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AMRN Looks Forward To Big Event, PBYI Plunges After-hours, SPARC Lights Up CERS

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Today's Daily Dose brings you news about an update on Amarin's REDUCE-IT cardiovascular outcomes study; Cerus' SPARC study; Corindus' preliminary revenue results; futility analysis of MacroGenics' breast cancer study and Puma's disappointment over negative "trend" vote for Neratinib.

Read on...

Amarin Corp. plc (AMRN) announced that more than 90% of the targeted 1,612 primary major adverse cardiovascular events (MACE) in the REDUCE-IT cardiovascular outcomes study have been reported and documented.

REDUCE-IT is a phase III cardiovascular outcomes study to determine whether the Company's approved drug Vascepa will reduce cardiovascular risk in statin treated patients that still have elevated or high triglyceride levels.

Approved in July 2012, Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

The REDUCE-IT study has enrolled 8,175 patients who have been randomized, in accordance with the study protocol, on a 1:1 basis between Vascepa and placebo.

The final patient visits of the study are expected to commence on March 1, 2018. The onset of the targeted 1,612th primary major adverse cardiovascular event (MACE) in this study is projected to occur before the end of Q1 2018.

The Company confirmed that it is on track to report clinical results from its REDUCE-IT trial before the end of Q3, 2018.

AMRN touched a new 52-week high of $4.60 on Tuesday, before closing the day's trading at $4.44, up 9.90%.

Shares of Cerus Corp. (CERS) surged more than 30% in after-hours trading on Tuesday, following positive results of its phase III study evaluating INTERCEPT Blood System for Red Blood Cells in thalassemia patients, dubbed SPARC.

The INTERCEPT Blood System inactivates a broad spectrum of viruses, gram-positive and gram-negative bacteria, spirochetes, parasites and leukocytes. INTERCEPT is intended to reduce the risk of transfusion-transmitted infection (TTI) in platelet and plasma components.

The INTERCEPT Blood System for platelets and plasma has received approval in the U.S. and Europe. The INTERCEPT Blood System for Red Blood Cells is not approved yet.

The Company plans to make a filing seeking CE mark for INTERCEPT RBC, in second half of 2018.

Upcoming event:

-- The Company is expected to report fourth quarter and full year 2017 financial results and host a call in early March.

For the fourth quarter, the Company expects to report revenue of $16.2 million, an increase of 60%, and for full year 2017, a revenue of $43.6 million, an increase of 17% compared to the year-ago period.

CERS closed Tuesday's trading at $4.33, up 3.34%. In after-hours, the stock was up 30% to $5.64.

Corindus Vascular Robotics Inc. (CVRS) rose more than 30% in extended trading on Tuesday, after the announcement of preliminary revenue results for the fourth quarter and year ended December 31, 2017.

Preliminary and unaudited revenue for fourth quarter 2017 is expected to be between $4.0 million and $4.2 million. Preliminary and unaudited revenue for full year 2017 is expected to be between $9.5 million and $9.7 million.

Analysts polled by Thomson Reuters expect the Company to report revenue of $3.45 million for the fourth quarter, and $8.9 million for full year 2017.

CVRS closed Tuesday's trading at $1.04, down 0.95%. In after-hours, the stock was up 30.77% to $1.36.

MacroGenics Inc.'s (MGNX) phase III clinical study comparing Margetuximab plus chemotherapy against Trastuzumab plus chemotherapy in subjects with metastatic breast cancer, dubbed SOPHIA, will have to run its full course, without any modification. The futility analysis by an independent data safety monitoring committee has not allowed for early stopping due to efficacy.

Margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy has been assigned a Fast Track status by the FDA.

The enrollment in the SOPHIA study is planned for completion by the end of 2018, with top-line data readout expected in 2019.

MGNX closed Tuesday's trading at $20.25, up 4.27%.

Shares of Puma Biotechnology Inc. (PBYI) were down more than 27% in after-hours trading on Tuesday, after the European Medicines Agency's Committee for Medicinal Products for Human Use rendered a negative "trend" vote for Neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

A negative trend vote means it is unlikely that the Committee for Medicinal Products for Human Use, or CHMP, will provide a positive opinion related to the Company's Marketing Authorization Application for Neratinib at the formal CHMP decision vote scheduled in February 2018.

In the U.S., Neratinib is marketed under the brand name Nerlynx for the extended adjuvant treatment of early-stage HER2-positive breast cancer. The drug was approved by the FDA last July.

PBYI closed Tuesday's trading at $90.90, down 3.25%. In after-hours, the stock was down another 27.61% to $65.80.

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