Mesoblast Plunges as FDA Questions Cell-Therapy Manufacturing

Shares of Mesoblast (NASDAQ: MESO) fell as much as 40% today after investors pored over a briefing document for an upcoming advisory committee (AdCom) meeting scheduled to take place on Aug. 13. The meeting will allow independent scientists to weigh in on the marketing application for remestemcel-L in treating pediatric steroid-refractory acute graft-versus-host disease (SR-aGVHD). The U.S. Food and Drug Administration (FDA) will make a decision on the application on Sept. 30.

According to the briefing document, AdCom members are prepared to drill Mesoblast on manufacturing processes for remestemcel-L, which is a mesenchymal stem cell (MSC) therapy. Investors were expecting the FDA to approve the drug candidate at the end of September, a confidence that was bolstered by a successful phase 3 trial and approval in other countries. 

While that approval deadline could remain intact, investors are now considering the possibility that regulators will require Mesoblast to provide more data, thereby delaying market launch beyond 2020. The small-cap stock isn't handling the uncertainty very well, but investors shouldn't necessarily panic just yet.

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Source Fool.com