Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
"Potential to Cause a Sharp Upward Move in the Stock "
Critical Upcoming Catalysts Have the Potential to Cause a Sharp Upward Move in the Stock
See https://smithonstocks.com/portola-critical-upcoming-catalysts-have-the-potential-to-cause-a-sharp-upward-move-in-the-stock-ptla-buy-29-19/
Best of luck!
PAS Date: December 31, 2018.
The Target is Set!!!
http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2366974
Why the PAS matters:
From SoS's July 12th article:
Jeffrey Bird Buys in August:
Transaction Date Sorted in descending order. Name Position Type Shares Range Market
Value Total Holdings
08/23/2018 BIRD, JEFFREY W. Director Buy 50,355 $26.65 1.3M 449,053
08/22/2018 BIRD, JEFFREY W. Director Buy 202,082 $26.09 5.3M 398,698
08/21/2018 BIRD, JEFFREY W. Director Buy 137,563 $25.17 3.5M 196,616
-- -- -- -
Submits PAS for broad Andexxa commercial launch
http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2365666
2Q18 Bevyxxa sales=$33K (not a typo). The skepticism expressed in #msg-137659892 has been borne out.
PTLA: $100M milestone payment!
That should help the cash position of the company and support the launch of the now FDA approved Andexxa!!!
SoS on approval:
"Portola: Approval of AndexXa is a Major Positive (PTLA, Buy, $41.19)"
https://smithonstocks.com/portola-approval-of-andexxa-is-a-major-positive-ptla-buy-41-19/
He lays out his model for a 2023 PPS well above today's. Long term and interesting to see what could be the NPV based on that 5 years outlook.
Cheers!
Thanks DD :)
Finally the news is out and positive. It's been a long haul, but hopefully worth it for patients and investors.
For now, I have paper losses, but I'm holding for 'a while' :)
Best of luck in your investments!
PTLA—FDA approves Andexxa—an antidote to bleeding caused by FXa inhibitors Eliquis and Xarelto:
https://globenewswire.com/news-release/2018/05/04/1496534/0/en/U-S-FDA-Approves-Portola-Pharmaceuticals-Andexxa-First-and-Only-Antidote-for-the-Reversal-of-Factor-Xa-Inhibitors.html
Within one week of PDUFA on Andexanet Alpha
BMY-JNJ collaboration could be bad for PTLA, if FXIa inhibition usurps FXa inhibition as the preferred MoA for anticoagulation:
#msg-140083631
Within one month now PDUFA on Andexanet Alpha
2018-05-04
PTLA Andexanet alfa $32.2
CRL August 17 2016. New PDUFA date initially set for February 2, 2018, extended by three months to May 4, 2018.
https://www.biopharmcatalyst.com/calendars/pdufa-calendar
Yes, it was baked in because it was preannounced (#msg-138700317).
It looks like that was baked in the PPS. No real reaction (so far).
Hopefully May 4th goes well. Not that far away!
CHMP rejects Betrixaban (as expected):
https://t.co/GUWZw6WRBd
Why PTLA is selling off a little more today: #msg-139225713.
Prediction from 5 years ago appears to be on-target: #msg-91053501.
CHMP likely to reject Betrixaban MAA: #msg-138699767.
PTLA -4%/AH—PDUFA date for Bevyxxa CMC issue delayed until 1/30/18:
#msg-136372321
PTLA sells 7.30M* shares @$55.00—a 1% discount to Monday’s close:
https://finance.yahoo.com/news/portola-announces-pricing-public-offering-023917543.html
*Assuming exercise of underwriter’s option.
PTLA CC—Bevyxxa launch delayed until Nov 2017—and possibly 1Q18. The issue is a disagreement with the FDA on the relevance of a second polymorph in the product.
PTLA holding CC to discuss Bevyxxa “launch plans” (which sounds somewhat bearish):
https://finance.yahoo.com/news/portola-pharmaceuticals-host-webcast-conference-223446670.html
Bevyxxa was approved by the FDA on 6/23/17 (#msg-132441130).
AndexXa BLA resubmission has PDUFA date of 2/2/18:
https://finance.yahoo.com/news/portola-pharmaceuticals-announces-andexxa-andexanet-120000017.html
Maybe they think the stock is a tad overvalued. This was probably the insiders' first opportunity to sell (legally) in quite a while.
Do have any ideas why the heavy insiders selling? Now Bevyxxa
is approved, do you have a estimate of peak sales number?
Thanks!
Four insiders sold cumulative $25M of stock since FDA approval of Bevyxxa:
#msg-132665429
PTLA had $318.8M cash at 12/31/16—expects $290-310M cash operating expenses in 2017:
http://finance.yahoo.com/news/portola-pharmaceuticals-reports-fourth-quarter-210500829.html
Little more room I think for higher prices - 100MA @ 33.45, Weekly RSI @ 67. Pay me a bit more!
Ah ok thanks, so I'm gonna read the previous messages
Each case has to be considered on its own merits. I'm not sufficiently familiar with the NBIX application to add any insight about that situation, but I've previously posted my reasons for being bearish about Betrixaban.
Hi,
This is a comment of an institutional broker for another company :
"We believe cancellation of the FDA Ad Com for Ingrezza in TD was a favorable event for NBIX. The FDA's comment that it was "no longer needed" bolsters our confidence in the Ingrezza TD NDA and, in our view, outweighs the Ph2 T-Forward study of Ingrezza in adults with Tourette Syndrome (TS) which failed to meet its primary endpoint"
Why should the same decision be bearish for Portola?
As I honestly haven't understood if it's a good or bad news I would like to hear also the "other side of the moon"
Thanks in advance
I consider the lack of an advisory panel to be more bearish than bullish (#msg-128550894).
Portola Pharmaceuticals Inc (NASDAQ:PTLA) Just Scored Twice In Quick Succession https://marketexclusive.com/portola-pharmaceuticals-inc-nasdaqptla-just-scored-twice-quick-succession/71490/?icd1
DD, valid point and agreed. But, why do you think they would accept the NDA after multiple meetings, and, on a priority review basis? And, keep in mind the other qualification points such as the central lab testing of the D-dimer, and, the overall population p value. Yes, the .054 was for the primary cohort, but, the central lab test data will be served up as supporting data. Lastly, this study was massive. Expecting two of these studies would use up excessive resources of time and money, and, I do not think two studies was the plan for the competitors who tried and failed to succeed in this space prior, rivaroxaban and apixaban.
For approval based on a single phase-3 trial, the FDA generally likes to see a p-value ≤ 0.01. 0.054 is pretty far from that.
DD, you are basing the FDA rejection on the .054 p value for cohort #1, which was requested by the FDA in an attempt to identify the high risk patient category, where the company has centralized lab data to qualify it and knowing the larger cohort data is fine, and, understanding the PK/PD advantages of Betrixiban on top of the fact that the FDA has confirmed this drug still has fast track designation and accepted the NDA under a priority review status? It seems to me there is a lot to lean on to expect approval, though I understand your point.
Actually, the opposite. I expect the FDA not to approve Betrixaban (#msg-127400575). Regards, Dew
I presume you are thinking Betrixiban PDUFA in June results in an approval in 2017. You must be suspect of the timing of the CRL resolution and resubmission. We should hear on Jan 10 but I am thinking the resubmission occurs by June and that it will be a Class 1 resubmission which will only take FDA 2 mos to review and decide, presumably approval. Jan 10 should be interesting.
One approval this year is more likely than two, IMO.
I got in at $22.87. Looking good today.
There is good reason to believe PTLA will have a dual product approval in 2017. They are a typical bio startup with limited resources. But, they have an experienced leadership team with two top products that have advanced FDA designations and are in a post successful phase 3 stage with both.
Position exit: 23.97
PTLA
Position entry: 23.80
Size 200
Weekend hold
Have a great Christmas everyone!
PTLA
Betrixaban: An NDA based on a single phase-3 trial that missed its primary endpoint doesn't seem like a good bet for approval.
Followers
|
22
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
196
|
Created
|
05/22/13
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |