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It's about time to cut the grass.
Baker Bros buying BCRX again. I know they have been in since 09 or before.
http://archive.fast-edgar.com//20160125/A4AZ6G2CZZ22QZZU22Z92ZZH39BKZB22ZG86/
New Bioinvest Med Tech Stock Letter - Met with ZIOP Mgt Team - 2016 Will See Clinical Data & Multiple Trials Launched - Expect more partnerships this yr - ZIOP is a BUY under 12 with a TARGET PRICE of 20
ZIOP – 2016 Will See Clinical Data & Multiple Trials Launched
We saw its presentation and met separately with ZIOP’s management team at the JP Morgan conference and came away impressed with their clinical development plans for 2016. The most advanced trials are the two evaluating the powerful immune cytokine, IL-12, against the highly lethal brain cancer, recurrent glioblastoma (GBM) and breast cancer. The GMB trial has already delivered data showing that neurotoxicity is both minimal and manageable since IL-12 expression is regulated by ZIOP’s RheoSwitch. Data will be presented in early June at ASCO and given the very short life expectancy of GMB patients we may even see survival data. The trial in breast cancer patients is designed to assess IL-12’s ability to impact disease progression. In addition, the trial should confirm an increase in memory T cells – a a sign that the patient’s immune system is fighting the cancer. A third IL-12 trial will start later this year and will combine the IL-12 gene therapywith a checkpoint inhibitor, possibly against GBM, – potentially highly efficacious combination. Preclinical data supporting the combination will be presented at the American Society of Gene and Cell Therapy meeting in early May.
In 2016, ZIOP will start two CD19-CAR T cell trials, with the first one incorporating a second-generation Sleeping Beauty in patients who have had a hematopoietic stem cell transplant for advanced B-cell lymphoma or leukemia. The second trial will use CD19-CAR T cells incorporating a lentiviral vector to treat myeloid malignancies. ZIOP will also begin a trial of allogeneic natural killer cells (derived from umbilical cord blood) to treat acute myeloid leukemia, in 2016. This was one of Dr. Cooper’s pet research projects at MD Anderson.
ZIOP is positioned for a busy and productive 2016 in the clinic. In addition, to the six trials discussed above, their partner Merck KGa will have two other trials up and running in 2016 using ZIOP’s second-generation gene therapy technology. We expect the company to sign additional corporate partners during the year which would add further clinical development drug candidates. In our view, the IL-12 program to treat GBM could serve as a significant catalyst with potential survival data at ASCO. Positive GBM data could move the drug into a pivotal trial by year end.
ZIOP is a BUY under 12 with a TARGET PRICE of 20
5:09 am Affimed Therapeutics collaborates with Merck (MRK) to investigate the combination anti-PD-1 therapy, KEYTRUDA (AFMD) :
Affimed (AFMD) announced that it has entered into a clinical research collaboration in immuno-oncology with Merck (MRK)
Under the terms of the agreement, Affimed will fund and conduct a Phase 1b clinical trial to investigate the combination of Merck's anti-PD-1 therapy, KEYTRUDA, with Affimed's proprietary drug candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with the marketed antibody-drug-conjugate AdcetrisTM (brentuximab vedotin).
Merck will supply Affimed with KEYTRUDA for the clinical trial. The purpose of the study is to establish a dosing regimen for this combination therapy and assess its safety and efficacy.
Affimed is on track to initiate the study in the first half of 2016.
Low Wednesday was. 65.
Abraxas Petroleum Corp. (AXAS) -NasdaqCM ? Watchlist
1.02 Up 0.0773(8.20%) 4:00PM EST
After Hours : 1.02 0.00 (0.00%) 4:25PM EST
IMO it is a very good long term hold. Read the ZIOP board on Investors Village. Especially Rob Cos.
ZIOP is up 6.36% pm. Maybe the shorts are finally going to cover?
RBC Capital maintained an Outperform rating on Synthetic Biologics (NYSE: SYN) with a price target of $8.
Ocean Power Technologies, Inc. Announces APB350 (A1) PowerBuoy Achieves Significant Performance Milestones
PENNINGTON, N.J., Jan. 20, 2016 (GLOBE NEWSWIRE) -- Ocean Power Technologies, Inc. (Nasdaq:OPTT) today announced that its APB350 (A1) PowerBuoy® has achieved several significant milestones. Total cumulative deployment time has exceeded 125 days and energy generated has surpassed 1,000 kWh (1MWh). In addition, a new maximum generation record of 32 kWh of energy for a 24-hour period was achieved. The APB350 A1, deployed off of the coast of New Jersey, has communicated key performance as well as meteorological data from the buoy's integrated weather station.
George H. Kirby, President and Chief Executive Officer of OPT, stated, "We continue to be very excited by the A1's overall performance, specifically its power generation in extreme ocean conditions. The A1 results are significant as it continues to confirm design robustness and demonstrates measurable progress toward commercial readiness on three key focus areas: the PTO; the survivability of the PowerBuoy system during high sea states; and the linear seal, which prevents water from entering the buoy."
Dr. Mike M. Mekhiche, OPT's Vice President of Engineering, stated, "In addition, the A1 has provided critical design, performance, and in-ocean operating data. The new 24-hour energy record is 3.8 times its nameplate daily rating of 8.4 kWh, which is a 14% improvement over the previously reported record.”
