Protocols

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.

Biogen vet Michael Cloonan has joined Sage Therapeutics $SAGE as its new chief business officer. In other moves, Christopher Silber was named Senior Vice President, Clinical Development, Paul Hodgkins is now Vice President, Health Economics and Outcomes Research and Value Demonstration and Frank Sanders was tapped as Vice President, Sales & Marketing. In addition, Amy Schacterle, has been promoted to Senior Vice President, Regulatory Affairs and Quality Assurance.

Immune Pharmaceuticals $IMNP, which recently completed a 1-for-20 stock split to stay in line with Nasdaq listing rules, is restructuring. CEO Daniel Teper has resigned and plans to lead oncology R&D in a subsidiary called Cytovia. The biotech’s stock dropped about 10% in pre-market trading Monday.


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RAPS Regulatory Convergence 2017