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Good Lord look at all the funds reporting positions in HGEN as of Mid-November. That is a very impressive list with Blue Chip Firms invested here. These guys know what they are doing and they have a much better read on the risk/rewards involved here than the average Joe.
https://whalewisdom.com/stock/kbio
Upon tumor challenge, CAR T cells produce granulocyte-macrophage colony-stimulating factor (GM-CSF; Giavridis T, et al. Nat Med. 2018), which acts to promote myeloid activation, expansion, and cytokine production (Spath S, et al. Immunity. 2017). GM-CSF was among the cytokines significantly associated with Grade ≥ 3 NEs in ZUMA-1 (Neelapu SS, et al. N Engl J Med. 2017). Notably, peak GM-CSF levels occurred before those of most other cytokines, and no direct association was observed between GMCSF levels and ORR (Rossi JM, et al. EMA Workshop, 2016). These findings suggest that GM-CSF may initiate inflammatory events that cause NEs and that GM-CSF inhibition has the potential to improve the safety of CAR T cells, without impacting efficacy. GM-CSF depletion with lenzilumab, a humanized monoclonal antibody that neutralizes GM-CSF, prevented CRS and NEs in preclinical models of CAR T cell toxicity (Sterner RM, et al. Blood2019). The Phase 1/2 ZUMA19 study is evaluating sequenced therapy with lenzilumab and axi-cel to prevent axi-cel-related CRS and NEs in pts with R/R LBCL.
The Car-T angle is huge as it reduces the risk of Cytokine Release Syndrome and Neurotoxicity in that patient cohort which dramatically adds to the healthcare costs and health risks. It is a quiet part of the story right now, but should be getting more attention.
Nice! Keep the updates coming, I'm out of range to listen this week and missing all the presentations. That is great news
Let's go, let's go, let's go. So happy to hear people are getting access! Great news
If both Venrock and Valiant are adding to positions in November I don't if there could be any bigger of a confirmation of where we are headed here. Something pretty special is unfolding for sure.
Be curious to know where else in the World something like this is happening? It is very possible that if it happened there that it's happening elsewhere, very scary stuff indeed.
Ha ha, I'd love to know why they wrote that garbage, it was based on pure deception but that weasel doesn't have what it takes to tell the truth.
Everything aside from Covid surrendering today speaks to the massive opportunity here. Even if Covid just quit Gov't will be stockpiling Lenz for future. This seems like an absolute no brainer.
Smart money is adding HGEN according to this tweet Valiant has increased their position and more.
https://twitter.com/hipcontractors/status/1328516109079883776?s=19
If that don't get your attention here you need to check your pulse.
“It did show that patients who received lenzilumab had a remarkable reduction in the need for a ventilator or death,” Robinson said. It also showed that they left the hospital in half the time compared with patients who received the standard of care, he said.
The St. David’s sites have enrolled between 15 and 20 people in this study, Robinson said. It’s a blind study, meaning Robinson has no idea which patients received the medication and which got a placebo.
What he has already seen in the patients enrolled is “some patients seem to recover pretty darn quickly,” he said. “That we haven’t seen in other patient populations. There is promise for this therapy. We just don’t know yet.”
I think this one was by Invitation only.
Bryan, Garnier & Co. Humanigen Information page. Conference is by Invitation only, but it is Day One of a Long Week of Presentations. Very excited about what could come from these Presentations.
https://www.bryangarnier.com/portfolio/bryan-garnier-co-acts-as-european-lead-manager-to-humanigen-on-its-usd-78-million-follow-on-offering/
Upcoming Presentations:
11/16 Bryan, Garnier & Co European Healthcare Conference
https://www.bryangarnier.com/home/sectors/healthcare/
11/17 Stifel Virtual Healthcare Conference
https://wsw.com/webcast/stifel27/hgen/2071712
11/19 Jefferies London Healthcare Conference
https://wsw.com/webcast/jeff141/hgen/1826850
12/5-12/8 Abstract describing the ongoing ZUMA-19 study for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition
https://ash.confex.com/ash/2020/webprogram/Paper135988.html
Quote:
The abstract, titled “ZUMA-19: A Phase 1/2 Multicenter Study of Lenzilumab Use with Axicabtagene Ciloleucel (Axi Cel) in Patients (Pts) With Relapsed or Refractory Large B Cell Lymphoma (R/R LBCL),” will be presented as a Trials-in-Progress poster (Abstract #2103) on Sunday, December 6 at 10:00 a.m. ET.
