Archive for October, 2013
Celldex: Why Investors Are So Excited About the Company (CLDX, Hold, $24.39)
This post is an excerpt from the report: Celldex: Pipeline Promise Has Been Embraced by Wall Street Comprehensive reports are now available to paid subscribers and can be found in the Reports section. Review of Amazing and Volatile Stock Price Performance From the closing price on December 30, 2011 through October 1, 2013 Celldex’s (CLDX) stock […]
Celldex Initiation Report: Pipeline Promise Has Been Embraced by Wall Street (CLDX, Hold, $22.79)
Review of Amazing and Volatile Stock Price Performance From the closing price on December 30, 2011 through October 1, 2013 Celldex’s (CLDX) stock price increased 15 fold from $2.60 to $37.83; its shares have recently backed off to about $26.00. The number of shares outstanding nearly doubled over this 21 month timeframe from 44.2 million […]
pSivida: Thoughts on pSivida in the Aftermath of the Complete Response Letter on Iluvien (PSDV, $2.87)
Background on the Complete Response Letter This note focuses on the implications of the complete response letter (CRL) received by Alimera (ALIM) for Iluvien. This product was developed by pSivida (PSDV) but was partnered with Alimera. This report deals only with the investment significance for pSivida. Alimera announced that it had received another CRL from […]
Agenus and Glaxo: Sizing Up the Potential for the RTS,S Malaria Vaccine (AGEN, $2.94)
Putting Malaria Vaccine Results in Perspective for Agenus Glaxo (GSK) has just released interim (18 month) results on its phase III trial conducted in sub-Saharan Africa for its malaria vaccine, RTS,S; this follows previous interim reports at 6 and 12 months. The results are not as good as the results normally seen with childhood vaccines […]
pSivida: Previewing the October 17th PDUFA Date for Iluvien (PSDV, $5.07)
Investment Scenarios: The Positive and Negative Case pSivida (PSDV) has a very important binary event upcoming on October 17, 2013; this is the PDUFA date for Iluvien, an ocular implant for diabetic macular edema that was licensed to Alimera (ALIM). I cannot answer the question of whether the government shutdown might delay the PDUFA date […]
Discovery Laboratories: What the Marketing Approval of Surfaxin Could Mean to the Stock (DSCO, $2.72)
Surfaxin is Finally Cleared for Commercialization in the US The long saga for Discovery Laboratories (DSCO) that began with the first filing of an NDA for Surfaxin in April of 2004 has finally come to an end as the FDA has cleared Surfaxin for marketing. The NDA was actually approved in March 0f 2012, but […]