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NIH/NIAID Locks ACTIV-5/BET-B Database
https://ir.humanigen.com/English/news/news-details/2022/NIHNIAID-Locks-ACTIV-5BET-B-Database/default.aspx
SHORT HILLS, N.J.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a late-stage clinical biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, confirms that notice was received today from the National Institute of Allergy and Infectious Diseases (NIAID) that they have completed database lock for the Big Effect Trial of lenzilumab (BET-B) being conducted as part of the National Institutes of Health (NIH) public-private partnership Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). NIH/NIAID has cleaned and locked the blinded data in the study. This significant milestone allows NIH/NIAID to complete topline analysis. Humanigen expects to receive topline results from NIH/NIAID in July.
“Locking the database marks a crucial step in the process of NIH/NIAID completing the evaluation of lenzilumab for patients hospitalized with COVID-19 and reporting the results of its study. We look forward to being able to share topline results once received from NIH/NIAID,” said Cameron Durrant, Chairman and Chief Executive Officer, Humanigen.
Lenzilumab is an investigational product and is not approved or authorized in any country.
About ACTIV-5/BET-B
The Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) is a National Institutes of Health (NIH) directed public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. ACTIV is led by a working group of senior scientists representing government, industry, non-profit, philanthropic, and academic organizations and is pursuing five fast-track focus areas most ripe for opportunity, one of which is accelerating clinical testing of the most promising vaccines and treatments. Within this focus area ACTIV-5 (Big Effect Trial, BET) is a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints to evaluate whether certain therapies, approved or investigational, show promise treating patients hospitalized with COVID-19.
Within ACTIV-5, lenzilumab is the first and only anti-human GM-CSF treatment to be tested in ACTIV as a concomitant therapy with remdesivir compared with placebo plus remdesivir. Lenzilumab was selected from among 400 compounds that were considered for investigation in ACTIV. The study began in October 2020 and was comprised of hospitalized patients who need medical care for COVID-19 pneumonia and randomized (1:1) to the treatment groups. Patients receive a loading dose of 200-mg intravenous (IV) remdesivir on day 1 followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized. Lenzilumab (or placebo) is administered at 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of three doses. Patients hospitalized with COVID-19 and requiring oxygen supplementation were recruited from 63 sites across the U.S. and two sites in South Korea. The pre-specified primary analysis population consists of patients in the intent to treat (ITT) population with a CRP<150 mg/L and age<85 years not requiring mechanical ventilation or ECMO at baseline. The primary endpoint is the proportion of patients, in the primary analysis population, that died or required mechanical ventilation or ECMO through day 29.
Insiders can't buy/sell until the next quarterly report is released in August. Dale literally bought shares last month. He is precluded from selling for 6 months after his last buy.
It is best to just ignore Yooo and dloggold. Everything they say is senseless and entirely stems from a feeling of bitterness. You would think that they would feel empathy toward their fellow bagholders but rage-filled minds are often irrational.
Rough day for the entire market. Lots of smallcap bio down more than HGEN. Cold comfort.
Crazy that someone would sell right before data. I guess they're getting cold feet. Last Friday's plummet probably caused some to second guess. Hopefully, TLD comes this week as guided by management. I can't imagine anyone who has paid attention to the science is worried that data won't be game-changing.
The primary endpoint population of the ACTIV trial had 17.3% placebo mortality vs. 7.5% lenz mortality in the LIVE-AIR trial. There is still no effective immunomodulator authorized for newly hospitalized patients. Lenz should instantly become the most important Covid therapeutic as soon as it gets the EUA.
4.183 million shares printed at 4:00pm EST. That had to be Russell rebalancing but of trades that happened previously. The 1+ million shares that were traded in the early afternoon were probably also Russell rebalancing related but were trades that actually happened on the market. The share price always rebounds when a huge drop happens for non-news reasons. We should bounce back to $2.50 quickly next week.
I'm surprised we aren't rebounding quickly. I guess people are shellshocked.
Russell rebalance happening today so the massive selling might be related to that. Very nice buying opportunity was created. We will surely go north the rest of the day.
@KnuckleSandwic8
“After the initial trial, we and Humanigen decided that ifabotuzumab is an ideal candidate to deliver cancer killing drug payloads to cancers, including brain cancer but also other cancers such as lung cancer, colon cancer and breast cancer. "https://t.co/rDR9iHKO9W$HGEN
— Knuckle Sandwich (@KnuckleSandwic8) June 20, 2022
Good time to buy. Options expire tomorrow. Max pain is $2.50. An entity might be intentionally lowering the share price today and selling puts but will be buying tomorrow to get the share price as close to $2.50 as possible.
Lenzilumab stops Cytokine Release Syndrome dead in its tracks. Lenzilumab literally makes CAR-T a viable therapy.
CRP data from LIVE-AIR will soon be published in peer reviewed journal “Thorax, an international journal from BMJ and BTS, publishes high impact research across all areas of respiratory medicine and critical care”
$HGEN CRP data from LIVE-AIR will soon be published in peer reviewed journal “Thorax, an international journal from BMJ and BTS, publishes high impact research across all areas of respiratory medicine and critical care” pic.twitter.com/hXgdNBT2CB
— Jerry Q*👁️🗨️ (@swandivr) June 10, 2022
So 84,000 treatments are ready and they sounded optimistic that another 41,000 treatments will be available once they pass specifications. That is 125,000 treatments. 125,000 x $10,000 per treatment = $1.25 billion in immediate sales. If the ACTIV trial hits stat sig again on the primary endpoint, HGEN's market cap should easily rise to $5 billion. A $5 billion market cap equates to each share being worth $70.
