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Taking a beating this week. About time for a reversal
Nice Day Friday!
Indeed, I have not seen any news, but somebody knows something
When you read the full (indepth) artical, this is really no big deal at all.
Ebola vaccine trial interruption ‘not a setback’ says WHO
(AFP) / 12 December 2014
The trials on two experimental vaccines are being suspended after several volunteers experienced unexpected joint pains.
The suspension of trials in Switzerland of an experimental Ebola vaccine over unexpected side-effects is not a setback in the fight against the deadly virus, the World Health Organisation insisted Thursday.
The Geneva University Hospital (HUG) announced Thursday it was suspending trials of one of two experimental vaccines being tested on humans in several countries, after several volunteers experienced unexpected joint pains.
But WHO assistant director general Marie-Paule Kieny insisted the hospital’s decision to suspend the trials of the VSV-ZEBOV vaccine a week ahead of plan should not be considered a big deal.
“It’s not a setback,” she told reporters in Geneva.
There is no licensed treatment or vaccine for Ebola, and the WHO has endorsed rushing potential ones through trials in a bid to stem the epidemic, which has killed nearly 6,400 people mainly in Guinea, Liberia and Sierra Leone.
The Geneva trials of the experimental vaccine, manufactured by the Public Health Agency of Canada and licenced by US firm NewLink Genetics began on November 10, are still expected to resume next month.
HUG said its decision came after four of the 59 volunteers taking part in the trial had experienced minor joint pains in their hands and feet 10-15 days after receiving the shot.
The pains had lasted a few days, the hospital said, pointing out that although joint pain had not figured among the expected side-effects of the potential vaccine, it was common after other kinds of vaccines.
“This phenomenon is very well-studied and not of concern to specialists,” it said.
Kieny, who is in charge of WHO’s Ebola vaccine quest, stressed that none of the affected volunteers had needed to be hospitalised.
The early suspension would allow an in-depth analysis of the vaccine, with the aim of resuming trials as planned on January 5.
“The investigators are looking at how frequently this happens in order to be able to document the future safety of the use of the vaccine,” Kieny said.
The VSV-ZEBOV vaccine is also being tested on volunteers in the United States, Canada, Germany and Gabon, and clinical trials are also due to start soon in Kenya.
Joint pain has not been reported from any of the other trial sites, Kieny said.
Another experimental vaccine, ChAd3, made by Britain’s GlaxoSmithKline, is being tested on another set of volunteers at another Swiss hospital, the CHUV in Lausanne.
Trials of that vaccine are also underway in Mali, Britain and the United States.
At talks in Geneva on Thursday, health chiefs from Sierra Leone, Guinea and Liberia expressed their eagerness to have trials conducted in their Ebola-hit countries.
For more news from Khaleej Times, follow us on Facebook at facebook.com/khaleejtimes, and on Twitter at @khaleejtimes
Excellent rebound, was a bit nervous with the premarket today!!
Me too, wish I could have added more, but fully loaded
Canada- maker of NLNK ebola drug- sending troops to Africa
https://finance.yahoo.com/news/canada-deploy-military-health-staff-190340132.html
Not too bad today, not bad at all.
The Company will also be eligible to receive tiered royalties on sales of the vaccine in certain markets, subject to certain conditions.
...important to note as well. I am not sure how much longer this stock can be held back before it hits the 50's.
NLNK agreement with Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.
NLNK agreement with Merck (NYSE:MRK). Merck known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.
NLNK agreement with Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.
And there we have the official announcement. Enjoy the day!!!!
Merck sold their vaccine division in 2013 which means they cut back their development efforts. They still have the means to help with the mass production of Newlinks VSV-EBOV. I think its interesting that there is a tie with GSK, since there was chatter last week that said Newlink and GSK may join forces for a more effective solution.
Check this out. So in 2013 Merck (who is in talks now with Newlink to help with production of VSV-EBOV) actually spun off and sold their vaccine division to GSK (which included GSK's current Ebola vaccine)
There was an article last week that said GSK and NewLink may actually join forces, apparently their vacines actually compliment one another for effectivness.
