Pharming Group Falls on FDA Letter Requesting Additional Data

By Elias Schisgall

Shares of Pharming Group fell after the Food and Drug Administration requested more information from the company on Joenja, its candidate to treat a rare immunodeficiency in children.

Shares were down 16% to $17.23 in Monday morning trading. The stock has more than doubled in value in the past year.

The biotechnology company on Sunday said the FDA highlighted a potential for underexposure among lower-weight patients, asking for additional data to confirm that those patients would achieve exposure levels comparable with adults and adolescents.

The FDA also asked for information related to a methodological issue with the company's production batch testing processes.

The agency's letter comes in response to a supplemental New Drug Application for Joenja to treat activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency known as APDS, in children between four and 11 years old.

"While we are disappointed in the FDA's response, we remain dedicated to making Joenja available to pediatric patients aged 4-11 with APDS," Chief Executive Officer Fabrice Chouraqui said Sunday. "We are going to work closely with the FDA to provide the necessary information and determine the best and most effective path forward."

The company said it plans to request a Type A meeting with the agency. It said the FDA's approval of Joenja for patients 12 years of age and older is unaffected by the letter.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

February 02, 2026 11:05 ET (16:05 GMT)