then the Motley Fool has a treat for you today.
Below, three of our contributors share their picks for biotechs on the cusp of a make-or-break FDA decision. The upside of a green light is huge considering how much the odds are stacked against an investigational compound making it all the way to approval.
It takes about 12 years for an experimental drug to travel from the laboratory to your medicine cabinet, and the chances it will make it are a meager one in 5,000. According to Forbes, the overall cost of creating a new drug averages $5 billion. Of course, that takes into account all the failures; companies don't spend that on each drug.
The good news is that about 80% of drugs that made it through the gauntlet of clinical testing to Phase III gain FDA approval. So, when a drug gets close to receiving a regulatory decision, investors should be on high alert.
Brian Feroldi: One upcoming FDA decision that I'm especially excited to hear about is for ACADIA Pharmaceuticals' (NASDAQ:ACAD) Nuplazid, which was submitted last last year as a potential treatment for psychosis associated with Parkinson's disease, or PDP.
The National Parkinson Foundation estimates that roughly 400,000 Americans suffer from PDP, which can cause hallucinations and delusions and places a huge burden on caregivers. In phase 3 trials, Nuplazid was shown to lower the impact that PDP had on patients' lives when compared to placebo, and it also helped improved patients' sleep cycles. Nuplazid helped to reduce the burden placed on caregivers, and the results were seen regardless of the patient's age, sex, or race.
With no other approved drugs on the market to treat PDP, the FDA granted Nuplazid with breakthrough therapy designation and has given it a priority review. The target PDUFA decision date is May 1, 2016 .
This date should be exciting for investors, as well, as peak sales for Nuplazid are currently running around $2 billion. That number could grow considerably in the future, too, since Nuplazid is also being studied as a treatment for Alzheimer's Disease Psychosis and Schizophrenia. If Nuplazid gets the green light on May 1st, then it bodes well for the drug's chances with future conditions. I, for one, am excited to see what will happen.
Pfizer terminated research on PF-05212377 for the treatment of AD-its a loser and why invest more $ on bad results, PFE cut their losses which is the smart thing to do saving millions. They are a great company. Now compare that to AXON, wasting more money on a RVT101 study which is very similar to the mechanism of the PFE drug...Oh and now AXON thinks that RVT101 will treat LBD. This is very close to the text book definition of insanity..."doing the same thing over and over again and expecting different results." Management feels there is still reason to believe they could have a treatment, ok. They were totally embarrassed by the PFE decision, and now trying to save face by continuing and expanding their studies. They can't just give up...I get it...there is a lot at stake.
So investors who are still behind the company are still holding and recently even buying over $10+. Consider if this stock came on as an IPO today...with the recent PFE failure, 100mil OS, 300m cash, thin pipeline and probably will get thinner with a high risk of failure...would you buy those shares?
Closed Over the EMA 8, so-called trigger point, by only 3 cents. Need a close on Tue $8+ would be a nice initial recovery signal.
The Peter principle is a concept in management theory formulated by Laurence J. Peter in which the selection of a candidate for a position is based on the candidate's performance in their current role, rather than on abilities relevant to the intended role. Thus, employees only stop being promoted once they can no longer perform effectively, and "managers rise to the level of their incompetence."
Not sure what was up with Davis....ah....ah....ah...Geez that was annoying. But reg the QT-I recall looking at the QT issue about 1 yr ago and thinking it is not going to be a major issue. A black box for that may be placed but it will not affect many patients. I am not worried about it, except how it might be blown out of proportion by investors who don't even understand what the QT issue is.
Many times when new drugs are released Drug Payers...your insurance that pays for your drugs ( less a Co-Pay ) will try to block the drug with their protocols. This will hurt sales of many new drugs. In the case of Nuplazid, it will be the ONLY drug indicated for PDP. Doctors will push hard to get this drug for their patients, esp those who have already tried 1 drug and had to change it due to side effects and that's a very high % of PDP patients and other psychotic patients. I can recall having these types of patients and calling the psychiatrist over and over again trying to get patients stabilized, but they kept having side effects- its a real pain. This drug is going to really be a God send for patients and the doctors treating them. And I believe it will see a very high amount of OFF -LABEL use.
A drug price comparison site goodrx-dot-you know what, showed the Abilify 20 mg BRAND NAME price, 30 tablets, per month for 12 months TOTAL 1 yr range is $15,216 to $17,316. So I think the price quoted (13K) will be a Brand Name price for 1 yr, but for the lowest dose tablet.
Abilify comes in 2mg, 5mg, 10mg, 15mg, 20mg and 30mg. It comes in Oral solution, disintergrating tab, tablet and vial(injection).
....perhaps a little disappointing for those hoping for news. But one thing this presentation wasn't...it was certainly not a reason to sell. My felling is the market sucks and I will see if this perhaps drops to a better entry point to add on. This stock and many Biotechs may not stabilize for another month or so. Please listen to the presentation and judge for yourself.