Dr. Mekhiche continued, “The A1 also demonstrated its ability to generate sufficient power at very low sea states, which is further confirmation of the PTO efficiency improvements as compared to the original design. These improvements expand the buoy's mission persistence and endurance capabilities in terms of providing required power to its payload over longer “zero wave” periods. This persistence is critical for a variety of autonomous offshore power markets of interest.”
OPT also announced that it will retrieve the A1 for necessary inspection, repairs and maintenance. The PowerBuoy has been deployed since October, and it will be redeployed at the earliest available weather window. Upon redeployment, sea trials of the A1 will continue off the coast of New Jersey to further validate the buoy reliability and survivability with periodic inspections as needed.
Dr. Mekhiche stated, “Further progress was also made on the ALT testing, which continues to validate the PTO design and generate important data on its reliability and life. The ALT process consists of operating PTOs in tandem with accelerated operating profiles, which subjects the PTOs to various load conditions encountered in extreme sea states. The objective of the test is to simulate an equivalent three-year ocean deployment during a period of approximately nine months using PTOs that are identical to those of the A1. The ball screw PTO has traveled the equivalent of approximately 1,200 km so far, corresponding to approximately 1.8 million strokes, without any mission critical issues. The PTO ALT, which is currently operating 24/7, has already exceeded the deployed A1 PTO in terms of strokes and total distance traveled by the PTO.
Mr. Kirby concluded, "We continue to believe that the combination of sea trials, ALT, and feedback from the Technical Advisory Panel are helping us shorten our product's validation and market introduction time. We are receiving significant commercial interest resulting from the positive sea trials and ALT results, which supports our goal of 2016 commercialization.”
About Ocean Power Technologies
Headquartered in Pennington, New Jersey, Ocean Power Technologies (Nasdaq:OPTT) is a pioneer in renewable wave-energy technology that converts ocean wave energy into electricity. OPT's proprietary PowerBuoy® technology is based on a modular design and has undergone periodic ocean testing since 1997. OPT specializes in cost-effective and environmentally sound ocean wave based power generation and management technology.
Forward-Looking Statements
I can't believe it is that low. Wish I had several thousand to throw at it.
I like SYN long term.
Synthetic Biologics, Inc.
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Synthetic Biologics Reports Positive Topline Data from Second Phase 2 Clinical Trial of SYN-010 in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
Download as PDF JANUARY 19, 2016
-- SYN-010 Demonstrated Ability to Reduce Methane Production, Abdominal Pain and Bloating, and Improve Stool Frequency and Quality of Life Scores in IBS-C Patients --
-- Conference Call Wednesday, Jan. 20, 2016, at 8:30 a.m. (ET); Mark Pimentel, MD, FRCP(C) Featured Guest Speaker --
ROCKVILLE, Md., Jan. 19, 2016 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused on developing therapeutics to protect the gut microbiome, reported that the second Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C) met its primary endpoint.
Synthetic Biologics, Inc.www.syntheticbiologics.com
Topline data from all patients who completed the second Phase 2 clinical trial of SYN-010 showed a statistically significant decrease in methane production (p=0.002) from the beginning of the first Phase 2 study (Study 1 baseline - Day 1) to the end of the second Phase 2 study (12 weeks of treatment - Day 84), thus meeting the study's primary endpoint. There were no serious adverse events observed.
Topline data from the second Phase 2 study also showed improvements in secondary efficacy endpoints, including:
A statistically significant reduction in the mean IBS Symptom Severity Score (IBS-SSS; p<0.0001), which includes abdominal pain, bloating, stool frequency and quality of life scores, for all patients from Study 1 baseline to the end of the second Phase 2 study.
An increase in the percentage of patients identified as Monthly Responders, an FDA-defined composite measure incorporating improvements in complete spontaneous bowel movements (CSBMs) and abdominal pain.1
"These topline data demonstrate the positive effect of SYN-010 on decreasing gut methane production, abdominal pain and bloating, and improving stool frequency and quality of life scores in IBS-C patients who are breath-methane positive," said Dr. Pimentel, Director of the GI Motility Program and Laboratory at Cedars-Sinai, and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board. "Current IBS-C treatments are focused on relieving symptoms. These latest SYN-010 findings, along with previously reported topline data, strongly suggest a potential role for SYN-010 in treating a major underlying cause of IBS-C by reducing the production of methane in the gut, versus relieving symptoms."
This second Phase 2, open-label SYN-010 clinical trial was conducted for eight weeks at multiple centers in the United States. The primary endpoint of this extension study was to evaluate the sustainability of the effect of one daily dose strength (42 mg) of SYN-010 on breath methane production in breath methane-positive patients with IBS-C. Secondary endpoints included evaluation of the reduction in abdominal pain and bloating, the improvement in stool frequency and overall quality of life. Fifty-four patients, who completed the first Phase 2 clinical trial of SYN-010 (a four-week study of patients randomly assigned to receive placebo, a 21 mg SYN-010 dose or a 42 mg SYN-010 dose once daily), rolled over into the second Phase 2 clinical trial of SYN-010.
