Portola Phramaceuticals (PTLA)

[H2R]

"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!

[H2R]

PAS Date: December 31, 2018.

The Target is Set!!!

http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2366974

U.S. FDA Assigns PDUFA Date to Portola Pharmaceuticals’ Prior Approval Supplement for the Large-Scale Generation 2 Andexxa Process

Action Date Set for December 31, 2018

SOUTH SAN FRANCISCO, Calif., Sept. 11, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Company’s Prior Approval Supplement (PAS) filing for the large-scale Generation 2 manufacturing process for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo]. The PAS has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 31, 2018. If accepted and approved, the PAS will allow for the broad commercial launch of Andexxa in the United States.

Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was approved on May 3, 2018 under the FDA's Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

[H2R]

Why the PAS matters:

From SoS's July 12th article:

I have a price target of $110 to $136 in 2023 based on the prospects for Andexxa alone. There is additional and meaningful upside on top of this from Bevyexxa and cerdulatinib but it is harder to quantify. I believe that the critical catalyst in 2018 for a major upward price movement is FDA approval of the Gen 2 manufacturing process for AndexXa which could occur in early 2019. The current, inefficient Gen 1 manufacturing process is unable to meet substantial demand. A second catalyst could be the approval of Andexxa in Europe in late 2018 or early 2019.

It's a long article, well argumented, but that's the investment gist of it.

Cheers!

[H2R]

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 
 --	--	--	- 
 

A little Bird told me ...

J. Bird is on the Board of Directors at PTLA:
https://www.portola.com/about-us/board-of-directors/#JEFFREY%20BIRD

[H2R]

Submits PAS for broad Andexxa commercial launch

http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2365666

SOUTH SAN FRANCISCO, Calif., Aug. 31, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced the submission of a prior approval supplement (PAS) to the U.S. Food and Drug Administration (FDA) for the large-scale Generation 2 manufacturing process for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo]. If approved, the PAS will allow for broad commercial launch of Andexxa in the United States.

Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was approved on May 3, 2018 under the FDA's Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

“We are pleased that patients are already benefitting from access to our limited supply Generation 1 product via an Early Supply Program,” said John Curnutte, M.D., Ph.D., interim co-president of Portola and head of research and development. “With the recent completion of three successful Generation 2 manufacturing campaigns, we have enough supply to stock more than 1,000 hospitals, and we look forward to working with regulatory authorities to achieve our goal of expanding patient access to this potentially life-saving medicine.”

Based on FDA timelines, the Company expects a final decision on the PAS in Q1 2019. In Europe, andexanet alfa received a positive trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in February 2018. Pending the submission of additional data requested by the CHMP, a final CHMP opinion is expected in Q4 2018 with the potential for approval in Q1 2019.

[DewDiligence]

2Q18 Bevyxxa sales=$33K (not a typo). The skepticism expressed in #msg-137659892 has been borne out.

[H2R]

PTLA: $100M milestone payment!

That should help the cash position of the company and support the launch of the now FDA approved Andexxa!!!

Portola Pharmaceuticals Receives $100 Million Milestone Payment from HealthCare Royalty Partners for FDA Approval of Andexxa®
Thu May 24, 2018 8:30 AM|GlobeNewswire|About: PTLA

SOUTH SAN FRANCISCO, Calif., May 24, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the company has received a $100 million milestone payment from HealthCare Royalty Partners (HCR) following the U.S. Food and Drug Administration (FDA) approval of Andexxa [coagulation Factor Xa (recombinant), inactivated-zhzo] on May 3, 2018.

In February 2017, Portola entered into a $150 million royalty agreement with HCR in exchange for a tiered, mid-single-digit royalty based on worldwide sales of Andexxa. Portola received $50 million at closing, with an additional $100 million payment contingent upon the FDA approval of Andexxa. The agreement is subject to a maximum total royalty payment of 195 percent of the $150 million funded by HCR, at which time the royalty obligation will expire.

“Our partnership with HCR provides us with non-dilutive capital to fund the further development and commercialization of Andexxa,” said Bill Lis, chief executive officer of Portola. “We appreciate HCR’s support during this pivotal time in the Company’s evolution and their recognition of the life-saving potential of Andexxa as a reversal agent for Factor Xa inhibitor-related bleeding.”

“We are pleased to support the Company’s ongoing efforts to bring novel medicines like Andexxa to physicians and patients,” said Clarke Futch, managing partner and chairman of HCR’s Investment Committee.

https://seekingalpha.com/pr/17173443-portola-pharmaceuticals-receives-100-million-milestone-payment-healthcare-royalty-partners

[H2R]

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!

