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DRR$X $1.95 trading halted.
Ventrus Phase 3 trial of Diltiazem showed no significant difference to placebo
Ventrus Biosciences announced top line efficacy and safety results from the second Phase 3 clinical trial of Diltiazem Hydrochloride 2% Cream, or VEN 307 in patients with pain related to anal fissure. VEN 307 efficacy was as expected; placebo effect greater than anticipated, resulting in no significant difference between treatments. Data demonstrate an excellent safety profile. The company plans to request pre-NDA meeting with FDA to determine next steps. In this randomized double blind trial comparing diltiazem 2% cream versus placebo cream in 434 subjects in 90 centers globally, both treatment arms demonstrated a clinically meaningful improvement. The diltiazem 2% treatment arm demonstrated no significant improvement compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation. The mean of worst AF-related pain score at baseline was 7.09 for diltiazem 2% and 7.18 for placebo, decreasing to 3.81 and 3.72 respectively. Outcomes for the secondary endpoints of overall AF-related pain and PGI-I parallel the primary endpoint. Age, gender, and race were equivalent between arms, and results were not meaningfully different between countries. Inasmuch as a primary purpose of this second Phase 3 trial was to complete the safety data package for a New Drug Application (NDA) with the FDA, Ventrus will request a pre-NDA FDA meeting to determine next steps in the program. Because diltiazem is approved in oral formulations for the treatment of angina and high blood pressure, VEN 307 is eligible for the FDA's 505(b)2 registration pathway.
http://yhoo.it/1dk6YYB
Huh??????????
Thanks for the explanation.
VTUS actually its not the only "pony". They also have ven 308 for fecal incontinence.
http://bit.ly/NCfBUY
I'm still holding. VTUS has 46% institutional ownership.
$VTUS halted, news pending.
$VTUS halted, news pending.
Thanks LJ
Do you have a link for that?
This is news from yesterday. LOL
If institutional investors want to buy some MSTX put up 30mil shares for sale yesterday with an ATM. I don't see them stepping up to the plate yet. But who knows.
$BONE
Bacterin to Present at the Leerink Global Healthcare Conference
BELGRADE, Mont.--(BUSINESS WIRE)--
Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of revolutionary bone grafts and coatings for medical applications, today announced that its CEO, Dan Goldberger, and CFO, John Gandolfo, will present at the Leerink Global Healthcare Conference, to be held February 12-13, 2014 at the Waldorf Astoria Hotel in New York. Bacterin's presentation will take place Thursday February 13, 2014 at 3:30 PM EST.
A live broadcast of the conference presentation will be available. To access the broadcast, go to the "Investor Info" section of the Company's website at www.bacterin.com. A replay of the conference presentation will also be available.
http://yhoo.it/1h4Kyhl
Have it as you will, the shares are still for sale and when they do it is dilution.
There is no "if at all" in there. They will be sold "over time" at the market. Look at it how you want to but it is still dilution.
$MSTX I sold today because of the 30 million plus shares that are coming at the market. Definite dilution.
Item 1.01. Entry into a Material Definitive Agreement.
On February 10, 2014, Mast Therapeutics, Inc. (the "Company") entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") to sell shares of its Common Stock, par value $0.001 (the "Common Stock"), having an aggregate offering price of up to $30,000,000 (the "Shares") from time to time, through an "at-the-market" equity offering program (the "ATM Offering") under which Cowen will act as sales agent.
The offer and sale of the Shares will be made pursuant to the Company's effective "shelf" registration statement on Form S-3 (File No. 333-179989), the base prospectus contained therein, dated May 1, 2012, and a prospectus supplement related to the ATM Offering, dated February 10, 2014.
http://bit.ly/1gmJv7O
I think the selling is due to the atm shelf they activated. Dilution.
MSTX activates shelf to sell up to $30m in stock.
http://bit.ly/1lVvfK5
MSTX activates shelf to sell up to $30m in stock.
http://bit.ly/1lVvfK5
$GEVA and I just sold it this morning for a small profit to buy $STML. LOL
$STML $22.66 Bought a small position @ $21.39, appears to have bottomed.
Balance Sheet
Total Cash (mrq): 87.67M
Total Cash Per Share (mrq): 6.93
Total Debt (mrq): 0.00
Total Debt/Equity (mrq): N/A
Current Ratio (mrq): 31.09
Book Value Per Share (mrq): 6.81
Share Statistics
Avg Vol (3 month)3: 219,929
Avg Vol (10 day)3: 201,762
Shares Outstanding5: 12.66M
Float: 9.62M
% Held by Insiders1: 9.68%
% Held by Institutions1: 11.20%
Shares Short (as of Jan 15, 2014)3: 424.19K
Short Ratio (as of Jan 15, 2014)3: 3.00
Short % of Float (as of Jan 15, 2014)3: 7.50%
Recommendation Summary*
Mean Recommendation (this week): 2.3
Mean Recommendation (last week): 2.3
Change: 0.0
* (Strong Buy) 1.0 - 5.0 (Sell)
Price Target Summary
Mean Target: 33.75
Median Target: 38.00
High Target: 50.00
Low Target: 9.00
No. of Brokers: 4
Data provided by Thomson/First Call
Upgrades & Downgrades History
Date Research Firm Action From To
Aug 29, 2013 Jefferies Initiated Buy
Jul 29, 2013 Roth Capital Initiated Buy
Jun 18, 2013 Ladenburg Thalmann Initiated Buy
Mar 18, 2013 Aegis Capital Initiated Buy
Feb 12, 2013 WBB Securities Initiated Sell
http://yhoo.it/MxG6K9
NEW YORK, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 16th Annual Biotechnology Industry Organization (BIO) CEO & Investor Conference on Tuesday, February 11, 2014 at 11:30 AM ET. The conference will be held at the Waldorf Astoria in New York on February 10-11, 2014. A live webcast of the presentation can be viewed on the Company's website at www.stemline.com.
NEW YORK, Feb. 6, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 3:30 PM ET. The conference will be held at the Waldorf Astoria in New York City. A live webcast of the presentation can be viewed on the Company's website at www.stemline.com.
$STML $22.66 Bought a small position @ $21.39, appears to have bottomed.
Balance Sheet
Total Cash (mrq): 87.67M
Total Cash Per Share (mrq): 6.93
Total Debt (mrq): 0.00
Total Debt/Equity (mrq): N/A
Current Ratio (mrq): 31.09
Book Value Per Share (mrq): 6.81
Share Statistics
Avg Vol (3 month)3: 219,929
Avg Vol (10 day)3: 201,762
Shares Outstanding5: 12.66M
Float: 9.62M
% Held by Insiders1: 9.68%
% Held by Institutions1: 11.20%
Shares Short (as of Jan 15, 2014)3: 424.19K
Short Ratio (as of Jan 15, 2014)3: 3.00
Short % of Float (as of Jan 15, 2014)3: 7.50%
Recommendation Summary*
Mean Recommendation (this week): 2.3
Mean Recommendation (last week): 2.3
Change: 0.0
* (Strong Buy) 1.0 - 5.0 (Sell)
Price Target Summary
Mean Target: 33.75
Median Target: 38.00
High Target: 50.00
Low Target: 9.00
No. of Brokers: 4
Data provided by Thomson/First Call
Upgrades & Downgrades History
Date Research Firm Action From To
Aug 29, 2013 Jefferies Initiated Buy
Jul 29, 2013 Roth Capital Initiated Buy
Jun 18, 2013 Ladenburg Thalmann Initiated Buy
Mar 18, 2013 Aegis Capital Initiated Buy
Feb 12, 2013 WBB Securities Initiated Sell
http://yhoo.it/MxG6K9
NEW YORK, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 16th Annual Biotechnology Industry Organization (BIO) CEO & Investor Conference on Tuesday, February 11, 2014 at 11:30 AM ET. The conference will be held at the Waldorf Astoria in New York on February 10-11, 2014. A live webcast of the presentation can be viewed on the Company's website at www.stemline.com.
NEW YORK, Feb. 6, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 3:30 PM ET. The conference will be held at the Waldorf Astoria in New York City. A live webcast of the presentation can be viewed on the Company's website at www.stemline.com.
$STML Worth reading. http://bit.ly/MxAfUV
RS: You may have seen that Stemline Therapeutics Inc. (STML:NASDAQ) stock has appreciated substantially during January. This represents a reawakening to the fact that this company is the only cancer stem cell-focused company that actually has an abbreviated path to market approval with its lead drug SL-401 (recombinant human interleukin-3 coupled to a truncated diphtheria toxin payload that inhibits protein synthesis). You and I talked about this last July.
"The IPO window is going to remain open for biotech companies."
This drug is focused on a niche hematological malignancy called blastic plasmacytoid dendritic cell neoplasm (BPDCN), which affects a very small number of people and, as such, essentially qualifies as an ultraorphan disease. Therefore, SL-401 potentially qualifies for breakthrough therapy designation. An abbreviated pathway to approval could position the drug to be priced at a very premium level, meaning hundreds of thousands of dollars per year, just like other drugs currently available for other ultraorphan diseases.
In addition, Stemline Therapeutics, in late September of last year, disclosed that it had demonstrated the activity of SL-401 preclinically in chronic myelogenous leukemia (CML). This is the disease that Novartis AG's (NVS:NYSE) Gleevec (imatinib mesylate), a receptor tyrosine kinase inhibitor, was originally developed to treat. Gleevec is currently a $4 billion ($4B)/year franchise scheduled to go off patent in 2015, but its substantial size as a commercial franchise clearly demonstrates what an important market opportunity CML is.