"Meeting the study endpoints and demonstrating positive clinical outcomes in this Phase 2 trial of SYN-010 bring us closer to offering a therapeutic to the millions of people who suffer from IBS-C," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "During the first half of 2016, we anticipate reporting detailed results from this Phase 2 clinical trial and requesting an end of Phase 2 meeting with the FDA. Concurrent with the analysis of the Phase 2 data, we are actively planning the Phase 3 program for SYN-010."
Conference Call
Synthetic Biologics' management will host a conference call tomorrow, Wednesday, Jan. 20, 2016, at 8:30 a.m. (ET), along with featured guest speaker, Mark Pimentel, MD, FRCP(C), Director of the GI Motility Program and Laboratory at Cedars-Sinai, and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board. The dial-in information for the call is as follows: U.S. toll free: 1-888-347-5280 and International: +1 412-902-4280.
Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/12885. An archive of the call will be available for approximately 90 days at the same URL https://www.webcaster4.com/Webcast/Page/1096/12885 beginning approximately one hour after the call's conclusion.
About SYN-010
SYN-010 is a proprietary, modified-release formulation of lovastatin lactone that is intended to reduce methane production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome to treat an underlying cause of IBS-C. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting a major cause of IBS-C, not just the symptoms. To access the SYN-010 mechanism of action video on Synthetic Biologics' website, please click here.
About Synthetic Biologics' Breath Methane Publication in Alimentary Pharmacology & Therapeutics
Synthetic Biologics' peer-reviewed article titled "Inhibition of Methanogenic Archaea by Statins as a Targeted Management Strategy for Constipation and Related Disorders", evaluating the therapeutic potential and mechanism of action of certain statins in inhibiting the production of methane was recently published in the journal Alimentary Pharmacology & Therapeutics. The article describes observational and experimental studies which show a strong correlation between the production of methane by the dominant methane-producing microorganism in the gut, M. smithii, and slowed stool transit in the intestines commonly seen in patients with IBS-C. To access the online publication, please use the following link: http://onlinelibrary.wiley.com/doi/10.1111/apt.13469/epdf.
About Irritable Bowel Syndrome
IBS affects an estimated 10 to 15 percent of the population, or as many as 45 million people in North America. The illness affects both men and women; however, two-thirds of diagnosed sufferers are women. It has been reported that up to 20 percent of all IBS patients have IBS-C and current FDA-approved therapies for the treatment of IBS-C, which include prescription and over-the-counter laxatives, do little to treat the underlying cause of the disease. These products provide patients with temporary relief from the symptoms of constipation by elevating the amount of water which passes through the gastrointestinal tract, but tend to cause an IBS-C patient to swing from suffering from constipation, to suffering from diarrhea.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company's lead candidates in Phase 2 development include: (1) SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD), and (2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (NYSE: XON), a preclinical stage monoclonal antibody for the prevention and treatment of Pertussis and discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.
This release includes forward-looking statements on Synthetic Biologics' current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the potential of SYN-010 to reduce methane production for the treatment of IBS-C, the ability of SYN-010 to protect the microbiome, the size of the market, the anticipated timing of the reporting of detailed results from the Phase 2 trial and an end of Phase 2 meeting with the FDA, and initiating a Phase 3 clinical trial of SYN-010. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics' forward-looking statements include, among others, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a failure of Synthetic Biologics' clinical trials to receive anticipated funding, a failure of Synthetic Biologics' products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics' inability to maintain its licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics' report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
1 A Monthly Responder is defined as a patient who has a Weekly Response in at least 50% of the weeks of treatment during the month. A Weekly Responder is defined as a patient who experiences a decrease in weekly average score for worst abdominal pain in the past 24 hours of at least 30% compared with Study 1 Baseline and a stool frequency increase of 1 or more CSBM per week compared with Study 1 Baseline.
Logo - http://photos.prnewswire.com/prnh/20160105/319502LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/synthetic-biologics-reports-positive-topline-data-from-second-phase-2-clinical-trial-of-syn-010-in-patients-with-irritable-bowel-syndrome-with-constipation-ibs-c-300206500.html
SOURCE Synthetic Biologics, Inc.
Released January 19, 2016
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before_its_news • 13 hours ago
The Money Show - Top Picks 2016: Ziopharm
By: John McCamant
MORE ON: STOCKS
STOCKS
Our Top Pick for 2016 is a great example of the recent disconnect between a Company’s fundamentals and its stock price, observes John McCamant, editor of The Medical Technology Stock Letter.
In our view, 2015 has seen Ziopharm (ZIOP) transform itself into one of, it not the leader in gene therapy for the treatment and possible cure(s) for certain cancer.
The MD Anderson partnership opened the flood gates at ZIOP as it led to Dr. Cooper joining as CEO (from MD Anderson) and the subsequent Merck KGaA and NIH partnerships.
ZIOP’s key technologies are the patented Sleeping Beauty non-viral gene delivery system and the RheoSwitch that controls (on, off, or titrates) a gene’s expression in vivo.
The company has a broad list of potential gene therapies in development as both mono and combination therapies including cytokines (IL-2, IL-12, IL-15), first- and second-generation CAR-Ts, Natural Killer (NK) cells, and T-cell receptor (TCR) cells.
