Monday, December 22, 2014 7:51:19 AM
5:56 AM ET 12/22/14 | Briefing.com
On the primary endpoint, the investigational drug abaloparatide-SC (n=690, fracture rate 0.72%) achieved a statistically significant 83% reduction of incident vertebral fractures as compared to the placebo-treated group (n=711, fracture rate 4.36%) (p<0.0001). The ACTIVE trial included an open-label teriparatide [rDNA origin] injection treatment group (n=717, fracture rate 0.98%) that showed a statistically significant 78% reduction of incident vertebral fractures as compared to the placebo-treated group (p<0.0001). On the secondary endpoints as compared to placebo, abaloparatide-SC achieved a statistically significant fracture-rate reduction of 43% in the adjudicated non-vertebral fracture subset of patients; a statistically significant reduction of 41% in the adjudicated clinical fracture group, which includes both vertebral and non-vertebral fractures; and a statistically significant difference in the time to first incident non-vertebral fracture in both the adjudicated non-vertebral fracture and the clinical fracture subset of patients.
"We are on track for NDA submission in the second half of 2015 and encouraged by the consistency of our Phase 3 results with those from our two Phase 2 studies...These results reinforce the emerging profile of abaloparatide, and we eagerly await the first six-month results from the ongoing ACTIVExtend trial expected in the second quarter of 2015."
Recent RDUS News
- Radius Recycling Reports Second Quarter Fiscal 2024 Financial Results • GlobeNewswire Inc. • 04/04/2024 12:00:00 PM
- US Index Futures Rise, Oil Dips Slightly • IH Market News • 04/04/2024 11:31:45 AM
- Second Quarter Fiscal 2024 Preliminary Results and Announcement of Earnings Date • GlobeNewswire Inc. • 03/14/2024 08:35:00 PM
- Radius Recycling Named One of the 2024 World’s Most Ethical Companies • Business Wire • 03/04/2024 01:30:00 PM
- Radius Recycling Reports First Quarter Fiscal 2024 Financial Results • Business Wire • 01/04/2024 01:00:00 PM
- Radius Recycling Announces First Quarter Fiscal 2024 Earnings Date and Webcast Details • Business Wire • 12/18/2023 02:00:00 PM
- Radius Recycling Publishes Fiscal Year 2023 Sustainability Report • Business Wire • 12/13/2023 02:15:00 PM
- Radius Recycling Executive Included on TIME100 Climate List of the 100 Most Influential Leaders Driving Business Climate Action • Business Wire • 11/16/2023 01:30:00 PM
- Radius Recycling Reports Fourth Quarter and Fiscal 2023 Financial Results • Business Wire • 10/25/2023 12:00:00 PM
- Radius Recycling Announces Fourth Quarter and Fiscal 2023 Earnings Date and Webcast Details • Business Wire • 09/29/2023 12:30:00 PM
FEATURED Integrated Ventures Files Q3/2024 With Mining Revenues Of $1,983,250 And Positive Earnings Of $0.05 Cents Per Share • May 15, 2024 10:30 AM
Swifty Global Announces Impressive Financial Results for Q1 2024 • DRCR • May 15, 2024 10:25 AM
Branded Legacy Inc. Invites Shareholders to Celebrate Milestones at Open House: Announces Share Buyback and Commitment to Authorized Share Count • BLEG • May 15, 2024 8:30 AM
Alliance Creative Group (ACGX) Releases Q1 2024 Financial and Disclosure Report with an 88% increase in Net Income from Q1 2023 to Q1 2024 • ACGX • May 15, 2024 8:30 AM
Category V Biotech, Inc. Announces Letter of Intent to Acquire Genetic Networks, Expanding into Biotechnology Sector • CATV • May 15, 2024 8:00 AM
POET Announces Design Win and Collaboration with Foxconn Interconnect Technology for High-speed AI Systems • POET • May 14, 2024 10:09 AM