Humanigen crashes as FDA shoots down its Covid-19 drug EUA
Humanigen, once led by the imprisoned Martin Shkreli, is finding itself in a similarly confined space.
On Thursday, the company said the FDA declined its request for an EUA for its lead drug lenzilumab to treat newly hospitalized Covid-19 patients, sending shares of the company’s stock $HGEN down by more than 50% pre-market.
Why exactly the FDA rejected the EUA remains largely unknown as the company offered few specifics.
“In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19,” the company said in a statement, while noting that it can submit additional data as it becomes available.
The NIH is still testing lenzilumab in combination with Gilead’s remdesivir in its ACTIV-5/BET-B study, which Humanigen said could provide further data to support a new EUA request.
Those results will be crucial for the company, which said that as of June 30, it had cash and cash equivalents of about $121 million. The long-suffering biotech was a penny stock player in the OTC market when Covid-19 came along and lifted its prospects, fueling a steep rise in share price and reviving its prospects with investors. Humanigen burned through more than $100 million in cash in the first half of 2021, compared to about $20 million in the first half of 2020.
Humanigen CEO Cameron Durrant, who took the reins of then-bankrupt Humanigen — known previously as KaloBios — from Shkreli, said in a statement, “We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an EUA to treat hospitalized COVID-19 patients.”
The rejection is an about-face for the company, which in March touted positive results from a 520-person, placebo-controlled study that found lenzilumab improved the odds of ventilator-free survival by 54%.
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