NEVDK schreef op 20 september 2018 19:21:
12-18 mo. Price Target €2.50
PHARM - NXT AM €0.97
Pharming Group N.V.
CRL Delays Prophylaxis Approval; Long-Term Story
Pharming (PHARM) announced the receipt of a Complete Response Letter (CRL)
regarding its sBLA for Ruconest use in prophylaxis for hereditary angioedema (HAE,
currently marketed in acute), ahead of the 9/21 PDUFA. The FDA requested a Phase
3 study be conducted before it will reevaluate Ruconest in prophylaxis; we expect
a 12-24-month delay.