Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-55

First 55 Last

Share
Profile

Follow
arjay

3,596 Posts.

779

12/08/21

13:22

Post #: 55235024
Share

Originally posted by itsagas ↑

Antisense Therapeutics (ANP) – SPEC BUY – TP A$0.44 FDA feedback – delay to short-term catalyst but +ve FDA feedback provides further confidence of receipt upon submissionANP has announced this morning that it has received feedback from the FDA on its Fast Track Designation (FTD) request.
The response suggests ANP is required to finalise its complete response from an existing partial hold on its ATL-1102 drug and include its yet-to-be-completed 9-month toxicology study amongst the protocol synopsis which is expected to support the dosing of patients in the US beyond 6 months. Given FTD submission included updated trial design features in-line with feedback from the FDA Type-C and EMA which include higher and longer dosing regimens – it requires to button these last technical requirements up prior to re-lodging.What this means is that ANP will pull its FTD request and re-lodge once these tox studies are completed and a complete response accepted to ANP’s partial clinical hold on studies which are dosing >25mg/week. Overall, no impact to the timing of the trial commencement or completion although it does push out a pricing catalyst which investors would view favourably if received.Whether ANP received an FTD this month or a year from now after it generates the required studies doesn’t matter as FTD’s are used post clinical trial completion and are designed to facilitate and expedite the review of a new drug application.While this is a delay to a potential short-term catalyst, commentary from the FDA provides further comfort on the likelihood (assuming toxicology studies are +ve) of obtaining the designation: ‘DMD is certainly a serious condition, and it appears that ATL1102 may have the potential to demonstrate an effect on a serious aspect of the condition and provide benefit over currently approved therapies’.In a further silver lining, this advice is likely to push ANP to accelerate it’s complete response to the FDA partial hold. If accepted, ANP’s IND would become active and open (allows access to patients via clinical programs) as well as clearing the path for FTD consideration. View – net net neutral newsNo changes to our long-term view or forecasts. The delay of a short-term pricing catalysts is disappointing although offset by +ve commentary which is suggestive of FDA’s view on the applicability of the drug to treat DMD and likelihood that FTD to be issued once the technical details have been addressed.
We continue to be buyers in this name. Any weakness from short-term holders would present an opportunity to continue to add to holdings. Target price and recommendation retained.

From Morgan’s this Am....
Akki: Stop going on about Teva ...?who dropped Atl1102 picked up another drug which was a failure.. lol

Expand

Where did you find this It'sa .nice article and makes complete sense...

Nice find..

ANP Price at posting: 18.0¢ Sentiment: Buy Disclosure: Held
5 Upvote

0 Great analysis

Reply

Top Stories

RKT

RocketDNA wins $350K contract to supply mine sits with autonomous security 'PatrolBots'

EMD

Emyria jumps 10% on 'interim' success treating PTSD patients with MDMA

IMU

Imugene's azer-cel trial sees tumours temporarily disappear in 3 of 10 patients

TAT

Tartana Minerals firms up producer status with recent 150tn shipment of copper sulphate to the NT

BAS

Bass completes successful testing work at Kiwi-1, showing higher-than-expected condensate yields

There are more pages in this discussion • 120 more messages in this thread...

First 55 Last

Add PER (ASX) to my watchlist

(20min delay)
Last 8.4¢		Change -0.003(3.45%)		Mkt cap ! $76.63M

Open	High	Low	Value	Volume
8.7¢	8.7¢	8.4¢	$63.50K	749.7K

Buyers (Bids)

No.	Vol.	Price($)
3	68703	8.4¢

Sellers (Offers)

Price($)	Vol.	No.
8.6¢	384321	2

View Market Depth

No.	Vol.	Price($)
4	460103	0.084
3	212500	0.083
1	21000	0.081
2	106250	0.080
3	132078	0.079

Price($)	Vol.	No.
0.086	384321	2
0.087	329525	1
0.088	457142	2
0.089	295000	3
0.090	294374	4

Last trade - 11.52am 02/09/2024 (20 minute delay)

PER (ASX) Chart

Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-55

RocketDNA wins $350K contract to supply mine sits with autonomous security 'PatrolBots'

Emyria jumps 10% on 'interim' success treating PTSD patients with MDMA

Imugene's azer-cel trial sees tumours temporarily disappear in 3 of 10 patients

Tartana Minerals firms up producer status with recent 150tn shipment of copper sulphate to the NT

Bass completes successful testing work at Kiwi-1, showing higher-than-expected condensate yields

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-55

Top Stories

RocketDNA wins $350K contract to supply mine sits with autonomous security 'PatrolBots'

Emyria jumps 10% on 'interim' success treating PTSD patients with MDMA

Imugene's azer-cel trial sees tumours temporarily disappear in 3 of 10 patients

Tartana Minerals firms up producer status with recent 150tn shipment of copper sulphate to the NT

Bass completes successful testing work at Kiwi-1, showing higher-than-expected condensate yields

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News