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re: Akebia Therapeutics (AKBA)- Vadadustat FDA Approved AT LAST!!

Posted on 2/25/21 at 11:40 am to
Posted by WDE24
Member since Oct 2010
54837 posts
Posted on 2/25/21 at 11:40 am to
I’m back in at 3.49/share
Posted by Lieutenant Dan
Euthanasia, USA
Member since Jan 2009
8391 posts
Posted on 2/25/21 at 11:52 am to
I hopped on it at 3.54.

I'm assuming this is a long play.
Posted by Louie
Locust Grove, GA
Member since Jun 2006
872 posts
Posted on 2/25/21 at 12:28 pm to
Waited and got in at 3.57
Posted by WDE24
Member since Oct 2010
54837 posts
Posted on 2/26/21 at 8:07 am to
It’s 3.31 premarket. A very good entry point IMO for anyone interested.
This post was edited on 2/26/21 at 8:13 am
Posted by supadave3
Houston, TX
Member since Dec 2005
31794 posts
Posted on 2/26/21 at 8:24 am to
Bought a bit more here. Like someone else said early on. Allah Akba!!
Posted by MrLSU
Yellowstone, Val d'isere
Member since Jan 2004
29001 posts
Posted on 2/26/21 at 2:49 pm to
Looks like a good stock to invest in!
Posted by oklahogjr
Gold Membership
Member since Jan 2010
40237 posts
Posted on 2/26/21 at 3:48 pm to
quote:

hopped on it at 3.54.

I'm assuming this is a long play.

Yes, the nda is behind schedule was the latest I heard
Posted by Vols&Shaft83
Throbbing Member
Member since Dec 2012
70096 posts
Posted on 2/27/21 at 10:52 am to
quote:

hopped on it at 3.54.

I'm assuming this is a long play.

Yes, the nda is behind schedule was the latest I heard




I was able to add another 200 shares @ 3.29...getting my basis down to 3.32 on 508 shares.

What's going on with the nda?

Posted by WDE24
Member since Oct 2010
54837 posts
Posted on 2/27/21 at 12:38 pm to
quote:

What's going on with the nda?
Expected during second quarter
Posted by GeneralLee
Member since Aug 2004
13946 posts
Posted on 3/1/21 at 11:48 am to
One of the few red ones today, but I'd rather be buying a stock that isn't ripping today.
Posted by itsbigmikey
NASHVILLE
Member since Aug 2018
450 posts
Posted on 3/1/21 at 1:04 pm to
Just bought a few $2.50 October calls. Seems to be minimal risk with some good upside
Posted by BigOrangeBri
Nashville- 4th & 19
Member since Jul 2012
12790 posts
Posted on 3/1/21 at 5:25 pm to
Damn. They missed earnings by $.20

That can’t be good
Posted by Vols&Shaft83
Throbbing Member
Member since Dec 2012
70096 posts
Posted on 3/1/21 at 5:35 pm to
quote:

Damn. They missed earnings by $.20

That can’t be good




Welcome to last week, Bri
Posted by BigOrangeBri
Nashville- 4th & 19
Member since Jul 2012
12790 posts
Posted on 3/1/21 at 6:29 pm to
quote:

Welcome to last week, Bri


I hold a decent amount and had no clue. Just happened to glance at it today. Guess I should pay a little more attention lol.
Posted by GeneralLee
Member since Aug 2004
13946 posts
Posted on 3/1/21 at 7:40 pm to
What do you see as the upside potential here if the NDA is filed? Flipped this from $3.5 to $4.3 a few weeks ago and bought back in at $3.35 but concerned that we might be nowhere near the bottom if the NDA is months away, given their earnings disaster on the recent call.
Posted by oklahogjr
Gold Membership
Member since Jan 2010
40237 posts
Posted on 3/1/21 at 9:02 pm to
I sold. I basically got out no harm no could not much made or lost.

I don't like companies who continually disappoint. Makes it very hard on the wallet
Posted by Fox McCloud
Member since Oct 2020
3525 posts
Posted on 3/1/21 at 9:06 pm to
I’m getting out first chance I get as well.
Posted by ISEN_AG
ThunderWolf Manor
Member since Aug 2013
2295 posts
Posted on 3/2/21 at 10:37 am to
I figured I would try this out. Put a little into it...43 shares at $3.44
Posted by bayoubengals88
LA
Member since Sep 2007
23479 posts
Posted on 3/2/21 at 11:17 am to
quote:

What do you see as the upside potential here if the NDA is filed?
No guesses. I like it in the 3s for a 2-3 year play. Not looking for 15%

Made 40% and didn't sell. Don't care. Long term investment.

Not much money in it at all. Yet.
Posted by Chucktown_Badger
The banks of the Ashley River
Member since May 2013
35807 posts
Posted on 3/31/21 at 9:59 am to
They submitted their NDA yesterday, so we're seeing a bump today. Not sure of a PDUFA date, if one exists. Having gotten burned on AUPH thus far, I'm thinking this could be one where I look to exit my position with some gains before the action date (assuming of course, I have gains to take).

quote:

In the wings and poised to reshape the treatment landscape for hematologic disorders are two potential blockbuster drugs - Valrox (valoctocogene roxaparvovec) for hemophilia A and vadadustat for anemia related to chronic kidney disease - that are among the 11 included in the Cortellis Drugs to Watch analysis predicted to achieve annual sales of $1 billion by 2024.


quote:

Several HIF-PH enzyme inhibitors are currently in development targeting the estimated $3.5 billion renal anemia market, including Cambridge, Mass.-based Akebia Therapeutics Inc.’s vadadustat, which has advanced to late-stage clinical trials. In July, its strategic partner, Osaka-based Mitsubishi Tanabe Pharma Corp., filed an NDA with the Japanese Ministry of Health, Labour and Welfare, seeking approval for the product as a treatment for anemia due to CKD.

The filing is based on data from four studies in Japanese patients: an active-controlled study in non-dialysis-dependent CKD anemia (J01), another active-controlled study but in dialysis-dependent patients with CKD anemia (J03), and two single-arm studies in patients with peritoneal and hemodialysis-dependent CKD anemia (J02 and J04). Vadadustat demonstrated non-inferiority with respect to hemoglobin level versus the active comparator (darbepoetin alfa) in both dialysis- and non-dialysis-dependent patients (J01 and J03 studies; 11.66 vs 11.93 g/dL, and 10.61 vs 10.65 g/dL, respectively) and showed therapeutic effect in the single-arm studies.

If approved, the company expects commercial launch during mid-2020, and filings in the U.S. and the EU are planned, those territories covered by Akebia’s alliance with Otsuka Pharmaceutical Co., Ltd.
This post was edited on 3/31/21 at 10:27 am
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