FDA OKs Xeris Pharma’s glucagon for severe low blood sugar in diabetics

The FDA approves Xeris Pharmaceuticals’ (XERS +0.9%) GVOKE (glucagon), a ready-to-use, room temperature-stable liquid glucagon for the treatment of severe hypoglycemia (low blood sugar) in diabetics at least two years old. It will be available in prefilled syringe and autoinjector (HypoPen) formats.

Management will host a conference call today at 12:30 pm ET to discuss the approval.

Separately, the company has increased its debt facility with Oxford Finance and Silicon Valley Bank to $85M from $45M with a maturity data as late as June 2024 (if second tranche is drawn) that the company may access to support commercial launch.

Shares, currently halted, will resume trading at 12:00 noon ET.

Update: Shares up 4% on resumption of trade.

Update: Selling has intensified, driving shares down 11% on more than an 8x surge in volume. On the competitor front, Eli Lilly (LLY -0.3%) is launching Baqsimi (glucagon) nasal powder, the first needle-free, ready-to-use glucagon. The FDA approved it in July.

https://seekingalpha.com/news/3498324-fda-oks-xeris-pharmas-glucagon-severe-low-blood-sugar-diabetics