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Anyone still in SVON? It's been pretty quiet, lately. Just a slow drip, drip, drip...
Here's what sheff said...
$heff Member Level Monday, 08/03/15 10:27:00 AM
Re: $heff post# 88786
Post # of 89416
$SNGX..$1.50: Soligenix Enters $10 Million Equity Purchase Agreement http://t.co/p6hbvhHhNx $SNGX hit low of $1.39 this morning. On watch
Everyone seems to be bailing on AVXL. Do you think that the data from the Phase 2a clinical trial of ANAVEX 2-73 will be bad?
Actually, SYN an excellent guess, as it turns out...
interesting, ENZN closed at 1.50 per Schwabs Streetsmart, oh well, what's pennies amongst friends anyway... I see yahoo had it at 1.57...
I had bought ENZN at 1.67, sold at 1.56. didn't like the action. I see it closed at 1.50, so maybe this time I got it right...
Actually, IMNP it's on the 26th...
I'm in the process of bailing on ARNI, now. down about 20%, enough for me...
Here's everything I have on ARNI...fyi, BS stands for Bob Stocks
--------------------------------------------------------------
5/11/15… BS ARNI Pick in at .99 ...Soros, Frost and presenting at ASCO
ARNI Make sure to get some of this also...thinking it hits $1.50 plus
ARNI once it breaks $1.00...it will go nicely...and it will happen
5/12/15... BS ARNI 0.91 Presenting 3 Abstracts at ASCO, Soros and Frost are big holders
Outstanding Shares 20,408,616
Float 7,000,000
ARNI will have three abstracts presented on Saturday, May 30. Abstract #TPS5615 will provide an update on the phase II trial of onapristone in patients with metastatic or recurrent endometrioid tumors that express the activated progesterone receptor. Abstract #5051 will provide an update to the phase 1/2 trial of onapristone in patients with castration-resistant prostate cancer whose tumors are progesterone receptor-positive. Abstract #5593 will be present the findings of a phase 1 dose escalation study of onapristone in women with progesterone receptor-expressing tumours.
On April 30 ARNI announced the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), has designated AR-12 as an orphan medicinal product for the treatment of two separate infectious diseases, cryptococcosis and tularaemia.
(Source http://www.microcapdaily.com/here-comes-arno-therapeutics-inc-otcmktsarni/110959/)
BS... ARNI Will be a great play going into ASCO...thinking it hits $1.50 plus...link back for DD
BS... ARNI thinking it moves to over $1.50 at least...float is small and market cap is only around 18 mill
BS... ARNI added at .93-94
5/13/15... ARNI 1 of 3 Abstract....
Background: ONA is a type I PR antagonist, which prevents PR-induced DNA transcription. Immediate release (IR) 100 mg ONA was active in multiple preclinical models and in patients (pts) with breast cancer (BC). We conducted a phase 1 study of extended release (ER) ONA to (i) determine a recommended dose and (ii) explore the role of transcriptionally-activated PR (APR), detected as an aggregated subnuclear distribution pattern, as a predictive immunohistochemical (IHC) biomarker. Methods: An open-label, multicenter, randomized, parallel-group, phase 1 study (target n=48; NCT02052128) included female pts =18 years with PRpostumors. APR analysis was performed on archival tumor tissue. Pts were randomized to 5 cohorts of ER ONA tablets 10-50 mg BID, or IR 100 mg QD until progressive disease or intolerability. This abstract reports the APR IHC analysis and clinical benefit (PR/SD=24 wks). Results: Phase 1 is complete (n=52). Tumors (n) were: endometrial carcinoma (EC) 13; breast cancer (BC) 20; ovarian cancer (OC) 13; other 6. Median age was 66 (37-85). No dose limiting toxicity was observed with only transient liver function test elevation, mostly related to liver metastases. PRpos/APRpostumors (n/n) were: EC 11/6, BC 8/3, OC 5/1, other 2/0 and 8 pts (6 BC) had missing/non evaluable IHC. Median therapy duration was 8 wks (range 2-44), and 8 pts had clinical benefit =24 weeks (see Table).
