Morgan Stanley sees MRIdian ramp challenges, starts ViewRay at Equal Weight. As previously reported, Morgan Stanley analyst Jonathan Demchick started ViewRay with an Equal Weight rating and $7 price target, stating that the company’s MRIdian system has the potential to disrupt the $4B-$5B radiation therapy market, but he sees headwinds that will make it more challenging for ViewRay to reach and sustain profitability. These challenges include the fact that the system’s broader applicability across disease states is still up for debate, its price point versus conventional linacs is high, and Elekta’s MR linac presents competition, Demchick tells investors.Target $7.
Tuesday, December 11, 2018
Portola Pharmaceuticals announces CHMP extended review period for Ondexxya MAA
Portola Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has extended the review period for the company’s marketing authorization application, or MAA, for Ondexxya and cancelled the oral explanation scheduled for December 12. An opinion is now expected by February 28, 2019. The CHMP informed Portola that it will provide a list of outstanding questions related to the data package the company submitted for Ondexxya last quarter, which will require additional responses from the company. The preliminary timetable provided to the company by the CHMP sets a deadline of January 29, 2019 for responses to the questions followed by a 30-day assessment period for the CHMP to review the company’s responses. Ondexxya is under review for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
Vanda downgraded to Perform at Oppenheimer on balanced risk/reward
As previously reported, Oppenheimer analyst Esther Rajavelu downgraded Vanda Pharmaceuticals to Perform from Outperform saying that with the tasimelteon Smith-Magenis Syndrome trial meeting one of the two primary endpoints, the stock fairly reflects the inherent risk/reward at current trading levels. The analyst will await on the sidelines the publication of the results and an update on the regulatory strategy post the pre-NDA meeting.
Neovasc announces follow-up data for Neovasc Reducer published in JACC
Neovasc announced that the Journal of the American College of Cardiology, or JACC, published new, peer reviewed Reducer data describing the long-term clinical and anatomical follow-up of patients with severe angina pectoris treated with the Neovasc Reducer 12 years ago. The publication is entitled: “First-in-Human Use of Coronary Sinus Reducer in Patients With Refractory Angina.” The publication is based on a prospective, non-randomized, single-arm anatomic and clinical evaluation of patients who underwent Reducer implantation at a single medical center as part of the first-in-human clinical study1. Seven patients described in the article were electively implanted with the Reducer in 2005. All had chronic refractory angina and evidence of reversible myocardial ischemia. At 12 years, all seven patients reported sustained improvement of angina class compared with baseline status.
Tivity Health selloff on Nutrisystem deal overdone, says Cantor Fitzgerald
Cantor Fitzgerald analyst Steven Halper views the selloff yesterday in shares of Tivity Health (TVTY) following the company’s acquisition of Nutrisystem (NTRI) as “violent and probably overdone.” Indeed, the acquisition is large, Tivity will be highly leveraged, and the company should no longer be viewed as a takeover candidate, Halper tells investors in a research note. However, he believes the acquisition is a “good strategic and financial fit.” Similar to Tivity, Nutrisystem is a strong generator of free cash flow, and the combined company should continue this trend, says Halper. Further, he believes the acquisition should be accretive to Tivity earnings in 2020. The analyst reiterates an Overweight rating on the shares with a $49 price target. Tivity Health closed yesterday down 32%, or $12.96, to $27.65.
Kiniksa to host conference call
Conference call to discuss Phase 2 clinical data and its recently initiated pivotal Phase 3 clinical trial of rilonacept in subjects with recurrent pericarditis will be held on December 11 at 9 am.
AstraZeneca initiated at Jefferies
AstraZeneca assumed with a Hold at Jefferies. Jefferies analyst Peter Welford assumed coverage of AstraZeneca with a Hold rating and $42 price target. The analyst is positive on the European large-cap Pharma space “as it enters a period of sustained earnings momentum.”
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