Monday, March 18, 2019
Piper sees minimal impact from FDA review of paclitaxel coated devices
The FDA on Friday afternoon updated healthcare providers on its review of paclitaxel coated devices, which include Medtronic’s (MDT) IN.PACT DCB and Boston Scientific’s (BSX) Eluvia DES, Piper Jaffray analyst Matt O’Brien tells investors in a research note. In their pooled post-approval analysis, the FDA found ~50% increased risk of crude mortality compared to control devices and will be convening a panel to analyze this issue further, adds the analyst. He points out that the FDA is also recommending providers monitor patients who have received the devices and encouraging these providers to consider alternatives where the risks may outweigh the benefits. While this data is concerning, the result is “unsurprising given that many of these patients were included in the meta-analysis,” contends O’Brien. Further, experts at the ISET 2019 conference in January were unconvinced about this connection to mortality, and a poll of the several hundred interventionists in the room indicated that it is unlikely to dampen usage in the interim, he says. As such, the analyst expects the FDA impact to have a minimal impact.
AstraZeneca begins push into digital tech for future growth, FT reports
AstraZeneca is preparing a big push into digital technologies, including hiring former Nasa artificial intelligence expert Richard Dearden, as it looks to ramp up drug discovery and show the value of its medicines in an increasingly tough pricing environment, the Financial Times’ Sarah Neville reports, citing CEO Pascal Soriot. Soriot suggested Astra would seek to broaden the range of drugs it offered where payment was dependent on results achieved as such medicines could be part of reducing health costs overall.
Bausch Health price target raised to $41 from $39 at Mizuho
Mizuho analyst Irina Koffler raised her price target for Bausch Health Companies to $41 from $39 following the company’s Q4 results and a meeting with management. Most companies struggle to attain long-term guidance targets, but Bausch’s 2019-2022 outlook is “within reach,” Koffler tells investors in a research note. She reiterates a Buy rating on the shares.
Arcus Biosciences initiated at BTIG
Arcus Biosciences initiated with a Buy at BTIG. BTIG analyst Thomas Shrader initiated Arcus Biosciences with a Buy rating and a price target of $20, citing the company’s work in chemotherapy and its focus on “driving antitumor immune responses beyond the level achievable by immune checkpoint inhibitors.” The analyst sees its data released thus far as “compelling” and notes “several trials” currently enrolling with data expected in mid-2019, with results that could potentially “establish proof of biology and validate patient selection biomarkers.” Shrader further notes that Arcus Biosciences’ $260M in cash “gives the company runway to optimize its long-term strategy.”
https://thefly.com/landingPageNews.php?id=2880285
https://thefly.com/landingPageNews.php?id=2880285
Aerie Pharmaceuticals initiates Phase 2 Clinical trial of AR-1105
Aerie Pharmaceuticals announced the commencement of patient dosing in a Phase 2 clinical trial of AR-1105, its investigational dexamethasone intravitreal implant, in patients with macular edema due to retinal vein occlusion. Safety and efficacy will be evaluated at six months.
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