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$HGEN $31 Pantginis Price Target Easily Met on November P3 Lenzilumab’s topline data -resulting EUA> $50 - this IS the Mayo Clinic’s COVID entry after all.
https://www.smarteranalyst.com/new-blurbs/analysts-offer-insights-on-healthcare-companies-humanigen-hgen-and-inmode-inmd/amp/
“Given the role of GM-CSF in granulopoiesis and enhancement of neutrophil survival,
alongside the neutrophil activation observed in late stage fatal COVID-19, these trials may inform
our understanding of the importance of this pathway in COVID-19 immunopathogenesis”
National Heart Ling Inst London
Plasma mediators in COVID-19 are coordinated around GM-CSF and influenced by age -National Heart Lung Institute -London
HGEN at $16.47 Premarket on Identification of high levels of its Target GMCSF in fatal COVID cases :
https://www.medrxiv.org/content/10.1101/2020.10.08.20209411v1
LLY Monoclonal Antibody + Remidesivir Halted on Safety- - Helps $HGEN’s BET trial case- “Lilly’s ACTIV-3 trial is intended to test a monoclonal antibody developed in partnership with Gilead Sciences' remdesivir, an antiviral drug granted emergency use authorization by the U.S. Food and Drug Administration to treat COVID-19 infections”
https://www.actionnewsjax.com/news/trending/eli-lilly-pauses-late-stage-covid-19-antibody-treatment-trial-amid-safety-concerns/V3LLTEPZNBEDDADEBWFZFH7Q5Y/?outputType=amp
HGEN Lenzilumab Four Manufacturing partners have a combined market cap of $275 B - Ajinomoto Bio-Pharma, Catalent, Lonza, and Thermo Fisher- intellectual property transfer already happened - loaded for EUA.
Great find -HGEN Lenz chosen by NIAID for evaluation on the way to anointment.
From Fauci’s NIAID BET - “Lenzilumab is a first-in-class recombinant monoclonal antibody targeting soluble human GM-CSF, with potential immunomodulating activity, high binding affinity in the pM range, and 94% specificity to the human germline, which reduces immunogenicity.”
$HGEN seems to sound promising to the #1 COVID Federal Agency - why it was the only GM-CSF mAb picked by Fauci over $KNSA $CYDY and Roivant.
https://clinicaltrials.gov/ct2/show/NCT04583969?term=Lenzilumab&draw=2&rank=4
HGEN in BET trial now listed on ClinicalTrials.Gov
Such a low bar (14>11d) discharge with Remdesivir - and continually mutating SARS-COV-2 - as stressed last night on 60 Minutes / where therapeutics we’re stressed over vaccines- will make HGEN behave better than an early NASH breakthrough -Intercept - as soon as EUA is approved by EOY-Parabolic with 1st day news.
Between the Australian COVID in Cancer Trial and BET - Lenzilumab will be most studied mAb.
My Stocktwits post )))
HGEN -Coincidence? Melbourne’s Peter Maccallum Cancer Center- which chose $HGEN over $REGN $KNSA and $LLY to trial in COVID in Cancer patients Happens to be a $GILD Yescarta trial site - kicking the tires for O’Day ?
https://clinicaltrials.gov/ct2/show/NCT03761056?term=Yescarta+Peter+Maccallum&draw=2&rank=1
HGEN -I’ve added every gift dip - ask yourself why NIAID, $GILD, and now Peter Macallum Cancer Center in Melbourne have chosen Lenzilumab as a COVID agent to investigate - you’re right and They’re Wrong? I think not.
Gov Christie has Long-standing Asthma - now with COVID / a perfect spokesman/Lobbyist for $ECOR - his former Donors.
This Australian Cancer Center Chose to Test $HGEN for COVID in Cancer Over $REGN, $KNSA, $LLY, and (of course) $CYDY.
https://clinicaltrials.gov/ct2/show/NCT04534725?term=Lenzilumab&draw=2&rank=4
$HGEN Included in Australian COVID during Cancer Trial :
https://clinicaltrials.gov/ct2/show/NCT04534725?term=Lenzilumab&draw=2&rank=4
Note all those NOT chosen:
“A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population.
ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts.
ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus.
ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection.
ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection.
The analysts of ROTH Capital Partners, LLC have rated Humanigen with a Buy rating. The price target was set to $25.00. At a current price of $ 12.29 there is upside potential of 103.42%. Bullish
REGN competes with GILD not HGEN - https://stocktwits.com/fezziwig2019/message/249251387
Trump - “Others (I’m not taking*) are miracles - Coming out soon”
https://stocktwits.com/fezziwig2019/message/249249228
HGEN EUA Any Day - Today?
Chris Christie will become a Gammacore Advocate. His Ashmatic COVID condition makes him a perfect spokesperson.
POTUS ARDS -$HGEN Lenzilumab is last line of Defense! From NYT Now- “Based on the doctors’ account, Mr. Trump’s symptoms appear to have rapidly progressed since he announced early Friday morning that he had tested positive for the coronavirus.
Mr. Trump had a “high fever” on Friday, and there were two occasions when his blood oxygen levels dropped, his doctors said — on Friday and again on Saturday. The president’s oxygen saturation level was 93 percent at one point, his doctors said, below the 95 percent that is considered the lower limit of the normal range.”
I’m long POTUS AND Chris Christie’s ARDS episodes - will be cut short by $HGEN Lenzilumab- with EUA any day -to be followed by Full Approval on Nov Phase 3 Readout
HGEN - POTUS on “Miracle” Lenzilumab -he’s distinguishing it from Dexamethasone, $REGN and $GILD - yesterday- as its EUA is pending - “ So many things are happening, if you look at the therapeutics which I’m taking right now some of them *AND OTHERS that are COMING OUT SOON that are looking like, frankly they’re miracles, if you want to know the truth.“ https://www.google.com/amp/s/www.dailymail.co.uk/news/article-8801437/amp/Trump-doing-told-Walter-Reed-doctors-walk-today.html
“Others that are coming out Soon” - Who just met with the FDA on a pending EUA? Awaiting a “Miracle”
You’re “weird” Read POTUS Statement
$HGEN - POTUS on “Miracle” Lenzilumab -he’s distinguishing it from $REGN and $GILD - yesterday- as its EUA is pending - “ So many things are happening, if you look at the therapeutics which I’m taking right now (Remdesivir REGN antibiotics and Dexamethasone) some of them and Others that are COMING OUT SOON that are looking like, frankly they’re miracles, if you want to know the truth.“ https://www.google.com/amp/s/www.dailymail.co.uk/news/article-8801437/amp/Trump-doing-told-Walter-Reed-doctors-walk-today.html
OCTOBER SURPRISE ! Trump touts an emerging therapy he HASN’T yet received as an emerging “Miracle” - as HGEN is working out it’s EUA weeks before Election Day - ARE YOU KIDDING ME?!
HGEN - POTUS on “Miracle” Lenzilumab -he’s distinguishing it from $REGN and $GILD - yesterday- as its EUA is pending - “ So many things are happening, if you look at the therapeutics which I’m taking right now some of them and others that are COMING OUT SOON that are looking like, frankly they’re miracles, if you want to know the truth.“ https://www.google.com/amp/s/www.dailymail.co.uk/news/article-8801437/amp/Trump-doing-told-Walter-Reed-doctors-walk-today.html
Case Report- Presching to the Choir: “ HGEN - case report out yesterday: “Humanigen unveiled findings that lenzilumab- targets GM-CSF helped an elderly man w/history included type 2 DM, coronary artery disease -a coronary artery bypass graft, systolic heart failure, severe COPD, emphysema and sleep apnea. The 77yo tested positive for SARS-CoV-2 and was admitted to an ICU in March on respiratory isolation-Rxd w/ steroids, antibiotics for community-acquired pneumonia, & bronchodilators for possible COPD exacerbation, hydroxychloroquine plus zinc. He deteriorated for 12 wks with an increase in O2 demand from continuous low to high-flow, eventually bilevel positive airway pressure. He developed ARDS.