Lenzilumab will be a very important piece of the Covid puzzle regardless of how quick a Vaccine can be rolled out. In addition to Covid Approval the BLA that will be coming for Lenzilumab will include Non-Covid ARDS and will continue to see it used on that front in a recurring basis plus any other angles these trials might open for Lenzilumab. It will be a necessary tool for National Stockpile as a first line in future Pandemics and possible mutations in Covid. BARDA and NIH know this which is way Funding and Trials are underway.
How many shares is thier CEO selling today?
Jay, this was from the most recent filing. I wonder if this means we are closer to EUA than we think? Does expanding trial from 300 to 500 have more to do with BLA information?
Lenzilumab is currently in a phase 3, multi-center, double-blind, placebo-controlled registrational trial for hospitalized, hypoxic patients with COVID-19 pneumonia. Based on our discussions with the U.S. Food and Drug Administration (“FDA”), including a recent Type B meeting, we believe that the phase 3 trial could lead to a potential filing of an Emergency Use Authorization (“EUA”) application if data warrant such a filing. If the EUA were filed and granted, we could begin commercialization. We also intend to file a Biologics License Application (“BLA”) in 2021. Based on discussions with FDA, we understand that a BLA will require us to generate and present more clinical data than would be required to support an EUA.
Absolutely! "BARDA will provide technical assistance on a Phase 3 clinical trial underway." It works and they are going to get this thing running at Warp Speed. Get Phase III finished and rushed into mass production. I am very anxious for the day to hear that Lenzilumab is widely available across the globe. If money is standing in the way that won't be for much longer. Some big money, smart investors jumped in early and they made it possible to get to this point and we will definitely see the finish line faster than imagined.
Very, very nice. It would be a shame if money was the only reason to hold Lenzilumab back, and I believe that Gov't will do what is necessary to make sure that is not the issue. It is good for the people and for the Hospital system to be able to treat more patients in a faster time. I have heard stories about people getting treatments in settings not fit for medical care because some hospitals are overwhelmed especially in rural settings. If anything People & Healthcare deserve the dignity and opportunity for treatments to take place in a proper setting. If we can get one more person out alive then one more can find a bed for treatments.
Absolute thing of beauty! Extremely validating to see HGEN on that list and with Phase III mentioned. Lenzilumab is the Bad Ass we all thought it was, and it getting so close to getting into the Fight in full force. Great Job BARDA for picking Lenzilumab up, and hopefully getting it to people in need rapidly. I have more faith today that it is coming.
Really sad to see so many getting hit again.
Ha ha Ha, why wouldn't he have just told the truth? The only people listening to HGEN news are a small core of informed investors that will call Bull Shit as soon as they see it, and Medical Professionals assuming they've got free time to look up new shit. That thing was written for a reason, and it has nothing to with the truth.
It is Humanigen Time! They have given enough fluff time to the runner up's but it's Time to Recognize the Actual Star that is and will be Lenzilumab.
Moderate, Severe and Critical right down the line they are recommending Lenzilumab or some combination of Lenz + Rem + Dex. Throw the Kitchen sink at it and let somebody have a chance at surviving, clear a bed and get the next one in there.
The Mayo Clinic is ranked The Top Hospital in the Country 5 Years in a row. When they tell you to do something, you listen.
ROCHESTER, Minn. (KTTC) -- If you are an employee of Mayo Clinic, you can be especially proud of where you work.
U.S. News and World Report has named Mayo Clinic the top hospital in the country for the fifth year in a row. Mayo was also ranked the leading hospital in Arizona, Florida and Minnesota.
"To be ranked the No. 1 hospital in the nation for five years consecutively is a testament to the excellence of our remarkable staff, who put our patients' needs first — even, and especially, during a pandemic," said Gianrico Farrugia, Mayo Clinic's CEO and president.
Mayo was ranked second for cardiology and heart surgery, second for orthopedics and third for cancer.
