.. a positive news item on 'Capitol Brief', featuring in Apple News:
Mesoblast rallies after FDA progress on treatments Revascor and Ryoncil The news: Mesoblast shares jumped after the biotechnology group reported "continued momentum" with the US Food and Drug Administration (FDA) on the accelerated approval pathway for its ischemic heart failure treatment Revascor.
The numbers: Mesoblast shares were up 4.9% to $1.89 at 1:45pm AEST and have gained 76.4% over the last 12 months.
The context: Mesoblast said it held a meeting with the FDA last week to discuss a biologics licence application (BLA) for Revascor. The company said there was "general alignment" on key items and it will await final minutes from the FDA before providing timelines for a potential BLA filing.Mesoblast also confirmed that it will meet the FDA in early July to discuss a pivotal trial of its cell therapy product Ryoncil in adults with steroid-refractory acute graft versus host disease (SR-aGvHD).SR-aGvHD is a life-threatening condition with high mortality rates that can arise from an allogeneic bone marrow transplant. The objective of the trial would be to extend the product's label from children to adults.Ryoncil became commercially available in the US in March after receiving FDA approval in December.
What they said: "We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs," said Mesoblast's chief executive Silviu Itescu."We are also encouraged by the strength of the Ryoncil commercial launch, the rate of hospital onboarding, physician adoptions, and payor coverage exceeding our expectations in the ten weeks since commercial launch."
MSB Price at posting:
$1.85 Sentiment: Buy Disclosure: Held
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