In an update to investors, Chiasma (NASDAQ:CHMA) announces that topline data from the Phase 3 OPTIMAL study evaluating Mycapssa (octreotide) in patients with acromegaly should be released by mid-Q3.
A second Phase 3, IMPOWERED, is also advancing. Only 10 subjects remain active in the run-in phase. Most have been randomized into the nine-month controlled phase. Topline results should be available in H2 2020.
The company says it plans to file a U.S. marketing application later this year based on a positive outcome of OPTIMAL. If all goes well, the FDA nod could happen by mid-2020.
On another note, it will join the Russell 3000 Index effective July 1.
Shares are up 2% after hours.
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