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Motley said this morning we have a lot of time left before the stock answers the bell so why buy cheap when you can stay on the sideline and wait for approval and a higher price.
Makes sense for the conservative investor. But we are not based on what we expect and know.
IMO/Base on experience.
This may have been posted already
Bristol-Myers Squibb ($BMY) has struck a $1.74 billion deal--fronted with a $350 million cash buy-in--to grab worldwide rights to an early-stage anti-immunosuppression drug from Five Prime that can be combined with its pioneering checkpoint inhibitor Opdivo.
In the deal Bristol-Myers is snagging San Francisco-based Five Prime's colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008, a drug that blocks a key mediator--tumor-associated macrophages--that blunts an immune response to cancer cells. That makes it an ideal combination therapy with Bristol-Myers' Opdivo, which dismantles a mechanism that prevents a T cell attack on cancer.
Five Prime's shares ($FPRX) rocketed up 78% in premarket trading this morning.
The deal marks yet another major collaboration in the immuno-oncology field, which has inspired dozens of partnerships and acquisitions over the past two years. And the pact provides fresh evidence that the leaders in the field are willing to gamble big sums in order to keep driving new advances in the clinic.
In this case Bristol-Myers has agreed to pay up to $1.05 billion in development and regulatory milestones to Five Prime, along with up to $340 million in development and regulatory milestone payments per anti-CSF1R product for non-oncology indications, as well as double digit royalties.
In the pact, which expands a combination deal set up in late 2014, Five Prime will continue to handle the ongoing Phase Ia/Ib trial underway, which matches Opdivo and FPA008. Five Prime--a 2004 Fierce 15 company--also retains co-promotion rights in the U.S.
Yes possible either event.
SK: "2 interim data analyses which we expect we'll probably have both of those by the time we're having the same meeting next year, and then looking forward to final unblinding by the end of 2016 assuming it's not triggered by one of those earlier events."
I also received very good feedback thanks for your post. Have a good flight
Well stated Jeff, I would agree investor relations has been very shallow but moving the science forward-which is very tangible brings some solace. I have picked my winners carefully over the years and this will no doubt be another one.
BTW I received some excellent feed back from some folks at the ASM.
Cheers
Jeff,
SUNRISE APPROVAL IMINENT as in down the pike
IMO/BASED ON MY UNDERSTANDING AND KNOWLEDGE
PLUS FEEDBACK FROM ASM
Excellent take MH
Pressed for time due to work pressure and was planning on sharing some thoughts later, but figured I can start with a quick high level read on how I interpret the news;
Peregrine-AZN new collaboration is a big deal that will go under most people's radar. Implications are quite substantial.
Phase II trial results are now used for filing and have driven approvals. Companies are delivering ORR for approval and OS for post-approval results.
To be included in a phase II for this combo there had to be very compelling reasons to skip a formal phase I.
For a company such as AZ, being a late arrival, this starts shaping up to reflect my assessment from a week or so back. There is an concerted effort to leap what would otherwise be me-too #4 or 5 and come to the game with a game changer. This is not a guarantee - but a bet they are making.
There are many multi downstream combo trials, and I/O with Chemo etc. This, I believe is the only PDx & upstream trial - going immediately into phase II, after a broad plan for multi phase I/Ib across many cancer targets. AZ is seeing something.
Don't read negative into Peregrine managing trial. For a major pharma to GIVE UP trial control is a big deal. It is what they will use to file. It shows trust in Peregrine, not the other way around. In addition, don't read 'managed by Peregrine' to mean the same as 'paid and sourced by Peregrine'. AZ will (my read here - not facts) furnish patients, locations, expertise, possible funds (in form other than direct $$), pay for expenses directly for some elements of the trial, and be there every step of the way to track progress and make decisions. This is not a back-seat partnership.
All good news, shows major commitment by a very significant player who is hungry for a spot at the podium of I/O winners, and also shows trust in a small company to (be one of those that may) help them get there.
I will leave thoughts about Nivo trial drop (that's how I interpreted it) to later.
Both very good and concerning reasons come to mind - but the neutral to ok (meh) is what I currently walk away with.
