Tracking Radius Health...

(RTTNews) - 2014 was a banner year for Radius Health Inc. (RDUS) - with its share price having risen by a whopping 501%.

The company's lead investigational drug product candidate is Abaloparatide for the potential prevention of fractures in post-menopausal women at risk of fracture from osteoporosis. It is estimated that about 33% of women over 50 will experience bone fractures as a result of osteoporosis.

Osteoporosis is a disease where bone mass decreases quicker than the body can replace it, leading to greater fragility and an increase in fracture risk. According to the National Osteoporosis Foundation, 10.2 million adults have osteoporosis and another 43.4 million have low bone mass in the United States.

Radius Health's Abaloparatide is a novel synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein), an anabolic, bone-building drug in development in both injection (Abaloparatide-SC) and transdermal (Abaloparatide-TD) methods of administration.

The company reported positive results from a phase 3 clinical trial, dubbed ACTIVE, evaluating Abaloparatide-SC for potential use in the reduction of fractures in postmenopausal osteoporosis last December.

According to the trial results, Abaloparatide-SC achieved a statistically significant 83% reduction of incident vertebral fractures compared to the placebo-treated group.

Another phase III trial, known as ACTIVExtend, which is an extension study to evaluate 24 months of standard-of-care osteoporosis management following completion of 18 months of Abaloparatide or placebo treatment, is underway, and results from this trial are expected in the second quarter of 2015.

The company is on track for the submission of an NDA for Abaloparatide-SC to the FDA in the second half of 2015.

Abaloparatide-TD, a next-generation, short-wear-time transdermal patch designed to improve patient compliance with convenience and ease of use of Abaloparatide has been successfully tested in a phase II proof of concept study.

According to the trial results announced last January, Abaloparatide-TD demonstrated a statistically significant mean per cent increase from baseline in bone mineral density compared to placebo at the lumbar spine and at the hip.

The other investigational drugs in the company's pipeline are:

- RAD1901, a selective estrogen receptor degrader, or SERD, at higher doses for the treatment of metastatic breast cancer, including breast cancer brain metastases.

A phase I clinical study of RAD1901 in patients with advanced ER+, HER2-negative breast cancer is recruiting participants.

- RAD1901, at lower doses, is also being developed as a selective estrogen receptor modulator, or SERM, for the treatment of vasomotor symptoms, commonly called hot flashes.

In a phase II proof of concept study, RAD1901 at lower doses demonstrated a reduction in the frequency and severity of moderate and severe hot flashes.

The company intends to commence a phase 2b clinical trial of RAD1901 in vasomotor symptoms in the second half of 2015.

Founded in 2003, Radius Health went public on the NASDAQ Global Market on June 6, 2014, offering its shares at a price of $8.00 each.

We alerted our premium subscribers to RDUS on October 20, 2014 when it was trading around $18. The stock touched an all-time high of $50 on January 30, 2015 before closing the day's trading at $48.19, which equates to a gain of 178% in a little more than 3 months.

Did you ride the rally in RDUS stock?