18.06.2015 07:04:46

What's Making News At Radius Health?

(RTTNews) - Radius Health Inc.'s (RDUS) top line data from the first six months of ACTIVExtend trial and the 25 month combined data from ACTIVE and ACTIVExtend trials are encouraging.

The company's study dubbed ACTIVE is a phase III trial of its product candidate Abaloparatide-SC in women with postmenopausal osteoporosis while ACTIVExtend is an extension of the ACTIVE trial where patients in the Abaloparatide and placebo groups received an approved Alendronate therapy for osteoporosis management.

According to the ACTIVExtend trial results, patients who previously completed 18 months of Abaloparatide-SC administration experienced no new vertebral fractures during the first six months on Alendronate.

Over the 25-month period, patients in the Abaloparatide-Alendronate treatment group on average achieved a 12.8% increase in BMD (bone mineral density) at the lumbar spine, a 5.5% increase in BMD at total hip, and a 4.5% increase in BMD at the femoral neck. In this treatment group, 20.4% of patients achieved a 6% increase or greater in BMD at all three sites (i.e., lumbar spine, total hip, and femoral neck), noted the company.

The results reported from the ACTIVE Trial last December have also been positive - with Abaloparatide-SC demonstrating the largest reduction ever reported in vertebral fracture risk versus placebo of 86%.

The 25 month combined data from ACTIVE and ACTIVExtend trials show an 87% reduction in new vertebral fractures, 52% reduction in non-vertebral fractures, 48% reduction in clinical fractures, and a 58% reduction in major osteoporotic fractures.

Radius Health expects to submit a NDA and marketing authorization application for Abaloparatide-SC in the second half of 2015.

We alerted our premium subscribers to RDUS on October 20, 2014 when it was trading around $18. The stock touched a new high of $52.50 on June 17, 2015, and that represents a gain of 191% in eight months.

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