Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
added significant position today. I feel we have a chance of FDA approval, nothing is predictable with the FDA.
Joseph Schwartz with Leerink gives $17 price target with 90% FDA approval on Zelrix. Mr. Schwartz covers biotechnology and was named #1 Stock Picker for Pharmaceuticals in the 2011 FT/StarMine Analyst Awards. In 2010, he earned the Wall Street Journal’s #1 ranking for biotech stock picking as part of its “Best on the Street” analysts survey, which topped his #2 ranking in the Journal’s 2008 “Best on the Street” rankings.
http://pulse.alacra.com/analyst-comments/Joseph_Schwartz-A10635
http://www.leerink.com/equity-research/analyst-bios/joseph-schwartz.aspx
Old news by the time it gets on this list not for nothing.
I usually get it from the FDA first or a few Investors on Twitter. For PTIE and DRRX I found out on Friday night. The company didn't release a PR till Monday morning after it started trading already PM.
The FDA notifies the company then it's up to the co. to pr it.
Where does one look to see what the FDA's decision is for PATH? Do you get on an emailing list or with PATH PR the decision?
Thanks,
Sho-Nuff
Yes I think they want to get it over with the Hurricane coming. They have also been ahead of the game lately especially with CRL's which have come way ahead as you probably already now.
AH is a good guess...if not possibly AH Monday?
It is but FDA can and has given early notice.
I thought the decision date was 8-29-11??
Thanks,
Sho-Nuff
Watch it be released today AH.
Non problem! As soon as I hear anything else I will post it immediately either here or on Twitter.
We may have to wait till Monday. Although I think she would would of stated that fact.
Thx for the update.
By the way in case you did not see it on Twitter. FDA states "no info to report at this time" I received the email personally!
@Investor666 Brian
$PATH Update from FDA. No info to report at this time!
Let's hope so. Cash/sh $2.46
I'm in for a small amount. If we get a CRL I'll be down a little. I can always average down. On the other hand if we are approved I'll make a few bucks. I think there is much more upside than down at these prices.
Ok thanks for the info.
If it is, I would expect after close of market...could be early in the week as well.
Is today the day?
I find myself, like the rat, no longer caring about the cheese, just wish I could get out of the trap.
DDay approaches, we will see what that brings us.
NuPathe Migraine Patch Faces Decision Day
By Brett Chase Aug 19, 2011 1:15 pm
The patch was shown to be effective and safe in company studies. Investors bailed following a sale of stock to one investor.
At the end of the month, the small specialty drug company NuPathe (PATH) will learn whether its patch for migraine headaches can be sold in the US. A number of investors are choosing not to hang around and find out.
NuPathe is down more than 50% this year as it inches closer to the August 29 deadline for the Food and Drug Administration to make it decision on Zelrix, a transdermal patch that delivers an older medicine, sumatriptan. The patch uses an electrical current to make sure the medicine is delivered through the skin.
Why do we need a patch to deliver a medicine that’s already on the market? NuPathe says some migraine sufferers delay taking sumatriptan pills when they’re vomiting or even nauseous (common conditions with migraines). NuPathe say these people may be more prone to wear the patch over taking a pill. The company also says the delivery of the medicine may be more consistent using a patch. Citing its own research, the company says the patch may have fewer side effects as existing products, including chest tightening, tingling and numbness of extremities.
The drug was tested against a placebo in company studies and found to be effective and generally safe. As part of its third and last phase of studies NuPathe conducted for approval consideration, the company tested to make sure the patch didn’t cause skin irritation. In a regulatory filing, the company says it may be asked by the FDA to conduct a skin sensitivity study.
The question on approval of Zelrix comes down to the same issues as any other drug application. The FDA weighs the unmet need, the effectiveness and the safety. This isn’t another breakthrough skin cancer treatment. Migraine patients have options for treatment already. The issue of skin irritation or sensitivity already has been raised for this drug. So investors will want to weigh the risk-reward factors that FDA officials are considering here.
In recent weeks, concerns over approval have not been the main catalyst for the sell-off. Investors didn’t like the company’s agreement announced August 2 to sell up to $30 million in stock to one investor, Aspire Capital Fund, over the next two years at an agreed-upon price of $7.07 a share. The deal is seen as dilutive to the stock even though Aspire agreed to buy at a premium to the current share price.
