Monday Is D-Day For AEZS, Watch Out For MRUS, FDA Nod For RDUS & Takeda

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZS.TO) is all set to announce top-line results from its phase III study of Zoptrex in women with locally advanced, recurrent or metastatic endometrial cancer prior to the commencement of trading on Monday, May 1, 2017.

The phase III study, dubbed ZoptEC, enrolled over 500 patients, who were centrally randomized in a 1:1 ratio and received either Zoptrex or chemotherapy medication Doxorubicin intravenously, every three weeks and for up to nine cycles.

Response was evaluated every three cycles during treatment, and thereafter, every 12 weeks until progression. All patients were followed for survival as the primary efficacy endpoint. Secondary endpoints include progression-free survival, objective response-rate, and clinical benefit rate.

AEZS closed Friday's trading at $3.35, up 9.84%.

Galapagos N.V (GLPG) presented pre-clinical data of GLPG1972, a first-in-class small molecule, for the treatment of osteoarthritis, which demonstrated cartilage protection in both rodent and human explant assays.

GLPG1972 is a potent and highly selective inhibitor of ADAMTS-5, a key enzyme involved in cartilage breakdown.

The Company plans to initiate a phase 1b study of GLPG1972 in osteoarthritis patients in the United States this quarter.

GLPG closed Friday's trading at $86.86, up 1.01%.

Merus B.V. (MRUS) has a couple of catalysts to watch out for in the coming months.

The Company is expected to submit an Investigational New Drug application for MCLA-117 to the FDA and initiate a phase I trial in patients with acute myeloid leukemia during the second half of 2017.

Top line data from part 2 of phase 1/2 monotherapy trial of MCLA-128 in patients with solid tumors in multiple indications are expected during the second half of 2017.

Interim results from Phase 1 clinical trial evaluating MCLA-117 in patients with acute myeloid leukemia are expected to be reported during the second half of 2017.

By the end of 2017, Merus expects to file a CTA for a planned Phase 1/2 clinical trial of MCLA-158 in patients with colorectal cancer.

MRUS closed Friday's trading at $22.20, down 0.63%.

The FDA has approved Radius Health Inc.'s (RDUS) TYMLOS for the treatment of postmenopausal women with osteoporosis.

Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving a majority of patients undiagnosed and undertreated.

TYMLOS, also known as Abaloparatide-SC, becomes the first new bone anabolic treatment option in the U.S. since 2002 for postmenopausal women with osteoporosis. (Anabolic means the building of tissue).

The drug is expected to be launched in the U.S. in May.

RDUS closed Friday's trading at $39.07, up 0.90%.

Sanofi (SNY) and Regeneron Pharmaceuticals Inc.'s (REGN) resubmitted Biologics License Application for Kevzara has been accepted for review by the FDA - with a decision date set for May 22, 2017.

The two companies are seeking approval of Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate.

Kevzara, also known as Sarilumab, was turned down by the FDA last October due to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility where Sarilumab is filled and finished, one of the last steps in the manufacturing process.

On April 24, 2017, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Kevzara in Europe. The European Commission is expected to make a final decision in the coming months.

Kevzara was approved in Canada in February of this year.

According to market research firm EvaluatePharma, Kevzara could garner peak sales of $1.8 billion by 2020.

REGN closed Friday's trading at $388.49, up 5.97%.

Takeda Pharmaceutical Co. Ltd. (TKPYY.OB) has received accelerated approval from the FDA for ALUNBRIG for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer who have progressed on or are intolerant to Pfizer's Xalkori.

ALUNBRIG, also known as Brigatinib, is developed by ARIAD Pharmaceuticals, which Takeda acquired early this year.

Since the indication has been granted only accelerated approval, continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ALUNBRIG is also under review in the European Union.

TKPYY.OB closed Friday's trading at $24.83, up 3.54%.