Conclusions: Clinical benefit was seen in heavily-pretreated pts with EC, OC and BC. Data support ongoing ONA development at 50mg ER BID in APRpos uterine endometrioid cancer with clinical validation of the APR diagnostic. Meanwhile, further development of APR IHC is needed in OC and BC.
ARNI news.... http://finance.yahoo.com/news/arno-therapeutics-announces-data-validating-213019447.html
FLEMINGTON, N.J., May 13, 2015 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced promising data supporting the ongoing clinical development program for lead compound onapristone to be presented at the upcoming 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29-June 2 in Chicago, IL.
Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics, commented, "Results from our Phase 1 study in women with progesterone (PR) positive tumors have been immensely informative and critical to the advancement of our onapristone clinical development program. In addition to demonstrating clinical benefit in a group of heavily pre-treated patients, the study demonstrated that Arno's highly purified onapristone extended-release formulation has a very manageable safety profile, providing the recommended dose for the Phase 2 study currently underway. Additionally, results from the first portion of our Phase 1/2 study in men with advanced castration-resistant prostate cancer (CRPC) confirm the very acceptable safety profile of onapristone. We look forward to sharing details of these two studies and providing an update on our ongoing Phase 2 trial in women with recurrent or metastatic endometrioid cancer that expresses the APR at the upcoming ASCO Annual Meeting."
Data from the three accepted abstracts are outlined below.
Abstract TPS5616 (Poster 168b) -- Phase 2 clinical study of onapristone (ONA) in patients (pts) with uterine endometrioid adenocarcinoma (EC) expressing the activated progesterone receptor (APRpos)
Presenting Author: Jacques Bonneterre, MD, PhD, Centre Oscar Lambret
5/14/15...BS ARNI the great thing they said they are are gonna release more data at ASCO ...and you know it's gonna be positive
5/15/15... after-hour news: http://finance.yahoo.com/news/arno-therapeutics-announces-preclinical-data-201500912.html
BS... ARNI nice news AH yesterday...Orphan drug status
http://finance.yahoo.com/news/arno-therapeutics-announces-preclinical-data-201500912.html
gotta love those glitches...keeps the heart pumping :)
us too :)
ditto on that jbem...
MRNS, was it because of this push out to Q1 2016?
• Adult Focal Onset Epileptic Seizures:
Enrollment is ongoing in Marinus's Phase 3 clinical trial evaluating ganaxolone in adults with drug-resistant focal onset epileptic seizures. The multi-national, placebo-controlled study is designed to enroll up to 300 patients. Patients are being randomized to receive either placebo or 1,800 mg/day of ganaxolone for 12 weeks. The primary endpoint of this trial is change in seizure frequency per month compared to baseline. Marinus anticipates releasing top-line data in the first quarter of 2016.
Welcome back, you'll need a vacation to recover from your vacation :)
CRMD Bob, when you wrote in the fourth sentence "All that does bother me as they are the only one that have the rights to market this product in the US. " Did you mean "All that DOESN'T bother me..."
I'm assuming you did, but, you know what happens when you assume...
CPRX, musthave, with the offering price set at $3.25 now, what do you see a good entry price? TIA
pharma, Are you a buyer of OCRX at these levels?
MEIP, I bought some more @ 4.31, I'll just be patient, haven't lost anything until I sell :)
kei, I was very lucky.. Bob's positive attitude on EDAP was why I bought again. I had bought some in June and sold and then bought some in Dec. and sold those, both with a small profit.
I think I will hold this buy for awhile and see where it takes me. With earnings and the PMA, we should see some nice upward movement.
EDAP, I'm holding, also. I bought 12,700 shares yesterday at 2.34 and since I'm down about about $26,000 on MEIP, I think I'll just see if EDAP can make me whole :)
Nice, when MEIP gets back to $8.00, I'll be in the black :}
Sheff, Do you still have the $MEIP you added on 11/03/14 at $8.00?
POZN ... now what I wonder?
FinancesStocks
$POZN POZEN Inc. and Sanofi US Mutually Agree to Terminate U.S. Partnership for PA8140/PA32540 http://stks.co/h1Mip
POZN ... now what I wonder?
