Replies to post #107 on Radius Health Inc. (RDUS)

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$RDUS - $62.31 -6.87 (-9.93%) Radius Health submits Marketing Authorization Application for once-daily subcutaneous injection of abaloparatide, updates on timing for NDA submission

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.