Radius Health Inc RDUS posted topline data from Phase 3 wearABLe study evaluating the non-inferiority (NI) of abaloparatide transdermal system (abalo-TDS) compared to abaloparatide subcutaneous injection (Tymlos) in postmenopausal women with osteoporosis.
- The study did not meet its primary endpoint of NI for abalo-TDS 300ug vs. Tymlos 80 ug in the percent change from baseline in lumbar spine (LS) bone mineral density (BMD) at 12 months based on a NI margin of 2.0%.
- On the secondary endpoint, the percent change in total hip and femoral neck BMD at 12 months vs. baseline was - Abalo-TDS group (2% and 1.9%) versus Tymlos group: (3.7% and 3.4%).
- The incidence of severe or serious treatment-emergent adverse events (TEAE) was similar in both groups.
- More subjects in the abalo-TDS group reported TEAEs related to the application site compared to the Tymlos group.
- The wearABLe study data and technical details are to be analyzed and utilized as a basis for future abalo-TDS plans.
- Price Action: RDUS shares are down 38.40% at $8.86 during the market session on the last check Wednesday.
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