Hi all - great news on orphan drug granted by FDA, let's keep jumping those hurdles Neuren.....
I have also found the following - the application for orphan drug to the European Medicines Agency is particularly of interest to me and cant remember reading this in any other announcement:-
Neuren (NEU) - ASX Announcement 16 February 2015 Neuren receives Orphan Drug designation from FDA for trofinetide in Rett syndrome Melbourne, Australia, 16 February 2015: Neuren Pharmaceuticals (ASX: NEU) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to Neuren's drug trofinetide for treatment of Rett syndrome.
Orphan Drug designation is a special status that the FDA may grant a drug intended to treat a rare disease or condition. Orphan Drug designation qualifies the sponsor of the drug for 7 years of marketing exclusivity following marketing authorisation. The FDA granted Orphan Drug designation to Neuren for trofinetide in Fragile X syndrome in October 2013.
Neuren has commenced the process of Orphan Drug applications to the European Medicines Agency for trofinetide in both Rett syndrome and Fragile X syndrome. Orphan Drug designation in the European Union qualifies the sponsor of the drug for 10 years of marketing exclusivity following marketing authorisation.
- Forums
- ASX - By Stock
- EMA Application
Hi all - great news on orphan drug granted by FDA, let's keep...
-
-
- There are more pages in this discussion • 15 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 NEU (ASX) to my watchlist
|
|||||
Last
$15.34 |
Change
-0.410(2.60%) |
Mkt cap ! $1.960B |
Open | High | Low | Value | Volume |
$15.88 | $15.93 | $15.34 | $6.463M | 415.6K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
3 | 6044 | $15.32 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$15.57 | 1411 | 2 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 170 | 15.600 |
1 | 36 | 15.410 |
3 | 2085 | 15.400 |
4 | 1583 | 15.300 |
2 | 1448 | 15.290 |
Price($) | Vol. | No. |
---|---|---|
14.580 | 346 | 1 |
15.300 | 500 | 1 |
15.400 | 3 | 1 |
15.500 | 303 | 1 |
15.750 | 630 | 1 |
Last trade - 16.10pm 28/08/2024 (20 minute delay) ? |
Featured News
NEU (ASX) Chart |
The Watchlist
HAR
HARANGA RESOURCES LIMITED.
Peter Batten, MD
Peter Batten
MD
Previous Video
Next Video
SPONSORED BY The Market Online