Pharming Stock Reaps Significant Gains After Landmark FDA Approval

(RTTNews) - Pharming Group N.V. (PHAR) touched a new 52-week high of $17.81 during intraday trading Friday, thanks to FDA approval of its immune disorder drug Leniolisib.

Leniolisib has been approved for the treatment of activated phosphoinositide 3-kinase delta syndrome in adults and adolescents 12 years of age and older.

Activated phosphoinositide 3-kinase delta syndrome (APDS) is a rare primary immunodeficiency that affects roughly 1 to 2 people per million. It is caused due to mutations in either PIK3CD or PIK3R1 genes, that regulate maturation of white blood cells. APDS impairs the immune system and the function of the white blood cells that recognize and attack viruses and bacteria to prevent infection.

Currently, the available treatments for APDS are limited to supportive therapies like antibiotics and immunoglobulin replacement therapy.

Leniolisib, which becomes the first approved treatment for APDS, will be marketed under brand name Joenja, and is expected to be launched in the US in early April.

Pharming secured the rights to Leniolisib from Novartis (NVS) back in August 2019.

The drug is under review in Europe. The European Medicines Agency's Committee for Human Medicinal Products is expected to issue its opinion on Leniolisib in the second half of this year.

PHAR has traded in a range of $6.10 to $17.81 in the last 1 year. The stock closed Friday's trading at $14.96, up 32.68%.