Shares of
Humanigen, Inc.
HGEN
were down 76.6% on Wednesday after the company’s investigational COVID-19 treatment, lenzilumab failed in a late-stage study.
The National Institute of Allergy and Infectious Diseases’ (NIAID) ACTIV-5/BET-B study evaluated Humanigen’s lenzilumab plus
Gilead
’s
GILD
Veklury (remdesivir) as compared to placebo plus remdesivir in treating hospitalized COVID-19 patients.
The study failed to achieve statistical significance on the primary endpoint —– defined as the proportion of patients with baseline CRP<150 mg/L and aged less than 85 years, alive and without mechanical ventilation through day 29.
The preliminary data from the ACTIV-5/BET-B study did not demonstrate a significant trend toward lowering mortality rates in the given patient population.
No new safety signals were observed for lenzilumab in the study. The benefit demonstrated in the ACTIV-5/BET-B study was not the same as that observed in previous studies on the candidate, like the phase III LIVE-AIR study
In March 2021, the company announced positive top-line data from the phase III LIVE-AIR study that evaluated lenzilumab in newly hospitalized COVID-19 patients.
The late-stage study showed encouraging data in survival without ventilation when treated with lenzilumab in combination with corticosteroids and remdesivir.
Humanigen’s stock has plunged 83.6% year to date compared with the
industry
’s decrease of 20.6%.
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Apart from COVID-19, Humanigen is also developing lenzilumab for treating other inflammatory indications like acute Graft versus Host Disease, eosinophilic asthma and rheumatoid arthritis.
In 2020, Gilead’s COVID treatment, Veklury, received FDA authorization for emergency use in adults and pediatric patients with severe-to-moderate COVID-19. The drug has received several label expansion approvals from the FDA for treating COVID-19 —– addressing various types of patient populations and different age groups.
For full-year 2022, GILD expects Veklury sales at around $2 billion.
Zacks Rank & Stocks to Consider
Humanigen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are
Leap Therapeutics, Inc.
LPTX
and
Precision BioSciences, Inc.
DTIL
, both carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 6.9% for 2022 and 2% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
Precision BioSciences’ loss per share estimates narrowed 5.7% for 2022 and 16.2% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.
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