In our view, Dr. Cooper is the ideal CEO to execute, leverage, and deliver value to ZIOP shareholders.
His unparalleled, encyclopedic knowledge of immune-oncology will allow ZIOP to mix and match the various technologies that will be required to deliver off-the-shelf gene therapy solutions for both blood and solid tumors.
One of the keys to unlocking ZIOP’s tremendous potential this year will be the formation of several value-added partnerships (academic and corporate).
In addition, Dr. Cooper knows intimately every single I/O program in development (when he was at MD Anderson earlier last year every company in the world was trying woo him to do a deal with his labs by showing him their respective I/O platforms).
Not only did ZIOP win the prize in the MD Anderson collaboration, the company’s technology platform is so attractive that it lured Dr. Cooper out of academia. As a result, in our view Dr. Cooper now has the upper hand with all corporate business development transactions.
2016 should be a transformative year as ZIOP and their partner Intrexon (XON) unveil their plans and data at scientific symposia to tackle a broad spectrum of solid tumor types including GBM (brain), neuroblastoma, breast, prostate, colorectal, head & neck, and gastric cancers.
Futhermore, the results and advantages using the RheoSwitch and Sleeping Beauty should really begin to differentiate ZIOP from the rest of the pack.
In our view, the company has built an impressive industry leading armamentarium of gene therapy tools enabling the development of off-the-shelf gene therapies that will allow ZIOP to cost efficiently tackle virtually all the major cancer markets listed above, not just niche indications.
Phase II data and corporate partnerships have significant potential to serve as strong catalysts for ZIOP’s share price. ZIOP is a buy under $12 with a target price of $18.
LLTP
By TAMMIE SMITH Richmond Times-Dispatch | Posted 3 days ago
A company that packages an opioid overdose reversal drug in an easy-to-use nose spray is making the product available at a discount price to cities and other public agencies through a purchasing program.
Adapt Pharma, which has U.S. headquarters in Radnor, Pa., is partnering with the National Association of Counties, the National Governors Association, National League of Cities and U.S. Conference of Mayors, to offer Narcan Nasal Spray at a discounted price of $37.50 per dose ($75 for a two-pack) through the U.S. Communities Purchasing Alliance and Premier Inc.
The wholesale acquisition cost for a carton of two nasal Narcan sprays is $125, and Adapt Pharma expects broad insurance coverage with co-pays, a company spokeswoman said.
“U.S. Communities, along with our partners, are proud to have joined forces with Adapt Pharma to help fight this epidemic and to facilitate public agencies’ access to this potentially lifesaving medication,” said Chris Robb, general manager of U.S. Communities.
Overdose deaths from opioid prescription painkillers and heroin have reached epidemic proportions in the U.S., according to the federal Centers for Disease Control and Prevention.
In 2014, there were 47,055 drug overdose deaths in the U.S., up 6.5 percent from 2013, according to the CDC. Sixty-one percent of the drug overdose deaths in 2014 involved an opioid, including heroin.
Drug overdose deaths in Virginia rose from 854 to 980 in 2014, a 14.7 percent increase, according to the CDC.
Narcan Nasal Spray was approved for the emergency treatment of opioid overdose by the U.S. Food and Drug Administration in November. It is the first FDA-approved nasal spray version of naloxone hydrochloride, a drug that has been available as an opioid antidote for years.
Naloxone hydrochloride also is the drug delivered by Evzio, an autoinjector device created by Richmond-based Kaléo pharmaceutical. Kaléo makes its product available to people who can’t afford it through its Kaléo Cares program.
TLSmith@timesdispatch.com
(804) 649-6572
http://m.richmond.com/business/article_f2d26fd1-fa37-598d-84f3-1789d7df4544.html?mode=jqm
XON/ZIOP.
XON patent (Rheo Switch IN the gene) - Weds Cooper 1st time noted how important)-Methods & Compositions for Diagnosing Disease by introducing into cells of subject a diagnostic gene switch construct & monitoring expression of a reporter gene..
Cooper for the first time Weds mentioned the importance of the Rheo Switch insertion IN the cell....when listening to the replay take into account this new patent
http://www.freepatentsonline.com/9222121.pdf
There is a reason MD Anderson - the largest cancer clinic in the world - thinks XON/ZIOP will be "The company most likely to cure cancer" Check out Table 1 & 2
Check out Axas for an Oil stock.
Is WW 3 about to happen or what? Holy Moly Guacamole.
Researchers Kill Drug-Resistant Lung Cancer With 50 Times Less Chemo
From Science Daily and interesting read!
http://www.sciencedaily.com/releases/2016/01/160114113632.htm
I won on the Powerball! 4 dollars ha ha. Hit the Powerball number 10 and that was it. Life goes on as usual.
CRMD
CEO close.."..EU approved product, Ph 3 in unmet medical need underway...we have Market Cap < $50 million, Cash of $30 million and an Net Operating Loss Carryforward of $38 million....we feel a compelling value" eom
From Benzinga: an unnamed fund forced by NYSE to liquidate at the 2:30 cash close for oil was the culprit of the massive selloff in S&P 500 futures.
Did A Huge Commodity Fund Blow Up Wednesday Afternoon?
Did A Huge Commodity Fund Blow Up Wednesday Afternoon?