Cam just said he expects the CRP peer review to be published in a highly prestigious journal in the next few weeks. He emphasized the word "highly". That probably means New England Journal of Medicine, Nature, or The Lancet.
Cameron again reiterated that ACTIV TLD is expected this month.
Annual Shareholders Meeting just began:
https://central.virtualshareholdermeeting.com/vsm/web?pvskey=HGEN2022
Frustrating day. However, the drop from $2.62 to $2.40 was 100% market-related and 0% HGEN-specific so HGEN should rebound nicely tomorrow. Closing at $2.49 wasn't too bad all things considered.
Ken Trbovich, SVP Investor Relations, just reaffirmed at the LD Micro Conference that ACTIV TLD is still expected this month.
Lenz's ACTIV-5 clinical trials webpage just updated. It now shows the trial having completed on April 22nd. The trial completing does not mean that data was locked by that date. It means that all the patients had completed every part of the trial.
https://www.clinicaltrials.gov/ct2/history/NCT04583969?V_71=View#StudyPageTop
Both the "Primary Completion" and "Study Completion" show being completed on April 22nd. And those are actual completion dates, not estimates.
Here are the definitions of those terms:
Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.
Study completion date
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
https://www.clinicaltrials.gov/ct2/about-studies/glossary
The quarterly report was released afterhours on Thursday, May 5th. Insiders' trading window started on either Monday, May 9th or Tuesday, May 10th. The trading window is 20 trading days. So by my estimates, Dale's last day to buy will be this coming Monday or Tuesday unless he is in possession of material nonpublic information. I am no expert in these matters so my estimate could contain errors. The SC 13D/A hasn't been released. In March, Dale submitted the SC 13D/A 2 days after his last form 4 was submitted even though there was plenty of time left in his trading window. There is a chance that Dale was buying on Friday.
@EricTopol
The "S" word for the pandemic is subvariants. Who even heard or used this word prior to Omicron's descendants?
— Eric Topol (@EricTopol) June 4, 2022
6 weeks ago the US was in the best shape since it all started. Then came BA.2, now BA.2.12.1, and next up BA.4, BA.5. pic.twitter.com/CwdlEZMdWJ
@ItsVeryJerry
ACTIV 1 changed to active, not recruiting on Jan 4th , reported TLD on June 3rd. ACTIV 5 changed to active, not recruiting on Jan 20th, +16 days, perhaps TLD on June 19/20.
— Jerry Q*👁️🗨️ (@swandivr) June 3, 2022
Pure guessing and speculation for fun. Don’t @ me.
Looks like that high volume selling at the end of the day was because of a rebalancing. A whole bunch of stocks tanked starting at 3:50pm EST. HGEN went from 1.1 million volume to 3 million volume in 10 minutes with 895,277 shares being sold right at 4:00pm EST.
Lots of chatter going on that CRP peer review is coming out pronto. That will be nice. The original peer review showed 54% efficacy on the primary endpoint which is very good but not amazing. The CRP peer review will show 243% efficacy on the primary endpoint. A lot of credible sources don't quote preprint numbers. When credible sources start quoting the 243% efficacy number, people will be very impressed. No therapeutic has efficacy anywhere close to that. The CRP mortality efficacy is even more impressive at 17.3% placebo mortality vs 7.5% lenz mortality. That is mind-boggling good. Again, no other therapeutic comes close.
My last post said that lenz's BET-B was last updated on Feb 28th. That is incorrect. BET-A, BET-B, and BET-C were all updated on Feb 24th. Last Friday's update of BET-C is the first update for any of the BET trials since Feb 24th.
The Clinical Trials website for ACTIV-5 / BET-C was updated on Friday to show that the trial has now completed. Lenz's BET-B trial is being done in conjunction with BET-A and BET-C. I believe the first 100 placebo patients were shared between the 3 trials. Before Friday's update, BET-C's last update was on Feb 24th. BET-A was last updated on Feb 24th. Lenz's last update was on Feb 28th. My guess is that lenz's Clinical Trials website will be updated to show it as completed sometime this week. TLD should be coming very soon.
BET-A https://clinicaltrials.gov/ct2/history/NCT04583956
BET-B https://www.clinicaltrials.gov/ct2/history/NCT04583969
BET-C https://clinicaltrials.gov/ct2/history/NCT04988035
Pandemic News @mildanalyst
https://twitter.com/mildanalyst/status/1530639269760483333
This chart.
Now think abt what we’re doing:
-Crashing booster demand
-Cancelling mask mandates
-Cancelling mitigation
Chart by @EricTopol
Covid is almost certainly endemic. Lenzilumab is going to have a large potential market for a long, long time. Maybe forever.
New trial showing that BA.4 and BA.5 are more infectious and cause more severe illness than BA.2. The worst of both worlds. Hospitalizations are sure to rise.
BREAKING🔔 The 10th preprint from G2P-Japan🇯🇵 is out at @biorxivpreprint. #Omicron BA.4 & BA.5 variants seem to be more contagious and pathogenic than BA.2 variant. Please RT. 1/7https://t.co/UjNFtAAADW
— The Sato Lab (Kei Sato) (@SystemsVirology) May 26, 2022
The 60,038 shares that were bought at 10:23am EST that raised the share price from $1.935 to $1.98 looks a lot like an insider buy. If Dale is buying this week, it would make the most sense for him to buy on Tue, Wed, and Thurs and then release the Form 4 afterhours on Thursday.