This is very positive for ALKS, as it delays or possibly removes a potential threat to Risperdal Consta. FDA cited concern over the excessive sedation that was seen in approximately 1% of patients in clinical trials, and the agency needs more information to better understand the risk and underlying cause of these events.
Firm notes JNJ submitted an NDA for another potential competitor to Risperdal Consta, paliperidone palmitate, on 10/29/07. Given Invega's poor launch (less than 2% market share after one year), they do not think that paliperidone palmitate is a serious threat to Risperdal Consta. Notes that JNJ is committed to Risperdal Consta as evidenced by the heavy investment in Phase IV clinical trials for the product.
Reits Outperform and $24 tgt on ALKS saying they are buyers of the stock.
Notablecalls: The LLY news hit in pre-mkt yesterday, yet there was no reaction in ALKS. I think we will get one today.