Coherus BioSciences (CHRS) surges on FDA Udenyca delivery system approval

Shares of Coherus BioSciences (NASDAQ: CHRS) surged 35% in 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.

Reacting to the news, Barclays analyst Balaji Prasad, who has an Overweight rating and a $7 per share price target on the stock, said the approval adds to the 2024 growth outlook for Coherus.

"Today's approval makes CHRS the only company with all three forms of pegfilgrastim on market. It also set a solid basis for CHRS's FY24," said Prasad. "With Udenyca OBI targeting Neulasta Onpro's ~42% share, the market dynamic for Udenyca looks set to improve in FY24, which takes the company one step closer to becoming cash flow positive."

By Sam Boughedda

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