The following updates were issued by Javelin Pharmaceuticals (JAV) at a recent quarterly conference call. The company is currently waiting for the EMEA to rule on its MAA to market Dyloject in Europe, beginning with the UK.
First, Dyloject MAA approval by EMEA for initial UK marketing approval is currently pending re-inspection of manufacturing facilities for cGMP compliance in response to issues raised during initial inspection. Management gave guidance during the Q&A session that this should be a non-event with ultimate approval expected. I believe the recent sell-off below $6/share represents a good buying opportunity for new investors or to add to an existing position.
Other recent milestones included positive topline results for Javelin's Phase 3 pivotal trial of Rylomine (intranasal morphine), a 10 year extension of European patent protection for Dyloject (injectable diclofenac) to 2024, and the selection of Javelin Pharma by Russell Research for the Russell 2000, 3000, Micro-Cap and Global Indices. The inclusion in the Russell indices is expected to lead to more widespread ownership of Javelin by both institutional investors and fund managers, as the stock is currently trading well above its yearly lows and appears poised to move higher with pending (although slightly delayed) Dyloject approval and a pipeline of products with a low level of clinical risk because they represent improvements upon existing, known drugs by way of unique delivery techniques.
Disclosure: Author has a long position in JAV
JAV 1-yr chart