Mesoblast Outlines Potential Pathway to Accelerated Market Entry for MPC-150-IM

Mesoblast (ASX:MSB; NASDAQ:MESO) announced a potential plan to get a market entry for their allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM.
As quoted in the press release:

Patients with NYHA Class III/Class IV experience high mortality rates, recurrent hospitalizations, and incur substantial cost of care despite maximal existing therapies. We believe that under new regulatory frameworks that recognize the serious and life-threatening nature of advanced CHF, positive results from our ongoing Phase 2b/3 trials in these patients could support accelerated approval for MPC-150-IM and an opportunity to create a paradigm shift in this potential multi-billion dollar market.
MPC-150-IM is being evaluated in two ongoing randomized placebo-controlled Phase 2b/3 trials in patients with either severe or end-stage advanced CHF. The mechanism of action (MOA) by which MPC-150-IM is thought to exert its effects in these patient populations is through immunomodulation and cardiac repair. Positive clinical signals supporting a common underlying MOA have been previously published in Phase 2 trials of Mesoblast’s allogeneic MPC therapy in moderate/severe and end-stage heart failure.^[1,2]

Click here to read the full press release.

Source: globenewswire.com