Guest post by Robert Jeng, Senior Scientific Analyst, BioMedTracker
BioMedTracker (BMT) has once again published its quarterly Outlook Report, now for the third quarter of 2015. Each quarter, the analyst group, which tracks the drug development landscape, releases its list of large-impact catalysts. This quarter’s list includes over 20 highlights plus a few medtech entries and a catalyst calendar.
Since its release several weeks ago, a number of important events highlighted in the report have already occurred including the first pivotal data from XOMA’s lead drug candidate, gevokizumab (resulting in a one-day stock price drop of nearly 80%), the release of top-line data from the buparlisib (NVS) BELLE-2 study of HR+/HER2- breast cancer, the approval of Rexulti (brexpiprazole, Otsuka) for MDD and schizophrenia, and the presentation of Alzheimer’s data from Biogen and Anavex at the AAIC conference.
Nevertheless, plenty of catalysts highlighted in the report remain. Perhaps the most intriguing catalyst of the quarter is the August 17 PDUFA decision for Addyi (flibanserin) for the treatment of hypoactive sexual desire disorder (HSDD). The drug is being developed by the privately-held Sprout Pharmaceuticals (in partnership with Boehringer Ingelheim) and would be the first non-hormonal treatment for HSDD which is itself a relatively newly-defined patient population. In June, the drug faced a high-profile FDA advisory committee meeting with a generally positive review but also strong concerns over its safety profile.
Another upcoming catalyst is a top-line data release expected for plecanatide for chronic idiopathic constipation (CIC) anticipated by mid-August. Results from the first pivotal trial were released just last month and demonstrated moderate efficacy but with a favorable safety profile. Data are now expected from the second pivotal trial, and the results should go a long way towards predicting how plecanatide will fare against Linzess (linaclotide, IRWD).
Other catalyst areas highlighted in the report include hypercholesterolemia (including the potential blockbuster PCSK9 drugs), tumor indications, diabetes, ophthalmology, and others. For the complete report, visit BioMedTracker.
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