[H2R]

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!

[DewDiligence]

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

The post-marketing requirement is a clinical trial that randomizes patients to receive either Andexxa or usual care (the type of care the enrolling institution would provide in the absence of Andexxa). This study is scheduled to be initiated in 2019 and be reported in 2023.

For obvious reasons, it will be hard to enroll such a trial if there are trial sites in countries where Andexxa is approved. This post-marketing requirement strikes me as the FDA’s attempt to save face; it’s highly unlikely, IMO, that this trial will ever be completed.

Although not in the FDA label, Andexxa is also an antidote for PTLA’s own Bevyxxa, which is approved in the US but not the EU.

Today was the PDUFA date. PTLA CC at 8:30am ET.

[H2R]

Within one week of PDUFA on Andexanet Alpha

2018-05-04
PTLA Andexanet alfa $34.19
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

[DewDiligence]

BMY-JNJ collaboration could be bad for PTLA, if FXIa inhibition usurps FXa inhibition as the preferred MoA for anticoagulation:

#msg-140083631

[H2R]

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

[DewDiligence]

Yes, it was baked in because it was preannounced (#msg-138700317).

[H2R]

It looks like that was baked in the PPS. No real reaction (so far).
Hopefully May 4th goes well. Not that far away!

[DewDiligence]

CHMP rejects Betrixaban (as expected):

https://t.co/GUWZw6WRBd

[DewDiligence]

Today's PR from ACC:

https://globenewswire.com/news-release/2018/03/12/1420761/0/en/Portola-Pharmaceuticals-Announces-New-Interim-Results-from-Ongoing-ANNEXA-4-Study-of-Factor-Xa-Inhibitor-Reversal-Agent-AndexXa-Andexanet-Alfa-in-Patients-with-Life-Threatening-Ble.html

[DewDiligence]

Why PTLA is selling off a little more today: #msg-139225713.

[Zeroze2002]

Buy

[DewDiligence]

Prediction from 5 years ago appears to be on-target: #msg-91053501.

[DewDiligence]

CHMP likely to reject Betrixaban MAA: #msg-138699767.

[DewDiligence]

PTLA -4%/AH—PDUFA date for Bevyxxa CMC issue delayed until 1/30/18:

#msg-136372321

[DewDiligence]

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.

[DewDiligence]

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.

[DewDiligence]

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).

[DewDiligence]

AndexXa BLA resubmission has PDUFA date of 2/2/18:

https://finance.yahoo.com/news/portola-pharmaceuticals-announces-andexxa-andexanet-120000017.html

[stocktrademan]

PTLA buy 62.18

inverted head and shoulders continuation
resistance breakout
bull flag breakout









normal chart




log chart

[DewDiligence]

Maybe they think the stock is a tad overvalued. This was probably the insiders' first opportunity to sell (legally) in quite a while.

[GD]

Do have any ideas why the heavy insiders selling? Now Bevyxxa
is approved, do you have a estimate of peak sales number?

Thanks!

[DewDiligence]

Four insiders sold cumulative $25M of stock since FDA approval of Bevyxxa:

#msg-132665429

[StephanR90]

Super active today!

[DewDiligence]

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

[jones99]

Little more room I think for higher prices - 100MA @ 33.45, Weekly RSI @ 67. Pay me a bit more!

[Radar_Mi]

Ah ok thanks, so I'm gonna read the previous messages

[DewDiligence]

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.

[Radar_Mi]

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

[DewDiligence]

I consider the lack of an advisory panel to be more bearish than bullish (#msg-128550894).

[trendmkr]

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

[doingmybest]

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.

[DewDiligence]

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.

[doingmybest]

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.

[DewDiligence]

Actually, the opposite. I expect the FDA not to approve Betrixaban (#msg-127400575). Regards, Dew

[doingmybest]

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.

[DewDiligence]

One approval this year is more likely than two, IMO.

[TClap]

I got in at $22.87. Looking good today.

[doingmybest]

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.

[QUANTUM314]

Position exit: 23.97
PTLA

[MiamiGent]

PTLA put on a starter short @ P-M session high

[QUANTUM314]

Position entry: 23.80
Size 200
Weekend hold
Have a great Christmas everyone!

PTLA

[DewDiligence]

Betrixaban: An NDA based on a single phase-3 trial that missed its primary endpoint doesn't seem like a good bet for approval.