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Does anyone have an update on Urigen?
If and when they get through Phase 2 then this will be a nice takeover target?
Big money coming into pharma stocks could give this a boost.
Maybe the comcany has some news coming that will help?
Up 61% today on low volume
Urigen Pharmaceuticals, Inc. (PINKSHEETS: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced that it has received $300,000 in a financing transaction. The financing was in the form of 2-year Convertible Notes, with a 10% coupon, convertible at $0.10 per share, with 100% warrant coverage. The Warrants are exercisable for a period of five years at an exercise price of $0.125 per share.
The net proceeds of the transaction will be used primarily for general corporate purchases, including supporting the activities required to bring the Company into compliance with its reporting requirements of the Securities and Exchange Commission, and to advance the Company's lead development program, URG101 for the treatment of interstitial cystitis/painful bladder syndrome.
Dan Vickery, MBA, PhD, Chairman, commented, "With this financing we continue to build on the platform we have created, and guide both URG101 toward further clinical development, and strengthen Urigen's corporate development."
About Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals, Inc. is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for urological disorders. Urigen's lead program targets significant unmet medical need and major market opportunities in urology. Urigen's URG101, a proprietary combination of approved drugs that is instilled into the bladder, targets interstitial cystitis / bladder pain syndrome, which affects approximately 10.5 million men and women in North America. For further information, please visit Urigen's website at http://www.urigen.com.
Forward-Looking Statement
This press release may contain forward-looking statements. These statements may be identified by the use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," or "will," or the negative thereof or other variations thereon or comparable terminology. Urigen has based these forward-looking statements on current expectations, assumptions, estimates and projections. While Urigen believes that these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond its control. Given these risks and uncertainties, investors and security holders are cautioned not to place undue reliance on such forward-looking statements. Urigen does not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments.
fifty cents coming
baby steps for approval
Can any kindly explain the meaning of this:"The FDA agreed to
our proposal that the next clinical trial would be a single dose 4 arm contribution of components study
and that this trial would satisfy the Combination Drug Rule."
Thanks.
maybe 6-8 months
can anyone update on the status?
everyone talks about fda approval, but isn't that a long way away?
they still need to do a study and then try to get approval.
"The FDA agreed to our proposal that the next clinical trial would be a single dose 4 arm contribution of components study and that this trial would satisfy the Combination Drug Rule."
how long will it take to complete this study and how long after this will they get approval?
anyone??
truly, it seems that this company, if it can do what it claims, should be worth a heck of a lot more than this...could do 0.5-1 billion in sales annually, putting this way above 10 dollars per share.
it was fixed .06 vs .046 a 30% spread
must be the mm's trying to make some big money?
good luck to them tring to get that spread
Fidelity Investments has the ask price 57% than the bid price?
.046 vs .080 ?
Maybe all the week hands will be dumping this week due to the instability of the corporate organization structure. Once they
release the new organization chart then investors may be calmed?
They do need to keep the share structure intact to keep stability, if they have to dilute then we could fall much lower long before (if and when) we get FDA approval.
You hit right on. It remind me back of a stock I used to hold and no one was trading it and it was around 4 to 5 cents per share. That compc was VRML. The Compnay was banckrupt and then their was approved by the FDA. The stock then skyrocketed almost to $34 per share in less than six months.
I hope the same thing would happen with URGP.
I just don't think there's a lot of people waiting for news in the form of updates on this stock. I think everyone involved with this one is just waiting for the fda approval, and that's it. I did expect a little increase today, but it doesn't matter in the long run, because if they get approval all our shares will be bought out at a nice pps anyway.
what a disapointing day
Keep an eye open for changes in the institutional ownership.
When this begins to increase then stock this stock will rise rapidly.
I got an order in for another 30K if it stays low?
My shares average at .07, so if we jump too quickly then I probably won't jump to much past my average. But I'm looking for some more this week if the pps stays low.
Anyone else going to buy more sheres this week?
That I do not know, maybe heading to greener pastures
They remain large shareholders?
I've got to agree. This all seems very positive, but what's with all the management switches?
Get ready for the ride
back into trials
Get ready for a huge move?
Direction is set for URGP so now it is safe to say that this can now head past 60-90 cents by years end. If clinal trials show stellar results before then then this can trade between $1-3/share up until the FDA approval then sales and production kick in.
Urigen Development and Management Update
Walnut Creek, June 30, 2011 -- Urigen Pharmaceuticals, Inc. (OTCPK: URGP), a specialty pharmaceutical
company focused on the development of treatments for urological disorders and pain, announced a
development update and management changes.
Urigen Pharmaceuticals confirmed it had successfully held a type C guidance meeting with the FDA in
order to get FDA’s input on the proposed program to develop URG101. Lowell Parsons, MD said “The
meeting went very well and the FDA was very helpful in providing positive advice and direction.
Importantly, the FDA agreed with Urigen’s plan to develop URG101 for the treatment of acute flares of
Interstitial Cystitis (IC/BPS) and provided input on the proposed outcome measures. The FDA agreed to
our proposal that the next clinical trial would be a single dose 4 arm contribution of components study
and that this trial would satisfy the Combination Drug Rule. In addition, the FDA had positive feedback
on the overall scope of our clinical development plan, including the proposed size of the safety database
to support a 505(b)2 NDA, given that URG101 has a large treatment effect and the safety of the
components are known.”