At week 13 after unsuccessful attempts at oxygen weaning, an emergency, single-use IND for lenzilumab was cleared by the FDA and administered to the patient. 7 days later, O2 need decreased from high to low-flow nasal cannula, and he was able to walk outside of his hospital room. 16d post treatment, he was discharged on home O2 - Bullish”
How will anyone trust my bullish posts if I don’t share an honestly
bearish post? I’m not a cheerleader, I’m an MD with a penchant for HGEN -but not to the degree that I would exclude valid pertinent Data that is inconvenient.
Can’t believe REGN-COV2 not discussed - their MAB combination has a signal in Mild-moderate COVID in those Who have not mounted an inherent antibody response- nothing to do with COVID pneumonia in severe - critical patients- as Don Corleone said to Salozo-“ …I wish to congratulate you on your new business, and I know you’ll do very well; and good luck to you — as best’s as your interests don’t conflict with mine. Thank you.”
Damn who leaked the EUA? - soaring in Pre Mkt - I wanted to add- damn.
AZN-Oxford Vaccine "May Be Done"
"But a person familiar with the situation told The Times the participant’s illness had been pinpointed as transverse myelitis too."
“If there are two cases, then this starts to look like a dangerous pattern,” said Mark Slifka, a vaccine expert at Oregon Health and Science University.
“If a third case of neurological disease pops up in the vaccine group, then this vaccine may be done.”
https://www.mirror.co.uk/news/us-news/coronavirus-vaccine-trial-hold-after-22711852
Lonza has 2 COVID-19 Deals: One Vaccine and One Therapeutic- with $MRNA and $HGEN - its CCO :
"In an effort to change the course of this pandemic, advancing lead COVID-19 therapeutics requires matched supply chain efforts and expertise to meet the continued and urgent patient needs. COVID-19 has highlighted the need for heightened industry collaboration and coordination and we are excited to work closely with Humanigen as we work to combat this global health crisis."
https://www.businesswire.com/news/home/20200914005914/en/Humanigen-and-Lonza-Announce-Collaboration-to-Expand-Manufacturing-of-Humanigens-COVID-19-Therapeutic-Candidate-Lenzilumab
https://www.reuters.com/article/us-health-coronavirus-moderna-lonza-grou/moderna-switzerlands-lonza-strike-deal-on-potential-covid-19-vaccine-idUSKBN22D4GM
Data attracts Money- Occam's Razor.
Yes great point - Mayo compared 12 treated to 27 control patients and found an 80% reduction in need for Ventilation - then DSMB unanimously finds a controlled randomized double blinded P3 trial should not be halted for futility....Walking and Quacking like a duck....
Please Toclizumab failed in Large Italian and Roche Covacta trial - recently showed minimal effect - Dexamethasone has only shown some improvement- nothing like the 80% reduction in Mechanical Ventilation Lenz showed at Mayo - but ONLY in intubated patients - So You my friend have LITTLE to pump - keep trying to bash a drug that resulted in Median 5 (that’s Five) day discharge in Severe to Critical Covid Pneumonia at Mayo Clinic hospitals- 1st 12 - now up to 39 patients- Wonder why Dr Fauci is pumping Lenz into his “BIG EFFECT” trial - if that’s not pumping what is? Maybe he’s seen interim P3 data - oh my.
HGEN Lenzilumab Targets the ligand GM-CSF - not the receptor - so dosing can be more aggressive with fewer AEs. “GM-CSF might also be a key mediator of the cytokine storm in COVID-19 and other inflammatory diseases 30, 31. First, GM-CSF was upregulated before TNF, IL-6, and MCP-1 in animal model of SARS-CoV infection 32, and its excessive production adversely contributed to the SARS-CoV-induced lung injury 32. Second, consistent with the critical contribution of myeloid cells to cytokine storm 28, the percentage of GM-CSF-expressing leukocytes was significantly increased in a subset of patients with severe COVID-19 33, 34. Thus, the excessive production of GM-CSF may adversely propagate a dysregulated cytokine storm in a subset of COVID-19 patients. GM-CSF can polarize mature myeloid cells into a pro-inflammatory phenotype, and stimulate the production of various proinflammatory cytokines (e.g., TNF, IL-1ß and IL-6) and chemokines (e.g., MCP-1). https://www.biorxiv.org/content/10.1101/2020.09.04.280081v1