Really all speculation on my part, love to read between the lines with DD. Link below is from 2013 where Merck sold off the division.
http://www.startupticker.ch/en/news/may-2013/gsk-acquires-okairos-ag-for-eur-250-mio#.VHEvllDIa7k
Under the terms of the transaction, GSK will take full ownership of the company and thus assume ownership of early stage assets for diseases such as respiratory syncytial virus (RSV), hepatitis C virus (HCV), malaria, tuberculosis, ebola and HIV, supplementing the company’s existing vaccines pipeline. GSK and the Okairos management team are committed to an innovative collaboration and will work together over the next few months to develop ways of working that will maintain the autonomy, spirit and agility of this unique small biotech firm which will be strengthened by the support and advantages that GSK can provide.
NewLink Genetics Corporation (NLNK) was among the biggest gainers on the Russell 2000 for November 21 as the stock popped 5.40% to $35.33, representing a gain of $1.81 per share. Some 1,299,640 shares traded hands on 7,082 trades, compared with an average daily volume of 1,775,719 shares out of a total float of 27,959,553. The stock opened at $33.70 and traded with an intraday range of $33.01 to $35.83. - See more at: http://www.equities.com/editors-desk/stocks/market-movers/newlink-genetics-corporation-nlnk-jumps-on-november-21#sthash.EPvWBwWx.dpuf
Looking good today! Loving it!!!
Link will not comment on deals that are not finalized, but stated things should be finalized in the 'not to distant future'!!!
This is a big deal, once the details are released we are going to have alot of fun here!
http://www.bidnessetc.com/29614-newlink-genetics-merck-co-mrk-in-talks-to-scale-up-ebola-vaccine-productio/
Another firm raising price target today
http://ficonewsmedia.com/stock-disclosure-newlink-genetics-corporation-piedmont-office-realty-trust/33043/
Also, Newlink is presenting at teh Stifel Healthcare Conference as we speak, they started at 9:45 today. Wonder if there is something coming out of that yet to be released. A real nice spike with no news yet...
With a $55 price target and all good things in the pipeline, there is nowhere else I'd rather be! Bring it on, just broke 6%
So, that makes the deal of 150Mil upfront and payments up to $1B official then.
http://www.bioworld.com/content/genentech-cozies-newlink-1b-cancer-immunotherapy-pact-0
http://www.scientificamerican.com/article/improved-ebola-situation-liberia-may-complicate-vaccine-trials/
It is a singular response to an enormous task: trying to test and scale up production of vaccines in a few months, a job that normally takes five to 10 years to achieve. The need for creative solutions has inspired executives of rival companies to openly share data and discuss using their products in combination. The hope: if neither of the frontrunners succeeds, maybe using company X’s vaccine as the prime and company Y’s as the boost might work. Discussions that "never happen" are happening now. “There is a willingness to consider trials that include combinations of the vaccines, to see how best they might be able to be used together, for example, in prime–boost strategies. This is very unusual. But it is going on,” says Ripley Ballou, vice president of biologics for U.K.-based GSK (aka GlaxoSmithKline), which owns the vaccine that is furthest along in this modified pipeline.
NewLink is talking with GSK about just such a strategy, if it is needed, Link acknowledges. "In my lifetime it's unprecedented to see this level of collaboration. It's the way, if the world was perfect, that maybe science would always work."
GSK’s vaccine, called cAd3-EBOV, was originally developed by scientists at the National Institute of Allergy and Infectious Diseases; GSK acquired the rights to it when it bought Swiss vaccine developer Okairos in 2013. It is an inactivated (killed) vaccine that uses a genetically modified chimp adenovirus to present an Ebola gene to the immune system.
The NewLink vaccine, rVSV-ZEBOV, was designed by scientists at the Public Health Agency of Canada. It is composed of a live virus (modified vesicular stomatitis) coupled with the primary protein found on the Ebola virus’s surface. Vesicular stomatitis viruses—VSV for short—sicken livestock but are harmless to people. It is a replicative vaccine; the virus in it generates a low-grade infection that provokes the immune system to pump out antibodies against Ebola. But the vaccine cannot trigger the disease itself.
OncoGenex Pharmaceuticals also presenting. Hmmm
At 9:45 am on Tuesday, November 18, 2014, NewLink will present at the Stifel Healthcare Conference in New York.
