BELL POTTER FLASH NOTE -
Mesoblast (MSB) has announced today that the
FDA has granted fast Track designation for remestemcel-L for the treatment of COVID-19 ARDS (Acute respiratory Distress Syndrome), based on the positive
data from the pilot study under emergency compassionate use at Mt Sinai hospital conducted in March/April’20.
Under Fast Track, remestemcel-L will be eligible for certain benefits which would shorten the FDA review time. These include priority review (which shortens the review time to 6 months vs. standard 10 months) and a rolling BLA submission and review process (which enables MSB to submit sections of the BLA when completed rather than waiting for all sections to complete).
Implications for MSB – BP view
We note that MSB will be applying for an EUA (Emergency Use Authorization) to the FDA for initial approval of remestemcel-L for COVID-19 ARDS subject to positive results from the ongoing 300 patients Phase 3 trial which is now ~two-thirds enrolled and has passed two interim analyses by the independent Data Safety Monitoring Board (DSMB). A third interim analysis when 180 patients have completed 30 day follow up is expected later this month, with completion of enrollment and Top-line results from the trial expected in 1QCY21.
However, as we have seen with Gilead’s remdesivir which was the first drug to be granted EUA for COVID-19, FDA expects companies in parallel to the EUA process to file a BLA to obtain subsequent full approval for the drug. The Fast Track designation granted by the FDA today will help in accelerating the subsequent BLA process for remestemcel-L for COVID-19 ARDS. Hence, we view the grant of this designation by the FDA as very encouraging.
We also note that remestemcel-L for COVID-19 ARDS is now partnered with Novartis in a worldwide licensing deal. We estimate that US$105m of the pre-commercialization milestones under the deal are linked to positive results and subsequent EUA approval by the FDA for remestemcel-L for COVID-19 ARDS which we expect to be received by MSB if everything goes to plan in 1HCY21.
No change to our estimates. We retain Buy (spec.) and $7.40/sh valuation on MSB.
- Forums
- ASX - By Stock
- MSB
- Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS
Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-189
-
- There are more pages in this discussion • 384 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
|
|||||
Last
$1.02 |
Change
0.025(2.53%) |
Mkt cap ! $1.158B |
Open | High | Low | Value | Volume |
99.5¢ | $1.02 | 98.5¢ | $853.8K | 852.1K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
14 | 136029 | $1.01 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.02 | 31625 | 9 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
15 | 139072 | 1.010 |
9 | 48497 | 1.005 |
13 | 100198 | 1.000 |
10 | 197660 | 0.995 |
10 | 608797 | 0.990 |
Price($) | Vol. | No. |
---|---|---|
1.015 | 3586 | 4 |
1.020 | 90789 | 16 |
1.025 | 61245 | 12 |
1.030 | 57237 | 10 |
1.035 | 35081 | 7 |
Last trade - 10.57am 15/08/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |
The Watchlist
I88
INFINI RESOURCES LIMITED
Charles Armstrong, CEO & Managing Director
Charles Armstrong
CEO & Managing Director
SPONSORED BY The Market Online