Edwards Lifesciences sees FY19 revenue growth of 11%-15%

Outlook coming from the company’s Analyst Day presentation slides yesterday. The company also forecast global TAVR, or Transcatheter aortic valve replacement, opportunity beyond 2024 reaching $7B from $3.5B in 2018.
https://thefly.com/landingPageNews.php?id=2832915

Edwards Lifesciences price target raised to $175 from $153 at RBC Capital

RBC Capital analyst Glenn Novarro raised his price target on Edwards Lifesciences to $175 and kept his Outperform rating after its Analyst Day presentation. The analyst notes that the 2019 revenue growth guidance of 11%-15% “demonstrates the sustainability of double-digit growth in transcatheter aortic valve replacement business despite increased competition and pricing/reimbursement headwinds.”
https://thefly.com/landingPageNews.php?id=2832921

Medicare Payment Advisory Commission will hold a conference

Medpac 2018 will be held in Washington, D.C. on December 6-7.
https://thefly.com/landingPageNews.php?id=2832937

LabCorp price target lowered to $165 from $210 at KeyBanc

KeyBanc analyst Donald Hooker lowered his price target for LabCorp to $165 from $210, while reiterating an Overweight rating on the shares. The analyst recommends LabCorp on relative valuation given the strength of its Covance Drug Development segment. However, the situation has deteriorated for its legacy lab business, he contended.
https://thefly.com/landingPageNews.php?id=2832939

Sellas Life Sciences shows more data from trastuzumab +/- nelipepimut-S trial

Sellas Life Sciences announced additional data on patterns of clinical relapses, as well as results from a preplanned secondary efficacy analysis across various predefined subgroups from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of trastuzumab +/- nelipepimut-S targeting HER2 low-expressing breast cancer patient cohorts at the San Antonio Breast Cancer Symposium, or SABCS. These new data show a decrease in the total number of clinically detectable relapses with the combination of NPS + trastuzumab vs. trastuzumab alone, p-value 0.004, which represents a 72.5% relative reduction in risk of relapse across time with a median follow up of 26.1 months in favor of the combination arm. Results from a planned analysis of the difference in disease free survival, or DFS, outcomes between the two arms of the study in prespecified TNBC patient subgroups showed a clinically meaningful and statistically significant effect in these subgroups in favor of the NPS plus trastuzumab combination arm. There was an average decrease of 84.2% in the relative risk of relapse or death at 24 months across these four subgroups of TNBC patients treated with NPS plus trastuzumab vs trastuzumab alone.
https://thefly.com/landingPageNews.php?id=2832965

Ultragenyx, Kyowa Kirin announce Health Canada approval for Crysvita

Ultragenyx, Kyowa Kirin announce Health Canada approval for Crysvita  Ultragenyx, Kyowa Kirin and Kyowa Kirin International announced that Crysvita has been approved by Health Canada for the treatment of X-linked hypophosphatemia, or XLH, in adult and pediatric patients one year of age and older. The product is expected to be available for prescription to Canadian patients in early 2019. XLH is a hereditary, lifelong disease.
https://thefly.com/landingPageNews.php?id=2832975

Omeros submits pediatric investigational plan for use of OMS721 to EMA

Omeros Corporation announced that it has submitted a pediatric investigational plan for the use of OMS721 for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy to the European Medicines Association. A pediatric study plan is also under development for submission to the U.S. Food and Drug Administration. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of the complement system. OMS721 was awarded breakthrough therapy designation for the treatment of high-risk HSCT-TMA earlier this year. Thrombotic microangiopathy is a life-threatening complication of HSCT, with mortality reported to be greater than 90 percent in high-risk patients. In addition to the data in adult HSCT-TMA patients forming the basis for its U.S. Biologics License Application (BLA) and E.U. Marketing Authorization Application currently in preparation, Omeros is proposing a plan including a small study in pediatric patients that will accelerate development of OMS721 for the treatment of HSCT-TMA in children. Rather than deferring initiation of a pediatric clinical trial until after approval in the E.U. or foregoing the study in the U.S., which is an option for an orphan drug, Omeros is proposing to initiate assessment of OMS721 in the pediatric population prior to approval in view of the strong OMS721 data observed to date and the significant unmet medical need. Because OMS721 has been designated as an orphan medicinal product in the EU, successful completion of an agreed PIP will provide two additional years of market exclusivity in member states of the European Union, and in Norway, Liechtenstein, and Iceland. Omeros is also developing a PSP for submission to the FDA. Successful completion of an agreed PSP in response to a Written Request from FDA provides an additional 6 months of market exclusivity in the United States. OMS721 also has been granted orphan drug designation for the treatment of HSCT-TMA by the FDA. Although the requirement for pediatric studies is waived for drugs with orphan drug designation, pursuing a PSP can help accelerate pediatric treatment in the U.S. and provide additional market exclusivity. A large prospective study reported that approximately 40% of pediatric patients who undergo HSCT will develop TMA and approximately 80% of these patients will have high-risk features. Omeros has also received notification from EMA of eligibility for the centralized procedure for submission and review of its MAA for OMS721 in the treatment of HSCT-TMA. The EMA’s centralized procedure allows submission of a single MAA that, when approved, authorizes the drug to be marketed in all European Union member states and European Free Trade Association countries rather than requiring separate national approvals.
https://thefly.com/landingPageNews.php?id=2832979