I knew you were watching it lol. Yes, nice PM pop!

UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
July 09 2021 - 06:30AM

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.

Leading up to initiating its submission for Marketing Authorization last month, Humanigen held meetings with various authorities in the UK, including a Rapid C-19 multiagency meeting with representatives from the MHRA, the Therapeutics TaskForce, (TTF), the Department of Health and Social Care (DHSC), National Health Service England (NHSE) and the National Institute for Heath and Care Excellence (NICE).

“We are grateful this submission will receive expedited consideration by MHRA,” said Cameron Durrant, CEO of Humanigen. “The global spread of variants of concern, such as the Delta variant, highlights the continued need for proven therapies that are variant-agnostic for millions who remain at risk of COVID-19.”

According to Public Health England, despite the first dose vaccination rate of 86% across the UK, the current seven-day hospitalization rate was nearly 2,500, representing a 45% increase over the prior period. Deaths from COVID in the UK reached 161 over the last seven days, an increase of more than 40% compared to the prior seven-day period.1

“We continue to work with our partners to prepare for distribution of lenzilumab pending conditional approval of its use to treat hospitalized patients with COVID-19,” noted Timothy E. Morris, COO and CFO of Humanigen. “In the event Emergency Use Authorization in the United States and Marketing Authorization in the UK are awarded concurrently or in parallel, we will work with the relevant authorities to ensure appropriate allocation of lenzilumab in each country.”

Nice article!

We hit our 52w high end of July last year. Maybe a repeat is in the cards? Still can't believe we're sitting at half of that price 1 year later. Guess I'm a glutton for punishment...have an order in for $16 if we get that low.

Chart is starting to look like the end of March, right before phase 3 data was released. Repeat in the works with EUA??

You know us Kentucky brothers stay together!!

I follow him on stocktwits. Amazing how some companies get eua’s. Not a big fan of the FDA!

FDA authorizes Roche drug for severely ill COVID-19 patients. Wonder when they applied for EUA?

https://www.foxnews.com/health/fda-authorizes-roche-drug-severe-covid-19-patients

I'll give you a great deal on my $SOLI shares if that would help. :)

Sorry I could only find one....Mike is really pissed that he didn't get her!

wow....fantastic! Thanks for sharing!

kt

Wow...what timing! Congrats!

Yep...frustrating to watch. Would love to see an early EUA! Hopefully 19 holds today....higher lows.

European Commission strategy on COVID-19 therapeutics. They expect to have 3 available by Oct and 5 total by years end.

https://ec.europa.eu/info/sites/default/files/communication-strategy-covid-19-therapeutics_en.pdf

kt

Go throw a couple mill at $HGEN so I can make a few $$ on my June $20's please. :)

The are failing as a public company. I think their business is doing okay just don’t know if we’re going to partake.

I agree and the fact that "friends and family" bought stock keeps a slim hope alive....but if nothing by end of summer that hope will fade. As the theme with this stock....we wait.


kt

Sadly I disagree. The longer this drags out the less hope I have of ever making any $ here. If this drags on until September I see this delisted and never trading again. Sure hope I'm wrong!!

kt

Starting to move now! Maybe we'll be green by close.

kt

Nice! Those are going to be up big this morning!

kt

Wonder how the "friends and family" holders are feeling now? What a $hit show!

Nice volume today! Maybe the start of an extended long overdue run.

Looks like it has a chance.

kt

Ha....I missed this one!

You're just jealous!

$AMC hit $72 today.....I have to start trading these meme stocks! Crazy!

Maybe someday soon $HGEN becomes a meme stock? :)

kt

That would be nice...I refuse to wait on the phone for a half hour to put in an order!

Still have to call in buys at Ameritrade for this one. Frustrating! They need to get this fixed!

kt

500k in volume the first 7 minutes. Sell on news crowd is going to regret it imo!

Wow....look at the volume. Could you imagine $HGEN with half that volume lol. Incredible.

Wow..beautiful!

We can't talk about him here anymore! He's a movie star now!

and probably true. :(

You just had to bring that one up….UGH!

I'm thinking we see a JP Morgan upgrade soon.

Still watching it but not really playing pennies now. $HGEN is getting most of my attention! :)

kt

Still amazed that we're trading at $20.

NP...I do it all the time! :)


kt

I have it going from grey to expert unless I'm missing something.

05/25/2021 CNRQ China Soar Information Technology Inc Grey Market Expert Market Common Stock