Garrett Cook
January 13, 2016 5:28pm Comments
Before you read it here, the story breaks on Benzinga Pro. Try the new Beta edition for FREE!
Did A Huge Commodity Fund Blow Up Wednesday Afternoon?
Related SPY
Tech Stocks Underperforming Other Major Indices, Nasdaq Index Plunges 2.5%
Full Beige Book Text For January 13th 2016
Bull Economy 2 (Seeking Alpha)
Related USO
Crude Surrenders Gains
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Oil And Natural Gas Crisis: How Credit Default Swap Traders Have Been Leading The Way For Equities (Seeking Alpha)
Markets took a beating Wednesday. This week, NYMEX Light Sweet Crude Oil futures fell below the $30 level and commodity-exposed names have been the wet dog in January.
At the cash close for oil futures at 2:30PM on Wednesday, there was a massive sell program running various stocks.
Sources participating actively in the oil trade, both physical trading and warehousing, tell Benzinga an unnamed fund forced by NYSE to liquidate at the 2:30 cash close for oil was the culprit of the massive selloff in S&P 500 futures.
This was seemingly done to mask the selling. Eric Hunsader of Nanex commented on the possibility of unique trading indicating a forced liquidation. He said he saw “no panic selling” and followed up by saying that if there was a planned liquidation, it was likely orderly and flew under the radar.
The past few months have seen many funds coming under pressure. SAB Capital Management returned client money, Renaissance Technologies closed a $1 billion fund, Third Avenue liquidated its Junk Bond fund, the list goes on. The standout is Nevsky Capital, which closed a $1.5 billion fund just eight days ago.
Tangent to a potentially forced liquidation event, two unidentified hedge funds have been absent from the trading floor since the holidays, according to the same sources.
Read more: http://www.benzinga.com/analyst-ratings/analyst-color/16/01/6140714/did-a-huge-commodity-fund-blow-up-wednesday-afternoon#ixzz3xAxXbEZx
ZIOP from JPM a little bit of go.
Q&A "Very encouraged through today IL-12 Glioma - patients since June - PFS weeks - months to death - but these patients are doing well....working with FDA....
Second cohort....we can share data - major inflection point at ASCO....very encourgaged....checkpoint inhibitors not working well....so this is key - MD Anderson single center trial also coming
Dose escalation - quite confident we will get permission from Data Monitoring - we are now accelerating recruitment...- confident enough data to accelerate recruitment
Level of interest in this Glioma trial VERY HIGH - we have had to turn down patients...we are VERY optimistic.
When I win the Powerball tonite I am going to be a majority owner! Ha
Here are links to today's webcasts - Intrexon 11:30 EST, Cormedix 12:30 EST, Ziopharm 4:30 PM (after the close this yr)......
Intrexon Corporation
This presentation will be webcast live on
January 13th, 2016, at 8:30 AM Pacific Standard Time (11:30 PM Eastern)
Location: Colonial Room
http://jpmorgan.metameetings.com/confbook/healthcare16/directlink.php?p=20046
CorMedix Inc.
Event: Biotech Showcase™ 2016
Date: Wednesday, January 13, 2016
Time: 9:30 a.m. (Pacific Time) (12:30 PM Eastern)
Location: Parc 55 San Francisco
http://edge.media-server.com/m/p/5c2n4vsd
ZIOPHARM Oncology
This presentation will be webcast live on
January 13th, 2016, at 1:30 PM Pacific Standard Time (4:30 PM Eastern)
Location: California West
http://jpmorgan.metameetings.com/confbook/healthcare16/directlink.php?p=19649
I came across this while researching something else.
http://www.centerwatch.com/clinical-trials/listings/studydetails.aspx?StudyID=203184
Webcast Link - Weds 12:30 eastern Biotech Showcase San Francisco. 9:30 am eastern
Link for CorMedix Inc.:
http://edge.media-server.com/m/p/5c2n4vsd
CorMedix to Present at Biotech Showcase™ 2016
CorMedix to Present at Biotech Showcase™ 2016
PR CorMedix Inc.
CorMedix, Inc. Earnings Analysis: Q3, 2015 By the Numbers Capital Cube q 19 days ago
CORMEDIX INC. Files SEC form 8-K, Other Events, Financial Statements and Exhibits EDGAR Online 22 days ago
More
BEDMINSTER, N.J., Jan. 6, 2016 /PRNewswire/ -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the Company will present at the Biotech Showcase™ 2016, taking place in San Francisco, CA, on January 11–13, 2016.
Randy Milby, Chief Executive Officer of CorMedix, will provide an overview of the Company's business during his live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference. Meetings with management may also be scheduled outside of Biotech Showcase by contacting CorMedix's Investor Relations Maureen McEnroe; (914) 588-1873.
Event: Biotech Showcase™ 2016
Date: Wednesday, January 13, 2016
Time: 9:30 a.m. (Pacific Time)
Location: Parc 55 San Francisco
A live audio webcast of the presentation will be available on the Investors section of the CorMedix website at www.cormedix.com. The webcast will be archived and available for replay for 90 days.
About CorMedix Inc.
