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Monday, May 6, 2019

Insulet price target raised to $110 from $100 at Canaccord

Canaccord analyst Kyle Rose raised his price target for Insulet to $110 from $100 and maintained a Buy rating following last week’s Q1 earnings report. In a research note to investors following the earnings report, Rose said he continues to believe Insulet is positioned favorably ahead of what he views as a compelling new product cycle in Dash.
https://thefly.com/landingPageNews.php?id=2903583

STAAR Surgical price target lowered to $38 from $43 at Canaccord

Canaccord analyst Jason Mills lowered his price target for STAAR Surgical to $38 from $43, saying he recommends adding to positions, notwithstanding the uncertainty around the timing of EVO ICL approval in the U.S. Mills tells investors in a research note that he came away from a meeting with ophthalmologists, industry consultants and STAAR management at the American Society of Cataract & Refractive Surgeons meeting this weekend “confident” in the firm’s near- and long-term ICL growth potential. Mills maintains a Buy rating.
https://thefly.com/landingPageNews.php?id=2903587

Omeros initiated with an Overweight at Cantor Fitzgerald

Cantor Fitzgerald initiated Omeros with an Outperform and $26 price target

Boston Scientific Gets U.S. FDA Approval for The VICI VENOUS STENT System

Boston Scientific (NYSE: BSX) announced today that the U.S Food and Drug Administration (FDA) has approved the VICI VENOUS STENT System for the treatment of iliofemoral venous obstructive disease, which occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies.
Venous obstructive disease affects nearly 40 percent of the population in the U.S. and can be caused by conditions such as deep vein thrombosis (DVT), post-thrombotic syndrome (PTS) and compressive diseases such as May-Thurner syndrome. In patients with venous obstructions, blood may pool in the legs, resulting in pain, swelling and skin ulcers.
Endovascular treatment for venous obstructive disease is focused on restoring the normal flow of blood from the legs back to the heart. The iliofemoral veins are located deep in the pelvis and may be subject to significant crushing forces from other anatomical structures such as the right common iliac artery. To help solve for this, the VICI stent system was specifically designed to be uniformly strong and crush resistant, capable of restoring blood blow by creating a cylindrical, patent vessel.

Merck, IMV Update Data from Phase 2 Lymphoma Combo Study

IMV Inc. (Nasdaq: IMV; TSX: IMV), the clinical stage immuno-oncology corporation, today announced that the 2019 International Conference on Malignant Lymphoma (ICML) will publish an abstract on the company’s combination immunotherapy trial titled, ‘Phase 2 Study: DPX-Survivac with Intermittent Low Dose Cyclophosphamide and Pembrolizumab in Patients with recurrent/refractory Diffuse Large B-Cell Lymphoma – The SPiReL trial.’
‘DLBCL is our first indication for DPX-Survivac in combination with Merck’s’ Keytruda (pembrolizumab) and we have been encouraged by the previously announced early data in this patient population with rapidly progressing cancer and short life expectancy,’ said Frederic Ors, Chief Executive Officer at IMV. ‘Given the high level of unmet need in recurrent/refractory DLBCL, we look forward to working with our partners at Sunnybrook Research Institute to provide an update on this important program.’ ICML will publish the full trial-in-progress abstract on June 12, 2019 via the 15-ICML ABSTRACT BOOK, a supplement to Hematological Oncology. IMV will provide an update on the Phase 2 clinical data related to this study at that time.

FDA OKs Genentech Kadcyla for Adjuvant Early Breast Cancer Treatment

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment.
‘This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.’
The goal in treating EBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach. While we come closer to this goal with each advance, many people still have a disease recurrence in the long term. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery and aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.

Teva to Present New Long-Term Data on Migraine Med at AAN

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced results from new long-term analyses of the efficacy and safety of fremanezumab, being presented at the 71st Annual Meeting of the American Academy of Neurology (AAN) in Philadelphia from May 4-10, 2019.
The findings, presented across 13 abstracts at this year’s meeting, describe the primary and other key endpoints, as well as pooled and subgroup data from a 52-week, multicenter, randomized, double-blind, parallel group long-term extension study that evaluated fremanezumab in adults with migraine. The results presented include data on the efficacy of fremanezumab observed through 12 months of treatment in patients with migraine, including populations with inadequate responses to multiple classes of preventive medications, quality of life and the safety profile.
‘We are pleased to join the neurology community at this year’s AAN meeting and share these long-term data results on fremanezumab as a preventive treatment option for patients living with migraine,’ said Danny McBryan, Senior Vice President, Head of Global Medical Affairs and Pharmacovigilance at Teva. ‘These data, studied in a wide range of migraine patient populations, add to our growing body of evidence about fremanezumab, and further demonstrate our ongoing commitment to improving the lives of those who suffer from migraine.’