Expert Financial Analysis and Reporting

Amgen issued a press release today in which it announced that Servier had decided to exercise its option to commercialize omecamtiv mecarbil in chronic heart failure in Europe, Russia and certain other territories. The companies announced that the Phase 3 program of omecamtiv mecarbil will move forward in collaboration with Cytokinetics. I think that the gating […]

You cannot turn on the business news channels without hearing extensive comments and condemnation by pundits and politicians about Mylan’s aggressive price hikes on EpiPen. Investors are asking if this could somehow expedite approval of Antares/Teva’s AB rated generic to EpiPen. As far as I know, Teva has not yet submitted a response to the Complete […]

A number of people have asked me if I know of any specific reason for the strength in Antares’s stock following the 2Q, 2016 conference call. The stock reached an inter-day high today of $1.34 today which is a high for the year. For much of the year to date, it has been trading around […]

Cytokinetics has announced that the VITALITY-ALS trial of tirasemtiv has completed enrollment. The study includes three phases. The first is a two week open label phase; those patients who can tolerate tirasemtiv are then randomized into the second phase. This is a 48 week double-blind, placebo-controlled trial in which patients are randomized 3:2:2:2 to placebo […]

Investment View Celldex has a broad array of clinical trials underway or in planning that involve five drugs. However, most of these trials are in an early exploratory stage and are designed to provide signals of activity for designing subsequent trials that could lead to approval. As such they are not likely to have much […]

Investment Thesis Repligen’s operating business results continue to be very strong as second quarter bioprocessing sales increased 36%. For perspective, full year bioprocessing revenues increased 38% in 2015 and 27% in 2014. The guidance for 2016 calls for a 21% to 26% increase, which probably is conservative. Management has not commented on 2017, but my […]

Investment Perspective I first started writing reports on Alimera in May of 2013, but have never recommended the stock. I thought then and continue to think that its first and only product Iluvien, has meaningful commercial potential. I think that Iluvien can potentially reach $300+ millions of worldwide sales and if so, Alimera would be […]

Perspective Bristol-Myers Squibb Company announced today that Opdivo had failed to reach its primary endpoint of progression free survival in the CheckMate -026 trial in first line non-small cell lung cancer. This was an open-label, study that randomized 541 patients to receive either Opdivo as monotherapy or investigator’s choice of chemotherapy. Patients enrolled in the […]

Investment Thesis This report focuses on product development efforts discussed in Agenus’ 2Q, 2016 conference call. My most likely investment scenario for Agenus is that it is acquired within the next three years and potentially at a valuation of as much as $25 per share. The reasoning behind this is discussed in my May 3, […]

Overview of Expanded Collaboration Cytokinetics and Astellas announced on July 27th that they had expanded their collaboration for the development of products based on skeletal muscle activation. Cytokinetics has pioneered this very promising field and I believe has a commanding edge in the understanding of drug development based on this biology. The expansion has two […]