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Shares of Stemline Therapeutics (NASDAQ:STML) tumbled nearly 37% this morning after investors learned that a patient died in a clinical trial involving its lead drug candidate, SL-401. The news was not reported by the company, but confirmed by the patient's family and first reported by Adam Feuerstein of TheStreet.
Not hearing the news directly from management is bad enough, but the death occurred the day before a Jan. 19 stock offering for $45 million. Worse still, this is the third death to occur in a clinical trial involving SL-401 from a side effect known as capillary leak syndrome, a form of low blood pressure. The company had responded to previous patient deaths by altering dosing regimens, so the recent death hints that the drug may not be safe enough for human use in its current form or dosing.
Safety concerns now seem likely to derail an otherwise effective drug candidate -- an increasingly common theme for next-generation immunotherapy treatments. As Feuerstein writes, in earlier clinical trials "SL-401 has demonstrated robust overall tumor response rates of 84%, including 56% complete or near-complete response in patients enrolled in its clinical trial." The company had previously expected to use phase 2 results to obtain marketing approval for the drug candidate, but that now could be in doubt.
https://www.fool.com/investing/2017/02/02/heres-why-stemline-therapeutics-stock-fell-369-thi.aspx
Side Effect Kills Cancer Patient in Stemline Therapeutics Drug Trial; Company Raises Money
https://www.thestreet.com/story/13975695/1/side-effect-kills-cancer-patient-in-stemline-therapeutics-drug-trial-the-company-raises-money.html
Traded a small amount here, but long term STML looks interesting.
$STML under rader but not by analyst 5 star firms have strong buy on this with price targets as high as $70 getting close!
$STML recent news/filings
bullish
## source: finance.yahoo.com
Mon, 28 Jul 2014 16:01:38 GMT ~ STEMLINE THERAPEUTICS INC Files SEC form 8-K, Other Events
read full: http://biz.yahoo.com/e/140728/stml8-k.html
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Mon, 28 Jul 2014 10:12:42 GMT ~ Stemline Therapeutics Announces Opening of SL-401 Corporate IND and Start of Clinical Trials in BPDCN and AML
[at noodls] - Initiation of Broad Clinical Development Program; Potential Accelerated Approval Path in Multiple Indications NEW YORK, July 28, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced ...
read full: http://www.noodls.com/view/E1EA05B7405808E2309AEC3105E1B8D8A0EB327D
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Mon, 28 Jul 2014 10:00:00 GMT ~ Stemline Therapeutics Announces Opening of SL-401 Corporate IND and Start of Clinical Trials in BPDCN and AML
[GlobeNewswire] - NEW YORK -- Stemline Therapeutics, Inc. announced today the opening of its SL-401 Investigational New Drug (IND) and initiation of a broad clinical development program including trials in blastic plasmacytoid ...
read full: http://finance.yahoo.com/news/stemline-therapeutics-announces-opening-sl-100000404.html
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Fri, 18 Jul 2014 14:01:49 GMT ~ Stemline (STML) Enters Oversold Territory
read full: http://finance.yahoo.com/news/stemline-stml-enters-oversold-territory-140149660.html
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Mon, 23 Jun 2014 21:24:36 GMT ~ STEMLINE THERAPEUTICS INC Files SEC form 8-K, Submission of Matters to a Vote of Security Holders
read full: http://biz.yahoo.com/e/140623/stml8-k.html
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$STML charts
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$STML company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/STML/company-info
Ticker: $STML
OTC Market Place: Not Available
CIK code: not found
Company name: Stemline Therapeutics, Inc.
