US clinical-stage biotech Sage Therapeutics (Nasdaq: SAGE) has entered into a strategic collaboration for the clinical development and commercialization of SAGE-217 for the treatment of major depressive disorder (MDD) and other indications in Japan, Taiwan and South Korea with Japanese pharma major Shionogi (TYO: 4507).
Sage received Breakthrough Therapy designation from the US Food and Drug Administration for SAGE-217 in MDD in February 2018, and recently announced an expedited development plan for SAGE-217 in the USA with a pivotal Phase III placebo-controlled trial in patients with MDD expected to commence this year, and an ongoing placebo-controlled trial in women with PPD, now also designated a pivotal trial. The goal of the collaboration is to accelerate development of a potentially groundbreaking medicine to patients in key Asian markets.
Sage’s shares were up a modest 1.46% to $172.-00 pre-market, having risen as much as 15% a day earlier on news of the expedited US approval path.
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