Best,
MH
v
Understand my sons youthful exuberance he made a couple grand this morning. Day trading PPHM. Me and you are holding piles of shares for the bigger picture. I will say he is as smart as a whip though.
Expect he will make millions and catch up to POP.
Yes but we can keep them guessing. LOL
Ease up my son just spreading his wings. We were all there once.
cheers
Thanks CJ. EOM
yes, let's not forget that. what, back in 1983 or 86 LOL Too much.
when Bavi wins the debate it is over.
They do, over 500,00 electronic entries last I heard.
well you could join in the on debate over the word imminent which seems to be in fashion at the moment.
I'll have some folks at the ASM. Hopefully some good info comes out of it.
Let's analyze this together.
Along4theRide Tuesday, 10/13/15 03:10:01 PM
Re: itsabouttime post# 238649
Post # of 238676
Imminent is immediate future. That means the time line put forth by Mr. King is a lie.
Hey, I hope you're right.. maybe I'll be retiring early like most here say.
Does not take much to take things out of context. Sigh.
How about one of these: expected, anticipated, brewing
IMMINENT has a broader meaning then-imminent is immediate future
Besides impending, close (at hand), near, (fast) approaching, coming, forthcoming, on the way, in the offing, in the pipeline, on the horizon, in the air, just around the corner, coming down the pike, expected, anticipated, brewing, looming.
And for the SHORT Crowd threatening, menacing.
Along,
Fear, uncertainty and doubt.
Talk about FUD... unreal claims on this board.
No, I am expressing confidence, assurance and clarity as I see it.
SUNRISE APPROVAL IMINENT
IMO/BASED ON MY KNOWLEDGE AN EXPEREINCE
SUNRISE APPROVAL IMMINENT.
IMO/BASED MY KNOWLEDGE AND EXPERIENCE
HMMMM I wander what the stock price will be win SUNRISE is approved?
That will be much more relevant to me unquestionably.
IMO/BASED ON MY KNOWLEDGE AND EXPERIENCE
Absolutely possible to make Billions in several indications. Patents can and do get extended upon FDA approval to.
Hundreds of billions first things first?
Bavi has 10-20 years of future Phase III's that will end up making hundreds of BILLIONS of dollars of profit for some BP.
FDA APPROVAL IMINENT.
IMO/BASED ON MY KNOWLEDGE AND EXPERIENCE AND THE CAC PRINCIPLE
Loofman knows...
LICKER =
Long investors confidence kindles enormous returns!
Jmo
Loofman
good one.EOM
Confidence Assurance and Clarity CAC verses fud-notice the lower case for diminutive thinking
FDA approval assured.
IMO/BASED ON MY KNOWLEDGE AND EXPERIENCE
Paul,
How correct you are. I am replacing fud (fear, uncertainty and doubt) with Confidence Assurance and Clarity CAC
Right on, Couch. The doubters will always point out something to discourage those who have not done their due diligence.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
IMO/Base on my knowledge and experience you make millions with Confidence Assurance and Clarity
Approval definite regardless on how you feel personally.
if a legit partnership deal was close, they wouldn't need 175 million new shares, unless it was part of a deal, which pphm said it is not.
if a good result in P3 was going to make somebody partner up, they wouldn't need 175 million new shares.
i suspect the Opdivo success has thrown us back a few years...until pphm can, hopefully, show Opdivo works better with bavi.
have we lost too much time? will we ever get ahead of the curve?
with all the supposed good news, i'm not particularly confident we'll ever get to the current price targets (set by analysts who rank at the bottom of the league standings year after year)
IMO/Based on my understanding and experience
Quite the contrary. Because of approval money needed.
More like a safety net should the Sun fail to rise
This will happen. Approval imminent.
I doubt it, sunrise will beat the PHII a hands down, so count on well over 100% and the new SOC....
150% increase in survival likely....
IMO/Based on my experience and understanding
Resilience pays off. EOM
Since AZ is not in the first Pole Position per SK commentary at the QC it kindles more competition for our I/O space.
CP The 33% event 1st look will be much later based on that design.
