Biopharmaceutical company NRx Pharmaceuticals, Inc. (NRXP) announced Monday that it has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With data-lock, the complete data set is transferred for independent statistical analysis. The top-line data release is expected in April 2024.
With positive data from this study and FDA comment, NRx becomes eligible to receive the balance of its first milestone (an additional $4 million) from partners Alvogen, Inc. and Lotus Pharmaceuticals, Inc. (1745.TW).
These partners would then be responsible for all future development costs in this indication. NRx retains rights for all other indications, including chronic pain and PTSD. NRx is then poised to receive $320 million in further milestones along with mid-teen royalties on Net Sales.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of Suicidal Treatment Resistant Bipolar Depression.
The Phase 2b/3 trial is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks.
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