Radius Health Osteoporosis Drug Positive in Phase III Study
Radius Health, Inc. RDUS announced positive data from the ACTIVExtend study on Tymlos. The 24-month ACTIVExtend study on Tymlos enrolled patients who had completed 18 months of treatment with Tymlos (abaloparatide) injections or placebo in the phase III trial, ACTIVE. These patients were then transitioned to receive 24 additional months of open-label alendronate.
Data from the study revealed that Tymlos (80 mcg), when dosed daily for 43 months (18 months in ACTIVE study + 24 months in ACTIVExtend study), led to a significant reduction (84%) in the incidence of new vertebral fractures in postmenopausal women with osteoporosis, compared to placebo. Results also demonstrated a 39% reduction in the risk of nonvertebral fractures, a 34% risk reduction in clinical fractures and 50% reduced risk in major osteoporotic fractures compared with women who received placebo followed by Merck & Co., Inc.’s MRK Fosamax.
Radius Health’s share price has outperformed the Zacks categorized Medical-Generic Drugs industry in the past one year. The stock increased 18.3% compared with an increase of 12.3% for the broader industry.
We remind investors that Tymlos was recently approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. The drug is under review in the EU.
The company is planning to file a supplemental New Drug Application (sNDA) for Tymlos based on the ACTIVExtend study.
An opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing application is expected in Jul 2017.
Although the osteoporosis market in the U.S. has great potential as approximately 1.4 million postmenopausal women in the U.S. experience osteoporotic fractures each year, Tymlos is expected to face significant competition from Eli Lilly and Company’s LLY Forteo and Amgen Inc.’s AMGN Prolia.
In addition, the company is developing abaloparatide-transdermal (abaloparatide-TD) for potential use as a treatment for osteoporosis.
As per the company’s press release, approximately 2 million osteoporotic fractures take place annually in the U.S. This number is likely to grow to 3 million by 2025.
According to the National Osteoporosis Foundation (NOF), an estimated 8 million women are already affected by osteoporosis, while an estimated 44 million individuals have demonstrated low bone mass, placing them at high risk for osteoporosis.
Radius Health, Inc. Price
Radius Health, Inc. Price | Radius Health, Inc. Quote
Radius Health currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana. Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look. See the pot trades we're targeting>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Click for Free Eli Lilly and Company (LLY) Stock Analysis Report >>
Click for Free Merck & Company, Inc. (MRK) Stock Analysis Report >>
Click for Free Amgen Inc. (AMGN) Stock Analysis Report >>
Click for Free Radius Health, Inc. (RDUS) Stock Analysis Report >>
To read this article on Zacks.com click here.
