Mesoblast slumps as it gets CRL for its Ryoncil BLA

Shares of Australian biotech Mesoblast (ASX: MSB) plummeted after it revealed that, the US Food and Drug Administration had issued a Complete Response Letter (CRL) to its Biologics License Application (BLA) for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast's shares, which went into a trading halt last Thursday in anticipation of the regulatory ruling, opened down 44% at A$2.87 on the back of the news Friday. The stock reversed some of the loss, closing up 11.6% to A$3.56 today.

While the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9:1 that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD, the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. As there are currently no approved treatments for this life-threatening condition in children under 12, Mesoblast will urgently request a Type A meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a post-approval condition for an additional study.