Flexion Therapeutics announced it submitted a supplemental new drug application to the U.S. Food and Drug Administration to revise the product label for ZILRETTA. The sNDA is based on data from an open-label Phase 3b clinical trial, which indicated that repeat administration of ZILRETTA for treatment of osteoarthritis knee pain was safe and well tolerated with no deleterious impact on cartilage or joint structure observed through X-ray analysis. The primary endpoint of the Phase 3b single-arm, open-label trial was the safety and tolerability of repeat administration of ZILRETTA in patients with symptomatic OA of the knee. The patients enrolled in the study generally had longstanding and extensive disease, with more than two-thirds of the participants presenting with Kellgren-Lawrence Grade 3 or Grade 4, the most radiographically severe form of OA. Participants received an initial intra-articular injection of ZILRETTA followed by evaluation at Weeks 12, 16, 20 and 24 to determine their eligibility for a second injection. In the trial, 95% of patients experienced clinical benefit after initial injection of ZILRETTA and 92% of these patients received a second injection on or after Week 12. The median time to a second injection was 16.6 weeks, with 74% of patients receiving their second administration of ZILRETTA between Weeks 16 and 24. There were no serious adverse events related to ZILRETTA reported during the trial, and the patterns of treatment emergent adverse events were consistent with those reported in previous clinical studies of ZILRETTA. An analysis of X-rays taken at baseline and Week 52 showed no harmful effects on cartilage or joint structure, as no incidences of chondrolysis, osteonecrosis, insufficiency fractures or clinically significant subchondral bone changes were observed. The trial also indicated that the magnitude and duration of pain relief experienced by patients after both the first and second injections was similar to results from the pivotal Phase 3 trial.
Monday, December 17, 2018
Calyxt receives EU patent for use of CRISPR/Cas9 for genome editing
Calyx (CLXT) announced the issuance of European patent number 3008186, which claims methods to create gene-edited plants by the transient delivery of sequence-specific nucleases, including CRISPR/Cas9. This patent, granted by the European Patent Office, is owned by Cellectis and licensed exclusively to Calyxt (CLLS).
Edwards Lifesciences initiated at Credit Suisse
Edwards Lifesciences initiated with an Outperform at Credit Suisse. Credit Suisse analyst Matt Miksic initiated Edwards Lifesciences with an Outperform rating and a price target of $188 as part of his broader research note on Medical Supplies and Devices partially titled “No Disruption, No Alpha”, calling the stock stock his top pick for exposure to Structural Heart medicine. The analyst anticipates the company to post “solid double-digit top-line growth in 2020-2022, and improving revenue mix and gross margins” with added tailwinds coming from his forecast for the addressable Transcatheter aortic valve replacement market to double in 2019.
Medtronic initiated at Credit Suisse
Medtronic initiated with an Outperform at Credit Suisse. Credit Suisse analyst Matt Miksic initiated Medtronic with an Outperform rating and a price target of $109 as part of his broader research note on Medical Supplies and Devices partially titled “No Disruption, No Alpha”, saying the stock offers “favorable exposure” to Structural Heart and Robotic Surgery medicine. The analyst also believes that Medtronic is a “sustainable market leader” with an attractive portfolio of “emerging-and high-growth businesses organically and via tuck-in deals”. Having integrated most of the Covidien assets, Miksic also expects Medtronic to be “more active on the M&A front”.
Abbott initiated at Credit Suisse
Abbott initiated with an Outperform at Credit Suisse. Credit Suisse analyst Matt Miksic initiated Abbott with an Outperform rating and a price target of $82 as part of his broader research note on Medical Supplies and Devices partially titled “No Disruption, No Alpha”, saying the stock offers “best exposure” to Diabetes medicine. The analyst contends that Abbott is “firing on all cylinders” with improving organic growth, sales mix, and investor returns, having produced organic revenue growth of about 8% over the last 4 quarters.
Stryker initiated at Credit Suisse
Stryker initiated with an Outperform at Credit Suisse. Credit Suisse analyst Matt Miksic initiated Stryker with an Outperform rating and a price target of $195 as part of his broader research note on Medical Supplies and Devices partially titled “No Disruption, No Alpha”, calling the stock his top pick for exposure to Robotic Surgery medicine. The analyst believes that the “sustainable share-gaining power of robot surgery” is “underappreciated” by the market, adding that Stryker has captured about 6% of market share in the U.S. knee market since taking over the platform in 2014 and is positioned to take another 2% in share by 2020.
J&J up over 1% after announcing buyback, affirming FY18 EPS view
https://thefly.com/landingPageNews.php?id=2838305
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