FinancesStocks
$POZN POZEN Inc. and Sanofi US Mutually Agree to Terminate U.S. Partnership for PA8140/PA32540 http://stks.co/h1Mip
POZN, from twitter Jason Napodano, CFA ?@JNapodano 1h1 hour ago
Pozen gets 3 more US patents to protect Vimovo >> http://investors.pozen.com/phoenix.zhtml?c=121701&p=IROL-NRText&t=NewsRelease&id=1980666&highlight= … $POZN $HZNP
Bob,
Got this from twitter, seems like quite a bit of selling...
ARNInsiderTrades
POZEN CEO John Plachetka Sells $262,972 in $POZN http://stks.co/h19hs
This doesn't sound that bad for MACK...
June 19 (Reuters) - Merrimack Pharmaceuticals Inc :
* To regain worldwide rights to develop and commercialize MM-121
* Says has reached an agreement with sanofi to regain worldwide rights to
develop and commercialize mm-121
* Says sanofi will continue to fund the existing mm-121 phase 2 program for the
next six months
* Source text for Eikon [ID:nBnz1FQ20F]
* Further company coverage
((Bangalore Newsroom; +1 646 223 8780))
For Reuters Top News page click the following link:
ADMP...He tweeted this on 5/8/14
Joe Springer ?@JoeSpringer 2h
$ADMP Update: 46 page monstrosity that I'm whittling down into English, very bullish especially on PFS to be big success and soon..
NAVB from May 7th Brent Larson (CFO)
Got this from the seekingalpha transcript.
Before I end, I do want to note one other corporate housekeeping matter, which I had mentioned previously in our year-end earnings call. The company's current shelf registration statement was originally filed in 2011 and is now expiring. As we have outstanding financial instruments which contracts to the acquirers to have an active registration statement, we will be filing in the next few days a shelf registration statement in order to continue to meet our obligations and abide by prudent corporate governance.
That is for all intention and purposes, a replacement shelf that will have the same original amount and cover the same basic types of instruments as the expiring shelf, basically a replacement to the previous instrument. However based on the financial strength recorded by our recent financing with Oxford finance and our existing line of credit with platinum, coupled with our growing revenue, we have no current plans to utilize this shelf.
And finally we’d like to let investors know that we have scheduled our annual meeting. It will be held on Thursday, July 17 at 09:00 a.m. in Dublin, Ohio. Proxy materials related to that meeting will be filed in the coming weeks and distributed to shareholders as appropriate.
ADMP...Tweet from Joe Springer, the article he alludes to should get us back moving on up...
Joe Springer ?@JoeSpringer 27m
Just got off the phone with $ADMP CEO Dr. Carlo, I think it's a real winner, I'll try to have article done in 1 week..
ADMP...Tweet from Joe Springer, the article he alludes to should get us back moving on up...
Joe Springer ?@JoeSpringer 27m
Just got off the phone with $ADMP CEO Dr. Carlo, I think it's a real winner, I'll try to have article done in 1 week..
Excellent news, thanks for the update.
Of course, my prayers for a full recovery are with the two young girls. What I don't understand is why it will take up to two days to get a search warrant for the 19 yr olds car, according to the news reports.. Seems a little wacky to me...
From flare9x on sheffs board,,,
IGXT DD - PDUFA Feb 3rd 2014
Institutional Ownership Summary
12.96% Holder - BLUMONT CAPITAL CORP In @avg Price of 0.575 – Holds 6,467,645 shares
4.97% Owner - AGF INVESTMENTS INC. – Shares: 2,286,000
9.2% Owner - Northern Rivers Capital Management Inc. -- Shares: 2,328,800 shares of Common Stock and Warrants to purchase 699,000 shares of Common Stock
Insider Ownership
CEO - Zerbe Horst G – Shares: 4,709,643.5
Total insider ownership: 23%
Share Structure
Market Cap: 29.55M
Shares Outstanding: 51.30M
Float 33.9M
Cash of $2.2 million as at March 31, 2013
52-Week High (8 Jan 2013)3: 0.75
52-Week Low (8 Mar 2013)3: 0.45
Catalyst
PDUFA Feb 3rd - Anti-Migraine VersaFilm(TM) Oral Film Product
http://www.marketwatch.com/story/intelgenx-announces-fda-acceptance-of-new-drug-application-for-anti-migraine-versafilmtm-oral-film-product-2013-06-18
The product is a novel, oral thin-film formulation, based on IntelGenx' proprietary VersaFilm(TM) technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT(R) orally disintegrating tablets. The FDA confirmed that IntelGenx' application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.
IntelGenx had previously announced a successful pre-NDA meeting with the FDA following the completion of a bioequivalency study demonstrating that its oral film product is bioequivalent with Maxalt MLT(R), a leading branded anti-migraine product manufactured by Merck. According to Merck's most recent annual report, sales of Maxalt(R) were $638 million in 2012. The thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialisation agreement with RedHill RDHL +1.45% (tase:RDHL) using IntelGenx' proprietary immediate release "VersaFilm(TM)" drug delivery technology.
The drug inside IGXT's Versafilm product -- Rizatriptan
http://en.wikipedia.org/wiki/Rizatriptan
Rizatriptan (trade name Maxalt) is a 5-HT1 agonist triptan drug developed by Merck & Co. for the treatment of migraine headaches. It is available in strengths of 5 and 10 mg as tablets and orally disintegrating tablets (Maxalt-MLT).
The patent protection on Maxalt has now expired....
Company Presentation
http://www.slideshare.net/fullscreen/ViralNetwork/intelgenx-corporate-presentation/1
Interview with CEO – Seekingalpha
http://seekingalpha.com/article/1157681-intelgenx-ceo-provides-insight-into-the-company-s-catalysts
Partnerships
In 2010, IntelGenx and Redhill Biopharma (RDHL) entered into a co-development and licensing agreement. Under the terms of the agreement, IntelGenx is responsible for the development of the product, including formulation and clinical development, regulatory affairs, as well as manufacturing scale-up and commercial manufacturing, while Redhill is responsible for funding the project. Redhill is also responsible for identifying a commercialization partner for the product. In return, the parties will share any revenues from royalties and milestone payments at varying rates based upon defined parameters.
Partnership details:
Partnership Link: http://yahoo.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHTML1?ID=8986092&SessionID=jlOvFqxOZWVY8T7
Pages 39/40
License Agreement for RHB-103
On August 26, 2010, we entered into a joint development and commercialization agreement with IntelGenx Corp. under which IntelGenx Corp. granted us a worldwide, exclusive and perpetual license to use its rights in patents and know-how relating to a triptan formula based on the VersaFilm TMtechnology and which we call RHB-103.
The license includes the right to grant sublicenses. The license covers the co-developing, selling, offering for sale and importing the product for all indications, including, but not limited to, acute treatment of migraine attacks with or without an aura and all other therapeutic, diagnostic, and other human /or animal uses.
The license provides that IntelGenx Corp. reserves the right to grant licenses to manufacture the product, subject to the approval of a steering committee. The agreement further limits our right to grant sublicenses by requiring that we give prior notice to IntelGenx Corp. of the identity of any proposed sub-licensee and provide IntelGenx Corp. with information regarding the main elements of the proposed sublicense agreement. If IntelGenx Corp. objects to a sublicense, the proposed sublicense will be presented for the approval of a steering committee.
Pursuant to the agreement, the parties agreed on joint product development activities. Accordingly, IntelGenx Corp. agreed to devote sufficient resources (subject to the approved budget in the agreement) in order to conduct clinical trials and file an application with the U.S. Food and Drug Administration for marketing of the product, and we agreed to finance the balance of the development in the amount of approximately $849,000, subject to deviations of 10%.
The joint development of the product is to be conducted through a steering committee, comprised of an equal number of members appointed by us and IntelGenx Corp. The committee is charged with supervising progress of our research and development efforts, reporting on possible delays and deciding on required revisions in the plan. IntelGenx Corp. has the deciding vote in any vote relating to issues of development, regulation and manufacture, while we have the deciding vote in any vote relating to issues of licensing, commercialization and collaborations.
In consideration for the license, we made up-front and milestone payments in the aggregate amount of $600,000 and we are required to make additional milestone payments of up to $700,000 as follows:
• $200,000 upon the filing of an NDA and acceptance of the filing by the U.S. Food and Drug Administration; and
• $500,000 upon receipt of U.S. Food and Drug Administration marketing approval for the product.