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Business Description:
$STML share structure
## source: otcmarkets.com
Market Value: Not Available
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$STML extra dd links
Company name: Stemline Therapeutics, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/STML/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/STML/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=STML+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=STML+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=STML+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/STML/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/STML/news - http://finance.yahoo.com/q/h?s=STML+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/STML/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/STML/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/STML/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/STML/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/STML/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/STML/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/STML/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/STML/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=STML+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/STML
DTCC (dtcc.com): http://search2.dtcc.com/?q=Stemline+Therapeutics%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Stemline+Therapeutics%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Stemline+Therapeutics%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/STML/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/STML
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/STML/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/STML/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/STML/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/STML/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/STML/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/STML/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/STML/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=STML&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=STML
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/STML/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=STML+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=STML+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=STML
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=STML
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=STML+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/STML/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=STML+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/STML.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=STML
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/STML/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/STML/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/STML/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/STML/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/STML
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/STML
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/STML:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=STML
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=STML
$STML DD Notes ~ http://www.ddnotesmaker.com/STML
p100k
Roth Capital Reiterates Buy On Stemline Following Initiation Of Clinical Development Program http://www.smarteranalyst.com/2014/07/28/roth-capital-reiterates-buy-on-stemline-following-initiation-of-clinical-development-program/
$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.
Check it our for yourselves: http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=9254269
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Bottomed. Expect it to move soon.
Insiders making big buys at 20$ here. Very good sign, the tides are turning, finally.
Still thinking 50 eoy?
Stemline Therapeutics target raised to $70 at Aegis Capital (29.14 -1.12)
Aegis Capital raises their STML tgt to $70 from $40. Co has reported favorable preclinical data for its lead drug candidate, SL-401, in areas such as multiple myeloma and chronic myelogenous leukemia (CML). In firm's view, market authorization for SL-401 in MM and additional niche hematological malignancies on top of blastic plasmacytoid dendritic cell neoplasm and acute myeloid leukemia could drive peak sales potential from $800mm to over $3bn. Further, Stemline's follow-up candidate to SL-401, known as SL-501, is a variant interleukin-3-diphtheria toxin fusion protein that could be used to target CML as a new product.
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz2jEBkpn66
Big gap up after the political dark clouds are dissipating. True value of excellent management and promising innovation back in sight. STML back above 40$+ by EOW, 50$+ by EOY. Love this company!
Taking a big position here. Tremendous underwriting support. Great pipeline and excellent management. 50$+ by EOY!
Jefferies initiates Stemline Therapeutics with a Buy; shares higher
Stemline Therapeutics (STML +5.7%) moves up today after Jefferies initiates coverage with a Buy and a hefty $60 price target.Jefferies says that STML's lead drug, SL-401, is entering pivotal trials in 2014 for the treatment of BPDCN, a rare lymphoma, and third-line acute myeloid leukemia.The firm views response rates in both settings as robust, including durable complete responses, after a single cycle of treatment, and believes that even better efficacy could be achieved with multiple SL-401 cycles. It estimates SL-401 peak sales of over $500M.
I thought it was very bullish.
Btw, APFC is a beast!!!
Wedbush presentation...
http://wsw.com/webcast/wedbush25/STML/
They may have a replay on their website. It was a wedbush presentation. Very exciting information imo.
They may have a replay on their website. It was a wedbush presentation. Very exciting information imo.
Oh was it? i missed that
I thought the presentation was very bullish
Wedbush 2013 Life Sciences Management Access Conference updates would be available here
http://www.earningsimpact.com/OnDemand.aspx
STML presentation @ JMP Healthcare conf...
http://wsw.com/webcast/jmp21/stml/
SL-401 receives Orphan Drug designation in BPDCN. A pivotal registration trial is expected to start in early 2014.
NEW YORK, June 10, 2013 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML) today announced that SL-401 has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive hematologic malignancy for which there is no effective treatment. SL-401 also has Orphan Drug status for the treatment of acute myeloid leukemia (AML).
SL-401 is a novel targeted therapy directed to the interleukin-3 receptor (IL-3R) present on tumor bulk and cancer stem cells (CSCs) of multiple hematologic cancer indications. SL-401 has demonstrated single agent clinical activity in patients with advanced hematologic cancers, including BPDCN, AML, and myelodysplastic syndrome (MDS).
