Shares of Sage Therapeutics gained nearly 6 percent Tuesday in premarket trading after the company said the Food and Drug Administration has cleared it to expedite development of its drug to treat major depressive disorder and postpartum depression.
Sage said its currently ongoing trial in women with postpartum depression will now be designated a pivotal trial, which allows the data, if positive, to support a regulatory filing. The company plans to start a phase 3 trial in major depressive disorder in the second half of this year.
The drug, SAGE-217, in February received breakthrough therapy designation, which allows for a potentially expedited regulatory approval process. This came after Sage wowed with results from a phase 2 trial in December.
Commissioner Scott Gottlieb has pushed the FDA to review and approve drugs faster. Last year, Gottlieb’s first leading the agency, the FDA approved a record number of generic drugs and a handful of biosimilars, or copycat versions of complex, biologic drugs.
“Sage is excited to receive feedback from the FDA that provides a possible groundbreaking path forward for the development of SAGE-217 for the treatment of depression,” said CEO Dr. Jeff Jonas.
Shares of Sage have slipped nearly 11 percent year-to-date.
Source: Investment Cnbc
Sage shares climb after company says FDA OKs expedited depression drug development