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By Ron Leuty
Staff Reporter, San Francisco Business Times
Jan 31, 2020, 3:04pm PST
Updated Jan 31, 2020, 3:15pm PST
Aimmune Therapeutics Inc. ended a nearly nine-year quest Friday by winning Food and Drug Administration for a first-of-its-kind peanut allergy treatment that protects people from potentially lethal accidental exposures.
The oral immunotherapy, a capsule of powderized peanut protein called Palforzia, is approved for kids ages 4-17 — a group whose parents kickstarted the Brisbane company's founding in 2011 after a venting meeting with clinicians, advocacy groups, regulators and drug developers.
"They were frustrated that there had been strides in other areas but not one in food allergy," Aimmune President and CEO Dr. Jayson Dallas told the Business Times earlier this month. "There was no clear and obvious regulatory pathway."
Aimmune (NASDAQ: AIMT) changed all of that, devising a way to create a biologic drug from food proteins, finding a method to consistently manufacture it and working with the FDA along a review process that took more than a year. Dosing of the drug is gradually increased over months to help the immune system acclimate to peanuts.
Palforzia will carry a wholesale acquisition cost of $890 per month, but Aimmune said it plans to offer patient co-pays that could reduce out-of-pocket costs to as low as $20 per month. The company also plans a patient assistance program that would provide the drug at no cost for eligible patients who do not have insurance coverage.
Aimmune's stock, which closed down 93 cents Friday to $31.05 per share, was up nearly 20% in after-hours trading to $37.03.
"This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families," Dallas said in a statement.
Palforzia's approval doesn't mean those with peanut allergy can down dozens of peanuts — it should be used in conjunction with a peanut-avoidance diet, the company said — but in clinical trials some patients were able to tolerate exposure to the nuts.
Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone. It has long been treated by allergy doctors by building up exposure to the allergen that perturbs the immune system and forces a reaction.
But there has not been a single drug available to patients on a widespread basis, and accidental exposures — from food cooked with peanut oil at a restaurant, for example — is a constant worry for patients and parents. Those exposures can be treated with an epinephrine pen, but coming in contact with peanuts can send those with the allergy into anaphylactic shock, which can be deadly.
Palforzia does come with caveats, namely side effects in the gut and potential complications for asthma patients. The drug also can cause anaphylaxis, the company said, and is available only through a restricted program
This looks like the news you guys have been looking for. Congratulations. I got a proverbial boatload of this in after hours trading after the PR today. This may have as much potential as my other stock. Well not really ;)
Who would the most likely buy out offers come from?
This is going to be big.
———————————-
FDA Approves Aimmune’s PALFORZIA™ as First Treatment for Peanut Allergy
Source: Business Wire
More than 1.6 Million Children and Teens in the U.S. are Allergic to Peanutsi,ii
Company to Host Conference Call Today at 5:30 p.m. ET
Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that the U.S. Food and Drug Administration (FDA) approved PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. PALFORZIA is the first approved treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged 4 through 17 years. Up-dosing and maintenance may be continued in patients 4 years of age and older. PALFORZIA is to be used in conjunction with a peanut-avoidant diet. PALFORZIA is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200131005593/en/
Well said Clucky. Let it ride…
Very thoughtful post dad. I believe you gave her the correct answer to her question.
I’m crouching behind home plate with my catchers mitt ready to stop any knuckleballs! The sellers are striking out today! When Kblb goes to bat we will load the bases and hit a grand slam. Very confident of ultimate success! If you can get some cheap chairs now, go for it!
The Long Kongs are strong!
Here is a blast from the past from MU_Redskin dated December 26, 2011:
By combining science with design and insights, Milliken tackles the issues and concerns of today. Every day, our community of innovators is invigorated by the challenge of finding creative ways to enhance people's lives and make the world around us easier, safer, more sustainable and more beautiful.
Milliken has long led the way for "knowledge-based" investment, employing over 100 PhDs and has accumulated over 2,200 U.S. patents - and more than 5,000 patents worldwide - since our founding in 1865.
With 39 manufacturing facilities located in the U.S., U.K., Belgium, France and China, and with other sales and service operations throughout the Americas, Europe and Asia, Milliken's nearly 7,000 associates work to create entirely new customer experiences, build for the future and create products that do good for the world.
http://www.milliken.com/en-us/Pages/default.aspx
There are a slew of possible great partners out there for KBLB !!!
Red
Replies:
Roger Millikan was a visionary. I almost went
King Bolaba on 12/26/2011 2:49:30 PM
Doesn't any one find it a bit distressing
jimmybuffett2 on 12/26/2011 4:39:03 PM
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Right you are. And this is the year! Banana nailed it!
Beautiful! Thanks for that.
Attention KBLB shoppers! Bluelight special!
Only one hour left in 2020 to pick up shares at the current bargain basement price. Let the buying begin
So true midnight. But that does not stop them from trying ha ha.
I must call bunkum and balderdash on your incorrect use of the word “puffery” to describe the substantially informative PR‘s the company has released over the last year my good man. Go KBLB!!!
Twas the night before Christmas, when all through the house
Not a creature was stirring, not even a mouse
The stockings were hung by the chimney with care
In hopes that St Nicholas soon would be there
The investors were nestled all snug in their beds
While visions of transgenic silkworms danced in their heads
Maybe he is right Z. We will be announcing many more than “one” customer! Ha ha
Thanks for the post mike.
“with volume gradually increasing as the input quantity of cocoons rises”
At what percentage rate would you guess the volume could be increasing?
Brilliant post beacham!!!!!
A must read!
There are many shareholders of the buy and hold variety who know that math is not on your side of the argument. Meanwhile, all along our prolific caterpillar numbers increase spinning more and more transgenic silk like the world has never seen before.
The old guard long term buy and hold guys are doing just fine and have a lot to look forward to.
Wise words!
“so this is a factor I'm guessing Prodigy already has factored in”
Good point. You can expect more of those.
Thanks for the “nutshell” presentation. What you call blah blah blah is really a next level progress progress. Thanks. Keep them coming.
Very thoughtful post w2r. Thanks
Good point
“my heart goes out to those who've invested early and held though all this manipulation, waiting for their chance to retire”
MM, you could not be more wrong. I am one of those who have been holding the stock for over 10 years and buying at every opportunity on major price dips. Because it has been a decade that I have been accumulating shares I have amassed more of the stock than I ever thought I would initially. I am up by many multiples on my cost and the future is so bright I got to wear shades. So don’t feel sorry for me my friend. All good!!!
Great post! Especially the last line.
Kblb is doing its part to help the environment and climate change and all of us who are invested here should be proud of that. However, Ray I’m going to have to agree with peach on this one. When it comes to arguments on climate change there are few fundamental arguments among qualified scientists. The arguments are political. I’ll put my faith in scientists over politicians and profiteers of carbon-based fuels every time. The rainforest is an obvious point of contention in the political argument. Climate change a global problem and is evident everywhere. Each year it gets worse at an ever increasing speed. You can take examples from all over the world. From the Amazon to Greenland to the Arctic. I live in the coastal southeast and have spent my life observing nature. In this part of the world we are seeing many species that historically have not called this area home. 20 years ago we would get excited when seeing the large black and white Florida storks. Now they are common. Also in the last five years we are beginning to see many more birds called pink spoonbills. More recently we are being overrun with armadillos. There are many other species migrating steadily north. Startling evidence of global warming and climate change. It’s happening fast. In the coastal city I live in each year we are experiencing higher mean high tides than the year before. This is causing lots of flooding on downtown streets that normally do not flood with salt water. I could go on and on but you get my point I hope. I have a friend who is a senior engineer for the Ports Authority and makes long-term decisions on building massive projects and spending lots of money building ports to unload container ships. When they make the plans they don’t think about the political arguments. Their designs take into account predicted sea level change caused by global warming. It’s all about the science. This type of attitude has brought me to KBLB who is also all about the science. Kraig Biocraft is aware of this problem and I am sure. Our production facilities will be distributed among many silk producing countries so flooding in Vietnam will not be a long-term problem for us. Production will be diversified to account for climate change.
https://www.washingtonpost.com/news/energy-environment/wp/2017/04/03/you-cant-deny-climate-change-once-you-see-these-images/
Great post peach.
As I mentioned previously Kraig Biocraft is a very green company and will have positive impacts on the environment on many fronts. Go Kblb
Hyperbole.
Excellent post Truth!!
Well said indeed.
I find it amusing at this stage of the companies development that the horse dusters still attempt to use the word “scam” at every opportunity.
My personal opinion is that even those investors who bought in at the all-time high share price will have fantastic returns if they exercise patience as we watch the business plan being executed.
If you find yourself telling your relatives today about the endless possibilities of recombinant spider silk applications and that you happen to be invested in transgenic silkworms and they start rolling their eyes. Throw this little bit of information in there just for good measure. Ha ha ha. Happy Thanksgiving everyone. https://phys.org/news/2019-11-untangling-secrets-worm-spider-silks.html
Wow!
Thoughtful clear logical accurate meaningful post beacham. You da man! Thanx!!!
Just relax hopester and buy when others panic. Long term is what it’s all about. A simple formula for substantive wealth as KBLB emerges as a successful company. It’s worked very well for me so far. There’s no guarantees of course but the biggest risk are in the rearview mirror at this point.
Smart money guys!! You will be making great returns on those cheap shares you guys got today. Congratulations.
The big picture is coming together and all the Longs should have a fabulous 2020! KONG ON!!!!!!!!
Go KBLB
That’s true hope.
The cool stuff is what has kept the longs here for over 10 years.
Thank you. A high compliment indeed.
People who will become millionaires by way of their patients and continuous buying at oportun dips in the price and holding long term for the ultimate success of KBLB. That’s who!
Well let’s see hope.
Of the well-thought-out list of options you have presented for me to choose from I would have to take the very last one:
“And so on and so on”
;)
Maybe household name is a close second.
Another option might be that we are licensing our new Technology to someone like Genentech to produce something amazing completely apart from silks through a newly structured subsidiary.
Expect the unexpected.
“These new technologies have the potential to significantly reduce future R&D costs and break open new markets for recombinant protein products, reaching far beyond silks and apparel.”
Enterprising!
The big picture is mind blowing!
There could ultimately be many Business Divisions within our corporate umbrella. It boggles the mind!
Damn right Red! Get them while they are cheap!
We have come a long way Libbe and it does seem like we are at the end of the beginning. We are crossing one finish line and starting another. This excerpt from today’s PR says a lot about the ultimate success of the company.
“The Company plans to continue to expand its throughput, over the next several quarters, as it builds up its capacity, expand operations, and prepares to ship materials to its collaborators and potential customers.”
Daytraders and flippers and the usual horse dusters may not be excited about the evidence of steady positive long-term success but in my view this is another fantastic PR of continuing momentum for all of us who have believed in the company for years and I am very excited to see this true substance moving forward.
Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.
Winston Churchill
So true banana!