"We are focused on the rapid development of SL-401 due to its potential for the treatment of IL-3R-expressing hematologic malignancies," commented Eric K. Rowinsky, M.D., Chief Medical Officer and Head of Research and Development at Stemline. "SL-401 is demonstrating robust clinical activity in heavily-pretreated patients with BPDCN who are refractory to available therapies, including high-dose chemotherapy and allogeneic stem cell transplantation. This Orphan Drug designation provides us with a number of benefits that further strengthen our SL-401 program. Stemline will progress SL-401 into pivotal trials in BPDCN and AML in the near-term, and we will continue to evaluate SL-401 in a wide range of additional IL-3R-expressing hematopoietic malignancies."
About Orphan Drug Designation:
Orphan Drug designation is granted by the FDA's Office of Orphan Products Development for drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. Orphan Drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for Orphan Drug grants; and waiver of Prescription Drug User Fee Act (PDUFA) and certain other administrative fees.
About Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN):
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and aggressive hematologic cancer for which there is no effective treatment, carries a poor prognosis and represents an unmet medical need. BPDCN had previous names, including blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm, until 2008 at which time the World Health Organization (WHO) renamed this disease BPDCN. The disease most commonly affects middle-aged and older patients and is approximately three times more common in men than women. BPDCN derives from plasmacytoid dendritic cells, which are specialized cells of the immune system. BPDCN cells express high levels of IL-3R. BPDCN, which has features of both leukemias as well as lymphomas, typically presents with skin lesions, and often also involves the bone marrow and blood, and can also involve the spleen and lymph nodes. BPDCN proliferation in the bone marrow results in decreased blood cell counts, which can lead to serious infections, anemia, bleeding, and invariably death. Although BPDCN can be controlled for brief periods with standard chemotherapy, including high-dose chemotherapy with bone marrow transplantation, overall prognosis remains poor and the median overall survival from diagnosis is approximately 12 months. There are currently no approved therapies for BPDCN, and an optimal therapeutic regimen for BPDCN has not yet been established.
About Stemline:
Stemline Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel oncology therapeutics that target both cancer stem cells (CSCs) as well as the tumor bulk. Stemline's clinical candidates, SL-401 and SL-701, have demonstrated clinical activity, including durable complete responses (CRs), in Phase 1/2 studies of patients with advanced hematological and brain cancer, respectively. For more information about Stemline Therapeutics, visit www.stemline.com.
Stemline's June 2013 Corporate Presentation can be downloaded here
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Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel oncology therapeutics that target both cancer stem cells (CSCs) as well as the tumor bulk. Among Stemline's drug candidates are SL-401 and SL-701, both of which have demonstrated single agent clinical activity in Phase 1/2 studies of advanced cancer patients.
In a multicenter Phase 1/2 trial in patients with advanced hematologic cancer, SL-401 demonstrated single agent activity in multiple indications, including durable complete responses (CRs) in relapsed or refractory acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), and an overall survival (OS) improvement relative to historical data in the most heavily pre-treated patients. In addition, SL-401 was well-tolerated and was not toxic to the bone marrow. SL-401 is being advanced into a pivotal Phase 2b trial in patients with BPDCN and a registration-directed Phase 2b study in patients with advanced AML. In Phase 1/2 trials, Stemline's second clinical stage therapeutic, SL-701, has demonstrated single agent activity including durable CRs and partial responses (PRs) in adult patients with refractory or recurrent glioblastoma and pediatric patients with malignant glioma, as well as an OS benefit in adult patients with refractory or recurrent glioblastoma compared with historical data. SL-701 is now poised for later stage trials in pediatric and adult patients with advanced brain cancer.
Stemline is also developing a broad portfolio of preclinical small molecules and antibodies for a variety of solid and hematological cancer types. Many of these compounds have derived from the Company's proprietary discovery platform, StemScreen®. Stemline also possesses a landmark portfolio of intellectual property that includes the earliest filings in the CSC field covering CSC-directed therapeutics, diagnostics, and drug discovery.
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