CorMedix Inc. is an emerging commercial-stage biopharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of infectious and inflammatory diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. CorMedix initiated a Phase III clinical study in the United States in December 2015. CorMedix enjoys a solid patent portfolio, and expanding product pipeline, and the important benefits of Fast Track status as well as a Qualified Infectious Disease Product designation. The initial and subsequent products under development will address significant unmet needs in the United States and in the rest of the world. For more information visit:www.cormedix.com.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150
Webcast Link - Weds 12:30 eastern Biotech Showcase San Francisco. 9:30 am eastern
Link for CorMedix Inc.:
http://edge.media-server.com/m/p/5c2n4vsd
Added ZIOP.
NEW YORK, NY / ACCESSWIRE / January 12, 2016 / Rite-Aid & CVS recently stated they will sell naloxone over-the-counter, creating a tailwind for Lightlake Therapeutics (LLTP) as its commercial partner launches their [recently] FDA-approved naloxone nasal-spray. Obama is allocating $133 million in 2016 towards tackling the overdose epidemic by tripling government purchases of [naloxone] to 400,000 units. Lightlake Therapeutics (LLTP) is the only FDA-approved nasal naloxone, but trades at an estimated 1.5x EV/sales compared to peers in the specialty drug space at 4.6x.
Nasal Naloxone Priced In Line With Alternatives Even Though It Offers Greater Benefits
At $70/kit, Narcan - the branded name for LLTP's nasal naloxone- has been competitively priced to alternatives already on the market, Figure 1, below. This pricing strategy came at a time when other specialty pharma companies Valeant, DepoMed et al. have been scrutinized for aggressively raising drug prices. Competing 'auto-injector' naloxone, Evzio, was priced at a significant premium ($575/kit) to alternatives.
Figure 1: LLTP's Narcan Is Competitively Priced While Offering a More Convenient Form of Naloxone
Lightlake's nasal naloxone is designed for the average person to use compared to naloxone in a syringe, which requires a trained medical professional to administer. Presumably, this will drive sales, particularly on shelves in CVS and Rite Aid.
We would also suggest that CVS and Rite Aid set precedent for other national pharmacies (Wal-Mart, Walgreens, Kroger et al.) to follow suit in offering naloxone over-the-counter (OTC), which could create further momentum for LLTP in 2016.
If Valued In-Line with Specialty Pharma, LLTP Shares Worth $30; 200% Above Current Price
If LLTP were priced in line with the average EV/Sales multiple that specialty pharma companies have been assigned, as shown in Figure 3, LLTP shares would be worth $30 today [1].
Figure 2: LLTP Currently Trades at 1.5x EV/Sales; Peers Command 4.6x EV/Sales.
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Adapt Pharma Needs 5% of Opioid OD Market to Justify LLTP at $30/Share
Indivior, a specialty pharma company with deep pockets and experience, was competing with Lightlake in 2015 on being the first company to get a nasal naloxone to market. Indivior's nasal naloxone was ultimately rejected by the FDA one week after the FDA approved LLTP's Narcan. This solidified Narcan as the market leader in the billion dollar opioid overdose market. Indivior had guided for peak sales of $50 - $100 million for their nasal naloxone product.
We conservatively assume that Lightlake's Narcan will generate $50 million in 2016 (or ~5% of the $1 billion opioid overdose market), the low end of Indivior's peak guidance. Adapt agreed to license Narcan from LLTP in exchange for up to double-digit royalties; which we assume to be 8%.
Figure 3: LLTP Could Receive $4.0M in 2016 Royalties
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Under our assumptions, Lightlake would receive $4 million in royalty revenue in 2016. In addition, the company expects [2] to receive a $2.5 million milestone payment from Adapt after the first commercial sale of Narcan in the US and an estimated $1.5 million from first sale of Narcan outside US markets. We also project that Adapt Pharma pays a $4 million milestone based on the $50 million 2016 Narcan threshold the company hits during first year of commercialization. If our projections hold true, Lightlake should see 2016 revenue of $12 million.
Figure 4: Breakdown of LLTP's Expected CY 2016 Revenues of $12M
Why You Should Be Paying Attention To LLTP Right Now
1) Political Funding Allocated to Overdose Pandemic Should Support Narcan's Commercial Roll-out
The President's Fiscal Year 2016 budget includes $133 million in new investments aimed at addressing the opioid epidemic (read more here), including expanding access to naloxone. In his plan, Obama will more than triple the number of naloxone doses provided, from 130,000 in 2013 to 400,000 in 2016[3].
Hillary Clinton's presidential campaign announced a $10 billion plan [4] to combat America's drug and alcohol addiction. The plan looks to boost treatment and ensure first responders have the necessary drugs to stop opioid overdoses from becoming fatal. Similarly, candidate Bernie Sanders pushed [5] to make naloxone more widely available and provide rebates that would lower the cost of the lifesaving drug.
2) CVS & Rite Aid Broadening Naloxone Distribution, Making it Easier for Patients to Buy Narcan
Each year, health care providers write nearly 300 million prescriptions for painkillers, enough for every American adult to have a bottle of pills. A first mover opportunity, and [likely] political influence has pushed pharmacies to make naloxone OTC. Certain CVS and Rite Aid locations are giving patients access to the essential medicine by consulting an in-house pharmacist rather than requiring a prescription from a physician.
