Stemline Therapeutics (STML)

[biotech_researcher]

STML: Stemline Therapeutics highlights recent clinical and regulatory developments and details upcoming milestones (14.32 -0.16)
Stemline continues to build out a European commercial infrastructure in advance of potential approval by the EMA. A scientific advisory group meeting is planned for September, and the ELZONRIS marketing authorization application (MAA) review will proceed on a standard timeline. Co expects an opinion by the Committee for Medicinal Products for Human Use later this year. If successful, Stemline is targeting a commercial launch in Europe in 1Q20.
In an ongoing market expansion effort, corporate and investigator-sponsored clinical trials with ELZONRIS in additional indications are ongoing in myelofibrosis (MF) and acute myeloid leukemia (AML) and others are planned to roll out later this year and next.