![](https://investorshub.advfn.com/uicon/297976.png?cb=1610114739)
Tuesday, November 17, 2015 12:59:42 PM
8:35 AM ET 11/17/15 | Briefing.com
Following the completion and reporting of the positive top line results for the Phase 3 ACTIVE trial and the first six months of ACTIVExtend, Radius has now submitted the MAA for the investigational drug abaloparatide-SC in the EU. The Company is now turning its focus to the completion of the work streams necessary for the submission of the New Drug Application to the FDA for the investigational drug abaloparatide-SC. For the MAA, the Company has submitted 6-month stability data for abaloparatide in accordance with European requirements. As additional data become available, they will be submitted in support of our targeted 3-year shelf life for the commercial product following receipt of regulatory approval.
Abaloparatide: In the US, the FDA requires that 12-month stability data be submitted at the time of the NDA. The 12-month time point for the abaloparatide stability samples will be reached in December 2015 and Radius expects to initiate data analysis in January 2016. To accommodate this analytic plan, the Company announced a change in the NDA submission timing to the end of the first quarter of 2016. Similar to the European submission, as additional stability data become available they will be submitted in support of Radius' targeted 3-year shelf life for the commercial product following receipt of regulatory approval. The Company believes that the stability data supporting both the MAA submission and the planned NDA submission will be sufficient to meet the regulatory standards for approval.Radius plans to commence a clinical evaluation for an optimized abaloparatide transdermal patch by the end of 2015.Radius confirmed that partnership discussions regarding abaloparatide commercialization are ongoing and that the Company expects to announce a partnership by the time of first commercial launch. Radius Health's ideal partner for abaloparatide would have experience in the development and commercialization of therapeutics to treat osteoporosis and related bone metabolic disorders.RAD1901:Radius plans to provide an update on the ongoing Phase 1 dose escalation study in metastatic breast cancer patients at the San Antonio Breast Cancer Symposium in December 2015. Radius expects to initiate an additional Phase I clinical trial in metastatic breast cancer patients in the European Union in December 2015. Radius intends to commence a Phase 2b trial for low-dose RAD1901 for vasomotor symptoms in December 2015.RAD140: Radius expects to commence a Phase 1 trial for the investigational drug RAD140 after making an Investigational New Drug submission in 2016.
Recent RDUS News
- Radius Recycling Reports Third Quarter Fiscal 2024 Financial Results • GlobeNewswire Inc. • 07/02/2024 12:00:00 PM
- Radius Recycling Announces Third Quarter Fiscal 2024 Earnings Date and Webcast Details • GlobeNewswire Inc. • 06/18/2024 09:10:00 PM
- 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 Mawson Finland Provides Update on Exploration Activities at Rajapalot • Aug 21, 2024 9:06 AM
Unitronix Announces Strategic Entry into Cryptocurrency Space • UTRX • Aug 21, 2024 10:00 AM
Avant Technologies to Implement Robust Cybersecurity Measures for AI-Driven Healthcare Solutions • AVAI • Aug 21, 2024 8:00 AM
HealthLynked Corp. Announces Second Quarter and First Half 2024 Results: Continued Cost Reductions Set the Stage for Strategic Shift to App-Based Technology Services • HLYK • Aug 16, 2024 8:00 AM
PickleJar Announces Official Name Change and New Ticker Symbol • NREG • Aug 15, 2024 2:23 PM
VAYK's Q2 Profit Added to Accumulated Net Profit of Over $2.2 Million In 18 Months • VAYK • Aug 15, 2024 9:07 AM