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39 pts in Mayo latest data showing 80% reduction in need for Mechanical ventilation- far superior to Roche and Lilly.
$11.99 in premkt
SO OVER - OVER THE COUNTER’!
Both Thumbs Up.
I added 12k shares at $9.70 now $10.40 - already had 21K - started at (presplit $0.85) where my mouth is.
Please- Best Bio Management I’ve Seen - Constantly working to improve value - $10.40 close just the beginning.
Watch the Horizon / the science is there- picked by Fauci GILD and Lonza
Why? Because science is being ignored- I use this price action to add-Lonza and Gild execs are where they are for a reason - not wasting their time on a loser.
HGEND - Crazy Price Action - Uplisting -Done -NIAID BET trial with Remdesivir - Done- Lonza Production deal - Done/ After Linda reviewed Interim P3 Data- Just as COVID spiking.
HGEND “Humanigen has received approval from The Nasdaq Stock Market, LLC for its common stock to begin trading on the Nasdaq Capital Market under the symbol “HGEN” on the trading day immediately following the pricing of the offering of the shares.” UPLISTING from OTC to NASDAQ Done! With Lonza deal yesterday - should trade At $20 soon.
Those who have no idea what they bought in the $0.70’s
LONZA with MRNA and HGEND - Both COVID bases covered
HGEN CEO- The DSMB assessed the Phase 3 trial data for safety, futility, sample size and power assumptions. After completing their analysis, the DSMB unanimously recommended that the trial continue according to the existing trial protocol without modification.
“This unanimous recommendation by the independent DSMB is encouraging and marks another major milestone for Humanigen as we progress towards a potential EUA for lenzilumab in COVID-19,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We consider the decision to continue according to the existing protocol as a signal that the trial is progressing to plan."
LLY does no better than failed Actemra with Remdesivir -1day sooner clearance only- “ The ACTT-2 trial, a follow-up that began after the remdesivir section was completed, enrolled over 1,000 hospitalized Covid-19 patients and found that those given the antiviral remdesivir plus the Eli Lilly JAK inhibitor baricitinib recovered a median of one day sooner than those given remdesivir alone. Similar to the IL-6 inhibitors from Regeneron and Roche — which failed in Phase III trials “ BET with HGEN will eclipse that.
https://endpts.com/covid-19-roundup-uk-gives-small-biotech-a-big-vaccine-deal-pfizer-details-their-surprise-antiviral-tight-lipped-merck-enters-ph1/
Major Add $1.73 .
Vaccines for COVID - Danger will sink them all-similar Targets no matter how they get there -
$AZN
Oxford- “When this weakened virus entered vaccinated people’s cells, it caused their cells to produce the spike protein, in turn training their immune system to recognize the foreign protein and produce antibodies to defend against it.” wired.com/story/everything-...
FDA Approves risk of PARALYSIS (transverse myelitis) with only 50% benefit - not in MY family- need Therapeutics- That’s why NIH-NIAID is pushing “Big Events Trial” with
$GILD
-
$HGEN
Remdedivir/Lenzilumab.
BTD on 1st VAX Serious AE.
AZN Halt HGEN Gain “Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events.”
HGEN Pops on AZN AE- AZN CVAC PFE MRNA NVAX INO will All see Transverse Myelitis if their Vaccines are given in great numbers for only a 50% benefit- flip of a coin- therapeutics -
GILD HGEN REGN
are Key to COVID :
“Transverse myelitis (TM) includes a pathobiologically heterogeneous syndrome characterized by acute or subacute spinal cord dysfunction resulting in paresis, a sensory level, and autonomic (bladder, bowel, and sexual) impairment below the level of the lesion. Etiologies for TM can be broadly classified as parainfectious, paraneoplastic, drug/toxin-induced, systemic autoimmune disorders, and acquired demyelinating diseases. “
Peg failed / oncology program with it - now a royalty company - not my cup of tea- but doing very well - I’m here and at ISEE - looking for “Big Effects”’
Good BET
AZN Vaccine AE-Transverse Myelitis - puts added emphasis on therapeutics in general and Lenz specifically.
BTD from P3 / BET
$HGEN - Why in G-D’s Name did Dr. Fauci name the $HGEN Lenzilumab + Small effect Remdesivir trial the “Big Effect Trial”? Puts a lot of pressure on HGEN!
