EXAS Abuzz, MACK Makes Deal With Ipsen, XENE Awaits Data

(RTTNews) - Adamas Pharmaceuticals Inc.'s (ADMS) New Drug Application for ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease has been accepted for review by the FDA.

The regulatory agency's decision on ADS-5102 will be announced on August 24, 2017.

If approved, ADS-5102 will be the first and only medicine for Parkinson's disease patients with levodopa-induced dyskinesia.

ADMS closed Friday's trading at $19.02, up 5.37%.

Exact Sciences Corp. (EXAS) expects to report revenues between $34.9 million and $35.4 million for the fourth quarter ended Dec. 31, 2016, which represents an increase of 142 percent from the same quarter of 2015.

For the full-year 2016, the company anticipates revenues between $99.0 million and $99.5 million, a year-over-year increase of 150 percent.

The consensus forecast among analysts polled by Thomson Reuters is $30.15 million for Exact Sciences' Q4 revenue and $94.24 million for full-year 2016.

EXAS closed Friday's trading at $15.10, down 0.53%.

Merrimack Pharmaceuticals Inc. (MACK), which has concluded its strategic review, is all set to divest some of its assets to Ipsen S.A. (IPSEY) in a transaction valued at up to $1.025 billion, plus up to $33 million in net milestone payments.

Under the deal terms, Merrimack will sell to Ipsen its first commercial product ONIVYDE, including U.S. commercialization rights and its licensing agreement with Shire plc; and generic DOXIL, advanced under a development, license and supply agreement with Actavis LLC.

The transaction is expected to be completed this quarter.

Merrimack will receive from Ipsen $575 million in cash at closing; and up to $450 million in additional regulatory approval-based milestone payments. Merrimack will also retain the rights to receive net milestone payments pursuant to Merrimack's exclusive licensing agreement with Shire for the ex-U.S. development and commercialization of ONIVYDE for up to $33 million.

MACK closed Friday's trading at $3.60, down 5.26%.

The Medicines Co. (MDCO) has announced positive top-line results from Day 180 interim analysis in an ongoing phase II study of Inclisiran in patients with atherosclerotic cardiovascular disease, dubbed ORION-1.

In the interim analysis, Inclisiran continued to demonstrate significant and durable LDL-C (low-density lipoprotein cholesterol) reduction, reaffirming the potential for a highly-differentiated, low-volume dosing regimen of two or three injections per year. Inclisiran was well tolerated and no material safety issues were observed.

The company has initiated ORION-2, a study of Inclisiran in patients with Homozygous Familial Hypercholesterolemia (HoFH).

MDCO closed Friday's trading at $36.23, up 2.00%.

Xenon Pharmaceuticals Inc. (XENE) has a couple of catalysts lined up for this year.

The topline results from a phase 2 trial of XEN801 for the treatment of moderate to severe facial acne are expected in the latter part of the first quarter of 2017.

Also in the pipeline is TV-45070, which is being developed in collaboration with Xenon's partner, Teva Pharmaceutical Industries Ltd., for the treatment of neuropathic pain. A phase 2b clinical trial of TV-45070 in patients with post-herpetic neuralgia is underway, with topline results expected in mid-2017.

XENE closed Friday's trading at $8.10, up 4.52%.