Street analysts have recently been getting behind Humanigen (HGEN), a company seeking to get a Covid-19 treatment approved.
One of the small biotech’s supporters is Oppenheimer’s Kevin DeGeeter, who thinks the company’s latest moves are “de-risking” the regulatory path for lenzilumab, the company’s prospective therapy for hospitalized COVID-19 patients.
The NIH – HGEN’s partner – recently advanced the ACTIV-5/BET-B study of lenzilumab to Phase 2/3 testing and made some important adjustments to the trial. The primary endpoint now includes survival without ventilation (SWOV), while the plans are to enroll 400 participants – double the previous enrollment rate.
The modifications were made following the positive results of another study of lenzilumab. In the Phase 3 LIVE-AIR trial, the treatment met the primary end point of SWOV.
In late May, the company submitted an EUA application for lenzilumab as a treatment for patients hospitalized with COVID-19. Although no official timeline for the review has been given, DeGeeter considers 2 to 3 months for an EUA decision as “reasonable,” implying an update sometime this quarter. The company hasn’t provided an update on the readout time of the ACTIV-5/BET-B study but had previously guided for 4Q21.
To support a BLA filing, DeGeeter still thinks HGEN will be required to undertake a separate “confirmatory study.”
“However,” the 5-start analyst added, “We view revisions as meaningfully increasing probability of an upside scenario based on use of ACTIV-5/BET-B as the second study to support regulatory submission and provide prospective data to inform sizing for future studies using the endpoint… Expect EUA approval based on evidence of potential additive survival benefit from lenzilumab beyond current SOC of steroids and direct antiviral therapy.”
In the meantime, the analyst “encourages” investors to keep an eye on the FDA’s EUA process.
All in all, DeGeeter sticks to an Outperform (i.e. Buy) rating, backed by a $90 price target. Shares could add 86% of muscle should the forecast pan out as planned over the next 12 months. (To watch DeGeeter’s track record, click here)
With a full house of Buys – 5, in total – the analyst consensus rates this name a Strong Buy. The projection is for big shares gains over the next year; going by the $34.2 average price target, the stock will deliver returns of 118%. (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.
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