In other words, I expect miracles from Bavi+Doce on ECOG 0 and 1 patients. Dr. Garnick tackled Bavituximab's latency by giving it more time by designing healthier ECOG 0,1 vs 2,3 patients into the trial
Couch
I stumbled upon a nest of feisty yellow jackets when I perched my foot on a log near the shoreline of a pond while fishing. I was focused on placing a cast and dropping my lure where a large bass had just scooped up a frog. I received countless stings all over
my lower torso and the bastards chased me through the woods for a few extra stings. I cannot say it cured anything I may of had at the time but I sure felt better a few hours later.
Sorry feeble attempt at some humor here.
I hear several stings from a bee can disrupt and even cure Lyme disease amongst a few other dis-eases. Why not wasp venom and cancer?
Thanks for links EOM
The science is solid and approval for Sunrise imminent. Many license labels will be approved for many indications over the ensuing months ahead after approval.
IMO/Based on my own research, understanding and knowledge.
eb0783 Thanks for revisiting some of late Dr. Thorps statements.
His life's work is moving forward to the benefit of so many in need.
Excellent points in your evaluation statement made. EOM
Read this recent post by Sunstar. This will help.
Bavituximab’s role in onco-immunotherapy is as a universal initiator of immune awakening. Evolution has designed immune systems to destroy and dispose of foreign “non-self” entities that may become present within the body. Evolution has also developed systems that can moderate immune activity to prevent it from over-reacting to routine events like apoptosis “natural cell death”. In this case the immune system performs slow and steady removal of the dead and dying cells without any alarm signals.
When cells are rapidly dying because of their association with cancer, the same routine cell clean-up takes place, but in this case for patient survival, it becomes important that more than just routine immune clean-up should occur.
On any dying cell, whether it’s natural or it’s because of cancer, the lipid ,PS, becomes widely exposed on the cell surfaces. This is a problem because exposed PS suppresses the immune system from acting vigorously, because the cancer appears to the immune system as, “the self”.
Peregrine’s Bavituximab is a mAb that has these PS lipids as its target. So, when anti-PS Bavituximab is infused in cancer patients it migrates through the bloodstream and finds a proliferation of exposed PS on and around the cancer. Bavi attaches to the PS which masks PS and allows the immune system “see” and mount an immune response to the cancer.
Through Peregrine’s pre-clinical work, it was found that anti-PS mAbs could be combined with anti-CTLA-4, PD-1 or PD-L-1 and increase their limited response rates to cancers by 200-300%.
We will be looking for data from the first clinical, I-O combination phase 1 study in about March 2016, the study completion date. This trial is combining Bavi with, already approved, (BMS) Yervoy in advanced melanoma. The pre-clinical data suggests that Bavi will be able to possibly double or triple Yervoy’s previous clinical response rates. Bavi also has a lengthening record of low side effects, and may lend some of that safer environment to Yervoy, when in combination.
Think what doubling or tripling Yervoy’s response rates would mean to Peregrine’s business dynamics.
Response rates occur up-front in trials. Survival times for patients, especially with immunotherapies are spelled out in “long tails” on Kaplan-Meier plots. It is on these extended long tails that companies developing immunotherapies have seen evidence of adaptive immunities to cancer.
In this melanoma trial with two immunotherapies combined, the immunotherapy community should see the rate of increase in response rates and then enhanced survival time data and some adaptive immunities for those increased responders.
Here is the Bavi plus Yervoy advanced melanoma trial link:
https://clinicaltrials.gov/ct2/show/NCT01984255?term=bavituximab&rank=16
As SUNRISE winds up, Peregrine is planning to start two more immunotherapy combination trials, one combining Bavi with (BMS) Opdivo, anti-PD-1, in NSCLC, and one with (AZN) durvalumab, anti-PD-L-1 in multiple cancers.
In each of the trials the I-O community will be watching for these increased response rates, longer term survivals, and the safety benefits that are on record for Bavituximab.
Quote:
“Much more important is that the Bavituximab-Opdivo and the AstraZeneca trials are not blinded and will generate data as of enrolment of patients.”
IMO
sunstar
ENDO that is correct. I owned shares then. Crazy rally up.