In addition, we are required to make royalty payments to IntelGenx Corp. of 20% of net sales if the product is marketed by us and 60% of the first $2 million of net sublicense fees, and 40% of net sublicensing fees thereafter, in if the product is marketed by sublicensees. However, if we bear the regulatory costs in a sublicense arrangement, royalties will be 20% of net sublicense fees until we recover these costs, plus 10% interest, and if IntelGenx Corp. bears such costs, royalties will be 70% of net sublicense fees.
Aegis Capital Research Report
http://www.thelifesciencesreport.com/cs/user/download/co_file/4164
Author - Raghuram Selvaraju, Ph.D. - Head of Healthcare Equity Research, Aegis Capital Corp
http://www.aegiscapcorp.com/raghuram-selvaraju/
Aegis Capital Corp - Price Target
Our 18-month price target for IGXT is $3.00 per share
A little more info about 12.96% Owner Blumont Capital Corp
Blumont Capital Corp
http://www.blumontcapital.com/investment_management.html
Hugh C. Cleland is an executive vice-president and portfolio manager at BluMont Capital Corp
http://www.thelifesciencesreport.com/pub/htdocs/expert.html?id=7733
The Life Sciences Report Interview with Hugh Cleland
http://seekingalpha.com/instablog/1256651-life-sciences-report/1992542-small-cap-biotechs-with-blockbuster-potential-hugh-cleland
Where is everybody?
Add my 47,127 shares purchased between May and Sept of 2011 to the 98,000.
TTNP... notes from AF's column today...
Jason M. writes, "Hey Adam I want to know if you would have the time or maybe shoot me a short email about the company Titan Pharmaceuticals (TTNP_). I have been holding since the 3 cents per share and have been buying up and down ever since. I have a cost average of 40 cents per share now and I am still up pretty big. I want to know if you think the FDA will approve or reject this drug. ... I am thinking about getting out of Titan if we hit the $3 mark."
The doubling of Titan's stock price since December seems mostly attributable to the run-up trade into the FDA approval decision for Probuphine on April 30. Titan has said it expects FDA to convene an advisory panel in March to review Probuphine but no definitive word yet, which has me wondering if FDA decided a panel wasn't necessary.
My prediction: FDA approves Probuphine. I don't see any glaring problems with the results from the two phase III studies in opioid addiction. Probuphine is an implantable, long-acting form of buprenorphine, which in oral forms is already approved and widely used to treat opioid addiction.
I'm less confident about the commercial potential for Probuphine. Depending on how much Titan shares run into the April 30 FDA decision, you could easily see the stock sell off post-approval. Drug reformulations have a tough time garnering sales, particularly in markets where they compete against cheaper generics.
-- Reported by Adam Feuerstein in Boston
This week's #Biotech Stock Mailbag --> http://bit.ly/XdrbTY $NWBO $AMRN $TTNP
RPTP...from twitter (gantosi) $RPTP just had a phone call with Georgia Erbez CFO, it's absolutely not ATM they have enough cash after the agreement with Royalty &get $25M
TSRX -
SAN DIEGO, Jan. 23, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) today announced that the underwriters of its previously announced public offering of common stock that priced on January 17, 2013, have exercised their option to purchase an additional 869,135 shares of common stock. With the sale of the additional shares, Trius will have sold a total of 7,169,135 shares of common stock in the public offering at a price to the public of $4.75 per share, resulting in expected aggregate gross proceeds to Trius of approximately $34.1 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Trius. The offering, including the sale of the additional shares, is expected to close on or about January 24, 2013, subject to customary closing conditions.
Trius anticipates using the net proceeds from the offering for general corporate purposes, including clinical trial, preclinical and other research and development expenses, capital expenditures, working capital and general and administrative expenses.
Citigroup and Leerink Swann acted as joint book-running managers and Baird acted as a co-lead manager in the offering.
The securities described above were offered by Trius pursuant to two shelf registration statements previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on September 15, 2011 and September 11, 2012. Prospectus supplements related to the offering have been filed with the SEC and are available on the SEC's website at http://www.sec.gov. Copies of the prospectus supplements and accompanying prospectuses relating to these securities may also be obtained from Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at 1-800-831-9146 or email at batprospectusdept@citi.com or from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, via telephone at 1-800-808-7525 or email at Syndicate@Leerink.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.