AMGN’s Xgeva To Face FDA In Feb, Double Treat For LPCN, SGEN Drops Cascade

Today’s Daily Dose brings you news about Amgen’s regulatory catalyst for next February; Axsome’s new addition to its Board; Clovis’ ARIEL3 results; Exelisis’ CABOSUN study; Lipocine’s study results of oral testosterone candidate LPCN 1021; FDA approval of Neos’ ADHD medication and Seattle Genetics’ CASCADE disappointment.

Read on…

Amgen’s (AMGN) supplemental Biologics License Application for XGEVA, seeking to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma, has been accepted for review by the FDA – with a decision date set for February 3, 2018.

XGEVA was approved by the FDA in 2010 for the prevention of skeletal-related events in patients with bone metastases from solid tumors; in 2013, to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor, and in December, 2014 for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

XGEVA sales totaled $1.53 billion in 2016, up 9% over the prior year.

AMGN closed Monday’s trading at $165.09, up 1.64%.

Axsome Therapeutics Inc. (AXSM) has appointed Myrtle Potter to its Board of Directors.

Potter is the Chief Executive Officer and Founder of Myrtle Potter & Company, a healthcare and life science advisory firm. She previously served as the President, Commercial Operations and Chief Operating Officer of Genentech, and held executive operating positions at Bristol-Myers Squibb and Merck.

AXSM closed Monday’s trading at $4.60, up 12.20%.

Shares of Clovis Oncology Inc. (CLVS) soared more than 46% on Monday, following positive top line results from a confirmatory phase 3 trial of Rucaparib in ovarian cancer patients, dubbed ARIEL3.

The trial met the primary endpoint of improved progression-free survival or PFS by investigator review in all three primary efficacy analyses: tumor BRCA-mutant,…

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