Coherus BioSciences surges on FDA Udenyca delivery system approval

Shares of Coherus BioSciences (CHRS) surged 35% in premarket trading on Wednesday after the company announced the U.S. Food and Drug Administration (FDA) approved its UDENYCA ONBODY product.

UDENYCA ONBODY is the company’s on-body injector (OBI) presentation of UDENCYA, designed for a five-minute injection time. The device features an automatic retractable needle mechanism.

“The on-body injector for UDENYCA is the result of years of significant investment in research and development to bring forward a novel and proprietary device that provides patients with an automatic delivery option for their medication,” said Denny Lanfear, CEO of Coherus.

Paul Reider, Coherus’s chief commercial officer, said: “Our market studies showed a significant demand for a novel on-body pegfilgrastim delivery device tailored to specific patient needs. We expect that UDENYCA ONBODY’s five-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers, and doctors.”

Coherus said it conducted extensive market research, revealing a strong demand for the system.

The company’s shares are trading just below the $3 per share mark ahead of Wednesday’s open.