The public markets have generally not been much fun in September but spare a thought for investors of Humanigen (HGEN). Shares have shed 64% of their value over the past month, with most of the losses coming directly after the FDA’s EUA rejection of lenzilumab – Humanigen’s prospective treatment for hospitalized Covid-19 patients.
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So, what next? Last Wednesday, the company provided an update on its regulatory strategy for lenzilumab, and Oppenheimer’s Kevin DeGeeter has been sifting through the details.
The company reiterated its plan to complete lenzilumab’s conditional Marketing Authorization Application (MAA) in the UK by the end of the month. Previous cases indicate the reviewing process should take between 60 to 100 days, although the company is “optimistic on a shorter time period.”
Despite the FDA’s stance, DeGeeter believes the regulatory body’s decision on the EUA is “not predictive of MAA review from MHRA (Medicines and Healthcare products Regulatory Agency).” In fact, the analyst sees “an opportunity for lenzilumab to reach the UK market in 1Q22.”
On lenzilumab’s EUA prospects, the company intends on submitting more data from the LIVE-AIR study. This includes subgroup analysis on patients with baseline CRP (C-reactive protein) <150mg/L and day-60 data. DeGeeter thinks “addressing the CRP subset” could differentiate lenzilumab from tocilizumab, the anti-inflammatory agent which in June was granted EUA approval to treat Covid-19 patients.
The data will be submitted before the completion of the ACTIV-5/BET-B study. So far, enrollment is 60% complete (from a target total of 550 patients). Although the company previously estimated enrollment would be complete by the end of the year, it has now taken that objective off the table with no set target currently in mind. DeGeeter views the ACTIV-5 study “as providing additional safety and efficacy data to support EUA or BLA submission.”
HGEN shares might have taken a beating recently, but DeGeeter expects the stock to claw back those gains and some. The analyst has a $17 price target for the shares, suggesting room for a 166% surge over the coming months. DeGeeter’s Outperform (i.e., Buy) rating stays as is. (To watch DeGeeter’s track record, click here)
Other analysts are even more optimistic, forecasting 12-month upside off 204%, based on an average price target of $19.4. Overall, the stock has a Moderate Buy consensus rating, predicated on 4 Buys and 1 Hold and Sell, each. (See HGEN stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