In late 2015, CVS announced that it was making naloxone available without prescription in 14 states. Similarly, naloxone is available at Rite Aid in 6 states and the cities of New York and Baltimore [6]. Both pharmacies are reviewing further opportunities to make the overdose drug OTC in other states.
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This move sets a precedent for other nationwide pharmacies like Walgreens and Wal-Mart to follow suit and make naloxone available OTC.
3) LLTP's Valuation Completely Discounts Value of Company's Drug Pipeline
Figure 5: At Current Valuations, Investors in LLTP Get Complementary Access to Company's Pipeline
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LLTP recently announced [7] that they will be testing their opioid antagonist drug in patients with Cocaine Use Disorder, a study that will be funded by National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). With 1.5 million current cocaine users and no FDA-approved treatments, Lightlake's candidate is targeting a $1.8 billion dollar unmet medical need [8].
Own LLTP to Capture Upside from Narcan's 2016 Commercialization
The Clinton Foundation funded EVZIO's distribution, despite the accompanying high price tag, because of the added benefits the auto-injector offered the average individual. This means that government funding will indeed be a tailwind for LLTP's product, which is not only more convenient, but also much cheaper.
Any distribution deals, such as Walgreens and Walmart following suit with making naloxone available OTC in their pharmacies, will act as a catalyst for Narcan's commercial rollout. Whatever the case, CVS and Rite Aid just gave the states with the biggest OD problem access to naloxone. Now the question is if consumers will choose nasal spray (LLTP) over syringe or automated needle?
Since Narcan is FDA approved and out-licensed to Adapt Pharma, a group led by entrepreneurs that founded & sold Azur to Jazz Pharma for $500M in 2011 (a deal now worth $2 Billion), LLTP can move their focus to developing candidates in their pipeline. The company's development strategy has been de-risked moving forward as its foundation revolves around a well-understood drug compound (naloxone).
Even if you place no value on LLTP's pipeline, the NARCAN milestone/royalties in 2016 alone value the Company at $30 a share, or roughly 3X recent market prices.
References & Endnotes
[1] Computation does not include Lightlake's ~4.6 million cashless options. Using a net share settlement feature would allow the company to only deliver the difference between the market price and strike price in issued shares when the options are exercised. At $10, for example, a total of ~580,000 shares would be issued from exercised options, bringing the diluted shares outstanding figure to approximately 2.38 million. The dilutive effect will vary depending on market price at time of exercise.
[2] http://finance.yahoo.com/news/lightlake-therapeutics-inc-receives-milestone-140000544.html
[3] https://www.whitehouse.gov/the-press-office/2015/10/21/fact-sheet-obama-administration-announces-public-and-private-sector
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[4] http://edition.cnn.com/2015/09/02/politics/hillary-clinton-10-billion-drug-addiction-fight/
[5] http://www.sanders.senate.gov/newsroom/press-releases/sanders-cummings-urge-mayors-and-county-officials-to-combat-overcharging-for-critical-drug
[6] http://www.unionleader.com/States-standing-order-makes-it-easy-to-buy-Narcans-generic-equivalent&template=mobileart
[7] http://finance.yahoo.com/news/lightlake-therapeutics-inc-announces-collaboration-140000063.html
[8] http://www.oneequityresearch.com/wp-content/uploads/2015/09/Nasal-Naloxone-Could-Make-2015-a-Hallmark-Year-for-Lightlake-04-17-2015.pdf
About One Equity Research
One Equity Research is a leading provider of proprietary and in-depth research crafted by respected financial analysts and domain experts. Our team includes trained finance professionals with diverse backgrounds that include equity research, investment banking, and strategic consulting at preeminent firms. We distribute our research through mainstream media partners and to subscribers of our Intelligence Service. To learn more please visit http://www.oneequityresearch.com/.
Legal Disclaimer: This research note has been prepared by One Equity Research, LLC ("One Equity") on behalf of Lightlake Therapeutics ("Lightlake" or the "Company") as part of research coverage services. We have received one hundred thirty thousand dollars and seventeen thousand restricted shares of Lightlake for our services as of the date of this report. One Equity intends to sell its shares in the Company as soon as it is legally permissible to do so. We expect to receive additional compensation in the future. This research note is not an offer or solicitation to buy or sell the securities of Lightlake. Information contained in this note is believed to be accurate as of the date of publication. This note is for information purposes only, and is not intended to (and is provided explicitly on the condition that it not) be used as a basis to make any investment decisions. Investing involves considerable risk. One Equity urges all readers to carefully review the Company's SEC filings and consult with an investment professional before making any investment decisions. Investors should make their own determinations whether an investment in any particular security is consistent with their investment objectives, risk tolerance, and financial situation. Please read our full disclaimer at http://www.oneequityresearch.com/terms/.
SOURCE: One Equity Research
SOUTH SAN FRANCISCO, CA--(Marketwired - Jan 12, 2016) - Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that Nasdaq has halted trading in its common stock. The U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) is meeting today to discuss the New Drug Application (NDA) for Probuphine® for the maintenance treatment of opioid addiction.
The Advisory Committee meeting is scheduled to take place from 8 a.m. to 5 p.m. The briefing materials and webcast information can be found on the FDA's web site at www.fda.gov. An agency action date has been set for Feb. 27, 2016.
