Here's more evidence that the biotech industry is giddy about the FDA's new "breakthrough therapy" designation. On speculation that its multiple myeloma contender could get the coveted status, Danish biotech Genmab's shares jumped in trading today as stock watchers see potential for a charmed development path for the experimental antibody.
The 1.8% bump in share price that Bloomberg reported was short of the 25% leap in value in late August after Genmab snapped up a potential $1.1 billion deal with Johnson & Johnson's ($JNJ) Janssen for global rights to the candidate, dubbed daratumumab. Nevertheless, it apparently helps a biotech to even raise hopes for getting a "breakthrough" tag, which has bestowed the status for treatments that show early clinical evidence of superior benefits for patients with serious diseases.
As the news wire reports, Danke Bank stirred speculation about Genmab's shot at a breakthrough listing for daratumumab, which targets CD38 on myeloma cells and has impressed investigators and biotech insiders with early study findings.
"We have been positively surprised by the efficacy that this antibody has demonstrated in myeloma," Danske analyst Thomas Bowers told Bloomberg. "Perhaps it can get on the market as a single agent. I think it ticks all the boxes to get the breakthrough designation from the FDA."
His prediction comes days after developer Pharmacyclics ($PCYC) became an early recipient of the designation for its blood cancer contender ibrutinib, which now appears to have an inside track on gaining a swift approval.
- check out Bloomberg's article