Urigen also announced that Martin Shmagin has resigned as CFO, and as a Director of the Company.
CFO duties will be managed through separate consulting arrangements with appropriate financial
consultants. Mr. Shmagin remains a significant shareholder in Urigen.
Dan Vickery, MBA PhD has become the Chairman and Secretary of the Company. In addition, through a
service agreement with BioEnsemble, Ltd., an entity which Dr. Vickery controls, he is now providing full
management services to the Company. The Board, in addition to Dr. Vickery, also includes Prof. C. Lowell
Parsons, and Ed Teitel, MD, JD. Dr. Vickery has experience in Business Development, Regulatory Affairs,
and urology Commercial Development. Dr. Parsons developed Elmiron, approved by FDA in 1996 for the
relief of bladder pain or discomfort associated with interstitial cystitis. Dr. Vickery noted “the board
continues to work toward positioning Urigen for success, by focusing on the development of the intrinsic
value that resides in URG101, and we plan to bridge from our successful meeting with FDA to continue
with that process.”
About Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals, Inc. is a specialty pharmaceutical company dedicated to the development and
commercialization of therapeutic products for urological disorders. Urigen's lead program targets
significant unmet medical need and major market opportunities in urology. Urigen's URG101, a
proprietary combination of approved drugs that is instilled into the bladder, targets interstitial cystitis /
bladder pain syndrome , which affects approximately 10.5 million men and women in North America.
For further information, please visit Urigen's website at http://www.urigen.com.
Forward-Looking Statement
This press release may contain forward-looking statements. These statements may be identified by the
use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "might," "plan," "potential," "predict," "should," or "will," or the negative
thereof or other variations thereon or comparable terminology. Urigen has based these forward-looking
statements on current expectations, assumptions, estimates and projections. While Urigen believes that
these expectations, assumptions, estimates and projections are reasonable, such forward-looking
statements are only predictions and involve known and unknown risks and uncertainties, many of which
are beyond its control. Given these risks and uncertainties, investors and security holders are cautioned
not to place undue reliance on such forward-looking statements. Urigen does not undertake any
obligation to update any such statements or to publicly announce the results of any revisions to any
such statements to reflect future events or developments.
SOURCE: Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals, Inc.
Dan Vickery, MBA, Ph.D.
Chairman
925-280-2861
http://www.urigen.com
could go either way but the move up will be dramatic
I didn't go that high, but I am in for some more too! Let's hope our gamble pays off!
I grabbed another 40000 today
I think any week now a letter will come from the FDA
This stock will rise over 1000% if they get a direction to precede
with clinical trials. Then $4-8 within 18 months after
I knew getting into this I was going to need patience, but what's your thought on some news coming out? You seem to have some idea of the process and it's timeline.
Maybe if all goes well
Maybe back to this level soon?
it would be nice
It's a huge gamble
If the FDA comes back with a positive direction then ...yes, This is a less than 25% of happening
They may refuse to allow any more phase 2+3 studies or may make them start all the way back to phase 1 along with several questons
that need to answered. It would cost them millions if this happens. I do not think they are in a good position if this happens. Read thier website
Many people that work there remain very positive
According to one of the other boards, this has a 1 yr. target of $9.00 They must be up to something serious to expect that.
Time to jump back in
something to watch?
The long wait to see what direction comes from the FDA
Buyers will poor in if the news is positive and a $1-2 trading range will be in the cards. Two cents or less if the news is bad?
For now everyone is staying away until that PR is released
lots of risk in this one
the volume seem very low to me. very little interest from buyers at this time. I am long this stock waiting for news. the 25% up on monday made up for the 25% down on friday, not much volume either day.
They are still waiting to hear from the FDA
do we know when this meeting is?
FDA Meeting
Urigen continues to prepare for the upcoming FDA type C meeting and has made progress in preparing questions and meeting materials. Dan Vickery, PhD, said, "We have crystallized our thinking about the regulatory strategy and pivotal study designs for the URG101 NDA, which we believe can be filed using the 505(b)(2) pathway."
Debt Restructuring
In preparation for the FDA meeting, Urigen has raised additional funding from Platinum-Montaur Life Sciences, LLC who restructured $461K of debt into a Senior Unsecured Promissory Note in the amount of $611K which included a new Senior Unsecured Promissory Note in the amount of $150K.
Management
Urigen is clarifying the press release of July 6, 2010 in which the Company announced that Lowell Parsons, MD, was appointed Chief Medical Officer; Dr. Parsons has never signed an employment agreement with Urigen and is not an officer of the company. While Dr. Parsons acts in the capacity of Chief Medical Officer, Urigen is clarifying that the position is honorary, and he has not been compensated. The board thanks him for his time and effort to move URG-101 forward in development. Going forward, Dr. Parsons intends to enter into a consulting agreement with the company for the provision of research and development services.
my crystal ball is cloudy
What sort of price appreciation should we expect to see with this equity?
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