Post archive for ‘Company Reports’
Neuralstem: The 2015 Decline in the Stock is in Contrast to Encouraging ALS Data and an Impressive Pipeline (CUR, Buy, $1.38)
Investment Background Neuralstem has been absolutely pummeled this year as the price has declined from a closing of $2.72 on December 31, 2014 to a current price of $1.38. The catalyst for this poor performance was the announcement of topline results for the phase 2 trial of the NSI-566 stem cells in ALS on March […]
Celldex: Meaningful Data on Two Lead Products, Rintega and glembatumumab, is not Likely Before 2017 (CLDX, Hold, $16.99)
Key Points; The big news of the 2Q, 2015 conference call was that the FDA has discouraged Celldex from filing an NDA on Rintega based on results in the phase 2 ReACT trial in recurrent glioblastoma. It was widely expected that they could file for approval in mid to late 2016. This caused a nearly […]
Discovery Laboratories: Update from the 2Q, 2015 Conference Call Provides Timelines for Important Aerosurf Phase 2 Trials (DSCO, Buy, $0.47)
Key Points Phase 2 trials are enrolling rapidly. Topline results from a trial involving babies of 29 to 34 weeks gestational age should be available in 4Q, 2015. There will be 16 babies on Aerosurf plus nCPAP and 16 babies on nCPAP alone. Topline results from a second trial involving babies of 26 to 28 […]
Quick Take on Antares Following 2Q, 2015 Conference Call (ATRS, Buy, $2.10)
Investment Opinion Antares stock has been pummeled by the “so far” disappointing launch of Otrexup and uncertainty as to when or if the AB rated generic to EpiPen will be approved. I think that investors will become more confident in the potential for Otrexup by the end of the year and that there is a […]
Chimerix: An Update (CMRX, $52.83, Neutral)
Company Description Chimerix is focused on the development and commercialization of antiviral drugs. Its lead product brincidofovir is a phospholipid derivative of Gilead’s existing anti-viral agent cidofovir. The differentiating feature is a much improved side effect profile that will allow much greater use of brincidofovir for treating infections caused by double stranded viruses, notably cytomegalovirus, […]
Cytokinetics: Comments on Sharp Price Decline After 2Q, 2015 Conference Call (CYTK, Buy, $6.28)
Key Points The reasons for my buy recommendation on CYTK as detailed in previous reports remain the same. There was nothing on the 2Q, 2015 call that I had not known for some time. The sharp rise in the stock before and the sharp fall after the 2Q call is consistent with my hypothesis that […]
Cytokinetics: Phase 3 Trial of Tirasemtiv Has Begun (CYTK, Buy, $7.17)
Cytokinetics announced on July 14, 2015 the start of the phase 3 trial of tirasemtiv in ALS-VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS). I would expect rapid enrollment in this trial as many of the centers participating in this study also participated in the phase […]
Discovery Laboratories: What I Intend to Do in the Aftermath of a Disastrous Stock Offering (DSCO, Buy, $0.54)
Quick Summary Discovery Laboratories has just completed a stock offering that was done at distressed prices. This was a disaster for existing shareholders as new shareholders participating in this deal now control about 58% of fully diluted shares. The Company now has cash to that could last until 1Q, 2017 which will allow for the […]
Repligen: Fundamentals Are Exceptional But The Stock Carries A Premium Valuation (RGEN, $39.97, For Paid Subscribers)
Investment Thesis When I wrote my first report on Repligen on December 4, 2012, I concluded that Repligen had one of the best business models that I have seen in the Life Sciences universe and that management was doing an excellent job of execution. This has cetrainly been reflected in the stock price which has risen […]
Cytokinetics: Phase 3 Trial for Tirasemtiv About to Begin with Topline Results Possible in 2H, 2016; Successful Outcome Could Make the Stock a Homerun (CYTK, $6.35, Buy, For Paid Subscribers)
Introduction Management has recently provided details of the upcoming phase 3 trial of tirasemtiv in the treatment of ALS; this trial is named VITALITY- ALS which is short for Ventilator Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS This trial will begin any day now and could report […]