Wright Medical upgraded to Outperform at BMO Capital on accelerating Q2 results

BMO Capital analyst Joanne Wuensch upgraded Wright Medical to Outperform from Market Perform and raised her price target to $31 from $28, saying her prior expectations of a plateau driven by in-line historical valuation proved to be short lived. The analyst points to the company’s faster than expected recovery in its Lower Extremities franchise in the most recent quarter and also the acquisition of Cartiva accelerating its revenues and EBITDA margins. Wuensch further cites the positive impact of FDA approval of Augment Inject product driving the management to boost its FY18 revenue guidance.
https://tinyurl.com/y8yyevc8

Deciphera initiated with an Outperform at Raymond James

Raymond James analyst Laura Chico initiated Deciphera with an Outperform and $47 price target saying it is an intriguing kinase inhibitor platform play, with wholly-owned assets and a unique inhibitor design strategy.
https://bit.ly/2POzkRR

Tesaro price target lowered to $85 from $100 at Citi

Citi analyst Robyn Karnauskas lowered her price target for Tesaro shares to $85 from $100 to reflect slowed penetration into medical oncologists and the most up-to-date market share data. The analyst sees catalysts for the stock in the “data-rich” second half of 2018 but thinks investors will have to watch and see if the changes Tesaro has implemented will increase its parp penetration. Karnauskas keeps a Buy rating on the shares.
https://bit.ly/2NtuLuS

Cronos Group enters joint venture agreement with affiliate of Agroidea SAS

Cronos Group is pleased to announce that it has entered into a joint venture agreement with an affiliate of Agroidea SAS, Colombia’s leading agricultural services provider with over 30 years of research, development and production operations. This partnership establishes a newly formed entity, NatuEra S.a r.l., in Colombia that will develop, cultivate, manufacture and export cannabis-based medicinal and consumer products for the Latin American and global markets. Under the terms of the joint venture, each partner will contribute capital as required by NatuEra to fund facility construction and operating expenditures. NatuEra will combine the operational expertise of Cronos in the production and global commercialization of medicinal cannabis products with the expertise in industrial scale cultivation, meristem laboratory operations, and local market experience of AGI’s management team. Construction of the facility remains subject to obtaining the relevant permits and other customary approvals. Commencement of operations at the facility will be subject to obtaining the appropriate licenses under applicable law.
https://bit.ly/2wupR9z

Sophiris Bio provides update on patient death in prostate cancer trial

Sophiris Bio announced the conclusion of the ongoing investigation into the previously reported death of a patient in the Company’s Phase 2b trial for the treatment of localized prostate cancer is unlikely to be related to either topsalysin or the procedure. The regulatory authorities in the U.S. and the U.K. where the study is being conducted have been notified. Following a comprehensive review of the recently received autopsy report, together with hospital records and the negative serology results for acute hypersensitivity, the Investigator and company believe that the cause of death is consistent with the autopsy finding of Sudden Cardiac Death probably due to an arrhythmia. The autopsy found that the patient had multiple risk factors for SCD. The investigator and the company concur that the event is unlikely related to topsalysin or the procedure.
https://bit.ly/2PLLpYb

Evolus announces acceptance of FDA BLA resubmission for prabotulinumtoxinA

Evolus announced the acceptance of its resubmission of its biologics license application, or BLA, for its lead product candidate, prabotulinumtoxinA, by the FDA. The FDA considered the resubmission a Class 2 response and has assigned a February 2, 2019 action date per the Prescription Drug User Fee Act.
https://bit.ly/2PlA14n

Argenx advised by Japan regulator on Phase 3 myasthenia gravis trial

argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced it has received feedback from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on the design of a Phase 3 trial and regulatory pathway towards potential marketing authorization of efgartigimod (ARGX-113) in patients with generalized myasthenia gravis (gMG).

Based on feedback from the PMDA, argenx expects the data from the planned global Phase 3 registration trial, if positive, will serve as the basis to submit for marketing authorization in Japan.

“Japan represents a very important potential market for us and one we see as a top priority as we advance the development of efgartigimod in gMG patients globally. There remains a significant unmet need in Japan for new treatment options for MG, and we are grateful for the feedback from the PMDA in facilitating a regulatory path towards achieving this goal,” commented Keith Woods, Chief Operating Officer of argenx. “We look forward to launching the global Phase 3 trial of efgartigimod in gMG before the end of the year, including in sites across Japan, and continuing the ongoing discussions with the PMDA as we map out a potential path to market for our drug candidate, if approved.”

The global Phase 3 trial expects to enroll approximately 150 patients with gMG, including patients from Japan as well as North America and Europe. The trial will be placebo-controlled and will evaluate the efficacy over 26 weeks of a 10 mg/kg dose of efgartigimod in approximately 150 gMG patients, including both acetylcholine receptor (AChR) autoantibody positive and AChR autoantibody negative patients whose disease is driven primarily by MuSK and LRP4 autoantibodies. In addition, patients can roll over into an open-label extension study for a period of one year.

argenx plans to initiate the global Phase 3 registration trial of efgartigimod in gMG before the end of 2018. Data from the trial, if positive, may also serve as the basis for a Biologics License Application (BLA) in the U.S. based on feedback from the U.S. Food and Drug Administration (FDA).

https://bit.ly/2wpvjLz