Why Humanigen, uniQure, bluebird bio, Amphastar Are Rallying Monday

Humanigen, Inc. HGEN, uniQure N.V. QURE, bluebird bio, Inc. BLUE and Amphastar Pharmaceuticals, Inc. AMPH were among the biotech gainers on Monday.

Humanigen's Lead Drug Aces Late-stage COVID-19 Study: Humanigen announced positive topline results from the Phase 3 study of its lead drug – lenzilumab – in treating patients hospitalized with COVID-19.

The clinical-stage biopharma that focuses on preventing and treating an immune hyper-response called cytokine storm said the trial that evaluated the safety and efficacy of lenzilumab showed that patients receiving lenzilumab and other treatments, including steroids and/or Gilead Sciences, Inc.'s GILD remdesivir, had a 54% greater relative likelihood of survival without the need for invasive mechanical ventilation compared with patients receiving placebo and other treatments.

"The dosing regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential foundational therapy. Lenzilumab could make the difference between going on a ventilator, which reduces one's chance of survival, and leaving the hospital alive," said Zelalem Temesgen, the principal investigator of the trial.

Humanigen shares were jumping 60.83% to $22.50.

Related Link: The Week Ahead In Biotech: Acadia's Dementia Drug Update, Clinical Readouts, Few Earnings In Holiday-Shortened Week

uniQure's Gene Therapy Candidate Vindicated of Link to Liver Cancer: Gene therapy company uniQure announced that an investigation into the case of liver cancer in one patient in the pivotal late-stage study of its investigational gene therapy etranacogene dezaparvovec found it's highly unlikely the reported cancer was caused by the treatment candidate. Etranacogene dezaparvovec is being evaluated for hemophilia B.

The FDA imposed a clinical hold on the study in late December after a safety report filed with the agency in mid-December raised the issue of a possibly related serious adverse event of liver cancer in one patient treated in the trial.

The company said it has now shared the data with the FDA and is prepared to have further communication regarding the clinical hold in the second quarter. The data will likely be submitted for presentation at an upcoming industry conference yet to be determined.

uniQure was advancing 10.09% to $32.19.

Amphastar Gets Nod For Injectable Dextrose: Amphastar said the FDA has approved its abbreviated new drug application for Dextrose injection 50% in the 50 ml Luer-Jet prefilled syringe system.

"The FDA's approval of Dextrose, a product often on the Agency's Drug Shortage list, offers an opportunity to ensure quality products are produced at the highest standard and highlights Amphastar's manufacturing capabilities to fulfill such market needs," said Dr. Jack Zhang, CEO of Amphastar.

Amphastar was adding 5.32% to $19.

bluebird bio Gains On Approval of First Cell Therapy For Blood Cancer: bluebird bio and partner Bristol-Myers Squibb Company BMY announced late Friday the FDA approved their cell therapy candidate ide-cel for the treatment of heavily pre-treated adult patients with multiple myeloma, a form of blood cancer.

Ide-cel, approved under the brand name Abecma, is a CAR T cell immunotherapy directed against B-cell maturation antigen. It is approved as a one-time infusion and is the first cell therapy approved for multiple myeloma.

Reacting to the approval, SVB Leerink analyst Mani Foroohar maintained an Outperform rating on bluebird bio shares and increased the price target from $69 to $72.

bluebird bio shares were rallying 6.27% to $31.86.