Ocular Therapeutix expects top-line data from OTX-TP’s first Phase III glaucoma study in the first half of 2019, Piper Jaffray analyst Joseph Catanzaro tells investors in a research note. The analyst believes investors have discounted this program based on mixed Phase I/II data that utilized different formulations and study designs. However, he thinks the Phase III design gives OTX-TP the best chance at demonstrating clinical efficacy in this setting. A successful outcome will be statistically significant IOP-reductions over placebo at all time points and importantly, at least a 5 mm Hg reduction in IOP from baseline at 6 of the 9 time points, Catanzaro contends, citing his review of literature and a survey of ophthalmologists. He believes such an outcome would represent “another successful application of the hydrogel platform and drive significant share appreciation.” The analyst has an Overweight rating on Ocular Therapeutix with a $14 price target.
Friday, January 4, 2019
Regeneron upgraded to Buy from Neutral at Guggenheim
https://thefly.com/landingPageNews.php?id=2843583
Pacific Biosciences cut to Market Perform from Outperform at Cowen
https://thefly.com/landingPageNews.php?id=2843625
Hologic downgraded to Market Perform from Outperform at Cowen
https://thefly.com/landingPageNews.php?id=2843627
Epizyme announces registration path for tazemetostat for follicular lymphoma
Epizyme announced a comprehensive set of pipeline updates, including that the company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma, both with and without EZH2 activating mutations. The company recently conducted a productive meeting with the U.S. FDA to discuss the FL registration strategy based on the current patient population in its ongoing Phase 2 clinical trial. Following the discussion, Epizyme has defined a registration strategy for tazemetostat in both EZH2 mutant and wild type FL patient populations, where patients’ disease has progressed following two or more lines of therapy. Based on this, the company anticipates submitting a New Drug Application for this indication in the fourth quarter of 2019. In addition, the company provided an update on its clinical and preclinical pipeline and anticipated milestones for 2019.
Healthcare IT pullbacks create ‘great’ opportunities, says Oppenheimer
Oppenheimer analyst Mohan Naidu says that recent pullbacks are creating some “great” opportunities in Healthcare IT and believes, in particular, Evolent Health (EVH), Omnicell (OMCL), Tabula Rasa HealthCare (TRHC) and Teledoc (TDOC) stand out. In a research note to investors, Naidu contends that Evolent will gain from the finalized CMS regulations and increased push to risk-based models, and says Omnicell’s story is significantly de-risked with traction in XT implementations. He also adds that Tabula Rasa should deliver on multiple growth drivers brewing in 2019 including PACE. and that despite the near-term distractions, Teledoc’s story remains intact with significant telehealth adoption and utilization focus.
Emergent BioSolutions CEO Abdun-Nabi to retire, Kramer to succeed
https://thefly.com/landingPageNews.php?id=2843682
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