Because Stemline appears to have a drug that is active in CML and, more important, works as a single agent as well as synergistically with Gleevec—and a drug that demonstrates activity against CML cells that are resistant to currently available tyrosine kinase inhibitors—we think there's substantially greater upside to the stock than investors imagine. The stock's recent rebound is primarily due to investors reawakening to the fact that the company is well financed for the next two years and could, in fact, have a drug on the market next year for the niche ultraorphan BPDCN market.
We have a $70 price target on Stemline, which is the highest on the Street. We believe investors are undervaluing the company's unique positioning and not giving it sufficient credit for what could potentially be a game-changing therapy in CML.
TLSR: You believe investors are undervaluing this stock because they are focused on the BPDCN indication, which only represents 2,000 patients each year, and don't understand the potential for CML?
RS: I don't believe any value is being ascribed to Stemline's SL-401 in CML. Stemline doesn't have an active clinical development program in CML as of yet, but we expect it to start one before the end of this year. The preclinical CML data were presented by a researcher from the MD Anderson Cancer Center at a very small conference in Portugal last year. No buysider (money manager or money manager analyst) that I know of attended that conference. The company did not get the attention it would have at the American Society of Clinical Oncology (ASCO) meeting, where everybody shows up and potential therapies become common knowledge in the biotech investment community.
TLSR: Even with its 56% increase in share value during January, I'm noting Stemline still only has a market cap of $400 million ($400M).
RS: Yes. But prior to this recent run-up, Stemline was the cheapest publicly traded cancer stem cell company in the market. We believe it ought to be the most highly valued of this group. Comparing OncoMed Pharmaceuticals Inc. (OMED:NASDAQ), Verastem Inc. (VSTM:NASDAQ) and Stemline Therapeutics, we think Stemline should have the highest valuation because it's the closest to commercialization, and could come to market first with a drug commanding ultraorphan-level premium pricing.
TLSR: Ram, I find it interesting that SL-401 is thought to increase in efficacy with subsequent administrations. This is quite the opposite of what we see in most oncology therapeutics.
RS: That is absolutely correct. We've seen this before, in a related drug called Ontak (denileukin diftitox; Eisai Inc. [ESALF:OTCPK]), which was originally brought to market by Ligand Pharmaceuticals Inc. (LGND:NASDAQ). Ontak, like SL-401, demonstrated the ability to increase in efficacy as more cycles were administered. In addition the safety profile—its tolerability—improved as more cycles were administered. Because it's an immunotherapy, the immune system of the cancer patient was essentially becoming more acute, more trained.
TLSR: Ram, in your notes you've made a point of describing SL-401 as a targeted therapy. Tell me about that.
RS: SL-401 is effectively delivering a toxic payload, in this case diphtheria toxin, specifically to the cancer cells. SL-401 contains the receptor-binding domain of interleukin-3 (IL-3), which homes to tumor cells and cancer stem cells that specifically express the interleukin-3 receptor (IL-3R) at high density on their cell surfaces. The cells internalize the diphtheria toxin, which kills the cells off.
"Investors must question the nature of the opportunity. They not only have to look at the competitive landscape, but they also have to look at the company's drugs and understand what they are."
SL-401 also activates the immune system against the cancer cells. In particular, if you administer this therapy in multiple cycles, it tolerizes the immune system to its presence just as Ontak did. The more cycles you administer, the lower the frequency of adverse events, including injection site reactions, as well as the higher the likelihood of getting a positive response on the cancer front. This is the best of both worlds.
$FPMI ditto on that one. Waiting for $ATOS to go back up tp $2.37 to dump that loser.
Yes they do. That's what I stick with during these corrections.
The difference between entry price $2.84 vs stop loss point $2.64 is .10 (turns out to be a 7% stop loss)
Wouldn't that be .20 difference?
$CBMX would like to see this break above the 200 dma and hold it.
Nobody gets their entries perfect. LOL
That's why I like to play the PDUFAs.
Yes it does depend on what type of trader you are. I'm doing well. Thanks for the kind words.
ero with $ONCS I think about it in MY terms......TA. and news when applicable.
$CHTP PDUFA
$CHTP PDUFA
Yesterday the market was up and so was $CHTP. Today the market is down and so is $CHTP, so who knows. If the market was up today I think $CHTP would be up. JMO
Did you expect to see the market down also?
$MSTX LOL
This is his opinion only; doesn't mean its going to happen. IMO if it does, $3.92 is it.
$GEVA $86.02 added shares @ $86.16