PHGUF - Pharming Group wins FDA nod for rare immune disorder therapy
2023-03-27 05:45:26 ET
- The shares of Dutch biotech Pharming Group N.V. ( NASDAQ: PHAR ) added ~24% on Monday in the Amsterdam stock exchange on the announcement of U.S. approval for the rare immune disorder therapy Joenja co-developed with Novartis ( NVS ).
- The FDA has greenlighted the oral therapy under the agency’s priority review for activated phosphoinositide 3-kinase delta (PI3K?) syndrome (APDS), a rare form of primary immunodeficiency.
- According to the labeling information, the treatment, also known as leniolisib, will be available for adults as well as pediatric patients aged 12 years and above.
- Pharming ( OTCPK:PHGUF ) is preparing for the U.S. launch of Joenja in early April, with shipments expected to be available in mid-April.
- Under a licensing arrangement with Pharming ( OTCPK:PHGUF ), Novartis ( OTCPK:NVSEF ) is entitled to milestone payments and royalties based on a low double-digit to a high-teen double-digit percentage of net sales of leniolisib.
- Read: Seeking Alpha contributor L.D. Investments argue that Novartis ( NVS ) is well positioned to face patent cliffs for certain blockbuster drugs in its portfolio.
For further details see:
Pharming Group wins FDA nod for rare immune disorder therapy