NewLink Genetics to Participate in the Upcoming Stifel, Jeffries, and Piper Jaffray Healthcare Conferences
November 17, 2014: 07:00 AM ET
AUSTIN, Texas, Nov. 17, 2014 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK) today announced that it will present at the following conferences:
At 9:45 am on Tuesday, November 18, 2014, NewLink will present at the Stifel Healthcare Conference in New York.
At 2:20 pm on Thursday, November 20, 2014, NewLink will present at the Jeffries Global Healthcare Conference in London.
At 11:10 am on Tuesday, December 2, 2014, NewLink will present at the Piper Jaffray Annual Healthcare Conference in New York.
All conference times listed are local time. These presentations will not be webcast.
About NewLink Genetics Corporation
NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens. For more information please visit http://www.linkp.com.
Cautionary Note Regarding Forward-Looking Statements
Statements made at the upcoming conference may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to, future financial performance, new product development, governmental approvals and market potential. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended December 31, 2013, and subsequent filings with the Securities and Exchange Commission. These forward-looking statements are made only as the date thereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Investor Contact:
Jack Henneman
Chief Financial Officer
(515) 598-2561
Investor@linkp.com
I am planning to add tomorrow. Too much in the pipeline here not to
Good Day thus far...
I don't know what the hell! They got my stop loss too. Dam it
$51-55 target!!! Just released! I'll take either, lol
http://www.benzinga.com/pre-market-outlook
WHO welcomes approval of a second Ebola vaccine trial in Switzerland
http://www.firstwordpharma.com/node/1244473?tsid=28®ion_id=3#axzz3IOCBeoyA
fafa, I don't really know either. When I read that part I assumed the enrollment complete means that the people have been identifed who will participate in the trial.
Nice day here!!
A transcript of todays call. They really have alot going on right now. Huge advances in the fight against cancer. The other point I picked up on is that the Ebola vaccine trials are virtually completely funded from the government and not pulling any of their internal resources away from their core business. Pretty cool stuff. NLNK long.
http://seekingalpha.com/article/2651345-newlink-genetics-nlnk-ceo-charles-link-on-q3-2014-results-earnings-call-transcript?page=5&p=qanda&l=last
http://www.desmoinesregister.com/story/money/business/2014/11/06/newlink-genetics-ebola-vaccine-trials/18590029/
An Ebola vaccine licensed by Ames-based NewLink Genetics has been "well-tolerated" in early human trials, the company's chief executive said today.
NewLink Genetics is developing an Ebola vaccine based off of initial work done by the Public Health Agency of Canada.
Phase 1 trials on healthy, human volunteers to test the vaccine's safety are underway at the Walter Reed Army Institute of Research in Silver Spring and at the National Institutes of Health Clinical Center in Bethesda.
"The first dose level in healthy volunteers at Walter Reed Medical Center has been completed and next dose level has begun. The vaccine was well-tolerated thus far, but the study is ongoing," NewLink CEO Charles Link said on a conference call with analysts Thursday.
The World Health Organization also said today that Swiss authorities approved trials of the NewLink-Canadian Ebola vaccine, which is known as VSV-EBOV.
The Swiss trials will start next week and involve 115 healthy volunteers in Geneva, Switzerland. Some of the volunteers will be sent as health care workers to West Africa, where Ebola has killed an estimated 4,800 people.
If the vaccine is deemed safe, both Link and the WHO have said larger scale trials will be conducted in Africa by early next year.
Ebola vaccines from other companies, such as GlaxoSmithKline, are also going through early trials.
Link spoke to analysts when presenting third quarter financial results Thursday. NewLink primarily focuses on the development of cancer therapies to boost the immune system's ability to fight tumors.
The company of about 120 employees has received more attention recently because of its work on the Ebola vaccine.
"We therefore find ourselves in one of the great infectious disease crises of our age," Link said during Thursday's call.
Link also said the company is "exploring the potential for collaboration with a larger pharmaceutical company that could complement and enhance NewLink's development of the Ebola vaccine in this time of crisis and beyond."
its is moving very nicely in premarket! up 7.32%
Setting up nicely here. Several alerts being posted. That one on Zacks is perfectly timed!
I couldn't make the call, in a meeting now. If anyone is on, please let us know about updating targets and developments with their projects