I don't think that I have heard anything about Lenz in Europe yet. Correct me if I am wrong, but since we have had so much huge news over the last 60 days it is hard to keep up with all of it. I wonder how much longer before we see something on that front? They all need Lenzilumab very badly at this point. Vaccines are great, but they don't empty hospital beds and save the lives of those already infected.
Yes, we need it done now. I know there is Science & Trials, etc but this needs to happen now. Stock price or not, hospitals and patients need it Yesterday.
Haven't seen it yet, been hearing about it coming for months. I'll be interested to check it out. They seem to be shifting focus to Long Haulers so I wonder how that will play out there. With all the data pointing to GM-CSF I wonder how that gets left out ?
Big Money will have a hay day with these prices. Little Risk, Lotta Rewards for smart investment right here. We all know it's coming, it's more of When and not If it seems anymore. Light up the board!
Exactly, we got to hit a double just to get back to 52 week high from July. Easily blast thru that as things have drastically improved since then, what was only a rumor is now the truth. Big Damn things coming here.
LOL! I drove thru Brooklyn once before he went to jail.
That's basically a $1.5 Billion Market Cap at $28 per share which is very conservative here. We should be sitting at $16 now based on speculation of what is coming here.
Collaboration with BARDA, CRADA, NIH, and OWS are all happening right now.
These guys are straight weasels, the first people you would exile. Makes your skin crawl when you realize what kind if trash is roaming around.
All parts of it are Garbage. When he attacked the Tucker Carlson appearance like Humanigen was just able to call up and say they want to come on the air and advertise Lenzilumab. Durrant was very clear that he got a call from them on short notice to setup the interview and not the other way around. Also Politics aside Tucker Carlson is one of the highest rated news shows, and this was all happening while The President of the US who was a High Risk Patient was taken to Walter Reed. Does he think Tucker didn't have other options to give 5 Minutes during a very critical time for The President and the Country? That story had purpose and was very relevant to exactly what was happening at that moment and not the other way around.
Thank you Tucker Carlson for covering the Lenzilumab Story. You are the only one in Main Stream Media who has taken the time to really dive into this story. Big Pharma does not want this story to get out, and it is obvious based upon the biased coverage we are seeing from these bloggers.
There is one hell of a story to tell here, but it seems others want it kept secret. I wish Tucker would do a follow up into why more people aren't willing to tell this story and what their motivations for slander are actually based on, wouldn't that be an interesting look?
The Complete 27 Day history of Martin Shkreli and KaloBios Pharmaceuticals.
In November of 2015 Martin Shrekli and a Investor Group acquired a Majority Stake in KaloBios
on 11-20-2015 with a Majority Stake in the Company Martin named himself CEO
on 12-17-2015 Martin was fired by KaloBios
That is 27 days from start to finish.
It was employment created by a purchase of a Majority Stake in a struggling publicly traded small cap biotech. A Company that filed for Bankruptcy 12/29/2015
Small Bio Techs often struggle and Bankruptcy or Buyout from Large Pharma is how the business works.
You are right about that, volume is non existent. I have seen trolls on this board make a better effort than that blogger just did.
Well, in 6 or so poorly researched paragraphs he basically calls all of the following organizations fools:
1. NIH
2. OPERATION WARP SPEED
3. NIAID
3. BARDA
4. CRADA
5. MAYO CLINIC
6. DARTMOUTH
7. EMORY UNIVERSITY
8. VENROCK
9. VALIANT
10. LONZA
11. CATALANT
12. HC WAINWRIGHT
13. ROTH CAPITAL
14. BRYAN, GARNIER & CO.
15. CANTOR FITZGERALD
16. KITE/GILEAD
17. UNIVERSITY OF ZURICH
18. TELCON PHARMACEUTICAL, INC
19. THE KNUCKLE SANDWICH & YOU
20. UC IRVINE
21. UNIVERSITY OF SOUTHERN CALIFORNIA
22. MD ANDERSON
The list goes on and on, but this was an absolute hack job written by a bought and paid for sorry excuse for a blogger.
LOL, that is a trash article, almost as if written by one of our local trolls. Was it an actual journalist piece or an opinion piece from some jackass sitting on the couch? The internet has destroyed quality journalism, that was nothing more than a paid hit piece.
Hell Yeah, that is really big news. I was not aware that OWS saw unblinded results. I'm feeling really good now.