Archive for April, 2013
Discovery Laboratories: Still Another Delay in the Surfaxin Launch (DSCO, $2.00)
Overview Discovery Laboratories just announced still another delay in the launch of Surfaxin. The Company received five Complete Response letters dating from 2004 before finally gaining approval of Surfaxin in March of 2012. Management then indicated that it planned to launch Surfaxin in November of 2012. However, in October it indicated that there was an […]
Cytokinetics: Key Issues for Beginning Phase III for Omecamtiv Mecarbil in Congestive Heart Failure (CYTK, $1.15)
Overview and Investment Importance Those who read my initiation report on Cytokinetics (CYTK) understand that the importance of successfully conducting a phase III trial for omecamtiv mecarbil and then commercializing the product cannot be overstated. It could bring in as much as $300 million of pre-commercialization milestones from its partner Amgen by mid-2017. In addition, […]
Trius: Clinical Trials Show Important Differentiation of Tedizolid from Zyvox (TSRX, $6.48)
Investment Summary and Opinion I attended Trius’ (TSRX) CEO Jeff Stein’s presentation at the BioCentury Conference in New York on April 5th; this note summarizes some key takeaway points, particularly on how clinical trial data differentiates tedizolid from Zyvox. I think that the clinical data underlying the upcoming NDA filing for tedizolid is solid and […]
Repligen Promises To Be a Cash Flow Machine (RGEN, $6.88)
Investment Overview Repligen (RGEN) has gone through a metamorphosis that has dramatically changed its business model and investment outlook. For many years, its primary focus was on high risk drug development, but it was also building a high quality bioprocessing business that provides consumable products used in the manufacturing of biological products. The acquisition of […]
Besivance Royalty Deal Extends InSite’s Cash Runway (INSV.OB, $0.31)
InSite Vision(INSV.OB) announced that it agreed to sell its royalty stream on future sales of Besivance, a product that is marketed by Bausch & Lomb. The Company will receive $15 million upon closing and an additional $1 million if certain undisclosed sales levels are met by February 2014. The deal was done with SWK Holdings […]