Ar­genx files for a $75M IPO; PDU­FA date loom­ing, Bio­Marin wins CHMP nod for Brineu­ra

→ Bel­gium’s Ar­genx has joined the IPO queue in the US, look­ing to trig­ger a $75 mil­lion of­fer­ing by at­tract­ing in­vestors to its an­ti­body Fc en­gi­neer­ing tech­nolo­gies. Ar­genx has done a num­ber of col­lab­o­ra­tions, in­clud­ing one with Ab­b­Vie, and has a pipeline of ther­a­pies with the most ad­vanced in Phase II. Here’s the F-1.

→ With an FDA PDU­FA date loom­ing this week, Bio­Marin $BM­RN an­nounced to­day that the Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use in Eu­rope has adopt­ed a pos­i­tive opin­ion for the com­pa­ny’s Mar­ket­ing Au­tho­riza­tion Ap­pli­ca­tion for Brineu­ra (cer­liponase al­fa) to treat chil­dren with Neu­ronal Ceroid Lipo­fus­ci­nosis Type 2 (CLN2) dis­ease, a form of Bat­ten dis­ease, which is al­so known as tripep­tidyl pep­ti­dase 1 (TPP1) de­fi­cien­cy. The FDA de­ci­sion is due to ar­rive by end of day on Thurs­day.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER