Mesoblast Limited
MESO: Price: $11.33; Market Cap (M): $1,323
Rating: Buy; Price Target: $21.00Swayampakula Ramakanth, Ph.D.
Arthur He, Ph.D.
Sean Lee
Sean Kang
We Remain Bullish on Ryoncil Approval; Reiterate Buy
Risk benefit ratio is still in favor of Ryoncil.On August 11, the FDA published the briefing documents for the upcoming Oncologic Drugs Advisory Committee (ODAC) meeting to evaluate Mesoblast’s biologics license application (BLA) filing for Ryoncil (remestemcel-L) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD), which is scheduled for this Thursday, August 13. Recall, the company submitted the BLA application in March and the agency has designated a PDUFA date of September 30, 2020. After reviewing the FDA briefing documents, we believe that Ryoncil is likely to be approved before the PDUFA date due to a strong combination of safety and efficacy, while the main issues raised by the FDA are addressable. At the same time, we note that the agency could request the company to complete a post-marketing study in order to provide additional data on these issues.
- Forums
- ASX - By Stock
- MSB
- FDA ODAC Meeting Material discussion analysis
FDA ODAC Meeting Material discussion analysis, page-387
-
- There are more pages in this discussion • 105 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add MSB (ASX) to my watchlist
(20min delay)
|
|||||
Last
$1.13 |
Change
0.035(3.21%) |
Mkt cap ! $1.284B |
Open | High | Low | Value | Volume |
$1.09 | $1.13 | $1.07 | $3.910M | 3.535M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
2 | 27197 | $1.11 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.13 | 43578 | 3 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
2 | 27197 | 1.105 |
8 | 87146 | 1.100 |
2 | 71941 | 1.095 |
2 | 33264 | 1.090 |
2 | 18897 | 1.085 |
Price($) | Vol. | No. |
---|---|---|
1.125 | 43578 | 3 |
1.130 | 87126 | 8 |
1.135 | 1090 | 1 |
1.140 | 141598 | 9 |
1.145 | 64500 | 3 |
Last trade - 16.10pm 27/09/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |