Post archive for ‘Smith On Stocks Blog’
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 […]
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 […]
A.P. Pharma Receives Complete Response Letter on APF530 (APPA.OB, $0.34)
Overview A.P. Pharma has just released the disappointing news that it has received a Complete Response Letter for APF530. The press release described three issues that led to the CRL. · With respect to chemistry, manufacturing and controls (CMC), the FDA has requested the refinement of one product quality analytical test method, and that certain […]
Investment Implications of the Acquisition of MAP Pharmaceuticals by Allergan
Allergan to Acquire MAP Pharmaceuticals Allergan (AGN) has announced that it will acquire MAP Pharmaceuticals (MAPP) at a price of $25 per share which represents a 60% premium over the closing price of $15.58 on Tuesday, the day before the deal was announced. This values MAPP at just under $1 billion. The deal was obviously […]
Cadence: Management Guides to a Near Doubling of Ofirmev Sales in 2013 (CADX, $5.23)
My confidence in my long standing Buy recommendation on Cadence (CADX) has been strengthened by its pre-announcement that 4Q, 2012 sales of Ofirmev surprised on the upside. For the last half year, I have been writing that the Ofirmev launch has gained traction. The evidence is becoming solid as the company pre-announced that 4Q, 2012 […]
InSite Vision: Upcoming Results on the DOUBle Trial May Not Be as Binary as I Have Been Thinking
I met with the CEO, Tim Ruane, and CFO, Lou Drapeau, of InSite Vision (INSV.OB) in early January during my trip to the JP Morgan conference in San Francisco. I have written an extensive introductory report and follow-up reports on my website. I would refer investors to those reports for a more in-depth analysis of […]
Discovery Laboratories Announces Changing of the Guard (DSCO, $2.21)
New Board and New CEO There has been a significant leadership change at Discovery Laboratories (DSCO) which has appointed a new CEO. In addition, changes have also resulted in an almost entirely new five member Board of Directors. Tom Amick has resigned as CEO and has been replaced by John Cooper, who was previously CFO. […]
Transcept: Direct to Consumer Advertising Campaign Could be the Tipping Point for Intermezzo
Investment Overview The launch of Intermezzo began on April 4, 2012 and so far, it has been disappointing for investors. Purdue and Transcept (TSPT) have just announced a major new stage in its commercialization strategy that I believe may be the tipping point for a significant upward inflection in sales and I believe that this […]