ECOR
“This is the first study that clarifies the positive effect of vagal-a7nAChR signaling at the reparative phase after lung injury. We found that the vagus nerve, via a7nAChR, promotes lung stem cell proliferation and expansion in an FGF10-dependent manner. Thus, vagus stimulation and a7nAChR agonist might be potent therapeutic targets for treating lung injury. The concept of vagal-a7nAChR signaling governing lung stem cell proliferation may open a new avenue of research in the field of lung regeneration.“
https://stemcellres.biomedcentral.com/articles/10.1186/s13287-020-01757-w
Gottlieb says FDA will approve vaccines if they meet the “high mark” of 59% efficacy. Therapeutics will have to answer to a higher standard - like Lenzilumab’s 80% reduction in Ventilation at Mayo! Thalidomide was repurposed at Celgene to create a multi Billion dollar MM franchise.
Science Magazine’s 8/14 List of all the Big Pharma Monoclonal Abs Dr. Fauci’s NIAID passed over then chose $HGEN Lenzilumab for Big Effect atrial partnering with Remdesivir:
https://science.sciencemag.org/content/369/6505/752.full
Good Points- Fauci lends credibility and clout to your prediction of productive PR - Remdesivir received an EUA based on Fauci’s altered primary endpoint and political clout. NIAID chose Lenz over REGN LLY CYDY etc- then they had the audacity to name the combined Lenz-Rem trial - The Big Effect Trial - Longs will be fine.
Only Lenz Chosen by Fauci ‘s NIAID for THIS pandemic as it’s the only anti-GMCSF that binds the ligand and is Phase 3 - perhaps the others will be tried against approved Lenz in head to head trials in years to comes -we’ll see.
Fact Based Investing- “ The NIH confirmed to GEN it has awarded contracts totaling $25.8 million to Leidos Biomedical Research toward managing, overseeing, and conducting the trial, the most recent being $14.3 million awarded on August 4. As for the Phase III study, it is about halfway through enrollment, and expected to finish by end of September or early October, with data expected to be released about a month later.”
https://www.genengnews.com/gen-edge/a-human-touch-vs-covid-19/
I’m Betting on BET - adding Anti-GMCSF to weak antiviral Remdesivir is BETter than Rem alone.
“Utility” - CMO uses this term in addition to safety when discussing the Goals of the DSMB interim read at 6:20ish of the KOLReplay.
At the KOL meeting, Durrant listed the Interim read among the near term catalysts - given the severity of the unmet need I don’t see the DSMB putting on blinkers and only looking at Safety data. Such a limited view will only contribute to slowing down the process and potentially to loss of life.
Jay - I rub my eyes sometimes to ensure I’m not misreading 80% reduction in need for Ventilator support, reduction in CAR-T CRS & neurotoxicity with simultaneous improvement in function, and early discharge of ICU patients from the hospital- then look at the price action - I guess the Pipe profits are too hard to pass up when one doesn’t understand that the EUA comes In Q4.
Yes I expect a Halt on Efficacy on interim analysis -Desperate times demand desperate measures such as the EUAs granted to Convalescent Plasma and many unworthy COVID tests - well how about to an extremely worthy Lenz handpicked by NIAID Fauci who can get behind it with the FDA after already showing he expects it through his choice of treatments to combine with Rem- he could have chosen REGN or LLY Antibodies it even Mav. So positive interim data will have many friends - one in the Oval Office.
Great DD MWM -as always- thanks. Many here don’t realize the importance of GILD Relationship.
No Increase in Shares- “ Following the approval of the reverse stock split, the Humanigen Board of Directors no longer expects to pursue the proposed amendment to the company’s charter to increase the number of authorized shares of common stock, which will remain at 225,000,000.“
Shorty - Read it and Weep
https://www.genengnews.com/gen-edge/a-human-touch-vs-covid-19/
39 Mayo Clinic patients are enough for EUA- ECOR got one on few Asthmatic COVID patients in pilot studies.
Gammacore works in my Migraine patients - this is the news Robinhood traders don’t know - so I added in a major way as they sell.
Um Phase 3 Coming Soon - :” HGEN “the Phase III study, it is about halfway through enrollment, and expected to finish by end of September or early October, with data expected to be released about a month later”
https://www.genengnews.com/gen-edge/a-human-touch-vs-covid-19/