ZIOP
Msg 41287 of 41296 at 1/11/2016 8:42:35 PM by
Rob Cos
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The following message was updated on 1/11/2016 8:44:21 PM.
Slide deck is excellent-Slide 17 says up to $941 million on 2 targets alone possible...Current mkt cap net of cash is $662 million....
Since they have many one on ones next 4 days they needed to 8K the slide deck....notice page 17 says up to $941 million for two targets recognizes value of CAR T programs and technology
http://ir.ziopharm.com/secfiling.cfm?filingid=1193125-16-425785&CIK=1107421
Right now we are trading above the gap from BEFORE the MD Anderson deal.... as such we have $0 in the price for the following:
1) The groundbreaking MD Anderson deal - the largest cancer clinic in the world. CAR T, Sleeping Beauty, NK Cells, TCR
2) NCI deal with Rosenberg-who recently penned the positive Sleeping Beauty TCR article- (is a Sleeping Beauty NCI deal coming?)
3) Merck Deal CAR T - up to 8 targets - $115 million each two ... total deal could be worth more than entire ZIOP current mkt cap
4) DR Cooper joining us as CEO
5) Data released in 2015
Also we have over $163 million in cash
http://www.investorvillage.com/smbd.asp?mb=16353&mn=41287&pt=msg&mid=15638653
Maybe Shire will do something now that they got their buy in for BXLT.
BIAD news out.
Biopharma’s top brass forms bold new immunotherapy coalition
Biopharma’s top brass forms bold new immunotherapy coalition
coalition
By MEGHANA KESHAVAN
Post a comment / 49 Shares / Jan 11, 2016 at 11:00 AM
scientists
[Story updated to reflect remarks from Dr. Patrick Soon-Shiong at the J.P. Morgan Healthcare Conference]
We’re one step closer to open-source collaboration in the life sciences – and could come a hell of a lot closer to completely revolutionizing cancer treatment – thanks to a promising new alliance formed by the top brass in biopharma.
Meant to accelerate the potential of immunotherapy in treating cancer, The National Immunotherapy Coalition has just been launched by leaders from Amgen, Celgene, GlaxoSmithKline, Merck, and NantWorks – along with Independence Blue Cross and many others. Here’s why:
“We’ve had a 40-year illusion that cancer is a single clone, when it’s really a multiclonal disease,” Soon-Shiong said. “We have pursued cancer the wrong way for 40 years.”
Chemotherapy is too blunt a tool, he says. And while immunotherapy has emerged as a powerful tool to combat cancer, researchers have found that it can work most effectively when different therapeutics are used in tandem to attack different cancers.
However, immunotherapy makers have closely guarded their science – and it’s often left up to the doctors and independent researchers to see whether one monoclonal antibody drug interacts more powerfully in the presence of another. There’s still a significant level of guesswork.
“It’s not good enough to measure just 200 genomes,” Soon-Shiong said. “You need to measure 20,000 genomes… And its’ not good enough to measure the whole genome – you need to measure RNA, and the proteome.”
The Coalition will allow access to more than 60 novel and approved immunotherapy agents to “enable the rapid testing of novel immunotherapy combination protocols” – forming the basis for an ambitious new cancer initiative called “Cancer MoonShot 2020.”
The NIC says it’ll run a series of clinical trials in all stages of cancer patients in up to 20 tumor types. The NIC will design, initiate and complete a number of Phase 2 randomized clinical trials – called the QUILT program – in some 20,000 cancer patients with cancer at all stages of disease in up to 20 tumor types by 2020. Some of the cancer types under study will be breast, lung, prostate, ovarian, brain, head and neck, multiple myeloma, sarcoma and pancreatic cancer.
These QUILT trials are meant to “harness and orchestrate all elements of the immune system” – deploying dendritic, T cell and NK cell therapies. It’ll test novel combinations of vaccines, cell-based immunotherapy, metronomic chemotherapy, low-dose radiation therapy and immunomodulators – such as checkpoint inhibitors – in patients that have not only had next-gen sequencing of their whole genome, but also their trascriptome and proteome.
“At Celgene, we are fully committed to the Cancer MoonShot 2020 Program as a part of our longstanding efforts to discover and develop new therapies for difficult to treat cancers,” Celgene CEO Robert J. Hugin said in a statement.
He added that Celgene will apply its “deep and diverse library of important molecules, both approved and in the development pipeline,” to the QUILT clinical trials.
The early framework for MoonShot 2020 was birthed in collaboration with Vice President Joe Biden, Soon-Shiong said in his JPM presentation. He gathered a diverse group of stakeholders in Los Angeles on December 1 and held a four hour meeting with a number of biopharma players, insurers, Bank of America, the Food and Drug Administration, and academia.
As this decade comes to a close, we’re seeing massive headway in the war against cancer. For instance, Illumina just announced it has plans to launch a pan-cancer diagnostic that will seek out the disease in asymptomatic individuals by 2019.
More details on the Coalition and the Moonshot will be unveiled tomorrow at 2 p.m. PST at the J.P. Morgan Healthcare Conference – so stay tuned.
[Image courtesy of Flickr user Mars DD]