ACOR Fails To Walk The Talk, SNY Gets FDA Nod, New Use For Genmab's Old Drug

(RTTNews) - Acorda Therapeutics Inc. (ACOR) has decided to discontinue the development of Dalfampridine for treatment of post-stroke walking difficulties, following disappointing results from its trial, dubbed MILESTONE.

Although the study indicated there was activity related to walking in people with post-stroke walking difficulties, clinically meaningful efficacy was demonstrated by Dalfampridine to warrant further development.

Dalfampridine, under brand name Ampyra, was approved by the FDA in 2010 to improve walking ability in people with multiple sclerosis. The drug garnered net sales of $436 million last year and $128.8 million in the third quarter ended September 30, 2016. The company expects net sales of Ampyra in 2016 to range between $475 million and $485 million.

ACOR closed Monday's trading at $20.40, down 4.23%.

GlaxoSmithKline plc (GSK) and Innoviva Inc. (INVA) have filed a New Drug Application in the U.S. for the Closed Triple for patients with chronic obstructive pulmonary disease.

The Closed Triple is a combination of Fluticasone furoate, Umeclidinium and Vilanterol in a single ELLIPTA inhaler.

The Closed Triple is also being explored for the treatment of symptomatic asthma. The companies plan to seek approval for the Closed Triple in this indication in 2018.

INVA closed Monday's trading at $10.92, up 0.09%.

Genmab A/S' (GNMSF.OB) supplemental Biologics License Application for the use of DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for relapsed or refractory multiple myeloma has been greenlighted by the FDA. The decision comes nearly 7 months ahead of the decision date of June 17, 2017.

Janssen Biotech Inc. has an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

DARZALEX was initially approved by the FDA in November 2015 for the monotherapy treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and immunomodulatory agent.

GNMSF.OB closed Monday's trading at $177.50, unchanged from the previous day's close.

The FDA has approved Sanofi's (SNY) combo drug Soliqua, known generically as iGlarLixi, for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin or lixisenatide.

An FDA panel in May of this year had voted 12 to 2 backing this diabetes combo drug.

Soliqua is a fixed-ratio combination of Lantus and lixisenatide, which was approved in the U.S. in July this year under the brand name Adlyxin. Soliqua is expected to be available in U.S. retail pharmacies in January 2017.

Earlier in November, the Committee for Medicinal Product for Human Use (CHMP) of the European Medicines Agency recommended approval of iGlarLixi under brand name Suliqua. A formal decision by the European Commission is expected in the coming months.

Invented by Zealand Pharma, lixisenatide is licensed to Sanofi, which finances all development, manufacturing and marketing costs for lixisenatide.

SNY closed Monday's trading at $40.16, up 0.32%.