Proactive Investors - Faron Pharmaceuticals Limited (LON:FARN) shares jumped over 11% after the company was granted orphan drug designation by the US Food and Drug Administration (FDA) for its bexmarilimab asset to treat acute myeloid leukaemia.
If ultimately approved, market exclusivity, exemption from application fees and tax credits for clinical trials could all be granted following the designation, Faron said in a statement.
“The designation represents a milestone in our development journey,” chief medical officer Marie-Louise Fjällskog hailed.
“One that we believe when combined with standard of care, will lead to better patient outcomes and improved quality of life.”
The FDA approves orphan status to support medicine development targeting rare disorders which affect fewer than 200,000 people in the United States.
Currently between phase one and two, Faron’s bexmarilimab immunotherapy is designed to treat myeloid cell function and ignite patients’ immune systems against the leukaemia.
“Receiving orphan drug designation from the FDA signifies our continued progress and commitment to develop bexmarilimab as a potential treatment,” Fjällskog added.
Phase two of clinical trials are expected to start in the fourth quarter of this year, Faron said.
Shares soared 11% to 299.80p on the news.