The Mesoblast Limited (ASX: MSB) share price has had a great run on the ASX over the past 12 months, rising from $1.34 a year ago to reach a 52-week high on Monday of $2.69.
Mesoblast shares are now trading for $2.62, a yearly gain of just under 100%. In particular, Mesoblast's share price growth has been very strong since the beginning of last September, with an 83% gain since then.
So, what does Mesoblast do?
Mesoblast is a world leader in developing allogeneic, off-the-shelf cellular medicines. Mesoblast has leveraged its proprietary cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Two products have been commercialised in Japan and Europe by its licensees, and it has established commercial partnerships in Europe and China.
What's behind Mesoblast's recent share price gains?
On 15 January, the United States Food and Drug Administration (FDA) agreed to the selection of Ryoncil™ as the commercial name for Mesoblast's lead allogeneic cell therapy remestemcel-L, which is used in the treatment of paediatric steroid-refractory acute graft versus host disease (aGVHD).
aGVHD is a potentially life-threatening complication of an allogeneic bone marrow transplant. Commercial plans for Ryoncil™ were recently presented at the 2020 Biotech Showcase held in San Francisco, CA. Mesoblast is preparing for potential FDA approval and a US launch of Ryoncil™.
The continued growth in revenues from royalties on sales in Japan of its related product TEMCELL1 for aGVHD by Mesoblast's licensee is also a positive indicator for its own US commercial plans.
Mesoblast is also waiting on outcomes of its Phase 3 trials for its blockbuster product candidates in advanced chronic heart failure and chronic low back pain due to degenerative disc disease.
The final module of the rolling biologics license application for Ryoncil™ will be filed with the FDA by the end of January, following which Mesoblast will request a priority FDA review under its existing Fast Track designation.
If approved, Ryoncil™ is planned to be launched in the US later in 2020.
This announcement followed another one made back on 2 January, where the FDA confirmed receipt of Mesoblast's filing of clinical efficacy and safety data for remestemcel-L. Study results demonstrate the effectiveness of remestemcel-L and in particular, the study noted efficacy and survival benefit in patients with the most severe forms of aGVHD, indicating that very promising progress has been made so far.