Shares of NuPathe rose 2% to $4.42 in midday trading Friday. The stock is down almost 40% in the past month.
For those investors who believe the company’s drug has a good shot at winning approval, some analysts predict stock will more than triple in the next year.
Leerink Swann analyst Joseph Schwartz is one such bull. He puts Zelrix approval at 90% probability and recommends buying the stock with a 12-month price target of $17 a share.
While it’s potentially a big drug for a small company, bear in mind Zelrix isn’t being touted by anyone as a future blockbuster.
Sales in five years may exceed $200 million, Stifel Nicolaus analyst Annabel Samimy estimates. She recommends buying the stock with a price target of $13 a share.
“We remain optimistic on the Zelrix opportunity and expect it to quickly find its place in the market,” she says in a recent note
I am in the same boat...down so far, may as well roll the dice
Sho;Nuf right there with you.
Funny stuff! I just hope it turns around quickly and they get approval now. I am probably going to hold now through the approval as I am already down!
JMO,
Sho-Nuff
Too bad, huh? LOL :)
On a positive note: We are not overbought
Corporate Presentation
August 16, 2011
http://media.marketwire.com/attachments/EZIR/747/12494_NuPathe_PresentationAugust_16_11.pdf
I'm holding my breath. LOL
Nice action last hour
Yeah would be nice.
Maybe today is the day we close above that $4.95 mark. Looking for higher pps over the next couple of weeks!
JMO,
Sho-Nuff
I'll take $4.70+ today and strive for $4.95 tomorrow! However, I am hoping either way it continues climbing from here!
I would also like to see a lot more volume coming in too!
JMO,
Sho-Nuff
We need to see PATH close above 4.95, the high from 8/5/11.
I sure would like to see PATH hold above $4.70 for the close. This could be the start of an upward trend if it does.
JMO,
Sho-Nuff
The conference call next week may give me a better 'gut feeling' of what I will personally do to with PATH.
GLTYA,
Sho-Nuff
I was reading Sheff's post. Most of the time he dead on. But he has been wrong before. However he does make some good points. Then again nobody gave XNPT, SOMX a chance but they were approved. I guess the bottom line is you have to go with your own gut felling.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=66071837
I haven't decided yet. If we have a major jump in the pps before the date, then I probably won't. If we hang around these prices, then I may take the risk and hold on through it!
Tough decision. What are your thoughts?
JMO,
Sho-Nuff
You guys plan on holding through the PDUFA date?
That would be Sho_Nuff nice
Looks like the pps is settling into a nice range. Hopefully we can break out soon and go back up much higher again!
JMO,
Sho-Nuff
I can't comment on that, as I am a registered equity analyst. however....http://seekingalpha.com/article/284514-top-buy-and-sell-ideas-based-on-wednesday-s-biggest-losers?source=etrade
check out the article with an emphasis on the infamous D word....
it is? Care to fill the rest of us in..
Alright well thanks for nothing, its very obvious why this stock is getting killed anyway.
No that was a tweet from early westerday.
can you send me a link to that tweet?
adam feuerstein.
Followers
|
36
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
724
|
Created
|
10/07/10
|
Type
|
Free
|
Moderators |
Our first commercial product is Zecuity™ sumatriptan iontophoretic transdermal system (patch) for the acute treatment of migraine. We are seeking commercialization partners in the U.S. and worldwide.
In addition, we have a strong pipeline based on our biodegradable implant technology that allows us to deliver therapeutic levels of medication over a period of months with a single dose. NP201, for the continuous symptomatic treatment of Parkinson's disease, utilizes a leading FDA-approved dopamine agonist and is being developed to provide up to two months of continuous delivery. NP202 is being developed to address patient noncompliance, a long-standing problem in the treatment of schizophrenia and bipolar disorder, by providing three months of continuous delivery of risperidone, an atypical antipsychotic. We are seeking a development partner for each of these candidates to capitalize on their commercial potential worldwide.
Beyond our current product pipeline, we intend to be a leader in the rapidly growing transdermal patch market with our active SmartRelief technology, delivering innovative solutions across a range of therapeutic areas.
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |