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Japan Approves Amgen/UCB's Osteoporosis Drug - Will U.S. Follow Suit?

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Today's Daily Dose brings you news about preliminary financial results of Globus Medical, Conformis, and GenMark Diagnostics; approval of Amgen/UCB's osteoporosis drug Evenity in Japan; Genmab's achievement of a milestone payment related to Darzalex; and executive changes in Abeona.

Read on…

Abeona Therapeutics Inc. (ABEO) has appointed Christine Silverstein to the position of Chief Financial Officer and named Edward Carr as Chief Accounting Officer.

Silverstein was previously Senior Vice President, Finance and Investor Relations for Abeon, and Carr most recently served as Vice President and Assistant Controller at Coty Inc (COTY), which manufactures, and sells beauty products worldwide.

Clinical Trials & Near-term Catalysts:

The Company's lead drug candidate is EB-101 for Recessive Dystrophic Epidermolysis Bullosa, or RDEB, a skin disease characterized by chronic epidermal wounds in which patients suffer from pain, itching, and widespread complications impacting quality-of-life and life expectancy.

A pivotal clinical trial evaluating the potential of EB-101 for the treatment of RDEB is expected to be initiated in the middle of 2019.

Another clinical drug candidate is ABO-102 for Sanfilippo Syndrome Type A (MPS IIIA), under phase I/II trial.

ABEO closed Tuesday's trading at $7.31, down 2.66%.

Amgen (AMGN) and UCB's drug Evenity has received approval in Japan for the treatment of osteoporosis in patients at high risk of fracture.

In the U.S., Evenity is all set to be reviewed by an FDA panel on January 16, 2019. The drug is also under review by the European Medicines Agency.

Related Reading:

Biotech Stocks Facing FDA Decision In January

AMGN closed Tuesday's trading at $200.61, up 1.28%.

Conformis Inc. (CFMS), a medical technology company, has announced preliminary, unaudited, revenue results for the fourth quarter and the year ended December 31, 2018.

Total revenue for the fourth quarter of 2018 is expected to be approximately $22.0 million, up 6% year-over-year on a reported basis and 7% on a constant currency basis. Total revenue for the full year of 2018 is anticipated to be about $89.8 million, up 15% year-over-year on a reported basis, and 14% on a constant currency basis.

The consensus revenue estimate of analysts polled by Thomson Reuters is $20.75 million for the fourth quarter and $86.37 million for the full year.

The Company expects to report its full financial results for the fourth quarter and the year ended 2018 on February 6, 2019.

CFMS closed Tuesday's trading at $0.50, up 4.43%.

Globus Medical Inc. (GMED), a musculoskeletal implant manufacturer, has reported preliminary unaudited sales results for the fourth quarter and full year ended December 31, 2018.

The Company anticipates fourth quarter 2018 sales of approximately $195.5 million, an increase of 11.0% over the fourth quarter of 2017. Full-year 2018 sales are expected to be approximately $712.5 million, an increase of 12.0% over the prior year.

The consensus revenue estimate of analysts polled by Thomson Reuters is $188.18 million for the fourth quarter and $705.17 million for the full year of 2018.

The Company expects to announce its fourth quarter and full year 2018 financial and operating results on February 21.

GMED closed Tuesday's trading at $39.84, up 2.84%.

Genmab A/S (GMXAY.OB) is all set to receive $75 million from Janssen Biotech, Inc. as a milestone payment from its Darzalex collaboration.

The milestone was triggered by confirmation by Janssen that sales of Darzalex reached $2 billion in the calendar year of 2018.

Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize Darzalex in August 2012. The drug is indicated for the treatment of patients with multiple myeloma.

GMXAY.OB closed Tuesday's trading at $17.00, down 0.50%.

Shares of GenMark Diagnostics Inc. (GNMK) rallied 10% on Tuesday, following solid preliminary operational and financial results for the year ended December 31, 2018.

The Company expects total revenue for 2018 to be approximately $70.8 million, representing an increase of 35% over 2017. Analysts polled by Thomson Reuters are expecting revenue of $70.05 million for the year.

The Company expects to issue full 2018 financial results and 2019 guidance in late February.

GNMK closed Tuesday's trading at $5.75, up 10.15%.

Karyopharm Therapeutics Inc. (KPTI) has submitted a Marketing Authorization Application to the European Medicines Agency for Selinexor, requesting conditional approval for the treatment of patients with Penta-refractory multiple myeloma.

In the U.S., Selinexor is under priority review by the FDA - with a decision expected on April 6, 2019.

KPTI closed Tuesday's trading at $10.25, up 0.20%.

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