re: Diamond in the Rough - Humanigen ($HGEN) a little DD

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UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
BURLINGAME, Calif.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.”

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Still in on this. Great spot to keep adding. EUA is imminent

Should be any day now IMO. Coming up on two months since the submitted application. No reason for me to believe they won't get it. I'd say short term PT in the $30's on approval, but I think that is low compared to what this stock will be.

FDA denied EUA... Bad news for the short term

I wish I had some extra powder to join you. Went in heavy in the $15's so I'm holding steady for now

So you all are suggesting this is a good entry point? I see that it’s plummeted this week by 50%. I haven’t followed it at all but will start reading up on this now. I have some powder to burn for a long term hold.

Just clinical stage. I think the real money is in the Car-T/lenzilumab therapy for relapsed/refractory large B-cell lymphoma (R/R LBCL). Check out the Zuma-19 ongoing clinical study if you're interested. It's still early but looks very promising.

This one continues to be painful. It was looking like the EUA would go through in Europe but it continues to drop to new lows. Holding a pretty large bag.

Ouch! Below the belt.