Why Shares of Mesoblast Are Down Monday
Shares of (NASDAQ: MESO) were down by more than 15% as of 11:45 a.m. ET on Monday, just days after the healthcare stock plunged more than 61% on bad news regarding one of its lead therapy candidates.
Mesoblast is a pharmaceutical company that uses allogeneic cellular medicines, derived from the bone marrows of healthy donors, to treat complex inflammatory diseases. Apparently, not all investors got the memo on Friday and continued to react negatively to the news that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) to Mesoblast regarding its resubmission of it Biologics License Application for remestemcel-L. The BLA was as a treatment for pediatric steroid-refractory acute graft versus host disease (SR-aGVHD).
The FDA is asking for more data before granting marketing approval for the therapy. Mesoblast said it will do a controlled study of the therapy on the highest-risk adults with SR-aGVHD. Current therapies give patients who contract SR-aGVHD after organ transplants a 90-day survival rate as low as 20% to 30%.
Source Fool.com
