Commercial RiskRisks include commercial risk with ENHANZE, particularly in the multiple myeloma indication, which is dynamic and rapidly evolving, and partnership risk, specifically with respect to Janssen.
Pricing RiskA research firm suggested that drugs using Halozyme's Enhanze additive may not be seen as new drugs, leading to potential earlier price negotiations.
Regulatory RiskHalozyme shares have tumbled due to a note from Leerink Partners interpreting recent draft guidance from the US CMS.