Recent times have seen a recovery for Humanigen (HGEN) stock; shares are up by 33% over the past month, following September’s sharp drop. Recall, shares took a tumble after the FDA spurned lenzilumab – the company’s drug candidate to treat hospitalized Covid-19 patients – with the regulatory body saying it required additional data before moving forward.
Meanwhile, the company is pursuing opportunities elsewhere and hoping to get the drug approved in the UK.
At the start of October, Humanigen submitted to the MHRA (The Medicines and Healthcare products Regulatory Agency) its Marketing Authorization Application (MAA).
Oppenheimer’s Kevin DeGeeter thinks the treatment has a good chance of making the grade.
“Our positive outlook for conditional approval of lenzilumab in UK for COVID is based on recent track record of MHRA drawing independent conclusions from FDA on COVID therapies and UK focus on C-reactive protein (CRP) as prognostic for COVID patients,” the 5-star analyst explained. “CRP subgroup analysis from LIVE-AIR study demonstrated statistically significant improvements on incidence of mechanical ventilator or death vs. placebo.”
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Humanigen: All You Need to Know Right Now
?Marty Shtrubel
Nov 05, 2021, 06:04 AM
AA
?
Recent times have seen a recovery for Humanigen (HGEN) stock; shares are up by 33% over the past month, following September’s sharp drop. Recall, shares took a tumble after the FDA spurned lenzilumab – the company’s drug candidate to treat hospitalized Covid-19 patients – with the regulatory body saying it required additional data before moving forward.
Meanwhile, the company is pursuing opportunities elsewhere and hoping to get the drug approved in the UK.
At the start of October, Humanigen submitted to the MHRA (The Medicines and Healthcare products Regulatory Agency) its Marketing Authorization Application (MAA).
Oppenheimer’s Kevin DeGeeter thinks the treatment has a good chance of making the grade.
“Our positive outlook for conditional approval of lenzilumab in UK for COVID is based on recent track record of MHRA drawing independent conclusions from FDA on COVID therapies and UK focus on C-reactive protein (CRP) as prognostic for COVID patients,” the 5-star analyst explained. “CRP subgroup analysis from LIVE-AIR study demonstrated statistically significant improvements on incidence of mechanical ventilator or death vs. placebo.”
Considering lenzilumab’s anti-inflammation MOA (mechanism of action), DeGeeter sees the CRP level as “reasonable patient stratification criteria.” If the treatment gains approval, based on presents case rates, all of HGEN’s current lenzilumab inventory could be heading the UK’s way.
However, one possible risk is that the MHRA will hold out until late 1Q22 with its decision. This is when Humanigen is expected to present data from the ACTIV5 study.
To-date, enrollment is 75% complete, up from mid-September’s 60%, and DeGeeter expects completion by the end of the year. The study’s primary endpoint is incidence of mechanical ventilation or death, compared to LIVE-AIR’s survival without ventilation. DeGeeter also counts the secondary endpoint of time-to-recovery as an “important” factor too.
With the UK decision a potential near-term catalyst, the Oppenheimer analyst sticks with an Outperform (i.e., Buy) rating and a bullish price target; at $17, the figure could generate returns of 107% over the one-year timeframe. (To watch DeGeeter’s track record.
All News
Humanigen: All You Need to Know Right Now
?Marty Shtrubel
Nov 05, 2021, 06:04 AM
AA
?
Recent times have seen a recovery for Humanigen (HGEN) stock; shares are up by 33% over the past month, following September’s sharp drop. Recall, shares took a tumble after the FDA spurned lenzilumab – the company’s drug candidate to treat hospitalized Covid-19 patients – with the regulatory body saying it required additional data before moving forward.
Meanwhile, the company is pursuing opportunities elsewhere and hoping to get the drug approved in the UK.
At the start of October, Humanigen submitted to the MHRA (The Medicines and Healthcare products Regulatory Agency) its Marketing Authorization Application (MAA).
Oppenheimer’s Kevin DeGeeter thinks the treatment has a good chance of making the grade.
“Our positive outlook for conditional approval of lenzilumab in UK for COVID is based on recent track record of MHRA drawing independent conclusions from FDA on COVID therapies and UK focus on C-reactive protein (CRP) as prognostic for COVID patients,” the 5-star analyst explained. “CRP subgroup analysis from LIVE-AIR study demonstrated statistically significant improvements on incidence of mechanical ventilator or death vs. placebo.”
Considering lenzilumab’s anti-inflammation MOA (mechanism of action), DeGeeter sees the CRP level as “reasonable patient stratification criteria.” If the treatment gains approval, based on presents case rates, all of HGEN’s current lenzilumab inventory could be heading the UK’s way.
However, one possible risk is that the MHRA will hold out until late 1Q22 with its decision. This is when Humanigen is expected to present data from the ACTIV5 study.
To-date, enrollment is 75% complete, up from mid-September’s 60%, and DeGeeter expects completion by the end of the year. The study’s primary endpoint is incidence of mechanical ventilation or death, compared to LIVE-AIR’s survival without ventilation. DeGeeter also counts the secondary endpoint of time-to-recovery as an “important” factor too.
With the UK decision a potential near-term catalyst, the Oppenheimer analyst sticks with an Outperform (i.e., Buy) rating and a bullish price target; at $17, the figure could generate returns of 107% over the one-year timeframe.
Looking at the consensus breakdown, based on 4 Buys, in addition to 1 Hold and Sell, each, the analyst consensus rates this stock a Moderate Buy. That said, the average price target is no less bullish than DeGeeter’s; in fact, at $17.25 it is even slightly higher.
