Mesoblast Limited (Nasdaq: MESO) has announced the receipt of a comprehensive response from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) resubmission for remestemcel-L. The FDA's response stipulates the need for supplementary data to bolster marketing approval for treating pediatric steroid-refractory acute graft versus host disease (SR-aGVHD).

In alignment with this response, Mesoblast is set to commence a targeted controlled study involving high-risk adults. This pivotal move aligns with their strategic commercial trajectory, aimed at advancing from pediatric to adult SR-aGVHD indications. Notably, adults encompass 80% of the SR-aGVHD market.

Trading of $MESO was temporarily halted upon Mesoblast's request, preceding this significant announcement

In other news, Nikola Corporation (Nasdaq: NKLA) is poised to disclose its second-quarter 2023 financial results this Friday, August 4, ahead of the market's opening. 

The consensus estimate points to a loss of $0.22 per share on revenue totaling $15.43 million.

$NKLA closed at $3.39 on Thursday, up $0.37 (+12.41%) 

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